(237 days)
These anaesthesia machines are apparatus for providing continuous gas inhalation for adults and children (neonatal and paediatric). They allow the administration of operator selected gas mixtures of oxygen, nitrous oxide and air with any of the anaesthetic agents; Halothane, Isoflurane, or Sevoflurane. They provide safe and accurate gas flows to maintain patient respiration during anaesthesia, and incorporate a ventilator, an oxygen monitor and a respiratory monitor. The ventilator provides the necessary power, as air or oxygen, to generate volumes and pressures in the ventilating system to ventilate a patient connected to the anaesthesia machine. They are recommended for use only by trained physicians, in the operating room or similar surgical environments.
These anaesthesia machines are apparatus for providing continuous gas inhalation for adults and children (neonatal and paediatric). They allow the administration of operator selected gas mixtures of oxygen, nitrous oxide and air with any of the anaesthetic agents; Halothane, Isoflurane, or Sevoflurane. They provide safe and accurate gas flows to maintain patient respiration during anaesthesia, and incorporate a ventilator, an oxygen monitor and a respiratory monitor. The ventilator provides the necessary power, as air or oxygen, to generate volumes and pressures in the ventilating system to ventilate a patient connected to the anaesthesia machine. They are recommended for use only by trained physicians, in the operating room or similar surgical environments.
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment. The document is an FDA 510(k) clearance letter for the "MIE Falcon Anaesthesia Machine fitted with the Kestrel Anaesthesia Ventilator" and "Datex Flexima II Anaesthesia Machine fitted with the Flexivent II Anaesthesia Ventilator."
It outlines the FDA's "substantially equivalent" determination for these anesthesia machines for gas inhalation for adults and children, including administration of specific anesthetic agents and monitoring capabilities. However, it does not include the detailed technical performance criteria or the results of a study designed to prove the device meets such criteria.
§ 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).