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IDE Software Handoff Disposition Log

Status: Active working log
Owner: BionicLoop engineering
Last updated: 2026-06-03 09:00 EDT

1. Purpose

Record the explicit scope and requirement dispositions used to prepare the engineering-owned IDE software handoff package.

This log is not a formal approval record. It is the engineering-side disposition source that the receiving quality/submission team can review, accept, revise, or carry forward into controlled approval workflow.

2. Package Scope Decisions

Topic Current Disposition Rationale Next Owner / Follow-up
Local app/runtime/algorithm/device software docs In scope This is the primary engineering-owned software package for IDE handoff. Engineering maintains and prepares for handoff.
STP package and software verification structure In scope Engineering owns the software protocol and evidence structure needed for downstream review. Engineering closes draft-to-handoff-ready metadata and ownership mapping.
IFU software package In scope IFU content and screenshot package are software-facing deliverables prepared by engineering. Engineering maintains current package; receiving team handles formal review workflow.
Masked fallback pump-delta reconnect recovery In scope for current local software baseline Current accepted behavior allocates credible pump-reported fallback delivery across missed primary/secondary algorithm replay steps using CGM=-1, per-step delivered insulin, and no catch-up pump commands; the resumed live step uses actual refreshed pump status without duplicate recovered delivery. Engineering maintains trace and freeze evidence plan; receiving team decides final freeze claims.
No-active-pod repeat critical alerting In scope for current local alert baseline Current accepted behavior repeats safety-critical notification attempts while no active pod remains unresolved. Engineering maintains trace and freeze evidence plan; receiving team decides final freeze claims.
Cloud / device-to-cloud verification closure Deferred from current software handoff package Current week is focused on local software package readiness, not cloud or web-system closure. Receiving quality/submission team decides whether to re-open later.
Part 11 readiness package closure Deferred from current software handoff package Part 11 closure requires broader system and quality-process decisions beyond this software handoff slice. Receiving quality/submission team.
Formal review / approval signatures Not engineering-owned in this pass Engineering prepares metadata placeholders only. Receiving quality/submission team.
Final submission assembly / release authorization Not engineering-owned in this pass Downstream release handling is outside the engineering handoff scope. Receiving quality/submission team.

3. Requirement Dispositions

Item Current Disposition Baseline Decision Rationale Follow-up
SRS-BG-008 Deferred from current software handoff baseline Keep step 0 CGM-only via SRS-BG-012 Step-0 BG rescue is not part of the current accepted software baseline. Current implementation explicitly keeps it disabled. Re-open only if future approved baseline intentionally enables BG rescue at step 0.
SRS-MEAL-004 Accepted for current software handoff baseline Late meal submit executes on current due step This is implemented behavior, covered by current runtime/verification paths, and should be represented as accepted current software behavior in the handoff package. Downstream clinical/review team may still challenge or change it before formal release approval.
SRS-CLIN-002 Accepted as investigational control for current software handoff baseline Current baseline uses subject-scoped offline clinical unlock codes with local single-use counter burn and expiration The offline unlock verifier is the current investigational software control for the single-device clinical-trial baseline. It avoids a shared hardcoded passcode and does not require internet after verifier material is provisioned. Broader production authorization/role-based access remains deferred unless explicitly pulled into scope.
SRS-SEC-003..009 Deferred from current software handoff package Do not claim closure for auth/provider/authorization/session-continuity package in this week's handoff These rows still mix implemented development behavior, unresolved provider policy, authorization model decisions, and broader cloud/compliance scope. Re-open when auth/security/cloud scope is explicitly pulled into the package with quality-team alignment.
SRS-RUN-006, SRS-PUMP-009, SRS-STATE-004, SRS-LOG-009 Accepted for current software handoff baseline Confirmed/corrected masked fallback recovery uses credible pump-reported delivery evidence for no-command same-session missed-step algorithm replay Current implementation does not require historical CGM; replay rows use CGM=-1 and ambiguous evidence remains logging-only. Promote or rerun evidence for these rows if they remain claimed at formal freeze.
SRS-ALERT-017 Accepted for current software handoff baseline No-active-pod safety-critical notification attempts repeat every 30 minutes while unresolved Current implementation and focused tests pin repeat behavior and latest-condition content refresh. Promote or rerun alert evidence if this row remains claimed at formal freeze.

4. Verification Dispositions Affected

Verification Rows Current Disposition Reason
TV-BG-007 Deferred with SRS-BG-008 Step-0 BG rescue is not part of the current accepted software baseline.
TV-MEAL-003 Accepted in current software handoff baseline Matches accepted SRS-MEAL-004 behavior.
TV-SEC-002..008 Deferred from current software handoff package Follow deferred cloud/auth security verification scope decisions for this handoff pass.
TV-PUMP-008, TV-STATE-004, TV-LOG-009 Accepted in current software handoff baseline Cover masked fallback pump-delta recovery, persistence, and logging behavior.
TV-ALERT-016 Accepted in current software handoff baseline Covers repeated no-active-pod critical notification behavior.

5. Notes for Downstream Review