Medizone said last week it will pursue de novo clearance for its AsepticSure disinfection system after speaking with the FDA about its 513(g) submission.
The AsepticSure system is designed to be turned on from outside the room to be disinfected, enabling the machine to safely fill the room with a disinfecting gas formula. The device later clears the atmosphere in the room and restores it to within EPA standards, according to the Kalamazoo, Mich.-based company’s website.
Medizone said it will support its de novo pathway application with “data demonstrating AsepticSure’s safety and efficacy profile and low risk nature,” and that it will continue to meet with the FDA to “discuss the best approach” to introduce the device into the US market.
The company had previously been pursuing a 510(k) application with the agency, which it announced in April.
“We look forward to an ongoing productive dialogue with FDA to demonstrate the potential of AsepticSure to make a positive impact in the US healthcare sector. As we address these next steps with FDA, we continue to support expanding our sales and marketing efforts in other segments in the US and markets across the world,” CEO David Esposito said in a prepared statement.
Last November, the company received clearance from the US Environmental Protection Agency to market the AsepticSure for use in disinfecting non-porous surfaces in hospitals, clinics, hotels, sporting venues, long-term care facilities, critical infrastructures and food industry venues. The FDA later asserted that it believes it has jurisdiction over the AsepticSure as a medical device, limiting its use as in medical environments.
Medizone said it will continue to market the device in non-medical uses under that EPA clearance.