(309 days)
The Evita intensive care ventilator (Evita V800 / Evita V600) is intended for the ventilation of adults, pediatric patients and neonates weighing a minimum of 0.4 kg (0.88 lb). The device is indicated for patients who require temporary or longer-term breathing support for different medical reasons. The device is intended for stationary use in hospitals and medical rooms or for intrahospital patient transport. The device is intended to be used by qualified and trained medical personnel. The device is indicated to provide critical care specific therapy. The device provides ventilation monitoring and modes for volume controlled, pressure controlled and spontaneous breathing.
The intensive care ventilators Evita V800 and Evita V600 were developed and are manufactured by Dräger in Lübeck, Germany. Evita V800 and Evita V600 are specified for the ventilation of adults, pediatric patients and neonates. These devices provide mandatory ventilation modes and ventilation modes for supporting spontaneous breathing as well as ventilation monitoring. Evita V800 and Evita V600 are available in different device variants and can additionally be upgraded by software and hardware options as well as attachable accessories. Evita V800 and Evita V600 are available with a basic device configuration that comprises the following: Trolley with four castors and brakes, Display unit (graphical user interface), Ventilation unit. The changes have been made in the device design including functional integration of the Infinity series C cockpit into the device by changing "PC based Cockpit technology" to an "Embedded Control Display (ECD) technology" including a visually updated (color) in the graphical user interface. The hardware complexity has been reduced. In addition, a Gas supply Unit has been added as well as the Power supply Unit as an option. The device software and firmware have been redesigned. The functionality and features of Babylog VN800 / VN600 are identical to the predicate device.
The provided text is a 510(k) Premarket Notification Summary for the Dräger Evita V800 and Evita V600 ventilators. It details the device's characteristics and its substantial equivalence to predicate devices. However, the document does not contain information regarding an acceptance criteria table, device performance report, details of a study with sample sizes, data provenance, expert ground truth, adjudication methods, MRMC comparative effectiveness study, standalone algorithm performance, or training set details.
The document focuses on demonstrating substantial equivalence to predicate devices (Infinity Acute Care System Workstation Critical Care K093633 and Puritan Bennett™ 980 Series Ventilator System K193056) through comparison of intended use, technological characteristics, and non-clinical testing.
The "Discussion of Non-clinical Testing" section lists various tests performed, such as sterilization, biocompatibility, software, electrical safety, EMC, alarm systems, respiratory gas monitors, waveforms, technical system requirements, accessories compatibility, and human factors engineering. It states that results were summarized in "Test Summary tables" and "evidence included in this submission," but these summaries and evidence are not present in the provided text.
Therefore, I cannot fulfill the request for information on acceptance criteria, device performance, or study details as this information is not included in the provided 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).