Question stringlengths 13 1.05k ⌀ | Answer stringlengths 2 801 ⌀ |
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What does the classification regulation designate this guidance document as? | the special control |
What does the firm need to show that its device addresses the issues of safety and effectiveness identified in this guidance? | The firm will need to show that its device addresses the issues of safety and effectiveness |
What are biomarker tests that rely on biological imaging assessments called? | MRI |
What must a manufacturer do to ensure the safety and effectiveness of full-field digital mammography devices? | conform to the general controls of the FD&C Act, including the premarket notification requirements |
What is the 21 CFR 807 Subpart E of the 21 CFR 807 Subpart E of the 21 CFR 807 Subpart E of the 21 CFR 807.81? | 21 CFR 807.87 |
What is the scope of this document limited to? | FFDM systems |
What is a full-field digital mammography system intended to produce? | planar digital x-ray images of the entire breast |
What is the FDA guidance document entitled? | Class II Special Controls Guidance Document: Full-Field Digital Mammography System |
What is the acquisition work station used for? | acquisition work station |
What is the detector readout device? | removable solid state detector |
What is the class of devices that display accessories to an FFDM System? | class II |
What should you identify your device by in a 510(k) premarket notification? | regulation and product code |
What is the (device name) intended to be used in the same clinical applica? | The (device name) |
What may require longer periods of time to evaluate? | clinically meaningful outcomes |
What is the screening use of an FFDM system? | An FFDM system can be indicated for screening use only or for both screening and diagnostic uses |
What is the amorphous silicon with deposit of cesium iodide? | cesium iodide |
What is the size of active area? | pixel dimensions and fill factor |
What is the flat-field correction procedure called? | the flat-field correction procedure |
What is the ADC? | bit depth, matrix size, and pixel width |
What is SID? | source to patient support device distance |
What should you describe for the x-ray tube if manufactured by a third party? | trade name and model |
What is the AEC detector used for? | low level pre-exposure |
What is acceptable if an alternative method is chosen? | it should be described completely |
What should describe the paddle types, sizes, geometries, and materials? | breast compression system |
What should be well established evidence and agreement in the clinical community that the chosen biomarker test reflects a characteristic that is important to 6 the underlying disease process and that it is associated with a? | the chosen biomarker test |
What is the level of concern? | the risks associated with software failure |
What is the replacement for film cassettes for detectors intended to be used with conventional mammographic x-ray systems? | computed radiography (CR) plate/reader/display systems |
What is the radiation dose a function of? | breast thickness and composition |
What measures are described in this guidance document? | measures recommended to mitigate these identified risks |
What is the name of the standard that should be used to evaluate the electrical safety of your device? | Clinical Image Evaluation 8. Physical Laboratory Testing Inadequate breast coverage 9. Clinical Image Evaluation Excessive x-ray exposure 8. Physical Laboratory Testing Inappropriate breast compression 8. Physical Laboratory Testing 7. Biocompatibility Testing Infection, skin irritation 10. Labeling 6. Electrical Safe... |
What is the Collateral standard? | Safety requirements for medical electrical systems |
What should you assess in your physical laboratory? | imaging characteristics of your system |
What should you describe as general guidance for these tests? | all phantoms |
What is a phantom? | Mammography Accreditation Program (MAP) phantom |
What should be performed under conditions that match the intended clinical use of the system? | testing |
What is the system code NFJ? | System, Image Management, Ophthalmic |
What is the MDDT program? | The FDA’s Medical Device Development Tools |
What should you report if you were to assess imaging performance? | the trade name, characteristics |
What should you provide quantitative data on? | sensitometric response |
What is the NPS? | noise power spectrum |
What is the measure of the efficiency of signal-to-noise ratio? | SNR |
What is the exposure level chosen from those used in clinical practice called? | the “reference” level |
What should you provide a quantitative measure of? | dynamic range |
What is a function of the number of erasures and exposures? | tests of image retention |
What should you provide results of with 100 or more repeated exposures and erasures showing that there are no residual or ghost images? | null |
What should you provide results of with 100 or more repeated exposures and erasures showing that there are no residual or ghost images? | Repeated Exposure Test |
What should you provide to evaluate AEC performance? | data sets for a range of thicknesses from 2 to 6 cm of a homogeneous material at standard mode and magnification mode if available |
What should be provided for imaging of the ACR MAP phantom and for the wax target plate of the phantom? | null |
What should clinical outcome assessments consist of? | direct quantitative measurement of the effect of a treatment upon disease progression and its impact upon the patient |
What should be included in the results of the AEC system if it has more than one mode of operation? | Exposure conditions and dose |
What is a C-D diagram? | a plot of the minimum detectable target thickness or contrast as a function of target size |
What is the k factor not greater than? | 80 m2 |
What is the minimum exposure level for FFDM devices? | 21 CFR 892.1950 |
What should your testing simulate? | 2, 4.2, and 6 cm thick compressed breasts |
What is the resulting patient radiation dose? | exposure level at the entrance surface of the phantom along with the resulting patient radiation dose |
What is the minimum and maximum powered compression? | Breast Compression System |
What is the purpose of this evaluation? | to determine if the FFDM images, when reviewed by expert radiologists, are judged to be of sufficiently acceptable quality for mammographic usage that they are substantially equivalent in safety and effecti |
What is the new device substantially equivalent in safety and effectiveness to? | laboratory performance of the predicate device |
What are the names of the craniocaudal and mediolateral oblique views? | craniocaudal (CC) and mediolateral oblique (MLO) views |
What should be considered when developing clinical effectiveness endpoints? | The patient population, the nature of the underlying condition, and how they will be studied over time |
How many expert mammographic radiologists should review clinical images submitted for MQSA accreditation? | two |
What is the verall assessment of whether these image sets collectively are of sufficiently acceptable quality for use in clinical mammography and to allow determination of substantial equivalence to a predicate device? | breast positioning |
What should the associated information include for each image? | compressed breast thickness, x-ray exposure conditions (anode, filter, kVp, mAs, exposure, half-value layer), and estimated dose |
What should be fully explained by the expert mammographic radiologists? | mammography quality control manual |
What must labeling satisfy? | 21 CFR 807.87(e) |
What should be discussed with the precautions regarding the potential for adverse events associated with the use of the device and mitigation measures? | The adverse events should include: • excessive breast compression; • excessive x-ray exposure; • electric shock; • infection; and • skin irritation, abrasions or puncture wounds |
What should you list for detector-only systems? | the x-ray system specifications and performance requirements |
What is the purpose of the ation dose? | to be used to verify proper AEC performance |
What should you include a summary of? | sensitometric response |
What is the patient population used for? | age, ethnic origin |
What should labeling of the device be consistent with? | manner in which it was studied |
What should be encouraged in the instructions? | local/institutional training programs |
What is the AEC? | Automatic Exposure Control |
How long have you been practicing radiology since residency? | at least five years |
What is the name of the department that evaluates Cardiovascular Devices? | Food and Drug Administration Center for Devices and Radiological Health Office of Device Evaluation Division of Cardiovascular Devices Cardiac Electrophysiology and Monitoring Branch 1 Preface Public Comment: What is the name of the department that evaluates Cardiovascular Devices |
Where can you submit electronic comments for Agency consideration? | Division of Dockets Management, Food and Drug Administration |
Where can you get ional copies of the guidance? | the Internet |
What does not apply to electrodes or dispersive pads used for defibrillation, pacing, or cardioversion? | This guidance |
What does this guidance document describe? | a means by which ECG electrodes may comply with the requirement of class II special controls (513(a)(1)(B) of the act |
What must a manufacturer submit to provide equivalent assurances of safety and effectiveness? | a 510(k) |
What must a class II device comply with as a class II device? | general and special controls |
What is a disease-altering benefit? | treatment of the underlying disease or condition |
What does FDA recommend that manufacturers document how they address the recommendations in their design history file? | how they address the recommendations in this special controls guidance |
Who does not need to submit a 510(k) to FDA and receive agency clearance prior to marketing a device of this type? | persons who intend to market a device of this type |
What is the scope of this document limited to? | ECG electrodes |
What are generally used to deliver a small amount of alternating current with a high frequency? | Bioimpedance electrodes |
What is the scope of electrodes used for? | external pacing or other treatment effect |
What is the FDA recommend to mitigate the risks identified in this guidance document? | 5 Recommended mitigation measures Identified risk Adverse tissue reactions to the skin-contacting Section 5. Performance Characteristics electrode materials Section 6. Labeling Section 5. Performance Characteristics Misdiagnosis Section 6. Labeling Section 5. Performance Characteristics Electrical shock 21 CFR 898 P A... |
What must you maintain for each type of device? | device specifications, including appropriate drawings |
What should be included in the cription? | a listing of all features and specifications of the device (a tabular format is desirable) |
What is the 21 CFR 820.20? | Quality Systems Requirements |
What is the type of electrodes? | bare |
What is the FDA's recommendation for early engagement with CDRH? | to obtain more detailed feedback |
What should not cause an irritating, sensitizing or cytotoxic effect upon the skin? | null |
What should not allow irritating sensitizing, or cytotoxic materials to enter the skin by iontophoresis? | electrodes |
What is the electrolytic composition of some electroconductive gels that contain high levels of saline? | saline |
What should the design of the electrode ensure? | it will adhere to the patient’s skin for the duration of use compatible with the intended use of the device |
What do you test if the electrode is intended to be used on a diaphoretic patient or during strenuous exercise? | adhesive performance |
What should monitor the critical parameters of your final finished disposable ECG electrode to assure adequate device performance during its entire shelf-life? | Stability studies |
What should be supported and validated by real-time shelf life testing? | accelerated shelf life testing |
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