(95 days)
The Performax SE Total Face Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilator failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency or obstructive sleep apnea.
The mask is for multi-patient reuse on patients weighing > 30 kg, who are appropriate candidates for noninvasive ventilation, in the hospital/institutional environment only.
The Respironics Performax SE Total Face Mask consists of a polycarbonate faceplate with silicon cushion seal for the face. Like the device predicate, Image 3SE full face mask (K023135), the interface to the patient circuit is a polycarbonate standard elbow. The design of the standard elbow (SE) is the same as the SE used on the Image 3SE Full Face mask. The mask when used with the standard elbow has one integrated exhalation feature, which includes one port on the faceplate. Similar to the device predicate, Total Face Mask (K992969), the mask faceplate contains headgear hooks upon which the premium headgear is attached. The mask is available in two sizes - small and large.
The Respironics Performax SE Total Face Mask is intended for use with a patient circuit that is used to connect the device to the patient interface device (mask). A typical patient circuit consists of a six-foot disposable or reusable smooth lumen 22mm tubing, a method of venting exhaled gases.
The provided document is a 510(k) summary for a medical device (Respironics Performax SE Total Face Mask). It is a regulatory submission demonstrating substantial equivalence to a predicate device, rather than a clinical study report with detailed acceptance criteria and performance metrics.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information cannot be extracted from this document.
This document focuses on:
- Device Description: What the device is, its components, and how it's designed.
- Intended Use: For what purpose and with what patients the device is meant to be used.
- Substantial Equivalence: How the new device is similar to previously cleared predicate devices (Respironics Total Face Mask K992969 and Image 3 SE Face Mask K023135). The submission discusses design modifications and states that "Based on the testing performed, none of the design modification affect the safety or effectiveness of the device."
The document does not provide details on the specific "testing performed" in terms of acceptance criteria, study design, or quantitative performance results relevant to the questions asked. It's a high-level summary for regulatory clearance, not a detailed scientific study publication.
§ 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).