(209 days)
The SERVO-i Ventilator System with Heliox option is intended for treatment and monitoring of patients in the range of neonates, infants, and adults with respiratory failure or respiratory insufficiency. SERVO-i is a ventilator system to be used only by healthcare providers in hospitals or healthcare facilities. The SERVO-i Ventilator System with Heliox option is also MR conditional.
The SERVO-i Ventilator System with Heliox option is indicated for use with the delivery of Air, Oxygen, or Heliox (a mixture of Helium and Oxygen).
The predicate device SERVO-i Ventilator System is a ventilator, which gives, ventilation (Invasive and Non Invasive) to critical care patients in the weight range 0.5 to 250 Kg's. The modified device adds an option, called "Heliox option", which is a mechanical adaptor along with software for SERVO-i Ventilator System integration.
The provided text is a 510(k) summary for the Maquet SERVO-i Ventilator System with Heliox option. It focuses on demonstrating substantial equivalence to predicate devices and describes the device's intended use and technological characteristics. Crucially, this document does not contain information about acceptance criteria, device performance metrics, or study designs used to prove the device meets specific performance criteria beyond establishing substantial equivalence for regulatory purposes.
Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth details. These types of studies are typically found in more detailed technical documentation or clinical trial reports, which are not part of this 510(k) summary.
§ 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).