(173 days)
The NM6000 is indicated as a continuous flow anesthesia system. The NM6000 may be used for manually assisted, or automatic ventilation, and delivery of gases, anesthetic vapor, and monitoring of oxygen concentration, breathing pressure, and respiratory volume. Federal law restricts this device to sale by or on the order of a physician.
The NM6000 is a continuous flow gas anesthesia system.
This document describes the Narkomed 6000 (NM6000) Anesthesia System, but it does not contain details about acceptance criteria or a study proving its performance against such criteria.
The document is a 510(k) premarket notification for substantial equivalence to a predicate device (Narkomed 4 Anesthesia System). This type of submission focuses on demonstrating that a new device is as safe and effective as a legally marketed device, rather than providing detailed performance studies against specific acceptance criteria.
Therefore, I cannot provide the requested table or answer the questions related to acceptance criteria and performance studies based on the provided text. The document primarily focuses on:
- Device Description: What the NM6000 is and its intended use.
- Substantial Equivalence Comparison: How the NM6000 is similar to and different from the Narkomed 4.
- Regulatory Information: The FDA's determination of substantial equivalence, classification, and general regulatory requirements.
The only mention of "testing" is: "Qualification of the NM6000 included hazard analysis, functional, communication, environmental, and electromagnetic compatibility testing." However, no results, acceptance criteria, or detailed study methodologies for these tests are provided.
§ 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).