(375 days)
The AS/3™ Anaesthesia Delivery Unit (AS/3™ ADU) is an Anesthesia Gas Machine for The A.J. > Anaesthetic breathing gas and manual or mechanical ventilation for patients undergoing anesthesia.
The AS/3™ ADU is indicated for all persons that require inhalation anesthesia.
The AS/3™ ADU shall be operated by qualified anesthesia personnel.
AS/3™ Anaesthesia Delivery Unit (AS/3TM ADU) is an Anesthesia Gas Machine.
This appears to be a 510(k) clearance letter for a medical device (AS/3™ Anaesthesia Delivery Unit), not a study report. Therefore, the requested information regarding acceptance criteria and a study proving the device meets them cannot be extracted directly from the provided text.
The document states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. This determination is based on a comparison to existing devices, not necessarily on a novel clinical study with explicit acceptance criteria as would be presented in a performance study report.
The letter explicitly mentions:
- Device Name: AS/3™ Anaesthesia Delivery Unit (AS/3™ ADU)
- Indications For Use: Anaesthetic breathing gas and manual or mechanical ventilation for patients undergoing anesthesia. Indicated for all persons requiring inhalation anesthesia and to be operated by qualified anesthesia personnel.
- Regulatory Class: II
Since the provided text is an FDA clearance letter and not a study report, I cannot provide the specific details requested concerning acceptance criteria and study data.
To answer your questions accurately, you would typically need a separate document, such as a "Summary of Safety and Effectiveness" or a clinical/device performance study report, which would outline the testing performed to demonstrate performance.
§ 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).