IDE Software Scope and Deferred Items¶
Status: Reviewer summary Updated: 2026-09-08
In Scope¶
| Topic | Current position |
|---|---|
| Local app, runtime, algorithm host, and device integration | Included |
| Runtime scheduling, persistence, relaunch, and guarded pump commands | Included |
| CGM acquisition, manual BG, and G7 replacement acquisition | Included; RA-023/D06 identify the accepted limitations and required predeployment exercise |
| Meal lifecycle and interrupted issued-dose attribution | Included |
| Programmed backup basal, masked fallback, and reconnect accounting | Included |
| Alerts and participant/study-staff workflows | Included |
| Clinical configuration and subject-scoped offline unlock | Included |
| Pregnancy Temporary Target and insulin suspension/resumption | Included |
| Protected local telemetry, active-session step evidence, and recovery export | Included |
| Software risk, cybersecurity local controls, verification, and IFU | Included |
Deferred or Not Claimed¶
| Topic | Position and rationale |
|---|---|
| Step-0 fingerstick rescue | Deferred; the frozen baseline remains CGM-only at step 0 |
| Historical CGM reconstruction for fallback replay | Not claimed; bounded replay uses unavailable-CGM input and documented delivery evidence or allowed assumption policy |
| Production role-based Clinical Settings authorization | Deferred beyond the investigational offline unlock |
| Commercial cloud and broader provider/authentication closure | Deferred; Scout is supportive/optional for this software package and is not a local dosing dependency |
| Part 11 closure | Deferred; requires broader system, data, and sponsor decisions |
| Formal participant usability or summative human-factors study | Not claimed; the available engineering UI, formative-use, and clinical-review evidence boundary was clinically approved on 2026-08-27 |
| Separate formal hardware-validation study | Not claimed; real-Pod formative observations remain supporting evidence under the clinically approved 2026-08-27 boundary |
Supportive Scout Package Position¶
The IDE software package uses the protected local step archive and clinical-gated exact-session recovery ZIP as its primary reconstruction evidence. BionicScout is supportive/optional corroboration for monitoring, troubleshooting, sequence correlation, and gap investigation; its availability does not control local dosing. The Cloud Telemetry Submission-Scope Decision records this package position. Official CGM outcomes come from Dexcom Clarity, insulin-delivery outcomes from the BionicLoop exported CSV, and adverse events and other safety information from staff-entered electronic case-report forms.
Evidence and Approval Boundary¶
The source baseline is frozen and exact-freeze engineering execution is complete. The 24 IDE-scope risk-analysis rows have execution evidence mapped. Build 843 and IFU-BL-001 revision 1.17 are approved for IDE submission. Evidence, traceability, residual risk, cybersecurity scope and controls, and the final software package are approved. The controlled multi-G7 exercise remains required before first participant deployment.
Formal evidence is limited to promoted controlled bundles. Working evidence is supportive only.
Ownership Boundary¶
The Software Developer provides the software package. The sponsor assigns and documents the qualified personnel responsible for the remaining clinical, regulatory, study-operations, and approval activities. See the Sponsor and Nonsoftware Ownership Map.