(100 days)
The Penlon Prima Anaesthesia Machine is intended to provide controlled concentrations and flows of anaesthesia gases into a patient breathing system, from where the anaesthesia ventilator and breathing circuit will deliver this fresh gas to the patient.
The Penlon Prima Anaesthesia Machine is designed to deliver a combination of medical gases and volatile anaesthetic agents to a breathing system.
The Prima Anaesthesia Machine is a continuous flow anaesthesia gas delivery device that enables the anesthetist to deliver mixtures of oxygen, air, nitrous oxide and volatile anaesthetic agents to a patient. Although the device has no direct contact with the patient it has an important role to play in a system that delivers anaesthesia gases to a patient.
The device comprises a trolley, a gas delivery system, gas control system. safety systems and facilities to mount and interface other modules of an anaesthesia delivery system, e.g. ventilators, vaporizers, absorbers plus other accessories. The design of the device conforms to all relevant national and international standards covering the safety of anesthesia systems.
This FDA submission focuses on a modification to an Anesthesia Machine, not an AI/ML powered device. Therefore, the typical acceptance criteria and study designs associated with AI/ML device approval (which involve metrics like sensitivity, specificity, reader studies, etc.) are not applicable here.
The document describes a Special 510(k) for a device modification, which emphasizes demonstrating that the modified device is substantially equivalent to a legally marketed predicate device. The information provided is primarily administrative and descriptive, outlining the device's function, intended use, and technological characteristics. There is no mention of a study involving clinical performance metrics, reader studies, or explicit acceptance criteria in the format you've requested for an AI/ML device.
Here's why the requested information cannot be fully provided based on the given document:
- No AI/ML Component: The device is an "Anaesthesia Machine," a hardware medical device. There's no indication of any AI or machine learning algorithms involved.
- Focus on Substantial Equivalence: For this type of device modification submission, the "study" is often a demonstration through engineering analysis, design documentation, and testing (e.g., electrical safety, mechanical integrity, gas delivery accuracy) that the modified device performs as intended and is as safe and effective as the predicate. These are typically internal validation activities, not public "studies" with performance metrics like those for diagnostic AI.
- Lack of Specific Quantitative Performance Data: The document does not contain tables of performance metrics (like sensitivity, specificity, AUC), sample sizes for test sets, expert ground truth establishment, or details about reader studies.
If this were an AI/ML powered device submission, the requested information would be crucial. However, for a traditional hardware device modification, the content of the provided 510(k) summary is typical.
§ 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).