PETERBOROUGH, N.H.– SoClean, a pioneer in bacterial reduction systems for CPAP hoses and masks, is pleased to announce it has been granted De Novo clearance by the FDA for the SoClean 3+. The SoClean 3+ is the only FDA cleared product intended to be used as an adjunct to reduce bacterial populations on certain compatible home use CPAP mask and ventilation hoses after cleaning. The SoClean 3+ has been demonstrated to achieve 99.9% bacterial reduction* in CPAP hoses and masks. SoClean is pleased to offer CPAP users this easy-to-use and convenient system to continually reduce bacterial build-up in CPAP hoses and masks.
SoClean is committed to CPAP users and the clinical need to develop products that are easy to use and significantly reduce bacterial populations in CPAP hoses and masks. “Sleep apnea is a growing issue worldwide, which impacts user’s ability to get a proper night’s rest. Ensuring bacteria in CPAP hoses and masks can be easily reduced following cleaning is essential for daily use and maintenance by users,” says CEO Robert Wilkins. SoClean has over 150 patents issued worldwide focused on SoClean’s bacterial reduction systems, methods, devices and designs.
The SoClean 3+ is an over-the-counter device. The SoClean 3+ is currently established for use with the ResMed Mirage FX (nasal mask), ResMed ClimateLine Air (tubing), and SlimLine (tubing) for the ResMed AirSense 10.** Moving forward, SoClean is working to establish additional hoses and masks for use with the SoClean 3+ bacterial reduction device.
SoClean is excited to introduce the SoClean 3+ home-use cleaning device for CPAP hoses and masks. SoClean will communicate to customers how to upgrade their current SoClean devices to a SoClean 3+ within the next 60 days. Additionally, SoClean will be offering an upgrade program to users of any other CPAP hose and mask cleaning devices.
* The SoClean 3+ device is intended to be used as an adjunct to reduce bacterial populations on certain compatible home use CPAP mask and ventilation hoses after cleaning. An in vitro 3-log (99.9%) bacterial reduction by SoClean 3+ has been demonstrated for the following bacteria: Staphylococcus aureus (ATCC 6538), Klebsiella aerogenes (ATCC 13048), Staphylococcus haemolyticus (ATCC 29970), Escherichia coli (ATCC 11229), Staphylococcus hominis (ATCC 27844), Klebsiella pneumoniae (ATCC 4352), Pseudomonas aeruginosa (ATCC 15442), and Streptococcus pyogenes (ATCC 14289) after a complete processing cycle. Any correlation between in vitro results and clinical outcome has not been established.
The SoClean 3+ bacterial reduction device is an over-the-counter device for single patient home use. This device must not be used to replace the cleaning procedures as recommended by the CPAP mask and hose manufacturers. SoClean 3+ has been tested for use with ResMed Mirage FX (nasal mask), ResMed ClimateLine Air (tubing), and SlimLine (tubing) for ResMed AirSense 10 CPAP device. The safe use of SoClean 3+ with any other respiratory devices or accessories has not been established.
