M
Hi Everyone,
I'm wondering if it's possible to select predicate devices in a different use-category, only as they pertain to demonstrating the safety of a specific element/feature of the device being approved.
Consider the following (hypothetical) example:
I am developing a new knee-brace.
Its main differences from the competition is that it uses a special cotton liner, and the hinges are a new type of metal.
So, the potential risks might relate to biocompatibility of the cotton, and strength of the metal.
I can't use another knee-brace as predicate, because none on the market use either of these materials. BUT: there are band-aids that use the cotton, and crutches that use the metal.
Obviously, band-aids and crutches have totally different intended uses from knee-braces. However, with respect to the risks associated with the materials, these do demonstrate a history of safe use (biocompatibility wrt the cotton, and strength wrt the metal).
...long winded example, I know. But I think it illustrates the point. Technologies can be used in devices with completely different categorization/uses, but still serve the same function. In such cases, is it possible to select predicates outside the intended-use of the device in question?
Thanks,
MM
I'm wondering if it's possible to select predicate devices in a different use-category, only as they pertain to demonstrating the safety of a specific element/feature of the device being approved.
Consider the following (hypothetical) example:
I am developing a new knee-brace.
Its main differences from the competition is that it uses a special cotton liner, and the hinges are a new type of metal.
So, the potential risks might relate to biocompatibility of the cotton, and strength of the metal.
I can't use another knee-brace as predicate, because none on the market use either of these materials. BUT: there are band-aids that use the cotton, and crutches that use the metal.
Obviously, band-aids and crutches have totally different intended uses from knee-braces. However, with respect to the risks associated with the materials, these do demonstrate a history of safe use (biocompatibility wrt the cotton, and strength wrt the metal).
...long winded example, I know. But I think it illustrates the point. Technologies can be used in devices with completely different categorization/uses, but still serve the same function. In such cases, is it possible to select predicates outside the intended-use of the device in question?
Thanks,
MM