Sterilization of the COSMIIC System

NIH RePORTER · NIH · U41 · $121,297 · view on reporter.nih.gov ↗

Abstract

Abstract Summary Sterilization testing of the COSMIIC System The aim of this supplement is to conduct sterilization testing of the COSMIIC System components, under currently accepted standards, and to make the testing procedures and results available to the public under our open source licenses. The specific tasks to be completed in this supplement are: Task 1.0- Complete a Q-Sub with the FDA to gain insights into sterilization requirements for a device covered in an early feasibility IDE Task 2.0- Perform all required tests on the device based on FDA feedback Task 2.1- Select a vendor and initiate the quoting process. Produce test materials for sterilization. Task 2.2- Finalize Packaging and land on challenge device Task 2.3- Validate the cycle and kitting process Task 2.4- Determine sample sizes for tests and shelf-life duration Task 2.5- Run shelf life and shipping tests. Task 3- Release results to the open-source platform

Key facts

NIH application ID
11074286
Project number
3U41NS129436-02S7
Recipient
CASE WESTERN RESERVE UNIVERSITY
Principal Investigator
Cynthia Anne Chestek
Activity code
U41
Funding institute
NIH
Fiscal year
2024
Award amount
$121,297
Award type
3
Project period
2024-06-01 → 2025-08-31