Skip to content

IDE Submission Decision Register

  • Purpose: Canonical list of software-package decisions requiring sponsor-designated disposition before submission
  • Baseline: ide-software-freeze-2026-08-21 / 91c0e98a9bc9429a0486bebdebffc7d8dbbe300e
  • Status: Software-package decisions closed; pre-deployment RA-023 exercise and final IDE assembly remain operational follow-through
  • Date: 2026-09-08
  • Latest clinical-document review: Clinical Documents Software Consistency Crosswalk

Open Software-Package Decisions

None. All software-package decisions are closed by the controlled records below.

Accepted D06 Disposition

The accepted submission disposition retains RA-023/RES-010 as a provisional Medium residual (S3 x P1) and completes the controlled multi-device exercise before first participant deployment rather than before IDE submission. No participant deployment may occur before the exercise passes and the final RA-023 disposition is recorded.

The required pre-deployment exercise must use an intended G7 and at least one active nearby non-intended G7. It must cover intentional replacement, relaunch and CGM-screen reentry, retry after the no-adoption timeout, producible automatic replacement triggers, candidate ordering, and confirmation that reading staleness alone never starts replacement acquisition. Objective acceptance criteria must address sensor adoption, processed glucose, algorithm input, episode persistence, and whether post-connection comparison is detection-only.

The implementation and control limitations requiring disposition are recorded in Risk Analysis 1.53, SDD 1.84, SVVP 1.91, and RTM 1.86. The 2026-09-03 Build 843 observation of a timeout followed by authenticated intended-sensor adoption is supporting evidence but does not establish nearby-sensor discrimination or close those findings. No product source change is required for IDE submission. The exercise result determines whether unchanged Build 843 is accepted for participant deployment or a separately classified and verified post-submission correction is required.

Closed Decisions

D01 - IDE Submission Build

  • Decision: BionicLoop 1.0 (843) / 1455cda7 is approved for IDE submission.
  • Closure record: Final Software Approvals - 2026-09-03
  • Status: Closed by controlled clinical/sponsor correspondence.

D02 - Final Protocol Identity

  • Decision: Treat Clinical Protocol BLS Clean-final.docx, Version 1.0, dated 1 September 2026, as the final protocol source for software-package consistency and external attachment identity.
  • SHA-256: 4bfb09542230c94c00dc5b5331a969657b5961b1c4bbd5a2759519a00f71d264
  • Status: Closed. Material software descriptions are consistent with Build 843.

D03 - Target Sets and Pregnancy Meal Setting

  • Decision: Standard permanent targets 110/120/130 mg/dL; Pregnancy permanent targets 90/100/110 mg/dL; time-limited Pregnancy Temporary Targets 120/130 mg/dL for 30/60/90/120 minutes; automatic return; unchanged permanent Pregnancy safety/backup basis; and the Standard-to-Pregnancy 90% meal-setting proposal with clinical review before save
  • Closure record: Clinical Approval of Software IDE Decisions - 2026-08-27 and 2026-08-31
  • Status: Closed by controlled clinical correspondence; the final protocol incorporates the approved behavior.
  • Decision: Treat Consent Form BLS Clean -final.docx, consent version date 1 September 2026, as the final consent source for software-package consistency and external attachment identity.
  • SHA-256: 6a0e1759997944522fa5dd9ba8dd9e9928cccb64ed7e6e4455b65f40c56a22cf
  • Status: Closed. The consent supplies the participant-facing fingerstick disclosure; the protocol and IFU carry the detailed outage instructions.

D05 - Initial Final Device-Labeling Identity

  • Decision: Treat Device Label_clean-final.docx as the final software/device-labeling source. It identifies BionicLoop 1.0 (843) and IFU-BL-001 revision 1.16.
  • SHA-256: e57838b3246965815af585887d9643b75987cc5ef459c854d04fbcf490b7e953
  • Status: Closed for the reviewed September 3 document set and superseded by the synchronized revision 1.17 attachment recorded under D14.

D06 - RA-023 Submission Disposition

  • Decision: Complete the controlled multi-G7 exercise before participant deployment rather than holding IDE submission, and retain the documented provisional S3 x P1 residual-risk rating for submission. The exercise will inform the final participant-deployment disposition.
  • Closure record: Tara Bresnahan, RN email in the controlled Bionic Loop Software - Final Approvals thread, 2026-09-04.
  • Status: Closed for submission. The exercise and final deployment disposition remain required before participant deployment.

D07 - Residual Risks and Known Limitations

  • Decision: Accept the documented software and use-related residual risks and known limitations.
  • Closure record: Edward R. Damiano, PhD email in the controlled Bionic Loop Software - Final Approvals thread, 2026-09-07 EDT.
  • Status: Closed.

D08 - Verification Evidence and Traceability

  • Decision: Accept the verification evidence and traceability for Build 843.
  • Closure record: Edward R. Damiano, PhD email in the controlled Bionic Loop Software - Final Approvals thread, 2026-09-07 EDT.
  • Status: Closed.

D09 - Cybersecurity Scope and Controls

  • Decision: Accept the documented cybersecurity scope and controls.
  • Closure record: Edward R. Damiano, PhD email in the controlled Bionic Loop Software - Final Approvals thread, 2026-09-07 EDT.
  • Status: Closed. Documented deferred and supportive-service boundaries remain part of the accepted scope.

D10 - ZIP/CSV Collection, Transfer, and Storage

  • Decision: Use of the recovery ZIP for CSV collection, transfer, and storage is approved. The existing data hierarchy and Appendix A17 define the detailed operating controls.
  • Closure record: Final Software Approvals - 2026-09-03
  • Status: Closed by controlled correspondence. Final protocol/data-plan references are incorporated in the final protocol recorded under D02.

D11 - Final Software-Package Approver

  • Decision: Edward R. Damiano, PhD is authorized to provide final software-package approval. Controlled correspondence references replace handwritten signature fields in the software package.
  • Closure record: Tara Bresnahan, RN authorization on 2026-09-04 and Edward R. Damiano, PhD acceptance and final package signoff on 2026-09-07 EDT, both in the controlled Bionic Loop Software - Final Approvals thread.
  • Status: Closed.

D12 - Build 843 Scout Service Environment

  • Decision: Confirm CC-DEV as Build 843's participant Scout service environment. Scout remains supportive and does not affect local dosing.
  • Closure record: Tara Bresnahan, RN email in the controlled Bionic Loop Software - Final Approvals thread, 2026-09-04.
  • Status: Closed. A different compiled service environment would require a new build identity and impact assessment.

D13 - IFU Revision 1.17

  • Decision: Prepare and submit IFU-BL-001 revision 1.17 with the six staged editorial and document-control corrections. The revision does not change Build 843 behavior.
  • Closure record: Final Software Approvals - September 2026
  • Status: Closed by controlled correspondence on 2026-09-04. Tara Bresnahan, RN supported the changes, and Camille Powe, MD directed the team to make the changes and submit revision 1.17.

D14 - Synchronized Device Labeling

  • Decision: Accept 008_Device_Labeling.pdf as the synchronized final device-labeling attachment. It identifies BionicLoop 1.0 Build 843 and IFU-BL-001 revision 1.17 dated 2026-09-04.
  • Controlled identity: 3 pages; 230,910 bytes; SHA-256 561c4cd26171888454c27d2350162680a867190754a448fd4096d1dd8b10fe0c.
  • Controlled locator: Study-team Dropbox submission folder, IDE Submission Package/008_Device_Labeling.pdf.
  • Status: Closed by software identity verification on 2026-09-08.

Completed Clinical Decisions

The controlled clinical records already close the fallback allocation, unavailable-CGM-freshness, participant-weight range, target-set behavior, supportive Scout scope, physical-use claim boundary, human-factors claim boundary, and clinical direction for the eight software-consistency changes. They are not repeated as open clinical decisions here. The accepted D06 pre-deployment exercise, release artifact generation, and final IDE assembly are operational follow-through rather than open software-package decisions.