Comparison of Subject and Predicate Device

Characteristic
Hepatica v1 (Subject device)
LMSv4 (Predicate device)

Where available, whole liver segmental cT1
and PDFF values are provided. For each
metric, the median, IQR and a ‘reference
range’ are provided.

Based on the placed ROIs, for each metric
the median and IQR are given as well as a
‘reference range’.

Installation of Hepatica v1 is controlled and is
installed on general purpose workstations
that meet the minimum technical
requirements at Perspectum’s image analysis
centre by specialist members of staff.

Installation of LMSv4 is controlled and is

Device performance was assessed with
previously acquired in-vivo data from healthy
and non-healthy volunteers.

Device performance was assessed with
purpose-built phantoms and in-vivo acquired
data from volunteers covering a range of
physiological values for cT1, T2* and PDFF.

Assessed in accordance with IEC 62366 and
FDA guidance document ‘Applying Human
Factors and Usability Engineering to Medical
Devices.’

Validated across all listed supported
manufacturers and field strengths.

Materials
Not applicable, standalone software
Not applicable, standalone software

Biocompatibility
Not applicable, standalone software
Not applicable, standalone software

Sterility
Not applicable, standalone software
Not applicable, standalone software

Electrical Safety
Not applicable, standalone software
Not applicable, standalone software

Mechanical Safety
Not applicable, standalone software
Not applicable, standalone software

Chemical Safety
Not applicable, standalone software
Not applicable, standalone software

Thermal Safety
Not applicable, standalone software
Not applicable, standalone software

Radiation Safety
Not applicable, standalone software
Not applicable, standalone software


Metric
Volume (% of total liver
cT1
PDFF

Liver Segment
Upper and Lower Limits of
Upper and Lower Limits
Upper and Lower Limits


Liver Segment (% of total liver
Repeatability
Reproducibility

Upper and Lower limits of Agreement
Upper and Lower Limits of Agreement


Classification Name:
Magnetic Resonance Diagnostic Device

Regulation Number:
90-LNH (Per 21 CFR § 892.1000)

Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction
Processing Unit for MR


Vantage Galan 3T, MRT-3020, V6.0with AiCE
Reconstruction Processing Unit for MR

Marketed By
Canon Medical Systems USA, Inc.
Canon Medical Systems USA, Inc.


Subject Device
Predicate Device (K192574)

Shoulder, Hip, Elbow, Wrist/Hand, Foot/Ankle

Pelvis
Female, Pelvis (soft tissue), Prostate
New

Addition of the following anatomical regions:


Item
Subject Device:
Predicate Device:
Notes

Vantage Galan 3T, MRT-3020, V6.0
Vantage Galan 3T, MRT-3020, V6.0

with AiCE Reconstruction Processing
with AiCE Reconstruction Processing

Operational Modes
Normal and 1st Operating Mode
Normal and 1st Operating Mode
Same

Allows screen access to 1st level
operating mode

4W/kg for whole body (1st operating
mode specified in IEC 60601-2-33:
2010+A1:2013+A2:2015)


Potential emergency
condition and means
provided for
shutdown

Shutdown by Emergency Ramp Down
Unit for collision hazard for
ferromagnetic objects


Predicate Device
FDA Clearance Number
Product
Manufacturer


Reference Devices
FDA Clearance Number
Product
Manufacturer

MAGNETOM Area,
MAGNETOM Skyra,
MAGNETOM
Prisma/Prismafit with syngo
MR XA30A


[1] Mescher et al, NMR Biomed 11, 266–272 (1998)

[2] Mikkelsen et al, NeuroImage 159, 32–45 (2017)

[3] Saleh et al, NeuroImage 189, 425–431 (2019)

[4] B. Bilgic et al., “Wave-CAIPI for Highly Accelerated 3D Imaging.”
MRM 73(6):2152-2162 (2015)

[5] F. Breuer et al., Controlled aliasing in volumetric parallel imaging (2D
CAIPIRINHA).” MRM 55(3):549-56 (2006)

[6] Essner M, Zinsser D, Kündel M, et. al. Performance of an Automated
Workflow for Magnetic Resonance Imaging of the Prostate: Comparison
With a Manual Workflow. Invest Radiol. 2020 May;55(5):277-284. Doi:
10.1097.

[7] Horger W, Thoermer G, Weiland E, et. al. Prostate Dot Engine – a
system guided and assisted workflow to improve consistency in prostate
MR exams.

of the following features and functions.


[8] Yadong C, Siyuan H, Chunmei Li, et. al. Performance and
Reproducibility of a Day Optimizing Throughput (Dot) Workflow Engine in
Automated Prostate MRI Positioning. Abstract accepted for the 28th
annual meeting of the International Society of Magnetic Resonance in
Medicine (ISMRM).

[9] Kellman P. et al. Image Reconstruction in SNR Units: A General

Method for SNR Measurement. MRM 2005; 54:1439. Erratum in MRM

[10] Blu T. et al. The SURE-LET approach to image denoising. IEEE
Transactions on Image Processing 16(11):2778-86

[11] D C. Alsop, J A. Detre, et al. Recommended Implementation of
Arterial Spin Labeled Perfusion MRI for Clinical Applications: A
consensus of the ISMRM Perfusion Study Group and the European
Consortium for ASL in Dementia. Magn Reson Med. 2015 Jan; 73(1):
102–116.

[12] R B. Buxton, L R. Frank, et al. A general kinetic model for
quantitative perfusion imaging with arterial spin labeling. Magn Reson
Med. 1998 Sep; 40(3):383-96.

[13] S. Yang, B. Zhao, et al. Improving the Grading Accuracy of
Astrocytic Neoplasms Noninvasively by Combining Timing Information
with Cerebral Blood Flow: A Multi-TI Arterial Spin-Labeling MR Imaging
Study. Am. J. Neuroradiol. 2016 Dec; 37 (12) 2209-2216

[14] P G Qiao, C Han, et al. Clinical assessment of cerebral
hemodynamics in Moyamoya disease via multiple inversion time arterial
spin labeling and dynamic susceptibility contrast-magnetic resonance
imaging: A comparative study. J Neuroradiol. 2017 Jul;44(4):273-280.

[15] Y Shen, B Zhao, et al. Cerebral Hemodynamic and White Matter
Changes of Type 2 Diabetes Revealed by Multi-TI Arterial Spin Labeling
and Double Inversion Recovery Sequence. Front Neurol. 2017; 8: 717.


C1:2009/(R)2012 and
A2:2010/(R)2012 (Consolidated
Text) Medical electrical
equipment - Part 1: General
requirements for basic safety
and essential performance (IEC
60601-1:2005, MOD)

Medical electrical equipment -
Part 1-2: General requirements
for basic safety and essential
performance - Collateral
Standard: Electromagnetic
disturbances - Requirements
and tests

Medical electrical equipment -
Part 2-33: Particular
requirements for the basic
safety and essential
performance of magnetic
resonance equipment for
medical diagnosis

Medical devices - Application of
risk management to medical
devices

Medical devices - Part 1:
Application of usability
engineering to medical devices

Medical device software -
Software life cycle processes
[Including Amendment 1 (2016)]

Acoustic Noise Measurement
Procedure for Diagnosing
Magnetic Resonance Imaging
Devices

Standards Publication
Characterization of Phased
Array Coils for Diagnostic
Magnetic Resonance Images

Digital Imaging and
Communications in Medicine
(DICOM) Set 03/16/2012
Radiology

Biological evaluation of medical
devices - Part 1: Evaluation and
testing within a risk
management process


ITEM
Proposed Device
Predicate Device
Remark

 160mm Detector
 Rotation speed：
up to
0.25s/rotation
 82cm bore

 40mm Detector
 Rotation speed：up
to 0.35s/rotation
(uCT 760); up to
0.3s/rotation (uCT
780)
 70cm bore

Substantially Equivalent
The changes did not raise new
safety and effectiveness
concerns.

Low Dose CT Lung
Cancer Screening
Protocol

uAI Vision -
Yes,
Substantially Equivalent


It’s a patient
positioning assistance
function based on deep
learning technology

The changes did not raise new
safety and effectiveness
concerns.

Yes
It can recommend the
suitable kVp for the
examination.

Yes
It can optimize the
dose modulation for
the combined chest
and abdomen scan
with deep learning
based organ
recognition.

Yes
It can recommend the
optimal phase for
cardiac reconstruction
with less motion
artifact.

Yes
It can reduce the
coronary motion
artifact with deep
learning based
coronary artery
extraction.

Yes
It can automatically
recommend the scan
range with a deep
learning organ
recognition
technology


Reference device #2
Deep Recon
(K193073)

Abdomen, pelvis,
chest, cardiac and
extremities

Abdomen, pelvis,
chest, cardiac and
head

It is an image
reconstruction
method that
combines a
modal-based
iterative
reconstruction
and deep learning
technology.

It is an iterative
reconstruction
algorithm.

Dedicated deep neural
network (DNN) which
is trained on low dose
FBP images to get
normal dose (high
quality) FBP images

Substantially
Equivalent
Testing did not
raise new safety
and effectiveness
concerns.

Table 2 Deep IR Comparison to Reference devices


Table 3 Dual Energy comparison to Reference Devices


Virtual Non contrast Images
Yes
Yes
Same

Component analysis of
kidney stones, uric acid
stones or non-uric acid
stones

Component analysis of joint
gout, uric acid gout or non-
uric acid gout


Predicate Device
Aidoc Briefcase (K190896)

Subject Device
Aidoc Briefcase (K203508)

BriefCase is a radiological
computer aided triage and
notification software indicated for
use in the analysis of cervical
spine CT images. The device is
intended to assist hospital
networks and trained radiologists
in workflow triage by flagging
and communication of suspected
positive findings of linear
lucencies in the cervical spine
bone in patterns compatible with
fractures.
BriefCase uses an artificial
intelligence algorithm to analyze
images and highlight cases with
detected findings on a
standalone desktop application
in parallel to the ongoing
standard of care image
interpretation. The user is
presented with notifications for

BriefCase is a radiological
computer aided triage and
notification software indicated for
use in the analysis of cervical
spine CT images. The device is
intended to assist hospital
networks and appropriately
trained medical specialists in
workflow triage by flagging and
communication of suspected
positive findings of linear
lucencies in the cervical spine
bone in patterns compatible with
fractures.
BriefCase uses an artificial
intelligence algorithm to analyze
images and highlight cases with
detected findings on a
standalone desktop application
in parallel to the ongoing
standard of care image
interpretation. The user is


presented with notifications for
cases with suspected findings.
Notifications include compressed
preview images that are
meant for informational purposes
only and not intended for
diagnostic use
beyond notification. The device
does not alter the original
medical image and is not
intended to be used as a
diagnostic device.
The results of BriefCase are
intended to be used in
conjunction with other
patient information and based on
their professional judgment, to
assist with triage/prioritization of
medical images. Notified
clinicians are responsible for
viewing full images per the
standard of care.

Appropriately trained medical
specialists

Anatomical region of interest
Cervical spine
Cervical spine

DICOM Information about the
patient, study and current image

No; device does not mark,
annotate, or direct users’
attention to a specific location in
the original image

Artificial intelligence algorithm
with database of images

Presentation of a small,
compressed, black and white
preview image that is labeled
“Not for diagnostic use”;
The device operates in parallel
with the standard of care, which
remains the default option for all
cases.


Predicate Device
Aidoc Briefcase (K180647)

BriefCase is a radiological
computer aided triage and
notification software
indicated for use in the
analysis of non-enhanced
head CT images.
The device is intended to
assist hospital networks and
appropriately trained medical
specialist in workflow triage
by flagging and
communication of suspected
positive findings of
pathologies in head CT
images, namely Intracranial
Hemorrhage (ICH).
BriefCase uses an artificial
intelligence algorithm to

BriefCase is a radiological
computer aided triage and
notification software
indicated for use in the
analysis of non-enhanced
head CT images.
The device is intended to
assist hospital networks and
trained radiologists in
workflow triage by flagging
and communication of
suspected positive findings
of pathologies in head CT
images, namely Intracranial
Hemorrhage (ICH).
BriefCase uses an artificial
intelligence algorithm to
analyze images and highlight


analyze images and highlight
cases with detected ICH on a
standalone desktop
application in parallel to the
ongoing standard of care
image interpretation. The
user is presented
with notifications for cases
with suspected ICH findings.
Notifications
include compressed preview
images that are
meant for informational
purposes only and not
intended for diagnostic use
beyond notification. The
device does not alter the
original medical image and is
not intended to be used as a
diagnostic device.
The results of BriefCase are
intended to be used in
conjunction with other
patient information and
based on professional
judgment, to assist with
triage/prioritization of medical
images. Notified
clinicians are responsible for
viewing full images per the
standard of care.

Appropriately trained medical
specialist

Non contrast CT scan of the
head or neck

DICOM Information about
the patient, study and current
image

No; device does not mark,
highlight, or direct users’
attention to a specific
location in the original image

Artificial intelligence
algorithm with database of
images

Presentation of a preview of
the study for initial
assessment not meant for
diagnostic purposes
The device operates in
parallel with the standard of

Presentation of notification
and preview of the study for
initial assessment not meant
for diagnostic purposes
The device operates in
parallel with the standard of


Predicate Device
Aidoc Briefcase (K190072)

Subject Device
Aidoc Briefcase (K203508)

BriefCase is a radiological
computer aided triage and
notification software indicated
for use in the analysis of non-
enhanced head CT and CTPA
images. The device is intended
to assist hospital networks and
trained radiologists in workflow
triage by flagging and
communication of suspected
positive findings of Intracranial
Hemorrhage (ICH) and
Pulmonary Embolism (PE)
pathologies. For the PE
pathology, the software is only
intended to be used on single-
energy exams.
BriefCase uses an artificial
intelligence algorithm to
analyze images and highlight
cases with detected findings on

BriefCase is a radiological
computer aided triage and
notification software indicated
for use in the analysis of non-
enhanced head CT and CTPA
images. The device is intended
to assist hospital networks and
appropriately trained medical
specialists in workflow triage
by flagging and communication
of suspected positive findings of
Intracranial Hemorrhage (ICH)
and Pulmonary Embolism (PE)
pathologies. For the PE
pathology, the software is only
intended to be used on single-
energy exams.
BriefCase uses an artificial
intelligence algorithm to
analyze images and highlight
cases with detected findings on


a standalone desktop
application in parallel to the
ongoing standard of care image
interpretation. The user is
presented with notifications for
cases with suspected findings.
Notifications include
compressed preview images
that are meant for informational
purposes only and not intended
for diagnostic use beyond
notification. The device does
not alter the original medical
image and is not intended to be
used as a diagnostic device.
The results of BriefCase are
intended to be used in
conjunction with other patient
information and based on their
professional judgment, to assist
with triage/prioritization of
medical images. Notified
clinicians are responsible for
viewing full images per the
standard of care.

Appropriately trained medical
specialists

Non-contrast head CT scan and
CTPA (single energy exams
only)

DICOM Information about the
patient, study and current
image

No; device does not mark,
annotate, or direct users’
attention to a specific location in
the original image

Artificial intelligence algorithm
with database of images

Presentation of a small,
compressed, black and white
preview image that is labeled
“Not for diagnostic use”;
The device operates in parallel
with the standard of care, which
remains the default option for
all cases.


Predicate Device
Aidoc Briefcase (K193298)

BriefCase is a radiological
computer aided triage and
notification software indicated for
use in the analysis of abdominal
CT images. The device is intended
to assist hospital networks and
trained radiologists in workflow
triage by flagging and
communication of suspected
positive findings of Intra-abdominal
Free Gas (IFG) pathologies.
BriefCase uses an artificial
intelligence algorithm to analyze
images and highlight cases with
detected findings on a standalone
desktop application in parallel to

BriefCase is a radiological
computer aided triage and
notification software indicated
for use in the analysis of
abdominal CT images.
The device is intended to
assist hospital networks and
appropriately trained medical
specialists in workflow triage
by flagging and communication
of suspected positive findings
of Intra-abdominal Free Gas
(IFG) pathologies.
BriefCase uses an artificial
intelligence algorithm to
analyze images and highlight


cases with detected findings on
a standalone desktop
application in parallel to the
ongoing standard of care
image interpretation. The user
is presented with notifications
for cases with suspected
findings. Notifications
include compressed preview
images that are
meant for informational
purposes only and not intended
for diagnostic use
beyond notification. The device
does not alter the original
medical image and is not
intended to be used as a
diagnostic device.
The results of BriefCase are
intended to be used in
conjunction with other
patient information and based
on their professional
judgment, to assist with
triage/prioritization of medical
images. Notified clinicians are
responsible for viewing
full images per the standard of
care.

Data acquisition protocol
Abdominal CT scan
Abdominal CT scan

DICOM Information about the
patient, study and current image

No; device does not mark,
annotate, or direct users’ attention
to a specific location in the original
image

Artificial intelligence algorithm with
database of images

Presentation of a small,
compressed, black and white
preview image that is labeled “Not
for diagnostic use”;
The device operates in parallel
with the standard of care, which
remains the default option for all
cases.


Subject Device
Aidoc Briefcase (K203508)


Predicate Device
Aidoc Briefcase (K201020)

BriefCase is a radiological
computer aided triage and
notification software indicated
for use in the analysis of
contrast-enhanced chest CTs
(but not dedicated CTPA
protocol). The device is
intended to assist hospital
networks and trained
radiologists in workflow triage
by flagging and communication
of suspected positive cases of
incidental Pulmonary Embolism
(iPE) pathologies. For the iPE

BriefCase is a radiological
computer aided triage and
notification software indicated
for use in the analysis of
contrast-enhanced chest CTs
(but not dedicated CTPA
protocol). The device is
intended to assist hospital
networks and appropriately
trained medical specialists in
workflow triage by flagging and
communication of suspected
positive cases of incidental
Pulmonary Embolism (iPE)


pathologies. For the iPE
pathology, the software is only
intended to be used on single-
energy exams. The device is
intended to work with GE and
Siemens scanners only.
BriefCase uses an artificial
intelligence algorithm to
analyze images and flag
suspect cases on a standalone
desktop application in parallel
to the ongoing standard of care
image interpretation. The user
is presented with notifications
for suspect cases. Notifications
include compressed preview
images that are
meant for informational
purposes only and not intended
for diagnostic use
beyond notification. The device
does not alter the original
medical image and is not
intended to be used as a
diagnostic device.
The results of BriefCase are
intended to be used in
conjunction with other
patient information and based
on their professional
judgment, to assist with
triage/prioritization of medical
images. Notified clinicians are
responsible for viewing
full images per the standard of
care.

Appropriately trained medical
specialists

Inclusion Criteria
- Contrast-enhanced chest
CTs (but not dedicated
CTPA protocol.
- Single energy exams.
- Scans performed with a
64 slice or greater
number of detectors.
- Scans performed on
adults/transitional adults ≥
18 years of age.

Inclusion criteria
- Contrast-enhanced chest
CTs (but not dedicated
CTPA protocol.
- Single energy exams.
- Scans performed with a 64
slice or greater number of
detectors.
- Scans performed on
adults/transitional adults ≥
18 years of age.


- Slice thickness: 0.5mm –
2.0mm axial.
Exclusion Criteria
- - All studies that are
technically inadequate,
including studies with motion
artifacts, severe metal
artifacts, or inadequate field
of view..

- Slice thickness: 0.5mm –
2.0mm axial.
Exclusion Criteria
- All studies that are
technically inadequate,
including studies with motion
artifacts, severe metal
artifacts, or inadequate field
of view.

Contrast-enhanced chest CTs
(but not dedicated CTPA
protocol)

DICOM Information about the
patient, study and current image

No; device does not mark,
annotate, or direct users’
attention to a specific location in
the original image

Artificial intelligence algorithm
with database of images

Presentation of a low-quality,
compressed, grayscale preview
image that is captioned “Not for
diagnostic use”.

No. The device operates in
parallel with the standard of
care, which remains the default
option for all cases. Unflagged
cases are not de-prioritized.

- AHS module (image
acquisition).
- ACS module (image
processing).
- Aidoc Worklist application for
workflow integration (worklist
and non-diagnostic basic
Image Viewer).


Predicate Device
Aidoc Briefcase (K192383)

Subject Device
Aidoc Briefcase (K203508)

BriefCase is a radiological
computer aided triage and
notification software indicated
for use in the analysis of head
CTA images. The device is
intended to assist hospital
networks and appropriately
trained medical specialists in
workflow triage by flagging
and communication of
suspected positive findings of
Large Vessel Occlusion (LVO)
pathologies.
BriefCase uses an artificial
intelligence algorithm to
analyze images and highlight

BriefCase is a radiological
computer aided triage and
notification soft-ware indicated
for use in the analysis of head
CTA images. The device is
intended to assist hospital
networks and trained medical
specialists in workflow triage
by flagging and
communication of suspected
positive findings of Large
Vessel Occlusion (LVO)
pathologies.
BriefCase uses an artificial
intelligence algorithm to
analyze images and highlight


cases with detected findings
on a standalone desktop
application in parallel to the
ongoing standard of care
image interpretation. The user
is presented with notifications
for cases with suspected
findings. Notifications
include compressed preview
images that are
meant for informational
purposes only and not
intended for diagnostic use
beyond notification. The
device does not alter the
original medical image and is
not intended to be used as a
diagnostic device.
The results of BriefCase are
intended to be used in
conjunction with other
patient information and based
on their professional
judgment, to assist with
triage/prioritization of medical
images. Notified clinicians are
responsible for viewing
full images per the standard of
care.

Appropriately trained medical
specialists

Inclusion criteria
• Head CTA protocol with a
64-slice scanner or higher;
• Scans performed on
adults/transitional adults ≥
18 years of age;
• Slice thickness 0.5 mm –
1.0 mm.
Exclusion Criteria
• All scans that are
technically inadequate,
including motion artifacts,
severe metal artifacts, sub-
optimal bolus timing or an
inadequate field of view.

Inclusion Criteria
• Head CTA protocol with a
64-slice scanner or higher;
• Scans performed on
adults/transitional adults ≥
18 years of age;
• Slice thickness 0.5 mm –
1.0 mm.
Exclusion Criteria
• All scans that are
technically inadequate,
including motion artifacts,
severe metal artifacts, sub-
optimal bolus timing or an
inadequate field of view.


DICOM Information about the
patient, study and current
image

No; device does not mark,
annotate, or direct users’
attention to a specific location
in the original image.

Artificial intelligence algorithm
with database of images.

Presentation of a small,
compressed, black and white
preview image that is labeled
“Not for diagnostic use”;
The device operates in
parallel with the standard of
care, which remains the
default option for all cases.

- AHS module (image
acquisition);
- ACS module (image
processing);
- Aidoc Worklist application
for workflow integration
(worklist and Image
Viewer).
Addition of minor changes in
the software platform, e.g.
notification filter, which
neither impacts the order in
which notification come in,
nor affects the safety and
efficacy profile of the device.


Manufacturer:
Philips Healthcare (Suzhou) Co., Ltd.

No. 258, ZhongYuan Road, Suzhou Industrial Park, 215024

Suzhou, Jiangsu Province, PEOPLE'S REPUBLIC OF CHINA

Establishment Registration Number: 3009529630

Classification Regulation:
21CFR §892.1750

Predicate Device:
Trade Name:
Philips Incisive CT

Classification Regulation:
21 CFR, Part 892.1750

Reference Device:
Manufacturer:
Auto Positioning


Based on the information provided above, the precise position is
considered substantially equivalent to the primary currently
marketed and predicate device Philips Incisive CT (K180015,
20/March/2018) in terms of fundamental scientific technology.
Attribute Predicate Device Proposed Device Precise
Philips Incisive CT Position
(K180015)
Patient Manually position Precise position provides
positioning the patient via the the auto workflow to set
workflow couch motion button the surview start/end
and laser. Normally, position, center of patient
need several round anatomy, and patient
adjustments by user. orientation.
Detection The manual Precise position adopt the
algorithm workflow does not AI algorithm (Convolution
need special Neural Network) to detect
algorithm. the joints of the patient
body automatically, and
then automatic detect
surview start/end position,
center of patient anatomy
and patient orientation.
Hardware Manual patient Precision position feature
need to positioning does not need color and depth
support the need any unique camera, high speed USB
patient hardware except transmission cable, and
positioning traditional exiting power cable, and relative
hardware on the CT the enhanced workflow.
or other system. The tradition exiting
Exiting hardware patient positioning
includes table hardware still be available
motion button for user all the time, it is
(in/out, up/down) on convenient to switch
gantry panel or between the camera
CTBOX, lasers and automatically detecting
etc. mode and manual mode.
Patient All ages More than 16 years old.
population
Environment Hospitals, outpatient Hospitals, outpatient
of use clinics, research clinics, research
institutions, and institutions, and other
other clinical clinical facilities.
facilities.

The Precise Position complies with the following international and
FDA-recognized consensus standards:


• AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)
2012 and A2:2010/(R) 2012
(Consolidated Text) Medical Electrical Equipment - Part 1: General
Requirements. For Basic Safety and Essential Performance (IEC
60601-1:2012, MOD).
FDA/CDRH recognition number 19-4
• IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2:
General requirements for basic safety and essential performance -–
Collateral standard: Electromagnetic disturbances - Requirements and
tests.
FDA/CDRH recognition number 19-8
• ISO 14971 Medical devices – Application of risk management to
medical devices. FDA/CDRH recognition number 5-40.
• IEC 62304:2015, Medical device software -- Software life cycle
processes
FDA/CDRH recognition number 13-79
There are no risks identified in risk management documentation that
require clinical data for the purpose of clinical evaluation; Risk
Management Plan as Appendix 001, Risk Management Report as
Appendix 002, and Risk Management Matrix as Appendix 003 of
Precise Position.
There are no clinical risks identified by the evaluated clinical data.
Sufficient evidence is available to demonstrate the ability of Precise
Position achieve the intended performances during normal condition
of use.
Full consistency exists between the state-of-the-art, the evaluated data,
the risk management documentation and the information materials
supplied.
Therefore, the Precise Position is substantially equivalent to the
primary currently marketed and predicate device (K180015,
20/March/2018) in terms of safety and effectiveness.

Precise Position is evaluation covered total 80 clinical scan positions
in which 40 cases used with Precise Position and another 40 cases
without the usage of Precise Position in order to meet the sample size
calculation of 40 cases performed average on a CT scanner per day.
The thorough clinical evaluation of this feature is done by 5 Clinical
experts.
The testing did not deliver radiation to volunteers as Precise Position
is only for supporting the positioning of the patient for the localization
radiograph and therefore “radiation” was not required for those
volunteers.


The clinical evaluation was done with 3 major objectives as follows,
To calculate the time saved per surview planning with and without
Precise Position.
To calculate the accuracy of vertical (iso)center positioning and
Surview (horizontal) start /end position with and without Precise
Position
Intra operator consistency in positioning the patient and surview scan
range
The summary of clinical evaluation testing was clearly demonstrating
the objectives in terms of user benefits as shown below
Average Time taken to position without Precise Position and with
Precise Position is recorded. Time at user select the patient from
Gantry Panel, to time when user pressed Go button from Gantry Panel
is measured and concluded that up to 23% time reduction in patient
positioning achieved with “Precise Positioning workflow”.
The average offset in mm for vertical (iso) center position among 5
operators without Precise Position and with Precise Position is
recorded and results shown that with “Precise Position” the vertical
position accuracy is increased up to 50%.
Standard deviation in mm for vertical (iso)center positioning &
Surview (horizontal) start position among 5 operators without Precise
Position and with Precise Position is recorded and results shown up to
70% increase in Vertical and horizontal position consistency with
Precise Position.
Overall, the Precise Position Clinical Review Report. (Appendix_007)
concluded that Philips Incisive CT systems with Precise Position,
under normal condition of use, perform as intended, are safe for its
intended use and have a favorable benefit-risk ratio. Further clinical
investigations are not necessary, as sufficient evidence exists to
support these conclusions.

The Precise Position is substantially equivalent to the primary
currently marketed and predicate device (K180015, 20/March/2018) in
terms of design features, fundamental scientific technology,
indications for use, and safety and effectiveness. Additionally,
substantial equivalence was demonstrated with non-clinical
performance tests, which complied with the requirements specified in
the international and FDA-recognized consensus standards, IEC 62304
and ISO 14971. The results of these tests demonstrate that Precise
Position met the acceptance criteria and is adequate for this intended
use.


Predicate device
cmTriage
CureMetrix.
K183285

21 CFR 892.2080 -
Radiological Computer-
Assisted Prioritization Software

comparison with the predicate device is provided in the following table:


Saige-Q is a software
workflow tool designed to aid
radiologists in prioritizing
exams within the standard-of-
care image worklist for full-
field digital mammography
(FFDM) and digital breast
tomosynthesis (DBT)
screening mammograms.
Saige-Q uses an artificial
intelligence algorithm to
generate a code for a given
mammogram, indicative of
the software’s suspicion that
the mammogram contains at
least one suspicious finding.
Saige-Q makes the assigned
codes available to a
PACS/EPR/RIS/workstation
for worklist prioritization or
triage.
Saige-Q is intended for
passive notification only and
does not provide any
diagnostic information
beyond triage and
prioritization. Thus, it is not
intended to replace the review
of images or be used on a
stand-alone basis for clinical
decision-making. The
decision to use Saige-Q codes
and how to use those codes is
ultimately up to the
interpreting radiologist. The
interpreting radiologist is
responsible for reviewing
each exam on a diagnostic
viewer and evaluating each
patient according to the
current standard of care.

cmTriage is a passive
prioritization-only, parallel-
workflow software tool used by
radiologists to prioritize specific
patients within the standard-of-
care image worklist for 2D
FFDM screening mammograms.
cmTriage uses an artificial
intelligence algorithm to
analyze 2D FFDM screening
mammograms and flags those
that are suggestive of the
presence of at least one
suspicious finding at the exam
level. These flags are viewed by
the radiologist via their PACS
worklist. The decision to use
cmTriage codes and how to use
cmTriage codes is ultimately up
to the radiologist. cmTriage
does not send a proactive alert
directly to the radiologist.
Radiologists are responsible for
reviewing each exam on a
diagnostic viewer according to
the current standard of care.
cmTriage is limited to the
categorization of exams, does
not provide any diagnostic
information beyond triage and
prioritization, does not remove
images from the radiologist’s
worklist, and should not be used
in lieu of full patient evaluation,
or relied upon to make or
confirm diagnosis.
cmTriage is for prescription use
only.

Both devices have the
same intended use
per 21 CFR 892.2080

The device provides triage or
notification that is informed
by artificial intelligence
algorithms.


Notification-
only, parallel
workflow tool

Preview of the
study for initial assessment,
not meant for diagnostic
purposes.
The device operates in
parallel with the standard of
care, which remains the
default option for all cases.

Yes; a continuous range of
operating points.

Similar but Saige-Q
uses a more
conservative
approach by pre-
specifying a discrete
number of operating
points.

Independent of
standard of care
workflow

End users
Radiologists
Radiologists
Same

Both devices operate
on screening
mammograms (x-ray
images), but
cmTriage is intended
for FFDM cases only
whereas Saige-Q is
intended for both
FFDM and DBT
cases.

Different, but does
not raise any new
questions regarding
safety and
effectiveness.

Output device
The end user interacts with
The end user interacts with the
There is no


the output of the device in the
facility’s PACS/EPR/RIS
software (worklist).

output of the device in the
facility’s PACS software
(worklist).


Manufacturer
AmCad BioMed Corp.
AmCad BioMed Corp.

Medical Image Management
and Processing System

AmCAD-UT is intended to
assist the medical
professionals in analyzing
thyroid ultrasound images by
quantification and visualization
of sonographic characteristics
of thyroid nodules.

AmCAD-UT® Detection 2.2 is
intended to assist the medical
professionals in analyzing
thyroid ultrasound images of
user-selected regions of
interest (ROI). After the initial
review of the ultrasound
images by the physicians, the
device further provides
detailed information with

The comparison as described in the following table:


AmCAD-UT is a
Windows-based
computer-aided detection
(CADe) device intended to
assist the medical
professionals in analyzing
thyroid ultrasound images,
acquired from FDA-cleared
ultrasound systems. The
region of interest (ROI) of a
user-selected thyroid nodule is
defined by users or suggested
by an AI contouring algorithm.
After the initial review of the
ultrasound images by the
physicians, the device further
provides detailed information
with quantification and
visualization of sonographic
characteristics of thyroid
nodules. The device is
intended for use on ultrasound
images of discrete thyroid
nodules larger than 1cm, for
which a biopsy
recommendation is required.

AmCAD-UT® Detection 2.2 is a
Windows-based
computer-aided detection
(CADe) device intended to
assist the medical
professionals in analyzing
thyroid ultrasound images,
acquired from FDA-cleared
ultrasound systems, with
user-selected regions of
interest (ROI). After the initial
review of the ultrasound
images by the physicians, the
device further provides
detailed information with
quantification and visualization
of sonographic characteristics
of thyroid nodules. The device
is intended for use on
ultrasound images of discrete
thyroid noduleslarger than
1cm, for which a biopsy
recommendation is required.

Functional
Capability of
Image
Processing

AmCAD-UT analyzes the
user-defined or AI-suggested
regions of interest (ROI) of a
user-selected thyroid nodule
for detection and
quantification of sonographic
characteristics (hyperechoic

AmCAD-UT® Detection 2.2
analyzes the user-selected
regions of interest (ROI) of
thyroid ultrasound image for
the detection and
quantification of sonographic
characteristics (hyperechoic


foci, echogenicity, texture,
margin, orientation and
anechoic areas). The device
further provides detailed
information with visualization
of sonographic characteristics
of thyroid nodules.

AmCAD-UT is to provide
quantification and
visualization of sonographic
characteristics after
physicians’ initial review of the
images.

AmCAD-UT® Detection 2.2 is
to provide quantification and
visualization of sonographic
characteristics after
physicians’ initial review of the
images.

The image can be annotated
with the detected sonographic
characteristics and be
recorded by the device. The
software also automatically
generates reports given the
user preference inputs in the
analysis process.

Type of Film to
be Processed
by the CAD
Device

Based on AI, Statistical Pattern
Recognition and Quantification
method

Based on Statistical Pattern
Recognition and Quantification
method

The ground truth to be
established for performance
studies of the device is the ROI
labeled by a panel of
specialists.

The ground truth to be
established for performance
studies of the device includes
the ROI, the presence of each
sonographic characteristic, and
the surgical pathology
examination result.


Image Type
Ultrasound Image
Ultrasound Image

Image Format
DICOM3.0, Bitmap, JPEG
DICOM3.0, Bitmap, JPEG

Report Storage
Paper printers, Local disk
Paper printers, Local disk

Performance
Testing Data to
Support SE
Determination

Results from standalone
performance testing of the AI
suggested ROI’s of
user-selected nodules

Results from standalone
performance testing and
clinical performance testing
(MRMC study)


Imaging tool in the evaluation of human
tissue microstructure by providing two-
dimensional, cross-sectional, real-time depth
visualization.

The OTIS 2.1 Optical Coherence Tomography
System is indicated for use as an imaging
tool in the evaluation of excised human tissue
microstructure, by providing two-
dimensional, cross-sectional, real-time depth
visualization, with image review manipulation
software for identifying and annotating
regions of interest.

Measurement Technique
Optical Coherence Tomography
Same

Optical Source
Super Luminescent Diode
Same

Axial Resolution
10 – 15 μm in tissue
Same


Characteristic
Perimeter OTIS™ 2.1
Perimeter OTIS™ 2.0


Picture archiving and
communications
system (PACS)

Regulation number
21 CFR 892.2050
21 CFR 892.2050

Classification Panel
Radiology
Radiology

qp-Prostate is an image processing
software package to be used by
trained professionals, including

Olea Sphere V3.0 is an image
processing software package to
be used by trained professionals


radiologists specialized in prostate
imaging, urologists and oncologists.
The software runs on a standard
"off-the-shelf" workstation and can
be used to perform image viewing,
processing and analysis of prostate
MR images. Data and images are
acquired through DICOM compliant
imaging devices and modalities.
Patient management decisions
should not be based solely on the
results of qp-Prostate. qp-Prostate
does not perform a diagnostic
function, but instead allows the
users to visualize and analyze
DICOM data.

including, but not limited to,
physicians and medical
technicians. The software runs on
a standard "off-the-shelf"
workstation and can be used to
perform image viewing,
processing, image collage and
analysis of medical images. Data
and images are acquired through
DICOM compliant imaging
devices and modalities.


Radiologists specialized in
prostate imaging, urologists and
oncologists.

Trained professionals including
but not limited to
physicians and medical
technicians

Any patient for which PACS MR
prostate data exists.

Image post-processing
and analysis plugins

DCE (for MR Imaging) Kinetics –
semi quantitative maps
(AUC, Peak enhancement map,
Peak percentage enhancement,
Time to maximum enhancement,
Washin, Washout, Relative
washout,
Signal Enhancement Ratio)

DCE (for prostate MR
imaging) Perfusion –
Pharmacokinetics
Modelling
(Ktrans [min-1], kep [min-1], ve [%])

DCE (for MR imaging) Permeability
– Quantitative parameter maps
(Ktrans, kep, Vp, ve, signal to
concentration time curve
conversion with fixed blood
and tissue T1 values)

DWI (for MR Imaging) Intra – Voxel
Incoherent Motion IVIM
(ADC, D, D*, f)

DWI (for MR Imaging) Apparent
Diffusion
Coefficient (ADC [mm2/s])

DWI (for MR Imaging) Apparent
Diffusion Coefficient
(ADC)

Not included
Metabolic (hepatic fat fraction FF)


Digital Reference
Object Analysis
(Diffusion – ADC)

QIBA’s Diffusion
Weighted Imaging
(DWI) Digital
Reference Object
(DRO)

Perfusion -
Pharmacokinetics
analysis module

Digital Reference
Object Analysis
(Perfusion –
Pharmacokinetics)

QIBA’s Dynamic
Contrast-Enhanced
(DCE) MR perfusion
DRO


Performance
testing with
prostate MR
cases

155 DCE-MR and DWI-MR
prostate sequences acquired form
155 different patients in different
machines with multiple acquisition
protocols

112 T2-Weighted MR, DCE-MR
and 108 DWI-MR prostate
sequences acquired from different


patients in different machines with
multiple acquisition parameters

51 transverse T2-weighted, DCE-
MR and DWI-MR prostate
sequences acquired from 51
different patients in different
machines with multiple acquisition
protocols

242 DCE-MR prostate sequences
acquired from 242 different
patients in different machines with
multiple acquisition protocols

243 transverse T2-weighted MR
prostate sequences acquired from
243 different patients in different
machines with multiple acquisition
protocols.

Comparison to the
Predicate Device
(OLEA Sphere, v3.0,
K152602)

157 T2-weighted MR, DCE-MR
and 141 DWI-MR prostate
sequences acquired form different
patients in different machines with
multiple acquisition protocols


Specification
Predicate Device
Proposed Device

Patient Population
Patients of all ages
Same

Dosimetrist
Medical Physicists
Radiation Oncologists

Part of scanned object is located out of
the scan field of view.

Compatible with Axial, Helical, and Cine
scan modes.

Analytical model – classic algorithm where
the measured sinogram is expanded to
cover a FOV larger than SFOV.

MaxFOV 2 uses a CNN which is trained on
multiple CT scanners. MaxFOV 2’s
reconstruction process (algorithm) contains
a Deep Learning based component.

Allows visualization of up to 80cm, same as

510(k) Premarket Notification Submission


2100 Fillmore Street #100, San
Francisco, CA 94115, U.S.A

Email: regulatory@arterys.com
Phone: 1 (650) 391-7111


Common Name
Medical image processing software

21 CFR 892.2050 Medical image management and processing system


System, Image processing, Radiological
(Predicate device)

GE MEDICAL SYSTEMS, LLC
3000 N GRANDVIEW
Waukesha, WI 53188, USA

The following table shows the predicate devices of the proposed ClariPulmo:


System, X-Ray,
Tomography,
Computed
(Reference
Device)

System, Image
processing,
Radiological
(Reference
Device)

VIDA|vision
(formerly VIDA
Pulmonary
Workstation 2
(PW2))

IMBIO LLC
227 COLFAX AVE
NSUITE 144
Minneapolis, MN 5
5405 USA

VIDA Diagnostics,
Inc. 500 Crosspark
Rd. W250
BioVentures Center
Coralville, IA 52241
USA

ClariPi Inc.
3F, 70-15,
Ihwajang-gil,
Jongno-gu, Seoul,
Republic of Korea
[03088]


Subject Device (K203783)
Predicate Device (103480)

ClariPulmo is a non-invasive image analysis
software for use with CT images which is
intended to support the quantification of lung CT
images. The software is designed to support the
physician in the diagnosis and documentation of
pulmonary tissue images (e.g., abnormalities)
from the CT thoracic datasets. (The software is
not intended for the diagnosis of pneumonia or
COVID-19). The software provides automated
segmentation of the lungs and quantification of
low-attenuation and high-attenuation areas
within the segmented lungs by using predefined
Hounsfield unit thresholds. The software
displays by color the segmented lungs and
analysis results. ClariPulmo provides optional
denoising and kernel normalization functions for
improved quantification of lung CT images in
cases when CT images were taken at low-dose
conditions or with sharp reconstruction kernels.

Thoracic VCAR is a CT, non-invasive
image analysis software package,
which may be used in conjunction with
CT lung images to aid in the
assessment of thoracic disease
diagnosis and management. The
software will provide automatic
segmentation of the lungs and
automatic segmentation and tracking of
the airway tree. The software will
provide quantification of Hounsfield
units and display by color the
thresholds within a segmented region.


Thoracic
VCAR
K103480
(Predicate
Device)

Imbio CT
Lung Density
Analysis
Software
K141069
(Reference
Device)

Automatic segmentation
of both the left and right
lungs and airways

Lung volume analysis
support: Both, Left, and
Right Lungs

Yes
Lung
density
result
quantificati
on with HU
density
range,
volume
measurem
ent, lung
density
index and
Perc15
measurem
ent

Yes
Lung density
result
quantification
with HU
density
range,
volume
measurement
, lung density
index and
PercX (where
”X”
corresponds
to the desired
percentile)
calculated in
the
Inspiration
Assessment
only.

Yes
Lung density
result
quantification
with HU
density range,
volume
measurement,
lung density
index and
Perc15
measurement


Yes
Lung
density
result
quantificati
on with HU
density
range and
volume
measurem
ent based
on selected
HU ranges
set by user

Adjustable density
thresholds for refining
and optimizing HU range

Viewer displays lung
density in color
according to Hounsfield
Unit (HU) range.

Viewer displays density
graph/histogram of the
classified lung voxels’
relative frequencies

Report includes overlay
of density quantification
results and density graph
histogram


Device Classification Name
System, Image processing, Radiological

Densitas, Inc.
1344 Summer Street, Suite 311.2
Halifax, CA B3h 0A8

substantially equivalent to the following commercially available software:


Subject Device –
Predicate Device-
Reference Device -

ClariSIGMAM is a
software application
intended for use with
compatible full field
digital mammography
systems.
ClariSIGMAM
calculates percent
breast density defined
as the ratio of
fibroglandular tissue to
total breast area
estimates and
provides breast
density group
information (BI-RADS
A+B as fatty and BI-
RADS C+D as dense)
to aid radiologists in
the assessment of
breast tissue
composition.
ClariSIGMAM
produces adjunctive
information. It is not a
diagnostic aid.

DM-Density is a
software application
intended for use with
compatible full field
digital mammography
systems. DM-Density
calculates percent
breast density defined
as the ratio of
fibroglandular tissue to
total breast area
estimates. DM-Density
provides these
numerical values for
each breast as well as
a density category to
aid interpreting
physicians in the
assessment of breast
tissue composition.
DM-Density produces
adjunctive information.
It is not a diagnostic
aid.

M-Vu Breast Density is
a software application
intended for use with
digital mammography
systems. M-Vu Breast
Density calculates
breast density as a
ratio of fibroglandular
tissue and total breast
area estimates. M-Vu
Breast Density
provides these
numerical values for
each breast as well as
a density category to
aid radiologists in the
assessment of breast
tissue composition. M-
Vu Breast Density
produces adjunctive
information, It is not an
interpretive or
diagnostic aid.

Interpreting
Physicians,
Radiologists and
Specialists

GE Senograph 2000D
GE Senograph DS
GE Senographe
Pristina
Hologic Selenia
Dimensions
Hologic Lorad Selenia

All digital radiography
(DR) systems and
computed radiography
(CR) systems

Image
DICOM digital
DICOM full field digital
DICOM digital

The following information compares the predicate devices and the subject device.


mammography imager
– For Presentation;
RCC, LCC, RMLO,
LMLO

mammography imager
– For Processing;
RCC, LCC, RMLO,
LMLO

For each breast:
• Area of fibroglandular
tissue (cm²)
• Area of breast (cm²)
• Area-based breast
density (%)
For each patient:
• Breast density group
information for the
patient (BI-RADS
A+B as fatty and BI-
RADS C+D as
dense)

BI-RADS 4th Ed.
For each breast:
• Area of fibroglandular
tissue (cm²)
• Area of breast (cm²)
• Area-based breast
density (%)
For each patient: DM-
Density breast density
grade and percent
breast density
BI-RADS 5th Ed.
For each patient: DM-
Density breast density
grade

For each breast:
• Area of fibroglandular
tissue (cm²)
• Area of breast (cm²)
• Area-based breast
density (%)
For each patient:
VuCOMP density
grade/BIRADS breast
density


Radiological Computer Assisted
Detection and Diagnosis Software

Regulation Number
21 CFR 892.2090
21 CFR 892.2090

ProFound™ AI V2.1 is a
computer-assisted detection and
diagnosis (CAD) software device
intended to be used concurrently
by interpreting physicians while
reading digital breast
tomosynthesis (DBT) exams from
compatible DBT systems. The
system detects soft tissue
densities (masses, architectural
distortions and asymmetries) and
calcifications in the 3D DBT
slices. The detections and
Certainty of Finding and Case
Scores assist interpreting
physicians in identifying soft
tissue densities and calcifications
that may be confirmed or
dismissed by the interpreting
Physician.

ProFound AI® V3.0 is a
computer-assisted detection and
diagnosis (CAD) software device
intended to be used concurrently
by interpreting physicians while
reading digital breast
tomosynthesis (DBT) exams from
compatible DBT systems. The
system detects soft tissue
densities (masses, architectural
distortions and asymmetries) and
calcifications in the 3D DBT
slices. The detections and
Certainty of Finding and Case
Scores assist interpreting
physicians in identifying soft
tissue densities and calcifications
that may be confirmed or
dismissed by the interpreting
Physician.

Symptomatic and asymptomatic
women
undergoing mammography.


Image processing device intended
to aid in the detection,
localization, and characterization
of soft tissue densities (masses,
architectural distortions
and asymmetries) and
calcifications in the 3D DBT
slices.

Output Device
Softcopy Workstation
Softcopy Workstation

Deployment
Standalone computer
Standalone computer

Supported Digital Breast
Tomosynthesis Systems

ProFound AI V2 Software:
• Hologic Selenia
Dimensions/3Dimensions
• GE Senographe Esssential
with SenoClaire
• GE Senographe Pristina
ProFound AI V2.1 Software:
• Siemens Inspiration both
Standard and Empire
Reconstruction
• Siemens Revelation both
Standard and Empire
Reconstruction

Profound AI V3.0 Software:
• Hologic Selenia
Dimensions/3Dimensions
• GE Senographe Esssential
with SenoClaire
• GE Senographe Pristina
ProFound AI V2.1 Software:
• Siemens Inspiration both
Standard and Empire
Reconstruction
• Siemens Revelation both
Standard and Empire
Reconstruction


SIS System version 5.1.0
SIS Software version 3.6.0

SIS System is an application
intended for use in the
viewing, presentation and
documentation of medical
imaging, including different
modules for image
processing, image fusion,
and intraoperative functional
planning where the 3D
output can be used with
stereotactic image guided
surgery or other devices for
further processing and
visualization. The device
can be used in conjunction
with other clinical methods
as an aid in visualization of
the subthalamic nuclei
(STN) and globus pallidus
externa and interna (GPe
and GPi, respectively).
Typical users of the SIS
System are medical
professionals, including but
not limited to surgeons,
neurologists and
radiologists.

SIS Software is an application
intended for use in the
viewing, presentation and
documentation of medical
imaging, including different
modules for image
processing, image fusion, and
intraoperative functional
planning where the 3D output
can be used with stereotactic
image guided surgery or
other devices for further
processing and visualization.
The device can be used in
conjunction with other clinical
methods as an aid in
visualization of the
subthalamic nuclei (STN).
Typical users of SIS Software
are medical professionals,
including but not limited to
surgeons, neurologists, and
radiologists.

Medical professionals,
including but not limited to
surgeons, neurologists and
radiologists.

Medical professionals,
including but not limited to
surgeons, neurologists, and
radiologists.

Allows for importing of
digital imaging sets

Uses proprietary
software algorithm to
generate 3D segmented
anatomical models from
patient’s MR scans


Allows for review and
analysis of data in 2D
and 3D formats

Performs image fusion
of datasets using
automated or manual
image matching
technique

Segments structures in
images with manual and
automated tools and
converts them into 3D
objects for display

Creates hybrid datasets
by filing in segmented
regions slice-by-slice
on anatomical datasets

Segmentation of CT
scan to identify
structures in relation to
those visualized on MR

Feature to Account for
CT images with gantry
tilt

Cross-registers images
and creates 3D (fused)
model

Uses registration
methods (linear and
non-linear) by multiple
registration tools (ANTS
and ELASTIX)


Classification Name
Computed tomography x-ray system.

The HealthCCSng device is substantially equivalent to the following Primary Predicate Device:


Corresponding Estimated Coronary Calcium
Detection Category

The software output will include the following calcium categories:


Primary Predicate Device:
HealthCCS Device v3.0
(K172983)

Secondary Predicate Device:
AI-Rad Companion (K183268)

The HealthCCSng device
is intended for use as a
non-invasive
post-processing software to
evaluate calcified plaques
in the coronary arteries,
which present a risk for
coronary artery disease.
The software generates an
estimated coronary artery
calcium detection category.
The HealthCCSng device
analyzes existing
non-cardiac-gated CT
studies that include the
heart of adult patients
above the age of 30. The
device generates a
three-category output
representing the estimated
quantity of calcium
detected together with
preview axial images of the
detected calcium meant for
informational purposes
only. The device output
will be available to the
radiologist as part of their
standard workflow. The
HealthCCSng results are
not intended to be used on
a stand-alone basis for risk
attribution, clinical
decision-making or
otherwise preclude clinical
assessment of CT studies.

The HealthCCS Device is
intended for use as a
non-invasive
post-processing software
that can be used to evaluate
calcified plaques in the
coronary arteries, which
may be a risk factor for
coronary artery disease.
The software can be used to
generate reports of the total
risk category of coronary
calcium. This information
can then be used by a
physician for further
analysis and treatment. The
HealthCCS Device
analyzes pre-existing heart
or chest
ECG-Gated/Triggered CT
scans. The Device is
indicated for use only on
patients whose age at the
time, when the CT scan
was taken, was above 20
years old. This device
generates a 4-category
Agatston-equivalent risk
score, and the patient
management, especially for
the patient with the score
from 0-10, will depend on
the physician’s own
judgment. It may require
further testing to evaluate
the appropriate clinical
management.

AI-Rad Companion
(Cardiovascular) is image
processing software that
provides quantitative and
qualitative analysis from
previously acquired Computed
Tomography DICOM images to
support radiologists and
physicians from emergency
medicine, specialty care, urgent
care, and general practice in the
evaluation and assessment of
cardiovascular diseases.
It provides the following
functionality:
• Segmentation and volume
measurement of the heart
• Quantification of the total
calcium volume in the coronary
arteries
• Segmentation of the aorta
• Measurement of maximum
diameters of the aorta at typical
landmarks
•Threshold-based highlighting
of enlarged diameters The
software has been validated for
non-cardiac chest CT data with
filtered backprojection
reconstruction from Siemens
Healthineers, GE Healthcare,
Philips, and Toshiba/Canon.
Additionally, the calcium
detection feature has been
validated on non-cardiac chest
CT data with iterative
reconstruction from Siemens
Healthineers.
Only DICOM images of adult
patients are considered to be
valid input.


Comparison of Techn
ological Characteri
stics

Technological
Proposed Device:
Primary Predicate
Secondary
Summary

Characteristics
HealthCCSng
Device:
Predicate Device:

Device v1.0
HealthCCS Device
AI-Rad Companion

Regulation Number
21 CFR §892.1750
21 CFR §892.1750
21 CFR §892.1750
Same

Contrast Non-contrast Non-contrast Non-contrast Same

Supported CT scan
Non-cardiac-gated
Cardiac-gated CT
Non-cardiac-gated
Different

Slice thickness
Up to 3mm
Up to 3mm
Up to 3mm
Same

Calcification Automatic Automatic Automatic Same

Default threshold of
130 HU
130 HU
130 HU
Same

calcium
(Hounsfield Units)
(Hounsfield Units)
(Hounsfield Units)

Coronary artery
CAC detection
Agatston
Calcium volume
Similar, p

calcification
category
equivalent CAC
detected c

quantification method
risk category,
for assess

Main Image Quality
DICOM
DICOM
Not applicable
Same

Comparison of Technological Characteristics


Does not
introduce
questions of
safety and
effectiveness

Similar, does not
introduce
questions of
safety and
effectiveness

Optional to copy
result to clipboard,
insert in report,
DICOM Secondary
Capture

Yes, Coronary
Calcium Detection
Category
3 categories:
0-99
100-399
>400

Yes, Coronary
artery calcium risk
category
4 categories
0-10
11-100
101-400
>400

Both the subject
and primary
predicate device
provide calcium
detection and
category


Manufacturer
Device Name
Application No.


Neurovascular or Neurosurgical
Specialist

Acquires medical image data from
DICOM compliant imaging devices
and modalities.

Computed Tomography, non-
contrast (NCCT)

Computed Tomography, non-contrast
(NCCT)

Initial assessment; non-diagnostic
purposes

DICOM Information about the
patient, study and current image.


Clinical Site
Sensitivity [95% CI]
Specificity [95% CI]


Age Range (Years)
Sensitivity [95% CI]
Specificity [95% CI]


Gender (Years)
Sensitivity [95% CI]
Specificity [95% CI]

Intraparenchymal Hemorrhage (IPH)
0.96 [0.92, 0.99]

Intraventricular Hemorrhage (IVH)
1.0 [0.81, 1.0]

Subarachnoid Hemorrhage (SAH)
0.86 [0.64, 0.97]

Subdural Hemorrhage (SDH)
0.93 [0.66, 1.0]

Extradural Hemorrhage (EDH)
1.0 [0.16, 1.0]


Slice Thickness
Sensitivity [95% CI]
Specificity [95% CI]


Device Performance by Scanner Manufacturer

Manufacturer
Sensitivity [95% CI]
Specificity [95% CI]


Device Performance by CT Scanner Make/Model

Manufacturer
Model
Sensitivity [95% CI]
Specificity [95% CI]


Sensitivity Below/Equal
Threshold [95% CI]


Device Performance by Scanner Reconstruction Method


Table 1: Time-to-Notification for PE and AD Image Processing Applications


Predicate device: Aidoc
BriefCase Software
(K190072)

Reference device:
Avicenna.AI CINA
software (K200855)

CINA CHEST is a
radiological computer
aided triage and
notification software
indicated for use in the
analysis of Chest and
Thoraco-abdominal CT
angiography. The device
is intended to assist
hospital networks and
trained radiologists in
workflow triage by
flagging and
communicating
suspected positive
findings of (1) Chest CT
angiographyfor
Pulmonary Embolism
(PE) and (2) Chest or
Thoraco-abdominal CT

BriefCase is a
radiological computer
aided triage and
notification software
indicated for use in the
analysis of non-enhanced
head CT and CTPA
images.
The device is intended to
assist hospital networks
and trainedradiologists in
workflow triage by
flagging and
communication of
suspected positive
findings of Intracranial
Hemorrhage (ICH) and
Pulmonary Embolism
(PE) pathologies. For the
PE pathology, the

CINA is a radiological
computer aided triage
and notification software
indicated for use in the
analysis of (1) non-
enhanced head CT
images and (2) CT
angiographies of the
head.
The device isintended to
assist hospital networks
and trained radiologists in
workflow triage by
flagging and
communicating
suspected positive
findings of (1) head CT
images for Intracranial
Hemorrhage (ICH) and
(2)CT angiographies of

BriefCase) and Reference Device (Avicenna.AI CINA)


Chest and Thoraco-
abdominal CT
angiography

Non contrast head CT
scan and CTPA (single
energy exams only)

Non contrast CT scan of
the head or neck and CT
angiogram images of the
brain

DICOM information
about the patient, study
and current image

No; device does not
mark, highlight, or direct
users’ attention to a
specific location in the
original image

Artificial intelligence
algorithm with database
of images

Presentation of a small,
compressed, black and
white preview image that
is labeled“not for
diagnostic use”;
The device operates in
parallel with the standard
of care, which remains
the default option for all

Presentation of a preview
of the study for initial
assessment not meant for
diagnostic purposes.
The device operates in
parallel with the standard
of care, which remains
the default option for all
cases.


-PEand ADimage
processing applications
-Compatibility of use
with the CINA Platform
reference device
(worklist and Image
Viewer)

-AHS module (image
acquisition),
-ACS module (image
processing),
-AidocWorklist
application for workflow
integration (worklist and
non-diagnostic basic
Image Viewer).

-LVO and ICH image
processing applications
-CINA Platform (worklist
andImage Viewer)


Predicate Device:
Logicon Caries
Detection (P980025)

Manufacturer
Pearl Inc.
Carestream Dental LLC

Same (Product code MYN
was recently
reclassified to class II)

Image Modality
Radiograph
Radiograph
Same

To aid in clinical detection of
pathologic and/or non-
pathologic dental features in
radiographs
of permanent teeth, as a
second reader, only after the
initial read is completed

To aid in clinical
detection of pathologic
features in
radiographs of adult teeth

Same indication as
predicate device as both
devices are intended to
identify pathologic features
in dental radiographs.

Second Opinion® is a
computer aided detection
("CADe”) software to
identify and mark regions in
relation to suspected dental
findings which include
Caries, Discrepancy at the
margin of an existing
restoration, Calculus,
Periapical radiolucency,
Crown (metal, including
zirconia & non-metal),
Filling (metal & non- metal),
Root canal, Bridge and
Implants. It is designed to
aid dental health
professionals to review
bitewing and periapical
radiographs of permanent
teeth in patients 12 years of
age or older as a second
reader.

The Logicon Caries
Detector is a software
device that is an aid in the
diagnosis of caries that
have penetrated into the
dentin, on un- restored
proximal surfaces of
secondary dentition
through the statistical
analysis of digital intraoral
radiographic imagery. The
device provides additional
information for the
clinician to use in his/her
diagnosis of a tooth
surface suspected of
being carious. It is
designed to work in
conjunction with an
existing Carestream
Dental RVG digital x-ray
radiographic system with
Carestream Dental
Imaging Software
(DIS/CSI) for WINDOWS
7 or higher.

For substantial equivalence comparison, the follow table is provided:


Intended body part
Dental
Dental
Same as predicate device

User may mark ROI with V
tool (to select a pie-wedge
shape: narrow end at the
center of the tooth, wide
end extending through
surface over the
suspicious region)
or the pencil tool to draw
the ROIs.

Utilizes computer vision
neural network algorithms,
developed from open-source
models using supervised
machine learning
techniques.

Utilizes computer vision
neural network algorithms
developed using proprietary
techniques.

The user can select specific
regions of interest (ROI) to
be analyzed by the
program

Standalone study for
pathological (Caries,
discrepancy at the
margin, calculus, and
periapical radiolucency)
and non-pathologic
feature detection
performance (Crowns,
fillings, root canal,
bridges, and Implants).
• Multiple-Reader,
Multiple-Case
(MRMC) study for
pathologic dental
features
• Analysis included:
• wAFROC-FOM
analysis for
primary endpoints
• Determination of
the changes in
sensitivity and
change in number
of false positive

• MRMC study for two
types of dental caries:
approximal/enamel into
dentin
• Analysis included: ROC
analysis for primary
endpoints

All devices included
MRMC studies to assess
effectiveness.


dental pathologies
of a given type per
image (FPPI).

Accepts image formats
from RVG, DICOM,
JPEG, TIFF,
and PNG and
converts to JPEG.

Limited to
Carestream
proprietary
radiography
equipment.

Analysis of digital
intraoral
radiographic
imagery


Unaided Reader Accuracy
Aided Readers Accuracy

determined using the ROC paradigm and showed an improvement of 12.8 percent:


Unaided Reader wAFROC-FOM
Aided Reader wAFROC-FOM


Radiological Computer Assisted Detection and
Diagnosis Software

Classification regulation
21 CFR 892.2090


Legal Manufacturer
ScreenPoint Medical B.V.


d) An exam score which categorizes exams on a scale of 1-10 with increasing

likelihood of cancer. The score is calibrated in such a way that approximately 10

percent of mammograms in a population of mammograms without cancer falls in

be utilized to enhance user interfaces and workflow.


Standard ID
Standard Title
FDA Recognition #

Medical devices - Part 1: Application of
usability engineering to medical devices

voluntary FDA recognized standards and guidelines:


Clinical investigation of medical devices

Medical Devices - Application Of Risk
Management To Medical Devices

Medical Device Software - Software Life
Cycle Processes

Medical devices - Symbols to be used
with medical device labels labelling and
information to be supplied - Part 1:
General requirements

Decision summary with special controls
for class II radiology device


AAMI ANSI ES60601-1:2005/(R)2012 and A1:2012,
C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text)
Medical electrical equipment - Part 1: General requirements for
basic safety and essential performance (IEC 60601-1:2005, MOD)

IEC60601-1-2: 2014(4th Edition) , Medical electrical equipment -
Part 1-2: General requirements for basic safety and essential
performance - EMC

IEC 60601-2-37 Edition 2.0 2007, Medical electrical equipment –
Part 2-37: Particular requirements for the basic safety and essential
performance of ultrasonic medical diagnostic and monitoring
equipment

ISO 10993-1:2009/(R)2013, Biological evaluation of medical
devices – Part 1: Evaluation and testing within a risk management
process

ISO 14971:2007, Medical devices - Application of risk management
to medical devices

NEMA UD 2-2004 (R2009)
Acoustic Output Measurement Standard for Diagnostic Ultrasound
Equipment Revision 3


Abbott Medical
4 Robbins Road
Westford, MA, 01886

Steven Vitale
(m)612-214-9102
steve.vitale@abbott.com

Jose Marquez
(m)978-846-2640
jose.marquez1@abbott.com

OPTIS™ Mobile Next Imaging System, OPTIS™ Integrated Next Imaging System
with Ultreon™ Software 1.0

K192019: Dragonfly Opstar™ Imaging Catheter, AptiVue™ Software version E.5.1,
cleared November 8, 2019

The OPTIS™ Next Imaging System is comprised of two devices providing the same set
of features:
• The OPTIS™ Mobile Next Imaging System is comprised of a cart-mounted
personal computer, imaging engine, and power supply that are placed inside an
ergonomically designed mobile cart. This system includes a keyboard, display
monitors, mouse, tableside controller, and a Drive-motor and Optical Controller
(DOC).
• The OPTIS™ Integrated Next is comprised of a PC, imaging engine, and power
supply that are housed in stationary cabinet which is located in the clinic/hospital
equipment closet of a catheter lab. The tableside controller, DOC and DOC Holster
are located in the procedure room, and the keyboard, display monitor, and mouse
are located in the control room.


With the Ultreon™ 1.0 software application, these systems perform Optical Coherence
Tomography (OCT) imaging of coronary arteries using compatible Dragonfly imaging
catheters. Resting Full-cycle Ratio (RFR), Fractional Flow Reserve (FFR), and Pd/Pa
at rest physiological waveforms are also measured by the system to assess the severity
of a coronary lesion by measuring the pressure drop across the lesion (distal vs
proximal pressure). The physician may use the RFR or FFR parameter, along with
knowledge of patient history, medical expertise, and clinical judgment to determine if
therapeutic intervention is indicated.

Indications for Use (Software)
The Ultreon™ 1.0 Software is intended to be used only with compatible OPTIS™ Next
Imaging Systems.
The OPTIS Next Imaging System with a compatible Dragonfly™ OPTIS™ Imaging
Catheter or Dragonfly OpStar™ Imaging Catheter is intended for the imaging of
coronary arteries and is indicated in patients who are candidates for transluminal
interventional procedures. The Dragonfly OPTIS Imaging Catheter or Dragonfly
OpStar Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The
Dragonfly OPTIS Imaging Catheter or Dragonfly OpStar Imaging Catheter is not
intended for use in the left main coronary artery or in a target vessel which has
undergone a previous bypass procedure.
The OPTIS Next Imaging System is intended for use in the catheterization and related
cardiovascular specialty laboratories and will further compute and display various
physiological parameters based on the output from one or more electrodes, transducers,
or measuring devices. The physician may use the acquired physiological parameters,
along with knowledge of patient history, medical expertise, and clinical judgment to
determine if therapeutic intervention is indicated.
Indications for Use (capital equipment hardware)
The OPTIS™ Mobile Next [and OPTIS™ Integrated Next] with a compatible
Dragonfly™ OPTIS™ or Dragonfly™ OpStar™ Imaging Catheter is intended for the
imaging of coronary arteries and is indicated in patients who are candidates for
transluminal interventional procedures. The Dragonfly OPTIS or Dragonfly OpStar
Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The
Dragonfly OPTIS or Dragonfly OpStar Imaging Catheter is not intended for use in the
left main coronary artery or in a target vessel which has undergone a previous bypass
procedure.
The OPTIS Mobile Next [and OPTIS™ Integrated Next] is intended for use in the
catheterization and related cardiovascular specialty laboratories and will further
compute and display various physiological parameters based on the output from one or
more electrodes, transducers, or measuring devices. The physician may use the


acquired physiological parameters, along with knowledge of patient history, medical
expertise, and clinical judgment to determine if therapeutic intervention is indicated.

Comparison of
Subject to
Predicate Device

The OPTIS™ Next Imaging System with Ultreon™ Software version 1.0 is equivalent
to the predicate OPTIS™ Imaging System with AptiVue™ Software version E.5.1
(K192019) in terms of intended use, indications for use, operational characteristics,
fundamental design, and technological characteristics. Changes to technological
characteristics of the device do not raise new questions of safety or effectiveness.

Feature
Predicate Device:
Proposed Device:

OPTIS System with
OPTIS Next Imaging System

AptiVue™ Software Version
with Ultreon Software version

The AptiVue™ E-series
software is intended for use only
with compatible OPTIS™
imaging systems. OPTIS™
imaging systems are intended
for use in the catheterization and
related cardiovascular specialty
laboratories.

The Ultreon™ 1.0 Software is
intended to be used only with
compatible OPTIS™ Next
Imaging Systems.

The AptiVue™ E series
software is intended to be used
only with compatible OPTIS™
imaging systems.
The OPTIS imaging system
with a compatible Dragonfly™
imaging catheter is intended for
the imaging of coronary arteries
and is indicated in patients who
are candidates for transluminal
interventional procedures. The
compatible Dragonfly™
imaging catheters are intended
for use in vessels 2.0 to 3.5 mm
in diameter. The compatible
Dragonfly™ imaging catheters
are not intended for use in the
left main coronary artery or in a
target vessel which has
undergone a previous bypass
procedure.
The OPTIS imaging system is
intended for use in the
catheterization and related
cardiovascular specialty
laboratories and will further
compute and display various
physiological parameters based
on the output from one or more

The OPTIS Next Imaging System
with a compatible Dragonfly™
OPTIS™ Imaging Catheter or
Dragonfly OpStar™ Imaging
Catheter is intended for the
imaging of coronary arteries and
is indicated in patients who are
candidates for transluminal
interventional procedures. The
Dragonfly OPTIS Imaging
Catheter or Dragonfly OpStar
Imaging Catheter is intended for
use in vessels 2.0 to 3.5 mm in
diameter. The Dragonfly OPTIS
Imaging Catheter or Dragonfly
OpStar Imaging Catheter is not
intended for use in the left main
coronary artery or in a target
vessel which has undergone a
previous bypass procedure.
The OPTIS Next Imaging System
is intended for use in the
catheterization and related
cardiovascular specialty
laboratories and will further


electrodes, transducers, or
measuring devices. The
physician may use the acquired
physiological parameters, along
with knowledge of patient
history, medical expertise and
clinical judgment to determine
if therapeutic intervention is
indicated.

compute and display various
physiological parameters based
on the output from one or more
electrodes, transducers, or
measuring devices. The physician
may use the acquired
physiological parameters, along
with knowledge of patient
history, medical expertise, and
clinical judgment to determine if
therapeutic intervention is
indicated.

OCT recordings, FFR, Pd/Pa at
rest, and RFR physiological
waveforms

Modifications to the Ultreon 1.0
software have been made to
include automated morphology
assessment of External Elastic
Lamina (EEL) and calcium,
display of live angiography
imagery on the OPTIS Next
Imaging System display
monitors, and user interface
guided workflows for image data
acquisition and review. Software
updates were made to the
following existing features:
• OCT image color map
• OCT pullback auto-trigger
• Angio co-registration
• Vessel sizing
• Stent analysis
• Stent expansion
• Cybersecurity
Software design verification and
validation testing have been
performed which concludes these
modifications demonstrate claims
of substantial equivalence to the
AptiVue E.5.1 software.

Feature
OPTIS Mobile, OPTIS
OPTIS Mobile Next, OPTIS

Integrated Hardware
Integrated Next Hardware


The OPTIS™ mobile system
[and OPTIS™ integrated
system] with a compatible
Dragonfly™ imaging catheter is
intended for the imaging of
coronary arteries and is
indicated in patients who are
candidates for transluminal
interventional procedures. The
Dragonfly imaging catheter is
intended for use in vessels 2.0 to
3.5 mm in diameter. The
Dragonfly imaging catheter is
not intended for use in the left
main coronary artery or in a
target vessel which has
undergone a previous bypass
procedure.
The OPTIS mobile system [and
OPTIS integrated system] is
intended for use in the
catheterization and related
cardiovascular specialty
laboratories and will further
compute and display various
physiological parameters based
on the output from one or more
electrodes, transducers, or
measuring devices. The
physician may use the acquired
physiological parameters, along
with knowledge of patient
history, medical expertise, and
clinical judgment to determine
if therapeutic intervention is
indicated.

The OPTIS™ Mobile Next [and
OPTIS™ Integrated Next] with a
compatible Dragonfly™
OPTIS™ or Dragonfly™
OpStar™ Imaging Catheter is
intended for the imaging of
coronary arteries and is indicated
in patients who are candidates for
transluminal interventional
procedures. The Dragonfly
OPTIS or Dragonfly OpStar
Imaging Catheter is intended for
use in vessels 2.0 to 3.5 mm in
diameter. The Dragonfly OPTIS
or Dragonfly OpStar Imaging
Catheter is not intended for use in
the left main coronary artery or in
a target vessel which has
undergone a previous bypass
procedure.
The OPTIS Mobile Next [and
OPTIS Integrated Next] is
intended for use in the
catheterization and related
cardiovascular specialty
laboratories and will further
compute and display various
physiological parameters based
on the output from one or more
electrodes, transducers, or
measuring devices. The physician
may use the acquired
physiological parameters, along
with knowledge of patient
history, medical expertise, and
clinical judgment to determine if
therapeutic intervention is
indicated.

Modifications to the OPTIS
Mobile Next, OPTIS Integrated
Next Hardware have been made
to support of the computational
speed, display, electrical
compliance, and cybersecurity
requirements of the system.
• Graphics processing unit
• Memory
• Power supply
• Main motherboard and CPU
• Solid-state drive storage


• Trusted Platform Module
(TPM) chip supporting
cybersecurity
• Ferrites added to the USB-
over-Ethernet Extender Cable
Design verification and validation
testing has been performed which
concludes these modifications
demonstrate claims of substantial
equivalence to the OPTIS
Mobile, OPTIS Integrated
Hardware.

Verification and Validation testing were completed to demonstrate safety and
effectiveness and ensure that the subject device performs as intended. Design
verification and validation included the following:
• Software Verification and Validation – performed to ensure that the subject
device meets requirements and functions as intended
• Human Factors -Summative Usability Study – performed to demonstrate that the
updated user interface, 1) does not trigger any serious harm based on use error or use
problems, for the intended uses, and under the expected use conditions; and, 2) shows
no pattern of use errors or problems that could result in serious harm and that could be
eliminated or reduced through further modification of the user interface, device
labeling, or user training.
• Hardware/System/packaging Verification – performed to demonstrate that the
OPTIS Next Imaging System products and packaging meet specifications, are
appropriate for their intended use, and do not raise new questions of safety or
effectiveness.

No new clinical testing was completed, nor relied upon, in support of this Traditional
510(k). However, clinical analysis of published literature was used to support a labeling
change to reflect the resting full cycle ratio (RFR) cut-off of 0.89
RFR Interpretation
RFR Value Interpretation 1,2
RFR ≤ 0.89 Indicates that a lesion is hemodynamically significant.
RFR > 0.89 Indicates that a lesion is not hemodynamically significant.
RFR has been validated for clinical accuracy and outcomes in over 2,500 patients 1-6. Multiple
peer-reviewed publications demonstrate the equivalence of RFR to other non-hyperemic
pressure ratios (NHPR). IRIS-FFR and 3V FFR-FRIENDS studies compared all NHPRs and
concluded that all have the same class effect and are broadly equivalent in terms of diagnostic
and prognostic performance 3-5. Therefore, RFR-guided treatment at a cut-off of 0.89 is
equivalent to other NHPR-guided treatment.
The above RFR dichotomous cut-off of 0.89 represents a threshold for lesions indicative of
hemodynamically significant. An RFR of 0.89 is, therefore, equivalent to an FFR of 0.80 as a
threshold for ischemia detection.
References:
1. Svanerud et. al. Validation of a novel non-hyperaemic index of coronary artery stenosis
severity: the Resting Full-cycle Ratio (VALIDATE RFR) study. EuroIntervention 2018;
14(7): 806-814.
2. Kumar et. al. Real world validation of the nonhyperemic index of coronary artery stenosis


Indicates that a lesion is hemodynamically significant.

Indicates that a lesion is not hemodynamically significant.

RFR has been validated for clinical accuracy and outcomes in over 2,500 patients 1-6. Multiple
peer-reviewed publications demonstrate the equivalence of RFR to other non-hyperemic
pressure ratios (NHPR). IRIS-FFR and 3V FFR-FRIENDS studies compared all NHPRs and
concluded that all have the same class effect and are broadly equivalent in terms of diagnostic
and prognostic performance 3-5. Therefore, RFR-guided treatment at a cut-off of 0.89 is
equivalent to other NHPR-guided treatment.
The above RFR dichotomous cut-off of 0.89 represents a threshold for lesions indicative of
hemodynamically significant. An RFR of 0.89 is, therefore, equivalent to an FFR of 0.80 as a
threshold for ischemia detection.
References:
1. Svanerud et. al. Validation of a novel non-hyperaemic index of coronary artery stenosis
severity: the Resting Full-cycle Ratio (VALIDATE RFR) study. EuroIntervention 2018;
14(7): 806-814.
2. Kumar et. al. Real world validation of the nonhyperemic index of coronary artery stenosis

change to reflect the resting full cycle ratio (RFR) cut-off of 0.89


severity-Resting full-cycle ratio-RE-VALIDATE. Catheter Cardiovasc Interv. 2020;
96(1): E53-E58.
3. Lee et. al. Physiologic and Clinical Assessment of Resting Physiologic Indices. Circulation
2019; 139:889-900.
4. Ahn J et al. Fractional Flow Reserve and Cardiac Events in Coronary Artery Disease.
Circulation. 2017 Jun 6; 135(23): 2241-2251.
5. Lee et al. Clinical Outcome of Lesions with Discordant Results Among Different Invasive
Physiologic Indices. Circulation J 2019; 83: 2210-2221.
6. Jeremias et al. RFR: A Novel Physiologic Index Compared to FFR.

As demonstrated by risk management activities, software verification, and HFE
usability study testing the proposed OPTIS Next Imaging System does not raise new
questions of safety or effectiveness, as compared to the predicate device, meets
requirements, supports claims of substantial equivalence, and is acceptable for use.
Modifications to the software of the device do no raise new questions of safety or
effectiveness.
As demonstrated by risk management activities, hardware/system verification, and
electrical compliance testing the proposed OPTIS Next Imaging System does not raise
new questions of safety or effectiveness, as compared to the predicate device, meets
requirements, supports claims of substantial equivalence, and is acceptable for use.
Modifications to the hardware of the device do no raise new questions of safety or
effectiveness.


Predicate Device
FDA Clearance Number
Product
Manufacturer


Reference Devices
FDA Clearance Number
Product
Manufacturer

Siemens Shenzhen
Magnetic Resonance
Ltd.


[1] C. H. OH et al., 1984. Line-Integral Projection
Reconstruction (LPR) with Slice Encoding Techniques:
Multislice Regional Imaging in NMR Tomography, IEEE
Trans Med Imaging. 1984; 3(4):170-178

[2] Matt A.Bernstein, Kevin F.king, Xiaohong Joe Zhou,
Handbook Of MRI Pulse Sequences, 2004: P706-P712.

[3] Zwanenburg JJ, et al. Fast high resolution whole brain
T2* weighted imaging using echo planar imaging at 7T.
Neuroimage. 2011; 56:1902-1907.
[4] Liu W, et al. 3D Flow Compensated Interleaved EPI for a
Fast High-Resolution Susceptibility-Weighted Imaging at
1.5T. Proc. Intl. Soc. Mag. Reason. Med 2019; 27: 3326.

Accelerated Shim
(STEAM-based field
map)

[5] Nehrke, K., and Börnert, P. "DREAM—a novel approach

for robust, ultrafast, multislice B1 mapping." Magnetic

[6] Hwang, T. L., van Zijl, P. C., and Garwood, M. 1999.
Asymmetric adiabatic pulses for NH selection. J. Magn.
Reson. 138: 173–177.
[7] Pfeuffer J. et al. “Zoomed Functional Imaging in the
Human Brain at 7 Tesla with Simultaneous High Spatial and
High Temporal Resolution” NeuroImage 17(1), 2002, p. 272-
286.

[8] Kellman P. et al. Image Reconstruction in SNR Units: A
General Method for SNR Measurement. MRM 2005;
54:1439. Erratum in MRM 2007; 58:311.

[9] Blu T. et al. The SURE-LET approach to image denoising.
IEEE Transactions on Image Processing 16(11):2778-86

[10] Yulun Zhang, et al. Residual Dense Network for Image
Super-Resolution, IEEE conference on computer vision and
pattern recognition. 2018

[11] Eirikur Agustsson, Radu Timofte. NTIRE 2017
Challenge on Single Image Super-Resolution: Dataset and
Study. CVPRW, 2017. 5

[12] Justin Johnson, et al. Perceptual Losses for Real-Time
Style Transfer and Super-Resolution. European conference
on computer vision. Springer, Cham, 2016


Medical electrical equipment -
part 1: general requirements for
basic safety and essential
performance

Medical electrical equipment -
Part 1-2: General requirements
for basic safety and essential
performance - Collateral
Standard: Electromagnetic
disturbances - Requirements
and tests

Medical electrical equipment -
Part 2-33: Particular
requirements for the basic
safety and essential
performance of magnetic
resonance equipment for
medical diagnosis

Medical devices - Application of
risk management to medical
devices

Medical devices – Application of
usability engineering to medical
devices

Medical device software -
Software life cycle processes

Acoustic Noise Measurement
Procedure for Diagnosing
Magnetic Resonance Imaging
Devices

recognized and international IEC, ISO and NEMA standards:


Characterization of Phased
Array Coils for Diagnostic
Magnetic Resonance Images
(MRI)

Digital Imaging and
Communications in Medicine
(DICOM) Set 03/16/2012
Radiology

biological evaluation of medical
devices - part 1: evaluation and
testing within a risk
management process
(Biocompatibility)


RSL-D-RS-10.1 510(k) Summary RayStation 10.1


In accordance with 21 CFR 80
7.87(h) (and 21 CFR 807.92) the

Contact and Primary
Robert Lindsey, Ph.D.

Device Common Name or
Medical Image Analyzer


Applicant
Imagen Technologies
Riverain Medical Group

Device Name
Chest-CAD
RapidScreen™ RS-2000

Identify and mark regions of
interest (ROIs) on chest
radiographs

Identified ROIs are assigned to
one of the following categories:
Cardiac, Mediastinum/Hila,
Lungs, Pleura, Bones, Soft
Tissues, Hardware, or Other

Identified ROIs are assigned to a
single category (i.e., features
associated with solitary
pulmonary nodules from 9 to 30
mm in size)

Device intended for use as a
reading aid for physicians
interpreting chest radiographs

Patient Population
Adults with Chest Radiographs
Adults with Chest Radiographs

Algorithm Methodology
Artificial Neural Networks
Artificial Neural Networks


Secure cloud-based processing
and delivery of chest radiographs

Secure on-premise processing
and delivery of chest radiographs


Table 2: AUC of the ROC Curve for Chest-CAD Model Predictions by Category


Table 3: Sensitivity and Specificity for Chest-CAD Model Predictions by Category


6F.-1, No.100, Sec. 2, Heping E. Rd., Da’an Dist., Taipei City 106, Taiwan
(R.O.C.)


Class II
Classification Product Code: QDQ
Subsequent Product Code: LLZ

Radiological Computer Assisted Detection/Diagnosis Software For
Lesions Suspicious For Cancer


TransparaTM (K181704) (primary), QuantX (K170195)

Reference Device:
Koios DS for Breast (K190442)


[0,100]
The SLC ranging from 0 to 25 corresponds to BI-RADS 2,
from 26 to 50 corresponds to BI-RADS 3, from 51 to 97
corresponds to BI-RADS 4, and from 98 to 100 corresponds
to BI-RADS 5.

BI-RADS category
2 / 3 / 4a / 4b / 4c / 5

Shape, Orientation, Margin, Echo Pattern, Posterior Features
(with limitations specified in User Manual)


Intended to be used by
clinicians interpreting
radiological images, to
help them with
localizing and
characterizing breast
abnormalities.
Intended to be used
concurrently with the
reading of images and
are not intended as a
replacement for the
review of a clinician
or their clinical
judgement.

QuantX is a
quantitative image
analysis software
device used to assist
radiologists in the
assessment and
characterization of
breast abnormalities
using MR image data.

CADe and CADx
software used to assist
in localizing
suspicious soft tissue
lesions and region-
based analyze of
malignancy using
ultrasound image data.

CADe and CADx
software used to assist
in localizing
suspicious soft tissue
lesions and suspicious
calcifications; region-
based analyze of
malignancy using
mammography image
data.

The software
automatically registers
images, and segments
and analyzes user-
selected regions of
interest (ROI). QuantX
extracts image data
from the ROI to
provide volumetric
and surface area
analysis.

Patients with soft
tissue breast lesions
who are being referred
for ultrasound
interpreting.

Patients with soft
tissue breast lesions
and suspicious
calcifications who are
being referred for

Patients who are being
referred for breast
MRI interpretation.

VI. Comparison with Predicate Device/Reference Device


Design
Software-only device
Software-only device
Software-only device

Medical images
provided in a DICOM
format

ROIs and lesion
contours placed on
suspicious soft tissue
lesion.
A region-based score
of lesion malignancy,
a BI-RADS category,
and BI-RADS
descriptors.

Marks placed on
suspicious soft tissue
lesion and suspicious
calcifications.
A region-based score
of lesion malignancy,
and an overall score of
the mammogram.

QuantX extracts image
data from the ROI to
provide volumetric
and surface area
analysis.

Software Package
Operates on off-the-
shelf hardware

Breast Ultrasound and
Mammography
(FFDM)

Breast MRI, breast
ultrasound, and
mammography

Primary
Interpretation
of Digital
Mammography
Images

BU-CAD is not
intended for the
primary interpretation
of digital
mammography
images.

QuantX is not
intended for primary
interpretation of
digital mammography
images


Statistical Parameter
Unaided (95% CI)
Aided (95% CI)

Sensitivity, Specificity, PPV, and NPV between Unaided and Aided Reading Scenarios


Statistical Parameter
Standalone (Frequency)
95% CI

With Modification for Wrong-location Penalty)

* The 95% Confidence Interval (CI) was estimated conditioning on the obtained prevalence rates of

Standalone Sensitivity, Specificity, PPV, NPV


* The cut-off value used in the standalone study.

Standalone Sensitivity and Specificity by Using Different Cut-Off Points


Medical Devices - Application Of Risk Management To Medical Devices

Medical Device Software - Software Life Cycle Processes

Evaluation of automatic class III designation for OsteoDetect – Decision
summary with special controls


Guidance for Industry and FDA Staff - Guidance for the Content of
Premarket Submissions for Software Contained in Medical Devices.

Guidance for Industry and Food and Drug Administration Staff -
Computer-Assisted Detection Devices Applied to Radiology Images
and Radiology Device Data – Premarket Notification [510(k)]
Submissions.

Guidance for Industry and FDA Staff - Clinical Performance
Assessment: Considerations for Computer-Assisted Detection
Devices Applied to Radiology Images and Radiology Device Data
in - Premarket Notification (510(k)) Submissions.

The following guidance documents were used to support this submission:


Guidance for Industry and Food and Drug Administration Staff -
The 510(k) Program: Evaluating Substantial Equivalence in
Premarket Notifications [510(k)].

Draft Guidance for Industry and Food and Drug Administration
Staff - Content of Premarket Submissions for Management of
Cybersecurity in Medical Devices.


Description
Subject Device
Predicate Device

Change Healthcare Enterprise
Imaging Network (EIN) cloud
platform

Identify locations of
anatomical structures

Abdomen, breast (MR only),
calf, chest, elbow, foot, forearm,
hand, head, arm, knee, neck,
pelvis, shoulder, spine cervical,
spine thoracic, spine lumbar, and
thigh

Brain, Heart, Heart
Vasculature, Liver, Lung

currently marketed predicate device is provided in the table below:


Machine learning based
algorithm
(non-adaptive)


Comparison of Features between Proposed Subject Device and Predicate Device

Caption Health, Inc., Caption
Interpretation Automated
Ejection Fraction (“AutoEF
2.5”) (K210747) - Proposed
Device

Caption Health, Inc., Caption
Interpretation Automated
Ejection Fraction Software
Application (“AutoEF 2.0”)
(K200621) - Predicate Device

The Caption Health, Inc.
Caption Interpretation
Automated Ejection Fraction
software is used to process
previously acquired
transthoracic cardiac
ultrasound images, to store
images, and to manipulate
and make measurements on
images using an ultrasound
device, personal computer, or
a compatible DICOM-
compliant PACS system in
order to
provide automated estimation of
left ventricular ejection fraction.
This measurement can be used
to assist the clinician in a cardiac
evaluation.
The Caption Interpretation
Automated Ejection Fraction
Software is indicated for use in
adult patients.


Fully automated, including clip
selection

Ejection Fraction reported
Whole number estimate
Whole number estimate

Quantitative feedback
to enable clinician to
assess EF calculation

● Confidence Metric
● Qualitative Bin Likelihood

Network Architecture
Simple Pooling
Advanced Pooling

Radial-basis-function (RBF) Support
Vector Machine

Grayscaling done first and integer
resizing.

Floating point resizing and grayscaling
done at the end


Technological Characteristics Comparison
Design and Fundamental Scientific Technology

Predicate Device:
Incisive CT System
(K180015)

Proposed Device:
Precise Image software
application

Proposed device has scan
types found in the
predicate,

Scan data used for
reconstruction - Identical,

Surview
Axial-after-Axial
Dynamic Scan
Helical Scan

Low Contrast
Resolution (20 cm
Catphan
phantom)

Improved, better low
contrast resolution at lower
dose levels.

Noise in Standard
Mode (as
measured on
21.6 cm water-
equivalent)

Noise Reduction
and Low Contrast
Detectability

N/A – Standard mode
(baseline for claim)

achieving up to 85% lower
noise at 80% lower dose
and 60% better low
contrast detectability

Improved, better noise
reduction and low contrast
detectability

Where noise is reduced
by at least 50%, the
system shall shift the
noise power spectrum of
images by no more than
6% as compared to the
same data reconstructed
without Precise Image

Proposed device has scan
types found in the
predicate.

Scan data used for
reconstruction - Identical.


Submitter’s Name:
Eko.ai Pte. Ltd. (d/b/a Us2.ai)

2 College Road, #02-00, Singapore 169850

Trade name: EchoMD Automated Ejection Fraction
Software
Manufacturer: Bay Labs, Inc.
(now known as Caption Health, Inc.)
290 King Street
San Francisco, CA 94107
Regulation Number: 21 CFR 892.2050
Regulation Name: System, Image Processing, Radiological
Device Class: Class II
Product Code: LLZ
510(k) Number: K173780
510(k) Clearance Date: June 14, 2018


Software package that operates
utilizing off-the-shelf hardware

The software processes DICOM
compliant image data

The software is designed for use on
a personal computer that has been
received images from a compatible
PACS

Fully automated, including clip
selection

Manual editing
of automated
result by user

Table 5-2. Summary of Technological Characteristics Comparison.


Systolic Blood Pressure
112.0 (± 9.7) mmHg
124.6 (± 18.1) mmHg

Diastolic Blood Pressure
71.2 (± 7.9) mmHg
74.1 (± 11.5) mmHg


GE Medical Systems SCS
Establishment Registration Number ‐ 9611343
283, rue de la Minière
78530 Buc, France

Ning WEN
Regulatory Affairs Leader
GE Healthcare, (GE Medical Systems SCS)
Tel: +33 6 4637 3852
Email: ning.wen@ge.com

John Jaeckle
Chief Regulatory Affairs Strategist
Tel: +1 262 424 9547
Email: john.jaeckle@ge.com

Device Trade Name:
Common/Usual Name:
Regulation Number:
Product Code:
Regulatory Class:

FlightPlan for Liver
FlightPlan for Liver, with Parenchyma Analysis option
21CFR 892.2050, Medical image management and processing system
LLZ
Class II

Predicate Device:
Device Name:
Manufacturer:
510(k) number:
Regulation Number:
Product Code:
Regulatory Class:

FlightPlan for Liver
GE Medical Systems SCS
K121200
21CFR 892.2050, Medical image management and processing system
LLZ
Class II

Reference Device:
Device Name:
Manufacturer:
510(k) number:
Regulation Number:
Product Code:
Regulatory Class:

FlightPlan for Embolization
GE Medical Systems SCS
K193261
21CFR 892.2050, Medical image management and processing system
LLZ
Class II

In accordance with 21 CFR 807.92 the following summary of information is provided.


Multi‐modality 3D review &
comparison of CBCT, CT, MR,
PET, NM datasets

Semi‐automatic segmentation
of the liver arterial tree

the predicate device and the proposed device:


Semi‐automatic segmentation
of “vicinity vessels”

Ability to manually add and
remove “vicinity vessels”

Segmentation and selective
display of parts of the
vasculature

Yes, using tool for Live Tracking of vessels.

Deep learning‐based full Liver
Segmentation

No, full liver
segmentation can only
be done manually.

Yes, DL based automated segmentation of
the full liver.

Selective display of the
estimated distal liver region
(Virtual Parenchyma)

Yes, the non‐deep learning Virtual
Parenchyma Visualization algorithm
selectively displays, for visualization
purposes, the estimated distal liver region
adjacent to the distal parts of the
computed skeleton of the vessel
segmentation (Virtual Parenchyma).

510(k) Premarket Notification Submission


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Common Name
Medical Image Processing Software

Classification Name
System, Image Processing, Radiological

Medical image management and processing system


Device
Multi-Modality Tumor Tracking (MMTT)


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