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510(k) Evidence Mapping
Describe the device, predicate context, clinical evidence available, performance testing complete, and known differences from the predicate. Get a Substantial Equivalence map (intended use + side-by-side technological characteristics), evidence gaps with FDA expectations and next steps, and Q-Sub topics that would meaningfully change submission strategy.
✓ Different-questions-of-safety-and-effectiveness analysis explicit✓ Subgroup performance flagged as P0-level gap area✓ Q-Sub (pre-submission) topics surfaced for FDA input
Results in ~45 seconds · Saves ~3 days per submission