(123 days)
The Revolution Full Face Mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for multi-patient reuse in the home or hospital/institutional environment. The mask is to be used on patients (>66lbs/30kg) for whom CPAP or bi-level therapy has been prescribed.
The RevolutionFull Face Mask consists of a Hyrel faceplate that holds multiple sizes of a removable and replaceable silicone cushion seal for the face. The mask cushion has eight integrated exhalation vents, four on either side of the cushion. The location of the exhalation vents on the silicone mask cushion is unchanged from K023068. A separate exhalation device is not required for the integrated exhalation vent design. The integrated entrainment valve elbow is polycarbonate with a silicone flapper. The functionality and performance of the entrainment valve with fresh air inlets is unchanged from K073600, based on performance test data. The mask frame contains slots for attachment of the headgear straps, lower headgear band and chin support band. The mask is available in three sizes - small, medium and large.
The Respironics RevolutionFull Face Mask is intended for use with a patient circuit that is used to connect a therapy 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 text is a 510(k) Summary for the Respironics Revolution Full Face Mask. It primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use, operating principles, technology, and manufacturing processes, along with outlining design modifications and intended use.
This document does not describe acceptance criteria for device performance in the manner that would typically be presented for a study proving a device meets specific performance metrics. Instead, it details the changes made to a new device compared to its predicates and asserts that these changes do not affect the safety or effectiveness based on "testing performed." However, it does not provide the study details, acceptance criteria, or results of that testing.
Therefore, I cannot populate the requested table and answer the study-specific questions because the information is not present in the provided text. The document is a regulatory submission for substantial equivalence, not a clinical or performance study report with detailed performance metrics and results against 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).