IDE Software Submission Core - Manifest¶
| Field | Value |
|---|---|
| Package | IDE Software Submission Core |
| Status | Approved FDA-facing software package; operational follow-through is listed in the canonical decision register |
| Baseline tag | ide-software-freeze-2026-08-21 |
| Baseline commit | 91c0e98a9bc9429a0486bebdebffc7d8dbbe300e |
| Last product-source commit in frozen baseline | ae00e754 |
| Prepared by | Software Developer |
| Date | 2026-09-08 |
Purpose¶
This manifest defines the FDA-facing software package and its reading order before the technical appendices.
Included Core Documents¶
| Order | Document | Purpose |
|---|---|---|
| 1 | IDE Software Submission Core | Integrated device, baseline, scope, risk, cybersecurity, testing, anomaly, human-factors, and limitation narrative |
| 2 | Human Factors and Use-Related Risk Summary | Study users, critical tasks, use hazards, controls, available evidence, approved evidence boundary, and residual risks |
| 3 | Known Anomalies and Residuals | Current unresolved anomalies, accepted residual behaviors, and explicit deferrals |
| 4 | Cloud Telemetry Submission-Scope Decision | Clinically approved supportive Scout role and official study-data sources |
| 5 | Protocol Fingerstick Consistency Issue | Resolved software-consistency review and external controlled-document/FDA-IRB handoff |
| 6 | IDE Submission Decision Register | Canonical approvals, closure records, and predeployment follow-through |
Referenced Controlled Material¶
- IDE Software Technical Appendices Manifest (appendix index)
- BionicLoop Instructions for Use, IFU-BL-001, revision 1.17, approved for IDE submission on 2026-09-04
- Technical Appendix A11, IDE Freeze Execution Report - 2026-08-21
Package Status¶
The baseline is frozen and verification execution is complete.
Build 843 has controlled source and archive identities, exact dependency
resolution, passing automated results, installed-build evidence, and focused
real-Pod evidence. Build 843 and the ZIP/CSV operating approach were approved
on 2026-09-03; IFU revision 1.17 was approved on 2026-09-04. The RA-023
submission disposition and the evidence, residual-risk, cybersecurity,
service-environment, approver, and synchronized-label decisions are closed in
the canonical decision register. The controlled multi-G7 exercise remains a
predeployment condition, and external submission assembly remains with the
study team.