FDA grants de novo clearance to bacterial reduction device for CPAP masks, hoses

The FDA has granted de novo clearance to SoClean 3+, an over-the-counter bacterial reduction device for certain CPAP masks and hoses designed to be used after their recommended cleaning procedures, according to a press release.

Robert Wilkins

“Many clinicians are familiar with SoClean and the benefits of using it; however, with the SoClean 3+ being granted FDA clearance, it provides a whole new level of confidence for them in recommending SoClean 3+ to their patients as an adjunct solution for consistent bacterial reduction in their CPAP hose and mask,” Robert Wilkins, CEO of SoClean, told Healio.

“Now, clinicians have a regulated product they can recommend to ensure patients have fresh equipment nightly with ease,” he added.

According to the release, eight types of bacteria in CPAP masks and hoses were reduced by 99.9% with use of SoClean 3+.

At the moment, there are three products that can use SoClean 3+. One is the ResMed Mirage FX nasal mask, and the other two are tubing for the ResMed ClimateLine Air and the ResMed AirSense 10 (SlimLine), the release said.

“The fact that SoClean 3+ is easy to use is a relief, given all the challenges CPAP users and their sleeping partners are already tasked with,” Wilkins told Healio. “This convenient system allows users to feel confident in the fact that they are consistently and easily reducing bacterial build-up in their CPAP hose and mask.”

The FDA explains on its website that de novo approval “provides a marketing pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device.”

Along with this clearance, a new class II category — respiratory accessory microbial reduction devices — was created by the FDA in collaboration with SoClean, Wilkins told Healio.

“SoClean 3+ is the sole FDA-cleared product that provides users with adjunct bacterial reduction of CPAP hoses and masks,” Wilkins said. “Not only does this make us the only product in this category, but it also opens the door for future product opportunities.”

Wilkins told Healio the next step is to quickly get the device to durable medical equipment providers and consumers.

Individuals who already have a SoClean device will hear from the company within the next 60 days on how to upgrade, according to Wilkins.

“Additionally, SoClean will be offering an upgrade program to users of any other CPAP hose and mask cleaning devices,” Wilkins told Healio. Those interested in these programs can visit https://www.soclean.com/upgrade for more information.

“SoClean created such a big market when inventing our product to help CPAP users with equipment maintenance that it also generated a huge market for potentially unsafe copycat products,” Wilkins said. “Prior to our de novo clearance, there was no way to regulate product performance requirements. With this new category, that’s now possible through FDA standards SoClean helped establish.”

Reference:

• De Novo classification request. https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/de-novo-classification-request. Last updated Oct. 4, 2022. Accessed Aug. 20, 2024.