On February 9, 2016, the FDA published a draft guidance entitled “Display Devices for Diagnostic Radiology.” The document, which will replace a 2008 guidance (“Display Accessories for Full-Field Digital Mammography Systems – Premarket Notification (510(k)) Submissions”), outlines what information should be included in 510(k) submissions for display devices used in diagnostic radiology.
Display devices, also referred to as soft-copy displays or medical grade monitors, “are used to display, store, transfer, or process medical images and are commonly used by radiologists to make diagnoses,” as defined by RAPS. These devices use LCD and LED technology to display images, which are then enhanced and analyzed using communication and storage hardware and software.
Display devices for diagnostic radiology are classified by the FDA “as class II devices that are intended to use used in controlled viewing conditions to display and view digital images for primary image interpretation.” Typically, 510(k) submissions for display devices are separate from those of other image acquisition or management devices. “However, this guidance may apply when displays intended for diagnostic interpretation classified under 892.2050 (product code, PGY) are included as part of a 510(k) submission along with other software and/or hardware.”
Describing Display Devices in a 510(k) Premarket Submission
The draft guidance provides a number of recommendations regarding the description of the device that is included in the submission. The Agency requires sponsors to provide information that shows how the device is substantially equivalent (SE) to a predicate device in their submission, and advises that they include the following information:
Indications for Use (IFU):
The IFU should clearly state whether or not the device is intended for mammography. If the device is intended for mammography, the IFU should address how the device will be used, such as:
- “The ________ is indicated for use in displaying radiological images (including mammography) for review, analysis, and diagnosis by trained medical practitioners.”
An example of the IFU for devices not indicated for mammography is:
- “The ________ is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.”
A complete description of the device should be provided in the 510(k), including the following information:
- Display Technology: A description of the technological characteristics of the display device (e.g., in-plane switching LCD panel with TFT active-matrix array with CCFL backlight).
- Screen size: A description of the physical size of the viewable area in diagonal and aspect ratio.
- Backlight type (transmissive displays only): A description of the backlight type and, if substantially different from the predicate device, main properties including temporal, spatial, and spectral characteristics.
- Frame rate and refresh rate: A description of the frame rate and refresh rate.
- Pixel array, pitch, subpixel pattern, pixel aperture ratio: A description of the pixel array including pixel size, pixel pitch, and subpixel pattern (e.g., chevron, RGBW);
- Subpixel driving (spatial and temporal dithering): A description that indicates if the subpixels are used to improve gray-scale or temporal resolution.
- Display Interface: A description of the display interface (e.g., DVI, display port, HDMI).
- Video bandwidth: A description of the capabilities of the information transfer pipeline between the image source and the digital driving levels in all associated components including the CPU/GPU, graphics card, and display interface.
- User controls: A description of either the on-screen display (OSD) or software available for end users that relate to the display image quality (e.g., brightness and contrast controls, gamma, white point, power saving options, etc.).
- Ambient light sensing: A description of the ambient light sensing method, instrumentation, and software tool description.
- Touch-screen technology: A description of the method, functionality, and any calibration or periodical re-tuning requirements.
- Luminance calibration tools: A description of the sensor hardware and associated software for performing luminance calibration, and if applicable, details about the user-level procedures, service-action tolerances, and centralized automatic calibration tools.
- Quality-control procedures: A description of the frequency and nature of quality-control tests to be performed by the user and/or the physicist with associated action limits. A detailed quality control manual should be included for regulatory review.
- Software/Firmware: A list with descriptions of any additional firmware or software features for image manipulation or analysis not covered by any of the above items.
In addition to the items listed above, the guidance provides the following recommendations regarding the contents of 510(k) submissions for display devices:
FDA recommends that the electrical safety of devices be evaluated according to the most recent FDA recognized standards contained within FDA’s Recognized Consensus Standards Database.
Firmware & Software Documentation
The 510(k) should include documentation for the software and firmware that has been developed for use with the device in question. The type of information that should be submitted is determined based on the risks associated with a potential software failure by the device.
“Display devices intended for diagnostic radiology may include firmware and software for the following functionalities:
- Display controls;
- Ambient light sensing;
- Luminance calibration tools; and/or
- Quality-control software.”
Physical Laboratory Testing
The Agency recommends that sponsors provide data for a variety of performance tests, along with a side-by-side comparison of the same data for the predicate device.
For additional information, view the FDA’s full draft guidance.