(113 days)
The GeNOsyl™ MV-1000 delivers nitric oxide (NO) for inhalation therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user. It is indicated to be used with the Bio-Med Devices CV-2+ ventilator. It provides continuous integrated monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system. It incorporates a battery that provides up to 1 hour of uninterrupted NO delivery in the absence of an external power source. It includes a backup NO delivery capability that provides a fixed flow of 250 mL/min of NO which along with user supplied 10 L/min of oxygen provides 20 ppm in the gas flow to a patient's breathing circuit.
GeNOsyl MV-1000 Delivery System includes four components: 1. Nitric oxide administration apparatus, primary delivery system 2. Nitric oxide gas analyzer 3. Nitrogen dioxide gas analyzer 4. Nitric oxide administration apparatus, backup delivery system. The nitric oxide administration apparatus adds nitric oxide to gases that are to be inhaled by the patient. The nitric oxide administration apparatus is to be used in conjunction with a ventilator or other breathing gas administration system. The concentration of nitric oxide is maintained approximately constant during the inspiratory flow regardless of the variation in flow rate within the inspiratory portion of the respiratory cycle. The concentration of inspired nitric oxide will or must be set by the user, typically in the range of 0 to 80 parts per million (ppm). The administration apparatus includes a pressure regulator and connectors with fittings which are specific for nitric oxide gas cylinders, containing 800 ppm nitric oxide in nitrogen. The nitric oxide delivery apparatus shall minimize the time that nitric oxide is mixed with oxygen and thus minimize the concentration of nitrogen dioxide in the gas inhaled by the patient. In the presence of O2, some conversion of nitric oxide to nitrogen dioxide will occur. The GeNOsyI™ administration apparatus includes a cartridge which will serve a dual purpose: a mixing chamber and to convert any transient nitrogen dioxide to nitric oxide prior to inhalation by the patient. The administration device includes two nitric oxide gas concentration analyzers, a nitrogen dioxide gas analyzer, and an oxygen analyzer with a programmable alarm system. Gas analyzers shall be identified in the labeling for the nitric oxide gas administration device. The administration device also includes an instantaneous backup circuit that delivers a fixed flow of NO and can be activated by the user in case of device failure. Nitric oxide and nitrogen dioxide gas analyzers are devices intended to measure the concentration of nitric oxide and nitrogen dioxide in respiratory gas mixtures during administration of nitric oxide. The gas should be sampled from the inspiratory limb of the patient circuit. The nitric oxide gas analyzer includes provisions for setting upper and lower measured nitric oxide concentrations at which an alarm will be activated. The nitrogen dioxide gas analyzer includes provisions for setting upper measured nitrogen dioxide concentrations at which an alarm will be activated and a shutdown condition will stop the NO injection. The delivery system shall include a nitric oxide administration apparatus for use as a "backup" system for administration of nitric oxide when the main administration apparatus cannot be used.
The provided text describes the GeNOsyl™ MV-1000 Nitric Oxide Delivery System, but it is a 510(k) summary for regulatory clearance and does not contain a dedicated study section with detailed acceptance criteria and reported device performance in the way a clinical study report would.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Ikaria INOmax DS - K061901) by comparing features and performance specifications. The "Performance Specifications" within the comparison table implicitly serve as acceptance criteria, and the statement "The proposed device's performance and specifications are equivalent to the predicate" implies that these criteria were met through various performance tests.
Here's an attempt to extract the requested information based on the available text:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
Since a direct "acceptance criteria" table is not provided, I will construct one based on the performance specifications listed for the GeNOsyl™ MV-1000, assuming these values represent the targets the device aimed to achieve and, by achieving substantial equivalence, implicitly met. The document states "The proposed device's performance and specifications are equivalent to the predicate," which is the reported device performance.
| Parameter | Acceptance Criteria (from GeNOsyl™ MV-1000 Specifications) | Reported Device Performance (Implied) |
|---|---|---|
| NO Delivery (set) | 0 - 80 ppm (800 ppm cylinder) | Achieved, equivalent to predicate |
| NO Resolution (set) | 0.1 / 1 / 2 ppm depending upon NO range | Achieved, equivalent to predicate |
| NO Delivery Accuracy | ± 20% or 2 ppm whichever is greater @ 21°C | Achieved, equivalent to predicate |
| Maximum NO Delivered | 10 15 |
§ 868.5165 Nitric oxide administration apparatus.
(a)
Identification. The nitric oxide administration apparatus is a device used to add nitric oxide to gases that are to be breathed by a patient. The nitric oxide administration apparatus is to be used in conjunction with a ventilator or other breathing gas administration system.(b)
Classification. Class II. The special control for this device is FDA's “Guidance Document for Premarket Notification Submissions for Nitric Oxide Administration Apparatus, Nitric Oxide Analyzer, and Nitrogen Dioxide Analyzer.”