F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)

The F6S Full Face Mask and P6S Nasal Pillows Interface are non-invasive respiratory interfaces for delivering CPAP or bi-level positive airway pressure therapy to patients weighing over 66 lbs (30 kg) in the home setting. Both devices connect to PAP devices through breathing tubes and are designed for single-patient reuse, with the full face mask sealing around the nose and mouth while the nasal pillows interface seals at the nares entrance.

Both devices feature silicone cushion assemblies, adjustable headgear with straps, tube connections, elbow assemblies with exhalation ports, and 22 mm swivel connectors compatible with standard PAP tubing. The F6S offers multiple cushion sizes (Small, Medium, Medium Wide, Large) and tube sizes, while the P6S offers three cushion sizes and tube sizes. Performance metrics including deadspace volume, pressure drop, CO2 rebreathing, and sound levels are similar to predicate devices and meet ISO 17510:2015 standards.

ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Sensitization), ISO 10993-23 (Intracutaneous Reactivity), ISO 10993-11 (Material Mediated Pyrogenicity), ISO 18562-1 through 18562-4 (Breathing Gas Pathway Biocompatibility), ISO 17510:2015 (Sleep Apnea Breathing Therapy), ISO 5356-1:2015 (Breathing Tube Connectors), and ASTM D4169-22 (Packaging and Transportation).

The subject devices are substantially equivalent to their predicates (DreamWear Silicone Pillows Mask K210844 and AirFit F30i Non Magnetic K234134) because they have identical indications for use, patient populations, environments of use, and anatomical sites, with similar construction, technology, and performance characteristics that meet the same applicable standards. The minor differences in size offerings and design details do not raise new questions of safety or effectiveness.