Sterilization of the COSMIIC System

Case Western Reserve University, Cleveland OH

Investigators

Linked publications & trials

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