The first thing I would do is slow down and identify the actual regulatory question. First establish intended use and risk. Search for a suitable predicate. If there is one, assess substantial equivalence. If none exists and risk is low to moderate, evaluate De Novo. Higher-risk products may require PMA
The first thing I would do is slow down and identify the actual regulatory question. Write your proposed intended use. Search FDA 510(k) summaries and the classification database. Shortlist legally marketed devices, compare intended use and technology, and identify differences that may raise new safety or effectiveness questions. That gives you something you can check, discuss, and defend rather than an answer based on memory.
