TSO3, a sterilization technology provider, has received 510(k) clearance from the United States Food and Drug Administration (FDA) for a universal design of its Sterizone VP4 Sterilizer. The new clearance allows the company to streamline assembly and shipping around a single design, while simplifying the system’s claims language globally.
“Since the new design addresses all applicable country and regional requirements for electrical scheme and hazardous substance restrictions, we can now harmonize production around a single design. This will allow us to reduce inventory costs and complexity, while improving production rates and efficiency,” said Ric Rumble, TSO3‘s president and CEO.
He added, “The Sterizone VP4 Sterilizer will now have the same claims language in both Europe and Canada. This will provide clarity to our customers, while facilitating sales and marketing in both regions. In sum, this clearance paves the way for us to sell a single product with consistent design and claims language around the globe.”
The sterilizer was originally cleared for commercialization in the US in December 2014. The device is a dual sterilant, low-temperature sterilization system that uses vaporized hydrogen peroxide (H2O2) and ozone to sterilize a wide range of compatible devices. In December 2015, the company filed additional claims that would enable reprocessing of multichannel endoscopic devices such as colonoscopes.
TSO3 has signed Getinge Infection Control AB, an infection control solutions provider, as the exclusive distributor for the Sterizone VP4 Sterilizer. Getinge anticipates delivering more than 100 sterilizers in 2016.
For more information, visit the TSO3 website.