The company’s Sterizone VP4 is a low-temperature sterilization system which uses dual-sterilants of vaporized hydrogen peroxide and ozone for the terminal sterilization of heat and moisture sensitive medical devices. The system has a single pre-programmed cycle which can be used to sterilize a wide range of devices, the Quebec City-based company said.
The response to the FDA includes a results summary from tests evaluating the company’s sterilization process on specifically identified scopes and additional labeling targeted at a selected scope.
The letter also includes recommended device inspection and use intervals to aid users in surveillance after performing such sterilizations.
“Our team has done an exemplary job of quickly addressing the questions and comments received from US regulators in September. In anticipation of receiving our response, a call to review the submission has already been discussed with the agency to address any additional changes or modifications to the suggested labeling in the response. The attention the file is getting is very positive and the Company continues to aggressively pursue all avenues for a final and favorable review this year,” prez & CEO R.M. Rumble said in a press release.
The company originally submitted a 510(k) application with the FDA seeking the terminal sterilization indication in July.