(132 days)
Blease Frontline Sirius Range, Anaesthesia Machines are intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air, and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of a mechanical ventilator, and may be used for the delivery of anaesthetic vapour by use of a dismountable vaporizer.
The device is intended for use only by a suitably qualified physician.
The Frontline Sirius is similar to the cleared Frontline Plus anaesthesia machine and the 6200 ventilator. The size and shape of the cabinet are the different, but the pneumatic systems and ventilator are the same.
The provided text does not contain information about acceptance criteria or a study proving the device meets them. The document is a 510(k) summary for the Blease Frontline Sirius Range Anaesthesia Machine, which focuses on regulatory approval based on substantial equivalence to predicate devices, rather than detailed performance studies and acceptance criteria typically found in a clinical trial report or specific performance testing document.
Therefore, I cannot extract the requested information.
§ 868.5160 Gas machine for anesthesia or analgesia.
(a)
Gas machine for anesthesia —(1)Identification. A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply.(2)
Classification. Class II (performance standards).(b)
Gas machine for analgesia —(1)Identification. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide).(2)
Classification. Class II (performance standards).