Case Medical announced that the company received a new FDA 510k for the SteriTite Universal Container System and MediTray products. The SteriTite container system is a family of a rigid, reusable, sterilization containers and trays used to enclose medical devices and instrument sets for sterilization, transport, and storage.
The SteriTite container system and MediTray products have been previously cleared for use in steam as well as low temperature sterilizers. The SteriTite container was previously cleared for 1-Year (365 days) Event Related Sterility Maintenance as well as a minimum dry time of 5 to 8 minutes in pre-vacuum steam sterilization.
Please refer to the company’s website for more information and for their FDA 510k listing and for access to the IFU. The new claims now specify that the SteriTite container system is compatible for use with the latest claims made by the sterilizer manufacturers for the following sterilizers: The Steris V-Pro60/s2 (Lumen and Flexible), V-Pro maX (Flexible, Lumen and Non-Lumen) and V-Pro maX 2 (Flexible, Lumen and Non-Lumen) as well as the STERRAD 100NX ALLCLEAR (Standard, Flexible and DUO cycle. The expanded lumen claims include efficacy over a broader range of lumen lengths and diameters.
Case Medical, Inc. follows the “overkill method” of sterility assurance to show an elimination of a biological challenge. All SteriTite containers were tested with inner baskets or trays representative of the MediTray line of products. Testing was designed to simulate worst-case scenarios with half cycles utilized with end of shelf-life concentrations of hydrogen peroxide for low temperature sterilization. The validation testing was conducted at qualified laboratories in accordance with FDA guidance and available ANSI/AAMI standards such as ANSI/AAMI ST77, AAMI TIR 12 and ANSI/AMMI ST79.
