(272 days)
The Servo-air ventilator system is intended for respiratory support, monitoring and treatment of pediatric and adult patients to be used only by healthcare providers to be used only in professional healthcare facilities and for transport within these facilities
The Servo-air 4.0 Ventilator System consists of a Patient Unit where gases are mixed and administered, and a User Interface where the settings are made and ventilation is monitored. The Servo-air 4.0 Ventilator System is based on the cleared predicate device Servo-U/n 2.1 Ventilator System (K180098), with some modifications. The ventilation modes in the Servo-air 4.0 are the same as the predicate device. Standard configurations of available modes and optional modes do differ between the Servo-air, and the cleared predicate device Servo-U/n 2.1. The ventilator delivers controlled or supported breaths to the patient, with constant flow, constant pressure, using a set oxygen concentration. Servo-air contains a dedicated controller circuit for the Aerogen Solo nebulizer (included as standard). The Servo-air 4.0 Ventilator System will produce visual and audible alarms if any parameter varies beyond pre-set or default limits and log alarm recordings. The system contains provisions for battery modules to supply the system in the case of mains power failure or during intra-hospital transport.
This document does not contain an AI/ML device or its associated performance study. It is a 510(k) premarket notification for a Servo-air 4.0 Ventilator System. The information provided describes the ventilator, its comparison to a predicate device (Servo-U/n 2.1 Ventilator System), and non-clinical testing performed to demonstrate substantial equivalence, focusing on engineering changes and performance specifications of a physical device.
Therefore, I cannot provide the requested information regarding acceptance criteria and the study that proves an AI/ML device meets acceptance criteria.
§ 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).