(287 days)
The Servo-u Ventilator System is:
- intended for respiratory support, monitoring and treatment of neonatal, 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-n Ventilator System is:
- intended for respiratory support, monitoring and treatment of neonatal and pediatric patients
- to be used only by healthcare providers
- to be used only in professional healthcare facilities and for transport within these facilities
The Servo-u MR Ventilator System is:
- intended for respiratory support, monitoring and treatment of neonatal, 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
- to be used in MR environment according to specified conditions
- with 1.5 T or 3 T MR scanners
- outside magnetic fields >20 mT/200 Gauss
The Servo-u/n/u MR Ventilator Systems 4.1 consist 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-u/n/u MR Ventilator Systems 4.1 are based on the cleared predicate device Servo-u/n Ventilator Systems 2.1 (K180098) with some improvements. The ventilation modes in the Servo-u/n/u MR 4.1 are the same as the predicate device. Standard configurations of available modes and optional modes do differ between the devices, i.e. Servo-u/n/u MR 4.1.
The ventilators deliver controlled or supported breaths to the patient, with constant flow, constant pressure, using a set oxygen concentration. The ventilators can also deliver High Flow therapy with a constant flow.
The Electrical activity of the diaphragm (Edi) is a measurement of the patients own breathing efforts. The Edi functionality makes it possible to monitor Edi activity in all ventilation modes, High Flow therapy as well as in Standby.
NAVA stands for Neurally Adjusted Ventilatory Assist and is a supported mode of ventilation based on the Edi, delivering assist in proportion to and synchronized with the patient's respiratory drive. NAVA is available as an invasive and a non-invasive mode. The included parts related to this mode, such as Edi module and Edi catheters are identical to the cleared predicate devices Servo-u/n 2.1 (K180098).
Servo-u/n contain a dedicated controller circuit for the Aerogen Solo nebulizer (included as standard). It is identical to the cleared predicate devices Servo-u/n 2.1 (K180098). Not available on Servo-u MR.
Accessories for CO2 monitoring and flow and pressure measurements at the Y piece (Y sensor) are integrated as options. It is identical to the cleared predicate devices Servo-u/n 2.1 (K180098).
The Servo-u/n/u MR Ventilator Systems will produce visual and audible alarms if any parameter varies beyond pre-set or default limits and log alarm recordings. The alarm handling is similar to the one used in the cleared predicate devices Servo-u/n 2.1 (K180098).
The Servo-u/n/u MR Ventilator Systems contain provisions for battery modules to supply the system in the case of mains power failure or during intra-hospital transport. The batteries are identical to the one used for the cleared predicate devices Servo-u/n 2.1 (K180098).
Based on the provided text, the device in question is the "Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1". This document is a 510(k) premarket notification to the FDA, asserting substantial equivalence to previously cleared predicate devices.
*Crucially, this document does not contain any information regarding clinical studies, acceptance criteria, or performance data in the context of an AI/human reader study. It focuses on the technical modifications, safety, and regulatory compliance of a medical device (ventilator systems) to demonstrate substantial equivalence to a predicate device.
Therefore, I cannot provide the requested information for the following reasons:
- No AI component or human reader study: The document describes hardware and software updates to ventilator systems. There is no mention of an Artificial Intelligence (AI) component or any study involving human readers or expert consensus on clinical images/data.
- Focus on Substantial Equivalence: The primary goal of this 510(k) submission is to demonstrate that the updated ventilator systems are "substantially equivalent" to previously cleared predicate devices, primarily through engineering testing, software verification, and adherence to performance standards, not through clinical comparative effectiveness trials in the way an AI diagnostic tool would be evaluated.
- Type of Testing: The non-clinical testing listed (code review, static code analysis, unit tests, integration tests, specification and system-level verification testing, waveform testing, biocompatibility, human factors validation testing) are typical for medical device development to ensure functionality and safety, not AI model performance.
In summary, the provided text does not contain the information necessary to answer your request about acceptance criteria and a study proving an AI device meets those criteria. The document pertains to the clearance of ventilator systems, not an AI diagnostic or assistive device.
§ 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).