FDA releases solid-state 510(k) draft

The Food and Drug Administration has readied a draft guidance for the submission of 510(k) applications for solid-state x-ray detectors. Published in the Federal Register on Oct. 1, the draft guidance addresses the type of data needed by the agency's Center for Devices and Radiological Health to establish the substantial equivalence of a solid-state x-ray detector to a previously cleared conventional radiographic screen-film system, fluoroscopic image-intensified imaging system, or another solid-state x-ray system.

As found on CDRH's Web site (www.fda.gov/cdrh), the draft guidance states that in addition to meeting regulatory requirements such as the performance standards for ionizing radiation-emitting products, the application must meet both nonclinical and clinical considerations for establishing equivalence to radiographic screen-film or fluoroscopic image-intensifying systems.

Nonclinical considerations for both fluoroscopic and radiographic applications include physical, operational, functional, and exposure characteristics, safety features, and test results.

Clinical considerations for fluoroscopic applications include:

• results of a study of 30 or more clinical image pairs showing the ability of the device to provide images of equivalent diagnostic ability to those of a cleared predicate device;
• representative sets of sample images for each anatomical region indicated for the device; and
• any other clinically significant findings that are discovered in the process of using the device.

The same clinical considerations are required for radiographic applications, although the representative sets of images are a suggested inclusion.

Information on labeling and promotional materials, as well as installation instructions, should also be provided, according to the draft. A complete description of the device's quality assurance program should be included.

Comments on the draft guidance can be sent to Robert Doyle at the Center for Devices and Radiological Health (HFZ-476), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. The deadline for comments is Dec. 30.