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Task
Draft Tidepool Loop Maintenance Plan
Unassigned
Raza Panjwani
None
Unresolved
Nov 6, 2020
Jun 25, 2021
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
[SC 7/8] Draft User-facing Training Materials
Unassigned
Raza Panjwani
None
Unresolved
Mar 3, 2020
Mar 4, 2021
Task
[SC 7/8] Draft HCP Training Materials (Summary)
Unassigned
Raza Panjwani
None
Unresolved
Mar 3, 2020
Mar 4, 2021
Task
Revise Loop Algorithm Documentation for Submission
Unassigned
Raza Panjwani
None
Unresolved
Mar 3, 2020
Jan 31, 2021
Task
Draft iCGM Sensitivity Analysis Methods and Results Summary
Unassigned
Raza Panjwani
None
Unresolved
Nov 6, 2020
Jan 31, 2021
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
[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
[SC 1.iv] Draft Functional Requirements for Compatible ACE Pump
Unassigned
Raza Panjwani
None
Unresolved
Mar 3, 2020
Nov 12, 2020
Task
[To Do] Document Functional Requirements for Tidepool Loop (Jira Review)
Unassigned
Raza Panjwani
None
Unresolved
Mar 11, 2020
Nov 11, 2020
Task
[SC 1.iv] Draft Functional Requirements for Compatible iCGM
Unassigned
Raza Panjwani
None
Unresolved
Mar 3, 2020
Nov 11, 2020
Task
[SC 1.vii] Draft Proposed Assignment of Post-Market Responsibility and Complaint Handling
Unassigned
Raza Panjwani
None
Unresolved
Mar 3, 2020
Nov 11, 2020
Task
Draft Iterative development plan
Unassigned
Raza Panjwani
None
Unresolved
Mar 2, 2020
Nov 10, 2020
Epic
Tidepool Loop 510(k) Submission
Unassigned
Janet Diehl
None
Unresolved
Mar 3, 2020
Nov 10, 2020
Task
[Section 16.j] Output of open bugs in Jira
Unassigned
Raza Panjwani
None
Unresolved
Jun 23, 2020
Nov 10, 2020
Task
[To Do] Draft Verification Test Plan for Tidepool Loop
Unassigned
Raza Panjwani
None
Unresolved
Mar 3, 2020
Nov 10, 2020
Task
[Section 20] Draft Summary of Clinical Study Report Data
Unassigned
Raza Panjwani
None
Unresolved
Apr 21, 2020
Nov 9, 2020
Task
[Section 16.d] Create Architecture Design Charts
Unassigned
Raza Panjwani
None
Unresolved
Jun 23, 2020
Nov 9, 2020
Task
Observational Study Adverse Event Summary and Reports
Unassigned
Howard Look
None
Unresolved
Sep 3, 2020
Nov 6, 2020
Task
[Section 16.a+d] Draft Software Description and Design and Architecture Overview
Unassigned
Raza Panjwani
None
Unresolved
Mar 2, 2020
Nov 6, 2020
Task
[Section 16.g] Include copy of Tidepool Software Life Cycle Management Plan
Unassigned
Raza Panjwani
None
Unresolved
Mar 2, 2020
Nov 6, 2020
Task
Hazard Analysis Table
Unassigned
Raza Panjwani
None
Unresolved
Mar 2, 2020
Nov 6, 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
Clinical Study Report (Covance)
Unassigned
Raza Panjwani
None
Unresolved
Jan 29, 2020
Nov 6, 2020
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
[Section 18] Draft Summary of Bench Testing
Unassigned
Raza Panjwani
None
Unresolved
Apr 21, 2020
Nov 5, 2020
Task
Draft Patient Testimonial Summary
Unassigned
Raza Panjwani
None
Unresolved
Nov 5, 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 13] Draft Summary of Proposed Labeling
Unassigned
Raza Panjwani
None
Unresolved
Jan 29, 2020
Nov 5, 2020
Task
Statement of SaMD
Unassigned
Janet Diehl
Done
Aug 5, 2019
Nov 5, 2020
Task
[Sections 14, 15, 19] Draft Statements of Non-Applicability
Unassigned
Raza Panjwani
None
Done
Jan 29, 2020
Nov 5, 2020
Task
[Section 04] Fill FDA Form 3881 - Indications for Use Statement
Unassigned
Raza Panjwani
None
Unresolved
Jan 29, 2020
Nov 5, 2020
Task
[Section 03] Draft 510(k) Cover Letter
Unassigned
Raza Panjwani
None
Unresolved
Jan 29, 2020
Nov 5, 2020
Task
[Section 09] Declarations of Conformity and Summary Reports
Unassigned
Raza Panjwani
None
Unresolved
Jan 29, 2020
Nov 5, 2020
Task
[Section 08] Draft Financial Certification or Disclosure
Unassigned
Raza Panjwani
None
Unresolved
Jan 29, 2020
Nov 5, 2020
Task
[Section 06] Execute Truthful and Accuracy Statement
Unassigned
Raza Panjwani
None
Unresolved
Jan 29, 2020
Nov 5, 2020
Task
[Section 16.h] Draft Summary of Verification and Validation Outputs
Unassigned
Raza Panjwani
None
Unresolved
Apr 22, 2020
Nov 5, 2020
Task
[Section 05] Draft 510(k) Summary
Unassigned
Raza Panjwani
None
Unresolved
Jan 29, 2020
Nov 5, 2020
Task
[Section 12] Draft Substantial Equivalence Discussion
Unassigned
Raza Panjwani
None
Unresolved
Jan 29, 2020
Nov 5, 2020
Task
[Section 11] Draft Executive Summary
Unassigned
Raza Panjwani
None
Unresolved
Jan 29, 2020
Nov 5, 2020
Task
[Section 10] Draft Device Description
Unassigned
Raza Panjwani
None
Unresolved
Jan 29, 2020
Nov 5, 2020
Task
Draft Summary Report of iAGC Special Controls Compliance
Unassigned
Raza Panjwani
None
Unresolved
Jan 29, 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 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
[Section 01] Pay Medical Device User Fee and attach Cover Sheet to submission
Unassigned
Raza Panjwani
None
Unresolved
Jan 29, 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 07] Draft Statement of Non-Class III Device
Unassigned
Raza Panjwani
None
Done
Apr 21, 2020
Nov 5, 2020
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