Extract to table

The checklist will serve as the master tracking document for all cybersecurity documentation that must be included in the complete 510(k) premarket notification, with a target FDA clearance date of Q3 2026

Accordingly, the System must be treated as a "cyber device" within the meaning of the Guidance, and the 510(k) submission must include a comprehensive cybersecurity section addressing all applicable requirements

The patch management plan and software update architecture documentation (addressed in Section VIII of this memorandum) must reflect post-market cybersecurity management considerations

Connection to Other Submission Requirements The cybersecurity documentation described in this checklist does not exist in isolation but must be integrated with and cross-referenced to several other components of the 510(k) submission

The Solstice QMS must reflect these expectations, and the 510(k) submission should demonstrate that cybersecurity has been integrated into the design controls framework

The cryptographic and authentication capabilities of the C14 Sensor are necessarily limited by these resource constraints, and the cybersecurity design must account for these limitations while still achieving an acceptable level of security for the BLE 5