FDA Issues Final Guidance on 510(k)s for Solid State X-ray Devices

After issuing draft guidance almost 16 years ago, the FDA issued final guidance that clarifies data required for 510(k) submissions for solid state x-ray imaging devices.

The FDA anticipates a significant number of 510(k) submissions as SSXI technology continues to evolve and replace conventional film/screen x-ray devices.

The guidance clarifies the type of data needed to establish substantial equivalence to a previously cleared conventional radiographic film/screen and image intensifier based fluoroscopic and image recording systems.

SSXIs indicated for mammography do not fall within the scope of the guidance.

The devices covered by the guidance are solid state transducers that intercept x-ray photons and convert them into electrical signals that create visible images.

Product code 90 MQB has been established for SSXIs, and they are currently classified as Class II devices.

Sponsors should submit the following nonclinical information to the FDA to determine equivalence to a predicate device: physical characteristics; operational functions; functional characteristics; exposure characteristics; safety features; and test results.

Clinical information should also be included if the nonclinical information alone is not sufficient. The guidance notes two options for providing clinical information:

• A concurrence study with 30 or more clinical image pairs that show how the images compare to the cleared devices; and sample images submitted for each anatomical region that is indicated for the device; or
• Qualified expert evaluation. A qualified expert is a U.S. board-certified radiologist or equivalent qualification.

Submissions should also include a complete description of the quality assurance program recommended to the user as well as labeling information.

Read the final guidance here: www.fdanews.com/09-02-16-Xrayguidance.pdf. — Tamra Sami