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The TI Nasal Mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single patient use in the home or multi-patient use in the hospital institutional environment. The mask is to be used on patients (>661bs/30kg) for whom CPAP or bi-level therapy has been prescribed.

The Respironics TI Nasal Mask is intended to be used with positive airway pressure devices such as CPAP or bi-level systems. The mask provides a seal such that positive pressure from the positive pressure source is directed into the patient's nose. It is held in place with an adjustable headgear. It may be cleaned by the patient in the home (single-patient use) or cleaned by the professional in the hospital/institutional environment through high-level disinfection processes (multi-patient use).

The TI mask's cushion consists of a silicone nasal cushion designed to seal around the patient's nostrils. The silicone mask frame supports the cushion by connecting to the lateral ends of the cushion and resting along the sides of the patient's face up to the crown of the fabric headgear is attached through the slots on the side of the frame to support the mask fit. The elbow is inserted into the opening in the frame.

The elbow can rotate freely through 360 degrees and has a 22mm quick disconnect swivel that is used to connect the conventional air delivery hose between the mask and pressure source. The 22mm quick disconnect swivel is designed in such a way that it can also rotate freely through 360 degrees and be easily removed from the elbow.

This document is a 510(k) summary for the Respironics TI Nasal Mask. It does not describe an AI/ML powered device, therefore no acceptance criteria or study data for such a device are available in this document.

The document focuses on demonstrating substantial equivalence of the TI Nasal Mask to existing predicate devices through material comparisons and non-clinical performance testing.

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