(163 days)
The EvitaXL is a long-term ventilator for intensive care for adults, children, and infants with a body weight of at least 3 kg (6.6 lbs).
With SmartCare™/PS the EvitaXL is intended to stabilize the patient's spontaneous breathing in a "comfortable zone" and to reduce inspiratory support for adults and children with a body weight of at least 15 kg (33 lbs). The patients should be haemodynamically stable with adequate oxygenation and spontaneous breathing. SmartCare can be used for intubated or tracheotomized patients. Patients with body weight between 15 and 35 kq (33.1 and 77.8 lbs) must be endotracheally intubated and ventilated with active humidification.
SmartCare™/PS is contraindicated in case of severe COPD and severe neurologic disorder that affects the cerebral control mechanism of the spontaneous breathing pattern.
The EvitaXL is a time-cycled microprocessor-controlled intensive care ventilator. The option SmartCare™ for the EvitaXL has been developed for assisting physicians and respiratory therapists with the standardization of the weaning process used in intensive care units. The system uses a computerbased representation of a protocol and focusses on the management of pressure support.
Scope of this submission is an extension of claims made in the promotional material, while the itself remains unchanged except for minor modifications that led to non-filing decisions for use, the intended use and the instructions for use also remain unchanged.
The provided text is a 510(k) summary for the SmartCare Option for the EvitaXL ventilator. This document describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include a study that proves the device meets specific acceptance criteria with performance metrics, sample sizes, or details about ground truth establishment.
The document states:
"Scope of this submission is an extension of claims made in the promotional material, while the itself remains unchanged except for minor modifications that led to non-filing decisions for use, the intended use and the instructions for use also remain unchanged."
And:
"The device and its labelling are identical to the predicate device. Substantial equivalence is claimed on that basis."
This indicates that the submission is primarily for an extension of claims based on an already cleared device (K051263), rather than a new device requiring performance validation against acceptance criteria in a new study. Therefore, the detailed information requested in the prompt, such as acceptance criteria table, sample sizes, ground truth establishment, or human-in-the-loop performance, is not present in this 510(k) summary.
Therefore, I cannot provide the requested information based on the provided text as the document does not contain details of such a study.
§ 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).