TSO3 Inc. (TSX: TOS) today announced that it has provided its final Additional Information (AI) response to US Regulators in support of extending the claims of the Company’s STERIZONE® VP4 Sterilizer to include the terminal sterilization of duodenoscopes.
In the AI response, the Company included data on modified leak test experiments, testing to confirm lack of fluid ingress occurring under the distal end cap of the devices, as well as real-world data from market research commissioned by TSO3 reflecting the actual use-life of duodenoscopes.
“The Company believes that its response is consistent with 510(k) requirements demonstrating the same intended use and the same technological characteristics as the predicate device, which is the existing cleared TSO3 STERIZONE® VP4 Sterilizer” stated R.M. (Ric) Rumble, TSO3‘s President and CEO. “The Company believes that the science supporting the data provided has met the same threshold as the predicate device with testing conducted on actual devices in simulated-use and in-use clinical conditions.”
Original Equipment Manufacturer (OEM) labeling requires healthcare institutions using a method not listed in the OEM labeling to carefully inspect the duodenoscope for damage before each patient use and to repair the device as needed. TSO3 recommends rigorous inspection according to the instructions provided by the device manufacturer and TSO3 as an essential part of best practices designed to improve patient safety.
The STERIZONE® VP4 Sterilizer is a low-temperature sterilization system that utilizes the dual-sterilants of vaporized hydrogen peroxide (H2O2) and ozone (O3) to achieve terminal sterilization of heat and moisture sensitive medical devices. Its single pre-programmed cycle can sterilize a large number and wide range of compatible devices, creating a cost-effective sterilization process with error free cycle selection. The device’s unique Dynamic Sterilant Delivery System™ automatically adjusts the quantity of injected sterilant based on the load composition, weight and temperature. This capability removes the guesswork and potential for human error, as there is no need to sort instruments and choose the appropriate cycles as with other machines.
The STERIZONE® VP4 Sterilizer is the only terminal sterilization method that is FDA cleared to sterilize multi-channeled flexible endoscopes (with a maximum of four channels) of up to 3.5 meters in length, such as video colonoscopes and gastroscopes – an industry first for any medical device sterilization process.
The STERIZONE® VP4 Sterilizer is also the only cleared low temperature sterilizer that can process a mixed load consisting of general instruments, single channel flexible endoscopes, and single or double channel rigid endoscopes in the same cycle with load weights of up to 75 lb. The ability to run mixed loads significantly reduces labor costs by minimizing the amount of instrument sorting required, while maximizing the device turns (more productivity from increased throughput capacity).
More information about the STERIZONE® VP4 Sterilizer is available through TSO3‘s website, under the Products section at http://www.tso3.com/en/products/sterizone-vp4/.