(259 days)
The Nihon Kohden NKV-550 Series Ventilator System is intended to provide continuous ventilation for adult, pediatric and neonatal patients who require invasive or noninvasive respiratory support. The NKV-550 offers mandatory and spontaneous ventilation modes as well as respiratory monitoring. The NKV-550 is intended for use in hospitals and hospital-type facilities, as well as, for in-hospital transportation.
The Nihon Kohden NKV-550 Series Ventilator System consists of a graphic user interface (GUI) and a breath delivery unit (BDU). The GUI allows clinicians to set ventilator control parameters such as tidal volume and inspiratory pressure, to set alarm limits such as high inspiratory pressure alarm, to view monitored numeric values, to view waveform and loops, and to operate various features through the apps. The BDU contains a microprocessor that receives inputs from the electronic system and controls the pneumatic system for breath delivery to the patient. It also provides various alarms, a safety valve, and other design features to maximize patient safety.
I am unable to extract specific acceptance criteria for the Nihon Kohden NKV-550 Series Ventilator System or details of a study proving it meets them. The provided text from the FDA 510(k) Summary primarily focuses on establishing substantial equivalence to predicate devices, rather than detailing a specific performance study with acceptance criteria.
The document states:
- "Performance of the Nihon Kohden NKV-550 Series Ventilator System was demonstrated by the following testing performed in compliance with Design Controls: Software Verification, Device Functionality Testing, Human Factors/Usability Testing, Bench Test Comparison with Reference Device, Risk Management."
- "Summary of Clinical Performance Data: Not Applicable – Clinical performance data was not required to demonstrate substantial equivalence."
- "Performance: Met ISO 80601-2-12 requirements on essential performance of critical care ventilator"
This indicates that the device's performance was evaluated against the general requirements of the ISO 80601-2-12 standard for critical care ventilators and through internal design control processes like software verification and functionality testing, but a standalone study with explicit acceptance criteria and performance metrics for the device itself (beyond meeting the ISO standard) is not detailed in this summary.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert involvement, adjudication methods, or MRMC studies, as this information is not present in the provided text.
§ 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).