UC-423
510(k) Predicate and Equivalence Pack
Finds comparable cleared devices, lines up technological characteristics side by side, and drafts the substantial equivalence table.
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The Challenge
Choosing the wrong predicate costs a submission cycle and months of market entry. Predicate reasoning sits with a few regulatory staff and the public clearance record is never searched the same way twice.
How It Works
- Reads the public clearance record, product codes, decision summaries and subject device inputs.
- Scores candidate predicates on indications, technology and product code, ranking risk.
- Hands regulatory affairs a ranked predicate shortlist and drafted table, every claim cited.
What It Removes
- Manual keyword searches of the public clearance record
- Hand-built comparison tables of device characteristics
- Re-deriving the equivalence rationale for each reviewer
Input Data RequirementsPublic device clearance database, product code and panel taxonomy, decision summaries, subject device design inputs, test reports, prior submissions
Output FormatRanked predicate shortlist with rationale, drafted substantial equivalence comparison table, gap list of tests still required before filing
“Picking a predicate is a judgement call we make from memory, then spend six weeks defending it in writing”