(246 days)
The SULLIVAN® VPAP™ II ST Ventilatory Support System is intended to assist the ventilation of adult patients with respiratory insufficiency, respiratory failure, and/or obstructive sleep apnea. When used for respiratory insufficiency and/or respiratory failure an external alarms monitor must be connected. The system is intended for use in a hospital or health care facility, such as a nursing facility, ambulatory surgical facility or hospice.
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The provided text is a 510(k) premarket notification letter from the FDA regarding the "Sullivan® VPAP™ II ST Ventilatory Support System." This document is a regulatory approval letter and does not contain any information about acceptance criteria, study designs, sample sizes, ground truth establishment, or expert involvement for evaluating the device's performance.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text. The letter only confirms that the FDA has reviewed the device and determined it to be substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It does not elaborate on the specific performance data or studies that led to this determination.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).