Search Results

The new Nasal CPAP Mask is intended to be used with nasal continuous positive airway pressure (CPAP), auto-adjusting CPAP and Bilevel systems for the treatment of adult (>30kg) Obstructive Sleep Apnea (OSA). The device is to be used in home and clinical environments by or on order of a physician. The device can be used with auto-adjusting PAP devices which depend on patient flow signals or flow-based snoring signals for the determination of pressure adjustment.

The new DeVilbiss Nasal CPAP Mask serves as a mechanism for reliably connecting an adult (>30kg) patient diagnosed with sleep apnea to a source of continuous or bilevel positive air pressure needed to maintain an open airway. The nasal mask is securely fastened over a patient's nose by use of specialized headgear. A soft contact area is provided on the side of the mask that contacts the patient's face; the front side of the mask assembly has a tubing connection which is compatible with the industry standard 22mm air tubing. The CPAP mask is required to be secure fitting to insure proper pressure delivery to the patient, but comfortable enough to maintain patient compliance with the treatment. Air is supplied to the mask by a CPAP device (the CPAP device can be a standard CPAP, AutoAdiust CPAP or Bi-Level type device). Air is channeled to the nose chamber via the tubing/swivel adapter connections. The patient inhales air from the mask and exhales into the mask where continuous airflow from the CPAP device purges the exhaled carbon dioxide from the mask through the mask diffusion based exhaust holes. The mask will be held in place on the patient through the use of a cloth/elastic headgear.

The provided text is a 510(k) summary for the DeVilbiss Nasal CPAP Mask. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, it does not contain information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications that are typically found in clinical trials or validation studies for AI-powered devices.

Therefore, I cannot provide the requested information from the given text. The 510(k) summary primarily focuses on regulatory approval based on demonstrating equivalence to existing devices rather than detailed performance metrics from a study.

Ask a specific question about this device