Extract to table

We note that CDRH's own guidance on the 510(k) program acknowledges the acceptability of multiple predicate references and that the Agency has not taken the position that a single predicate must be identical in all respects to the subject device

This distinction must be clearly articulated in the Pre-Sub meeting package and reinforced during the Pre-Sub meeting itself

Most Likely FDA Position The software documentation question is an area where FDA's expectations have evolved significantly in recent years, and Solstice must ensure that its approach reflects the current regulatory framework rather than historical practices

This documentation should include, at a minimum: • Software requirements specification (SRS) for each component • Software architecture design document • Detailed software design document • Software development plan and software development environment documentation • Software verification and validation (V&V) protocols and test reports • Requirements traceability matrix linking requirements to design elements, verification tests, and risk controls • Unresolved software anomaly analysis (open bug list with risk assessment and disposition) • Software revision history and change control documentation • Software of Unknown Provenance (SOUP) analysis for any third-party software components or libraries This documentation must be provided for each of the four software components: Lumina Firmware v3

) must confirm by May 15, 2025 whether any AI/ML components are incorporated into LuminaPredict v2

That analysis identified the following potential gaps that must be addressed before the 510(k) submission: (a) The software architecture documentation for the Lumina Mobile App v1