(240 days)
The Nihon Kohden NKV-330 Ventilator is intended to provide ventilation and oxygen concentration for patients who are breathing spontaneously but need partial ventilation support due to respiratory failure or chronic respiratory insufficiency. It is intended for children weighing 12.5 kg or greater to adult patients. It offers noninvasive ventilation, invasive ventilation, and respiratory monitoring. The NKV-330 is intended for use in hospital-type facilities, and in-hospital transportation by qualified and trained users under the directions of a physician.
The NKV-330 is a servo-controlled ventilator that is designed to meet the gas delivery and performance requirements for pediatric through adult patients. The NKV-330 design is comprised of two major components, a Breath Delivery Unit (BDU) and a Graphic User Interface (GUI). The GUI allows clinicians to set ventilator control parameters such as PEEP and inspiratory pressure, to set alarm limits such as high inspiratory pressure alarm, to view monitored numeric values, and to view waveforms. The BDU assembly contains a blower and the electronics required to perform breath delivery. Ambient air is taken into the blower and mixed with oxygen which is flow rate controlled by a proportional valve. The mixed gas is provided to the patient. The microprocessor controls the blower and the proportional valve to deliver the pressure and oxygen concentration which are set by the user. It also provides various alarms and other design features to maximize patient safety.
The provided document is a 510(k) summary for the Nihon Kohden NKV-330 Ventilator System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific acceptance criteria through a clinical study or detailed performance metrics.
Therefore, the document does not contain the specific acceptance criteria, reported device performance in those terms, details of a specific study proving it, sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth details as requested.
The document primarily states that the device's technical characteristics are "substantially equivalent" to a predicate device (Philips/Respironics V60 Ventilator) and lists various non-clinical performance data and standards compliance to support this claim. It explicitly states "Clinical performance data was not required to demonstrate substantial equivalence."
§ 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).