# Sterilization of the COSMIIC System

> **NIH NIH U41** · CASE WESTERN RESERVE UNIVERSITY · 2024 · $121,297

## 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 organization:** CASE WESTERN RESERVE UNIVERSITY
- **Principal Investigator:** Cynthia Anne Chestek
- **Activity code:** U41 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $121,297
- **Award type:** 3
- **Project period:** 2024-06-01 → 2025-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11074286

## Citation

> US National Institutes of Health, RePORTER application 11074286, Sterilization of the COSMIIC System (3U41NS129436-02S7). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/11074286. Licensed CC0.

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