IDE Cloud Telemetry Submission-Scope Decision

Field	Value
Status	Clinically approved: Scout supportive
Decision owners	Sponsor representative with clinical-investigator input
Date opened	2026-08-21
Package position recorded	2026-08-25
Clinical approval and source clarification	2026-08-27
Updated	2026-08-27

Issue

Prior software scope language deferred cloud and device-to-cloud verification, while the Cybersecurity Plan described secure cloud telemetry as a primary study transport. Those statements could not govern the same package.

The software package uses the supportive Scout scope. Clinical approval and the authoritative clinical data sources were recorded on 2026-08-27.

For the IDE software package, Scout is classified as supportive. The device-local clinical-gated recovery ZIP is the primary session-reconstruction record used for software evidence, and Scout telemetry is corroborating backup for monitoring, correlation, and gap investigation. Temporary Scout delay or loss does not affect local algorithm execution or dosing.

The clinical correspondence identifies the official study sources in the decision table below.

Approved Scope

If Scout is not relied upon for safety decisions or required endpoint data:

• describe Scout as supportive monitoring and engineering/operational evidence
• identify the authoritative sources for dosing, safety, and endpoint data in the protocol, data-management plan, and submission
• state that temporary Scout delay or loss does not affect local dosing
• retain local protected step evidence and recovery export as support controls
• defer broader cloud, provider/authentication, Part 11, and commercial closure with explicit rationale
• ensure the IFU and monitoring plan do not instruct staff to depend on Scout for a safety action that lacks another authoritative path

Approved sources and purposes:

Required identification	Sponsor response
Software verification/session reconstruction	Protected local step archive and clinical-gated exact-session recovery ZIP; reconcile to pump records where the protocol requires
Official CGM outcome source	Dexcom Clarity
Official insulin-delivery outcome source	BionicLoop app exported CSV file
Official adverse-event and other safety-information source	Electronic case-report forms entered by study staff
Scout support purpose	Study monitoring, troubleshooting, corroborating software evidence, sequence/gap review, and recovery assistance; not a local dosing dependency

Decision Record

Field	Decision
Decision / date	Scout supportive; engineering package position recorded 2026-08-25 and clinically approved 2026-08-27
Rationale	The controller retains protected local step evidence and a clinical-gated exact-session recovery export; local dosing does not depend on Scout availability. Scout remains valuable corroborating evidence and monitoring support.
Authoritative data sources	Software evidence: local protected records/recovery ZIP and formal verification bundles. Official study outcomes: Dexcom Clarity for CGM and the BionicLoop exported CSV for insulin delivery. Adverse events and other safety information: staff-entered electronic case-report forms.
Required Scout contract/evidence	No Scout round trip is required as the primary software-verification record. Retain available sequence-correlated Scout data as corroborating backup and investigate material gaps.
Deferred cloud scope	Commercial cloud, broader provider/authentication, Part 11, and production-role closure remain deferred unless the relied-upon study scope is later widened.
Approval reference / date	Camille Powe, MD email, Re: A few final software decisions for the IDE package, 2026-08-27
Controlled decision record	Clinical Approval of Software IDE Decisions

Sequence-correlated phone-to-Scout observations may be retained as operational transport evidence and used to investigate gaps. They are not required to establish local dosing execution or reconstruct a software session when the protected local archive and exact-session recovery ZIP are available.