IDE Software Scope And Deferred Items
Status: Reviewer summary
Owner: BionicLoop engineering
Last updated: 2026-06-03 09:00 EDT
Purpose
State clearly what engineering is claiming in the current IDE software packet, what is deferred, and what belongs to the receiving quality/submission team.
In Scope For The Current Packet
| Topic |
Current Position |
| Local app/runtime/algorithm/device software docs |
In scope |
| Software verification structure and STP ownership mapping |
In scope |
| Software-facing IFU package and screenshots |
In scope |
| Study-relevant software risk summary |
In scope |
| Proportionate cybersecurity summary for local software posture |
In scope |
| Masked fallback safety behavior and reconnect recovery accounting |
In scope for current local software behavior |
| No-active-pod critical alerting and repeat notification behavior |
In scope for current local alert behavior |
Deferred From The Current Packet
| Topic |
Current Position |
Why Deferred |
| Cloud / device-to-cloud verification closure |
Deferred |
Current handoff is focused on local controller software readiness, not cloud-system closure. |
| Part 11 readiness package |
Deferred |
Requires broader system and quality-process decisions beyond this software handoff slice. |
SRS-SEC-003..009 auth/provider/session-continuity closure |
Deferred |
These rows still involve broader provider-policy, auth-model, and cloud/compliance scope decisions. |
SRS-BG-008 / TV-BG-007 step-0 BG rescue |
Deferred |
Current accepted baseline keeps step 0 CGM-only. |
| Historical CGM reconstruction for masked fallback recovery |
Deferred / not claimed |
Current accepted candidate baseline replays missed algorithm steps with CGM=-1 and per-step pump-delivery input only when same physical pod continuity and credible pump-reported delivered insulin are available; it does not reconstruct historical CGM. |
Accepted Current-Baseline Decisions
| Item |
Accepted Decision |
SRS-MEAL-004 |
Late meal submit executes on the current due step. |
SRS-CLIN-002 |
Current clinician gate uses the investigational subject-scoped offline clinical unlock control with local single-use counter burn and expiration; broader production role-based authorization remains deferred unless explicitly pulled into scope. |
SRS-RUN-006, SRS-PUMP-009, SRS-STATE-004, SRS-STATE-005, SRS-LOG-009 |
Confirmed/corrected masked fallback recovery uses credible same-pod pump-delta evidence for no-command missed-step primary/secondary algorithm replay with CGM=-1 and per-step delivered-insulin input; non-continuous or unknown pod evidence continues the same session without replay. |
SRS-ALERT-017 |
No-active-pod safety-critical notification attempts repeat every 30 minutes while the condition remains true. |
TV-MEAL-003 |
Remains in scope because it reflects accepted current meal behavior. |
Not Engineering-Owned In This Pass
| Topic |
Current Position |
| Formal review and approval signatures |
Receiving quality/submission team |
| Final IDE submission assembly and release authorization |
Receiving quality/submission team |
| Residual-risk acceptance signoff |
Receiving quality/submission team |
| Supplier/manufacturing/training/non-software QMS artifacts |
Outside engineering-owned packet |
Practical Review Rule
If a reviewer asks whether a topic must block this software packet, default answer should be:
yes only if it is part of the accepted local software baseline being claimed for study useno if it is deferred from the current packet or outside the engineering-owned software handoff scope
Primary Support References