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Task
[SC 7] Draft "Training Plan for Tidepool Loop for Users and HCPs" summary for inclusion in 510(k)
Unassigned
Raza Panjwani
None
Unresolved
Nov 10, 2020
Mar 4, 2021
Task
Draft iCGM Sensitivity Analysis Methods and Results Summary
Unassigned
Raza Panjwani
None
Unresolved
Nov 6, 2020
Jan 31, 2021
Task
Draft Post-Market Study Plan
Unassigned
Raza Panjwani
None
Unresolved
Nov 6, 2020
Nov 6, 2020
Task
Create Tidepool Loop Full Demo Video
Unassigned
Raza Panjwani
None
Unresolved
Nov 6, 2020
Nov 6, 2020
Task
Draft Tidepool Loop Maintenance Plan
Unassigned
Raza Panjwani
None
Unresolved
Nov 6, 2020
Jun 25, 2021
Task
Draft Patient Testimonial Summary
Unassigned
Raza Panjwani
None
Unresolved
Nov 5, 2020
Nov 5, 2020
Task
Complete/Consolidate 510(k) Body Master Document
Unassigned
Raza Panjwani
None
Unresolved
Nov 5, 2020
Nov 5, 2020
Task
Observational Study Adverse Event Summary and Reports
Unassigned
Howard Look
None
Unresolved
Sep 3, 2020
Nov 6, 2020
Story
White paper on Guardrails and warnings based on data analysis from the Jaeb Observational Study
Unassigned
Janet Diehl
None
Unresolved
Aug 17, 2020
Aug 17, 2020
Task
Draft Jaeb Data Safety Analysis - Tidepool Loop Settings, Related Mitigations
Unassigned
Raza Panjwani
None
Unresolved
Aug 7, 2020
Aug 7, 2020
Task
[To Do] Generate Submission Check-list from Meeting Minutes and Written Feedback from All FDA Q-Subs
Unassigned
Raza Panjwani
None
Unresolved
Aug 7, 2020
Aug 7, 2020
Epic
Documentation of Requirements iAGC Special Controls
Unassigned
Raza Panjwani
None
Won't Do
Jul 22, 2020
Aug 7, 2020
Task
iCGM and ACE Pump Functionality Accessible from within Tidepool Loop
Unassigned
Howard Look
None
Unresolved
Jul 20, 2020
Nov 5, 2020
Task
[To Do] Determine whether and how to include Patient Preference Information (PPI) documentation in support of Submission
Unassigned
Raza Panjwani
None
Done
Jul 15, 2020
Nov 5, 2020
Task
[Section 16.j] Output of open bugs in Jira
Unassigned
Raza Panjwani
None
Unresolved
Jun 23, 2020
Nov 10, 2020
Task
[Section 16.i] Output of Github Releases Page for Tidepool Loop
Unassigned
Raza Panjwani
None
Unresolved
Jun 23, 2020
Nov 5, 2020
Task
[Section 16.d] Create Architecture Design Charts
Unassigned
Raza Panjwani
None
Unresolved
Jun 23, 2020
Nov 9, 2020
Task
[Section 16.c, e, f] Draft Summary of how Tidepool has documented "requirements" "specifications" and established traceability
Unassigned
Raza Panjwani
None
Unresolved
Jun 23, 2020
Jul 23, 2020
Task
[Section 16.h] Draft Summary of Verification and Validation Outputs
Unassigned
Raza Panjwani
None
Unresolved
Apr 22, 2020
Nov 5, 2020
Task
[To Do] Confirm Traceability of all Requirements, Hazards, Mitigations, Verification, and Validation (Jira Review)
Unassigned
Raza Panjwani
None
Unresolved
Apr 21, 2020
Nov 5, 2020
Task
[Section 16] Draft Statement of Major Level of Concern
Unassigned
Raza Panjwani
None
Unresolved
Apr 21, 2020
Nov 5, 2020
Task
[Section 18] Draft Summary of Bench Testing
Unassigned
Raza Panjwani
None
Unresolved
Apr 21, 2020
Nov 5, 2020
Task
[Section 07] Draft Statement of Non-Class III Device
Unassigned
Raza Panjwani
None
Done
Apr 21, 2020
Nov 5, 2020
Task
[SC 5/6] Documentation of Tidepool Loop Restricting Compatibility to only iCGMs, ACE Pumps, and other devices deemed appropriate by FDA
Unassigned
Raza Panjwani
None
Unresolved
Apr 21, 2020
Nov 5, 2020
Task
[SC 4] Documentation of Measures to Record Critical Events
Unassigned
Raza Panjwani
None
Duplicate
Apr 21, 2020
Jun 24, 2020
Task
[SC 1.vi] Documentation of Measures to Ensure Safety During Loss of Connected Device Communications
Unassigned
Raza Panjwani
None
Unresolved
Apr 21, 2020
Nov 5, 2020
Task
[SC 1.iii] Documentation of Measures to Ensure Reliability and Security of Connected Device Communications
Unassigned
Raza Panjwani
None
Unresolved
Apr 21, 2020
Nov 6, 2020
Task
[Section 20] Draft Summary of Clinical Study Report Data
Unassigned
Raza Panjwani
None
Unresolved
Apr 21, 2020
Nov 9, 2020
Sub-task
Review proposed outline for documentation
Unassigned
Raza Panjwani
None
Done
Apr 10, 2020
Apr 21, 2020
Task
[SC 4] Documentation of Logging, data sharing, critical events recording measures
Unassigned
Howard Look
None
Unresolved
Apr 7, 2020
Nov 5, 2020
Task
[SC 1.v] Draft Device Qualification Plan for Controller Devices
Unassigned
Raza Panjwani
None
Unresolved
Apr 5, 2020
Nov 18, 2020
Task
[SC 1.iv] Draft Device Qualification Plan for Representative ACE Pumps
Unassigned
Raza Panjwani
None
Unresolved
Apr 3, 2020
Nov 18, 2020
Task
[SC 1.iv] Draft Device Qualification Plan for Representative iCGM
Unassigned
Raza Panjwani
None
Unresolved
Apr 3, 2020
Nov 18, 2020
Task
Draft Summary and Rationale of Changes from DIY Loop to Tidepool Loop
Unassigned
Raza Panjwani
High (4)
Unresolved
Apr 2, 2020
Jan 8, 2021
Task
[Q-Sub] Draft April Q-Submission Cover Letter and Request for Feedback Questions
Unassigned
Raza Panjwani
None
Done
Apr 2, 2020
Jun 18, 2020
Task
[Q-Sub] Draft iCGM Sensitivity Analysis Plan
Unassigned
Raza Panjwani
High (4)
Done
Apr 2, 2020
Jun 18, 2020
Task
[Q-Sub] Draft Diabetes Metabolic Model
Unassigned
Raza Panjwani
High (4)
Done
Apr 2, 2020
Jun 18, 2020
Task
[Q-Sub] Draft iCGM Simulator Assumptions
Unassigned
Raza Panjwani
High (4)
Done
Apr 2, 2020
Jun 18, 2020
Task
[Q-Sub] Finalize Draft HF Testing Protocol with CoreHF
Unassigned
Raza Panjwani
High (4)
Done
Apr 2, 2020
Jun 18, 2020
Task
[Q-Sub] Draft Bolus Calculator Documentation
Unassigned
Raza Panjwani
High (4)
Done
Apr 2, 2020
Jun 18, 2020
Epic
June FDA Q-Submission
Unassigned
Raza Panjwani
None
Done
Apr 2, 2020
Jun 18, 2020
Task
[Section 16.k] Draft Summary of Cybersecurity Plan
Unassigned
Raza Panjwani
None
Unresolved
Mar 29, 2020
Jul 23, 2020
Task
Draft Verification Test Plan for Integrated iCGM/ACE Pump Components
Unassigned
Raza Panjwani
None
Unresolved
Mar 29, 2020
Aug 7, 2020
Task
[Appendix] Complete FDA Refusal to Accept Checklist
Unassigned
Raza Panjwani
None
Unresolved
Mar 29, 2020
Nov 5, 2020
Task
[Section 17] Draft Electromagnetic Compatibility Summary
Unassigned
Raza Panjwani
None
Unresolved
Mar 29, 2020
Jul 23, 2020
Task
[Section 08] Fill out FDA Form 3454 (Financial Certification)
Unassigned
Raza Panjwani
None
Unresolved
Mar 29, 2020
Nov 5, 2020
Task
[Appendix] Fill out FDA Form 3674 - Certification of Compliance with 42 U.S.C. § 282(j) - Compliance with ClinicalTrials.gov Data Bank
Unassigned
Raza Panjwani
None
Unresolved
Mar 12, 2020
Nov 5, 2020
Task
[To Do] Document Functional Requirements for Tidepool Loop (Jira Review)
Unassigned
Raza Panjwani
None
Unresolved
Mar 11, 2020
Nov 11, 2020
Task
Documented Process for Adverse Event investigations and MDRs
Unassigned
Howard Look
Medium (3)
Unresolved
Mar 4, 2020
Sep 30, 2020
Task
[SC 3] Documentation of Tidepool Loop and Connected Device Functional Requirements for Connected Device Interface
Unassigned
Raza Panjwani
None
Unresolved
Mar 3, 2020
Nov 5, 2020
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