(161 days)
The Hawk Anaesthesia Induction Unit is a medical device for providing continuous gas inhalation for adults and children above 5 kg body weight. It facilitates the control and administration of operator selected gas mixtures with anaesthetic agents . The anaesthetic agents are accurately dispensed by a suitable anaesthetic vaporiser, of the type specified, which may be safely and securely attached to the modular backbar.
The Hawk provides safe and accurate gas flows to maintain patient respiration during induction of anaesthesia. It is specified for use with an oxygen monitor and other suitable monitoring, these monitors are specified in the operator's manual.
The Hawk may be safely used with magnetic resonance imaging systems (MRJ) as it is MRI compatible.
The MIE Hawk Anaesthesia Induction Unit is a medical device for providing continuous gas inhalation.
I am sorry. This document does not contain the information you are requesting. This looks like an FDA clearance letter for a medical device called the "Hawk Anaesthesia Induction Unit". It states that the device is substantially equivalent to legally marketed predicate devices and can be marketed.
The letter does not contain the following information:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- If a standalone performance study was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
This type of information is typically found in a clinical study report or a technical capabilities document, not in an FDA clearance letter.
§ 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).