Guidance: Class II Special Controls Guidance Document: Full Field Digital Mammography System

For questions regarding this document contact Mary Pastel (OIVD) at 301-796-6887 or by e-mail at [email protected] or Kyle J. Myers (OSEL) at 301-796-2533 or by e-mail at [email protected].

This document supersedes “Class II Special Controls Guidance Document: Full-Field Digital Mammography System,” issued November 5, 2010.
 

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Division of Imaging and Applied Mathematics
Office of Science and Engineering Laboratories (OSEL)

Preface

Public Comment

You may submit written comments and suggestions at any time for Agency consideration to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, (HFA-305), Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. Identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register. Comments may not be acted upon by the Agency until the document is next revised or updated.

Additional Copies

Additional copies are available from the Internet. You may also send an e-mail request to [email protected] to receive an electronic copy of the guidance or send a fax request to 301-827-8149 to receive a hard copy. Please use the document number (1616) to identify the guidance you are requesting.

Table of Contents

1. INTRODUCTION
2. BACKGROUND
3. SCOPE
4. DESCRIBING YOUR DEVICE IN A 510(K) PREMARKET NOTIFICATION
   • INDICATIONS FOR USE
   • DEVICE DESCRIPTION
   • DESCRIPTIONS COMMON TO INTEGRATED DETECTOR AND DETECTOR-ONLY SYSTEMS
     • Detector
     • Flat Field Correction and Pixel Defects
     • Image Acquisition
   • DESCRIPTIONS SPECIFIC TO INTEGRATED SYSTEMS
     • X-ray Unit
     • X-ray Tube
     • X-ray Generator
     • X-ray Anti-Scatter Grid
     • Breast Compression System
     • Principles of Operation
     • Software
   • DESCRIPTIONS SPECIFIC TO DETECTOR-ONLY SYSTEMS
5. RISKS TO HEALTH 
6. ELECTRICAL SAFETY
7. BIOCOMPATIBILITY
8. PHYSICAL LABORATORY TESTING
   • SENSITOMETRIC RESPONSE
   • SPATIAL RESOLUTION
   • NOISE ANALYSIS
   • SIGNAL-TO-NOISE RATIO TRANSFER – DQE
   • DYNAMIC RANGE
   • IMAGE ERASURE AND FADING
   • REPEATED EXPOSURE TEST
   • AUTOMATIC EXPOSURE CONTROL PERFORMANCE
   • PHANTOM TESTING
   • PATIENT RADIATION DOSE
   • BREAST COMPRESSION SYSTEM
9. CLINICAL IMAGE EVALUATION
10. LABELING
    • INDICATION FOR USE
    • PRECAUTIONS
    • DEVICE DESCRIPTION
    • DEVICE INFORMATION
    • SUMMARY OF PHYSICAL LABORATORY TESTING
    • SUMMARY OF CLINICAL IMAGE EVALUATION
    • DIRECTIONS FOR USE
    • ADDITIONAL INFORMATION

APPENDIX A – RECOMMENDED MAMMOGRAPHY READER QUALIFICATIONS

Guidance for Industry and FDA Staff

Class II Special Controls Guidance Document: Full-Field Digital Mammography System

1 and the Premarket Notification 510(k) section of CDRH’s Device Advice web page.²

3 in the proposed new regulation 21 CFR 892.1715, product code MUE.

21 CFR 892.1715 – Full-Field Digital Mammography System.

(a) Identification. A full-field digital mammography system is a device intended to produce planar digital x-ray images of the entire breast. This generic type of device may include digital mammography acquisition software, full field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories.

(b) Classification. Class II (special controls). The special control for the device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Full-Field Digital Mammography System.”⁴ See §892.1(e) for the availability of this document.

A mammography system usually consists of an x-ray generator, x-ray control, x-ray tube, collimator, beam filter, breast compression system, grid, image receptor system, and accessories. In the case of integrated FFDM systems, the image receptor system consists of a built-in full-field solid state detector, acquisition software, acquisition work station, and accessories. In the case of detector-only type FFDM systems, the image receptor system consists of a removable solid state detector, detector readout device, acquisition and readout software, acquisition work station, and accessories.

This guidance does not cover display accessories to an FFDM System, i.e., softcopy output devices (monitors), hardcopy output devices (printers), and review workstations. These devices are classified as class II; see 21 CFR 892.2040 and 21 CFR 892.2050. For softcopy (monitors) and hardcopy (printers) output devices, image review manipulation software, and review workstations, please refer to the FDA guidance entitled “Display Accessories for Full-Field Digital Mammography Systems – Premarket Notification [510(k)] Submissions.”⁵

6 and “ Guidance for Off-the-Shelf Software Use in Medical Devices.⁷” The information you should submit is determined by the “level of concern,” which is related to the risks associated with software failure. The level of concern for an FFDM system is moderate.

Descriptions Specific to Detector-Only Systems

For detectors intended to be used with conventional mammographic x-ray systems, as direct replacements for the film/screen cassettes [such as computed radiography (CR) plate/reader/display systems], you should list the x-ray system specifications and performance requirements necessary to assure the proper function of the mammographic system using your detector-only system. Given the range of mammographic x-ray systems that can be used with your detector, describe in as much detail as possible the procedure to be used for calibrating the AEC function. Describe the tests and target values for radiation dose as a function of breast thickness and composition that are to be used to verify proper AEC performance. Also indicate whether the user needs to do anything other than follow the x-ray device’s instructions to calibrate the AEC for your detector.

8 or provide equivalent testing information.

9 We recommend that the observers participating in the rating experiment have experience (please describe) in evaluating images of the phantom selected. We also recommend that you provide a description of the soft-copy and hard-copy display systems used in the phantom image evaluation.

Test results may be presented in the form of a C-D diagram or using the image quality factor (IQF) method described in Thomas, et al.,¹⁰ or both. A C-D diagram is a plot of the minimum detectable target thickness or contrast as a function of target size. If you use the IQF evaluation method, calculate the IQF at a diameter no larger than 1.8 mm and a thickness no larger than 0.25 μm. According to Thomas et al., the k factor is the product of the thickness and the diameter of the smallest correctly identified disks in the phantom. If you follow this methodology, we recommend using a k factor of 60 μm ² but not greater than 80 μm ².  We recommend that multiple readers examine multiple images of the phantom and score each of them. We also recommend that you estimate the error bars on your results. In addition, you should perform these scoring tests at multiple exposure levels typical for mammography.

In accordance with 21 CFR 807.87(l), we may request that you provide representative phantom images acquired with your FFDM device.

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sharpness, assessing the edges of fine linear structures, tissue borders, and benign calcifications;

tissue visibility at the skin line;

noise, i.e., noise obscuring breast structures or suggestive of structures not actually present;

artifacts due to image processing, detector failure and other factors external to the breast on hard-copy and soft-copy displays; and

overall clinical image quality.

The associated information provided should include compressed breast thickness, x-ray exposure conditions (anode, filter, kVp, mAs, exposure, half-value layer), and estimated dose, for each image.   For detectors-only type FFDM systems,  breast positioning and breast compression do not have to be included in the image evaluation.

Any issue with image evaluation should be fully explained by the expert mammographic radiologists.

Investigations involving clinical subjects must comply with 21 CFR Parts 50 and 56.

If the physics laboratory testing or clinical image evaluation raise any specific concerns between your device and the predicate device, you should meet with the Division of Radiological Devices, OIVD, to discuss your options.

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Your user manual should include the information described below.

Guidance for Industry and FDA Staff Format for Traditional and Abbreviated 510(k)s.

Device Advice: Premarket Notification 510(k).

Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Full-Field Digital Mammography System

Guidance for Industry and FDA Staff: Display Accessories for Full-Field Digital Mammography Systems-Premarket Notification (510(k)) Submissions

Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

Guidance for Off-the-Shelf Software Use in Medical Devices

Use of International Standard ISO-10993, ‘Biological Evaluation of Medical Devices Part 1: Evaluation and Testing’ (Replaces #G87-1 #8294) (blue book memo)

⁹ A radiographic anthropomorphic phantom that meets the requirements of 21 CFR 892.1950.

¹⁰ Thomas, J. A., Chakrabarti, K., Kaczmarek, R., and Romanyukha, A., “Contrast Detail Phantom Scoring Methodology,” Med. Phys. Vol 32 (3), pp 807-814, 2005.

¹¹ Mammography Quality Control Manual, Clinical Image Quality, American College of Radiology, 1999, pp. 79-112.

¹² In the case of soft-copy display, image contrast assessment may require adjustment of the window and level settings.

¹³ Although final labeling is not required for 510(k) clearance, final labeling must comply with the requirements of 21 CFR Part 801 before a medical device is introduced into interstate commerce. In addition, final labeling for prescription medical devices must comply with 21 CFR 801.109. Labeling recommendations in this guidance are consistent with the requirements of Part 801.