Clinical Documents - Software Review Response Sheet¶
Status: Final protocol, consent, and synchronized IFU 1.17 device label checked; not an FDA submission attachment Crosswalk date: 2026-09-08
Reviewer¶
| Field | Entry |
|---|---|
| Clinical direction approved by | Camille Powe, MD |
| Study role | Clinical investigator |
| Approval dates | 2026-08-27 and 2026-08-31 controlled correspondence |
| Decision record | Clinical Approval of Software IDE Decisions |
| Protocol version reviewed | Clinical Protocol BLS Clean-final.docx; Version 1.0; version date 1 September 2026; 41 pages; SHA-256 4bfb09542230c94c00dc5b5331a969657b5961b1c4bbd5a2759519a00f71d264 |
| Consent version reviewed | Consent Form BLS Clean -final.docx; consent version date 1 September 2026; 19 pages; SHA-256 6a0e1759997944522fa5dd9ba8dd9e9928cccb64ed7e6e4455b65f40c56a22cf |
| Device-labeling version reviewed | 008_Device_Labeling.pdf; BionicLoop 1.0 Build 843 / IFU 1.17 dated 2026-09-04; 3 pages; SHA-256 561c4cd26171888454c27d2350162680a867190754a448fd4096d1dd8b10fe0c |
Revised-Document Acceptance Checklist¶
The clinical direction is already approved. For each returned controlled file, record whether the approved behavior is incorporated accurately and identify any remaining discrepancy. Do not reinterpret the approved software behavior during this check.
| ID | Topic | Approved direction | Revised file/section | Verified | Remaining discrepancy or action |
|---|---|---|---|---|---|
SW-01 |
Fingerstick BG mode | Approved | Protocol loss-of-CGM sections; consent CGM-unavailable section | [x] | Final documents verified against Build 843 |
SW-02 |
Meal availability during CGM interruption | Approved | Protocol loss-of-CGM sections; consent CGM-unavailable section; IFU outage instructions | [x] | Final document set verified against Build 843 |
SW-03 |
Standard, Pregnancy, and Temporary Targets | Approved | Protocol device description/outcomes; labeling | [x] | Verified against Build 843 |
SW-04 |
Standard-to-Pregnancy meal setting | Approved | Protocol device description; labeling | [x] | Verified against Build 843 |
SW-05 |
Participant-weight range | Approved | Protocol background/device description; labeling | [x] | Verified against Build 843 |
SW-06 |
Same-Participant Reset | Approved | Protocol Visit 10; consent Visit 10 sections | [x] | Final documents verified against Build 843 |
SW-07 |
G7 startup/replacement wording | Approved | Protocol loss-of-CGM sections; IFU replacement-sensor instructions | [x] | Final document set uses intended-sensor startup and usable-readings behavior |
SW-08 |
Official study-data sources | Approved hierarchy | Protocol monitoring/source-data section | [x] | Final protocol hierarchy verified |
SW-09 |
Software testing claim | Approved claim boundary | Protocol device description; labeling | [x] | Verified against controlled software evidence |
SW-10 |
Participant-facing CGM-outage disclosure | Approved | Consent CGM-unavailable section; protocol loss-of-CGM section; IFU outage instructions | [x] | Final document set verified |
SW-11 |
Software build and IFU labeling | Build 843 approved 2026-09-03; IFU 1.17 approved 2026-09-04 | Device-labeling cover and software description | [x] | Synchronized 008_Device_Labeling.pdf verified under D14 |
Controlled-Document Follow-Up¶
| Required record | Owner | Final identifier/version/date or status |
|---|---|---|
| Final protocol | Protocol owner | Version 1.0, version date 1 September 2026; final software consistency verified |
| Final consent form | Consent/IRB document owner | Consent version date 1 September 2026; final software consistency verified |
| Final software/device labeling | Labeling owner | 008_Device_Labeling.pdf; Build 843 / IFU 1.17; verified under D14 |
| Designated study build and IFU | Study-team approver | Build 843 approved 2026-09-03; IFU 1.17 approved 2026-09-04 |
| Final consistency review | Software Developer | Protocol, consent, and synchronized device label complete |
Review Statement¶
Completion of this sheet confirms that the listed controlled documents were
checked against the approved software-description directions and Build 843.
The synchronized IFU 1.17 device-labeling copy was received and verified under
D14.