Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L)

The Nasal Pillow Mask is a patient interface device for delivering continuous positive airway pressure (CPAP) or variable positive airway pressure (VPAP) therapy. It uses silicone nasal pillows that fit directly into patients' nostrils to create a sealed interface, available in three sizes (small, medium, large) for patients weighing over 30 kg in home, hospital, or institutional settings under physician direction.

The device is identical to the predicate in all technological aspects: nasal plugs are silicone; frame, L-connector, and connectors are polycarbonate; tube is Hytrel®; headgear is polycarbonate with nylon fabric. Specifications include deadspace volumes of 90.8-95 mL, resistance values of 1.35-1.78 cmH₂O at 50 L/min, therapy pressure range of 5-20 cmH₂O, and noise levels of 34.2-36.8 dB.

Not stated in this summary.

The subject device is substantially equivalent to the predicate device (Hsiner Nasal Pillow Mask, K120920) because it is identical except for manufacturer name, brand name, and labeling updates. The indications for use, design principles, materials, construction, and all technical specifications are unchanged from the FDA-cleared predicate device. No new non-clinical testing is required because no technological changes have been made to the device itself.