TSO3 Inc, announced that the U.S. Food and Drug Administration has cleared TSO3’s expanded indications for use (IFU’s) of its STERIZONE® VP4 Sterilizer.“Our extended IFU claims have been cleared by the FDA demonstrating the truly superior capabilities of our STERIZONE® Sterilization System,” said TSO3 President and CEO, R.M. (Ric) Rumble.
“These extended claims further expand our technology leadership – offering enhanced patient protection in applications where terminal sterilization was not previously possible. With these enhanced claims, we no longer talk about evolutionary claims advancement; rather the STERIZONE® VP4 Sterilizer is set to revolutionize the medical industry’s standard of care.”
“We look forward to presenting these enhanced claims in addition to our already industry-leading value proposition to our customers, and will be assessing the need to further expand production capacity in response to customer feedback and demand,” continued Rumble. “I am extremely proud of our team and their unwavering dedication to continue to improve patient care through creating new and meaningful patient infection reduction strategies.”
Testing was conducted to demonstrate the performance of the STERIZONE® VP4 Sterilizer using both double-channel and multi-channel flexible endoscopes including a ureteroscope and video colonoscope. The expanded claims now cleared for the STERIZONE® VP4 Sterilizer correspond to increasing scrutiny by regulatory authorities over medical device reprocessing, particularly for colonoscopes and other complex medical devices used during minimally invasive surgical procedures.
The STERIZONE® Sterilization System has now achieved a number of industry-firsts: First and only dual-sterilant sterilizer cleared by the FDA for sale in the U.S., First single cycle, low-temperature sterilizer cleared to process a 75-pound load of general instruments, single channel flexible endoscopes, and rigid and semi-rigid channeled devices, First low temperature sterilizer validated to sterilize multi-channeled endoscopes (with no more than four channels) such as video colonoscopes and gastroscopes, First low-temperature sterilizer with a load-sensitive Dynamic Sterilant Delivery System™, First documented "wet" cycle with validated micro-condensation sterilant layer , First Biological Indicator Test Pack to survive past the first half-cycle
TSO3 originally filed for expanded indications for use of its STERIZONE® VP4 Sterilizer with the FDA in December 2015. For clarity, the extended clearance announced today covers all medical devices contemplated in the December 2015 submission.
