(80 days)
The Opus HC482 Direct Nasal Mask is intended for multiple patient or single patient adult use by individuals who have been diagnosed by a physician as requiring CPAP or Bilevel ventilator treatment in the home, hospital or other clinical setting.
The Opus HC482 Direct Nasal Mask is a non invasive patient interface that is ideal for people who want an alternative to a traditional nasal mask. The unique design of the mask and the headgear minimizes facial contact and reduces pressure points. The HC482 Direct Nasal Mask is a non invasive patient interface, the pillows of which are positioned inside the patient's nostrils. The mask is held on the face with headgear straps. It connects to a single breathing tube via a swivel adaptor, to receive pressurized gases. On the mask base are exhalation vents (bias holes) located on the elbow that allows exhaled gases to be continually flushed and removed to room air. The nasal prongs on the silicone seal are contoured for comfort and to reduce leakage.
This document is a 510(k) summary for a medical device called the Opus HC482 Direct Nasal Mask. It does not contain information about the acceptance criteria or a study proving the device meets said criteria in the format requested.
The document states that "Testing of the Opus HC482 Direct Nasal Mask was compared to the predicate RESMED Mirage Swift™ for performance and biocompatibility. These tests demonstrate substantial equivalence of the Opus HC482 Direct Nasal Mask to the predicate mask. Copies of test reports are included in Appendix B." However, Appendix B and the specific test reports are not provided in the given text. Therefore, I cannot extract the detailed information requested regarding acceptance criteria and study particulars.
Without the specific test reports (Appendix B), I am unable to provide the detailed information requested in points 1-9. The provided text is a summary seeking FDA clearance based on substantial equivalence to a predicate device, not a detailed study report with performance metrics and acceptance criteria.
§ 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).