DeltaWave Nasal Pillow System

The DeltaWave Nasal Pillow System is a non-invasive mask device that delivers pressurized air from CPAP or bi-level machines directly to a patient's nostrils using nasal pillows. It is intended for adult patients weighing ≥66 lbs (30 kg) who have been prescribed positive airway pressure therapy for sleep apnea, for single-patient reuse in home, hospital, institutional, and sleep center environments.

The subject device is identical in technology and construction to its predicate device (K233415, also DeltaWave Nasal Pillow System). Both feature nasal pillows with two ports, 1.19 cubic inch dead space, 22mm tubing connection, pressure range of 4–20 cmH₂O, identical exhaust flow rates, and identical resistance/pressure drop characteristics. The only difference is expansion of the intended environment from home-only to home plus hospital/institutional/sleep center use.

ISO 17510:2015 (sleep apnea breathing therapy masks), ISO 10993 series (biological evaluation including cytotoxicity, genotoxicity, irritation, sensitization, and systemic toxicity), ISO 18562 series (biocompatibility of breathing gas pathways), and FDA guidance on biocompatibility and reprocessing validation.

The subject device is substantially equivalent to the predicate because they are identical in design, technology, construction, and performance characteristics. The sole difference—expanded use environment from home to home/hospital/institutional/sleep center settings—does not raise new safety or efficacy concerns, as the reference device (DreamWear Silicone Pillows Mask, K210844) demonstrates equivalent devices are already cleared for multi-environment use with identical performance specifications.