(80 days)
The Waste Gas Scavenger is designed for use with vacuum (suction) waste gas disposal systems with anesthesia machines and heart/lung bypass machines.
Active Waste Gas Scavenger
The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called an "Active Waste Gas Scavenger." It is a regulatory document and does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as would be found in a study report.
Therefore, I cannot provide the requested information based solely on the text provided. This document simply states that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices.
§ 868.5430 Gas-scavenging apparatus.
(a)
Identification. A gas-scavenging apparatus is a device intended to collect excess anesthetic, analgesic, or trace gases or vapors from a patient's breathing system, ventilator, or extracorporeal pump-oxygenator, and to conduct these gases out of the area by means of an exhaust system.(b)
Classification. Class II (performance standards).