Before marketing a medical device, manufacturers must ascertain if their product necessitates a Premarket Approval application (PMA) or a 510(k) submission. The 510(k) process entails submitting a premarket application to the U.S. Food and Drug Administration (FDA) to establish that the new medical device is substantially equivalent to a legally marketed “predicate” device in terms of intended use and technological characteristics.
In this instance, a goniometer within the FDA database (Figure 1) was identified as a suitable predicate for the proposed product. (Zhu, 2021) The approved predicate device is classified under Class I, implying that the new goniometer should also be similarly categorized. Both the predicate device and the proposed product exhibit analogous functionality and applications.
To proceed with the 510(k) submission, manufacturers must compile the necessary documentation, consisting of:
- Comprehensive description: This encompasses the design, components, materials, and operating principles of the new device.
- Substantial equivalence explanation: A comparative analysis of the proposed device and the predicate device, demonstrating their identical intended use and analogous technological characteristics.
- Performance testing: Data from the bench and clinical testing to substantiate the safety and efficacy of the proposed device. This includes information on biocompatibility, sterilization, and shelf life, as well as software, electromagnetic compatibility, and electrical safety data, if applicable.
Once the 510(k) submission is assembled, it should be submitted to the FDA along with the requisite fee. The FDA will evaluate the submission and may request additional information if needed. Upon completion of the review process, the FDA will issue a decision under the Medical Device User Fee Amendments (MDUFA). If the proposed device is deemed substantially equivalent to the predicate device, it will receive 510(k) clearance, permitting the manufacturer to market the device within the United States.
Figure 6. Information about the predicate of our product.