FDA 510(k) TraceMatrix
11 traceability gaps in the Aerion SW-2 wrist pulse oximeter design controls (6 high): 6 of 9 design inputs verified, 4 of 5 user needs validated, 3 of 6 risk controls verified.
Followed the parent IDs of DI-108 up the requirements list: no parent ID is given, so it reaches no user need. Every design input must trace to a user need (820.30(c), ISO 13485:2016 7.3.3).
Method1Design inputs trace to user needs through their parent IDs; a chain of design inputs is followed up to the first user need (21 CFR 820.30(c), ISO 13485:2016 7.3.3).
2Each design input needs at least one verification test and each user need at least one validation test; a requirement counts as verified or validated only when every linked test passed (820.30(f) and (g), ISO 13485:2016 7.3.6 and 7.3.7).
| Gap | Item | Detail |
|---|---|---|
| Design input with no user need | DI-108 | DI-108: no parent ID is given. |
| Design input with no user need | DI-109 | DI-109: parent UN-08 is not in the requirements list. |
| User need with no design input | UN-05 | UN-05 is not decomposed into any design input. |
Requirements, risk controls and verification test exports (CSV)
Traceability matrix and a design controls gap list (QMSR, formerly 21 CFR 820.30) (Traceability matrix (CSV), Gap list (CSV), Coverage and gaps (JSON))
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