(238 days)
The Nasal-Aire //™ Interface is an accessory to positive pressure ventilation devices for patients suffering from Obstructive Sleep Apnea requiring positive pressure breathing therapy (i.e. CPAP, BiLevel)
Nasal-Aire IITM Accessory to a Positive Pressure Ventilation Device
This looks like a 510(k) clearance letter for a medical device (Nasal-Aire II accessory) that does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.
The provided text is a standard FDA 510(k) clearance letter, which states that the device is "substantially equivalent" to legally marketed predicate devices. This type of clearance generally relies on demonstrating similarity to existing devices rather than presenting novel performance studies with specific acceptance criteria.
Therefore, I cannot extract the requested information from the provided text. To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness (SSE) or a clinical study report submitted with the 510(k) application, which would detail any performance testing conducted.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).