(134 days)
The AV-S Anaesthesia Ventilator is intended to provide continuous mechanical ventilatory support during general anaesthesia. The ventilator is a restricted medical device intended for use by qualified trained personnel, i.e. Nurses and Respiratory Therapists and Technicians under the direction of a Physician. Specifically the ventilator is indicated for use by both adult and pediatric patients.
The AV-S Ventilator is a software controlled multi-mode ventilator designed for mechanical ventilation of adult and paediatric patients under general anaesthesia. In addition, in spontaneous mode, it can be used to monitor anaesthetised patients. It is designed for use in closed circuit anaesthesia and also to drive a Mapleson D circuit.
The AV-S Ventilator is also available with a remote display screen unit that can be affixed to an anaesthesia machine and be located remotely from the ventilator control unit. The display screen is affixed to the anaesthesia ventilator by a swivel mounting arm. An interconnecting cable is provided to transmit data between the control unit and the remote display screen unit.
The provided document is a 510(k) summary for the AV-S Anaesthesia Ventilator. It focuses on demonstrating substantial equivalence to predicate devices and outlines the device's technical characteristics and intended use. Crucially, this document does not contain information on acceptance criteria, a study proving device performance against such criteria, or details regarding ground truth establishment, sample sizes, or expert adjudication for performance evaluation studies.
The text consistently refers to the device as an "Anaesthesia Ventilator" and its purpose is for "continuous mechanical ventilatory support during general anaesthesia." It emphasizes the similarities with predicate devices (Penlon Limited AV800 Anaesthesia Ventilator and Datex-Ohmeda 7900 Anaesthesia Ventilator) in terms of software control, multi-mode functionality, and indications for use. The only noted technological differences are the incorporation of the Prima Oxygen monitor and additional software for advanced spontaneous breathing support modes.
Since the document does not contain the requested information about acceptance criteria and performance studies, I am unable to populate the table or provide details for points 2 through 9.
Therefore, the response for the requested information is that it is not present in the provided text.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).