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510(k) Data Aggregation
(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 | < 9 LPM Ventilator Mean Flow rate: 80 ppm ± 20% | Achieved, equivalent to predicate |
| 9 - 10 LPM Ventilator Mean Flow rate: 75 ppm ± 20% | Achieved, equivalent to predicate | |
| > 10 < 15 LPM Ventilator Mean Flow rate: 55 ppm ± 20% | Achieved, equivalent to predicate | |
| > 15 < 20 LPM Ventilator Mean Flow rate: 35 ppm ± 20% | Achieved, equivalent to predicate | |
| Maximum NO₂ delivered | < 3 ppm (typically < 0.5 ppm) | Achieved, equivalent to predicate |
| Nitric Oxide Analyzer (NO Range 0-10 ppm) | 0 - 10 ppm | Achieved, equivalent to predicate |
| Nitric Oxide Analyzer (NO Resolution 0-10 ppm) | 0.1 ppm | Achieved, equivalent to predicate |
| Nitric Oxide Analyzer (Accuracy 0-10 ppm) | ± (20% of reading + 0.5) ppm | Achieved, equivalent to predicate |
| Nitric Oxide Analyzer (NO Range 10-100 ppm) | 10 - 100 ppm | Achieved, equivalent to predicate |
| Nitric Oxide Analyzer (NO Resolution 10-100 ppm) | 0.1 ppm | Achieved, equivalent to predicate |
| Nitric Oxide Analyzer (Accuracy 10-100 ppm) | ± (10% of reading + 0.5) ppm | Achieved, equivalent to predicate |
| Nitrogen Dioxide Analyzer (NO₂ Range) | 0 - 10 ppm | Achieved, equivalent to predicate |
| Nitrogen Dioxide Analyzer (NO₂ Resolution) | 0.1 ppm | Achieved, equivalent to predicate |
| Nitrogen Dioxide Analyzer (Accuracy) | ± (20% of reading + 0.5) ppm | Achieved, equivalent to predicate |
| Backup System Flow Rate | Fixed flow - 250 mL/min | Achieved, equivalent to predicate |
| Battery Life | Provides up to 1 hour of uninterrupted NO delivery | Achieved, equivalent to predicate |
| Ventilator Inspiratory Flow rate | 2 - 120 LPM (Compatibility) | Achieved compatibility |
| Ventilator Respiratory rate | 6 - 80 BPM (Compatibility) | Achieved compatibility |
| Ventilator Airway Peak pressure | 0 - 70 cm H2O (Compatibility) | Achieved compatibility |
| Ventilator PEEP | 0 - 20 cm H₂O (Compatibility) | Achieved compatibility |
2. Sample Size Used for the Test Set and Data Provenance
The document lists "Performance Testing" which included various categories (e.g., NO delivery apparatus, NO analyzer, NO2 analyzer, electrical safety, EMC, environmental, mechanical safety, biocompatibility, ventilator compatibility, endurance). However, it does not specify the sample sizes used for these tests or the data provenance (e.g., country of origin, retrospective/prospective). This document is a summary of the conclusions drawn from testing, not a detailed report of the testing itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. The performance testing described is likely based on objective measurements against engineering specifications and international standards rather than expert-established ground truth in a clinical context.
4. Adjudication Method for the Test Set
No adjudication method is mentioned. Since the testing appears to be objective performance verification (e.g., measuring gas concentrations, electrical safety), clinical adjudication typically associated with human interpretation of medical images or diagnostic outputs would not be applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
No, an MRMC comparative effectiveness study was not done. This device is a nitric oxide delivery system and gas analyzer, not an AI-powered diagnostic tool requiring human reader studies. Therefore, there is no discussion of human reader improvement with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is a standalone system for delivering and monitoring nitric oxide. The "Performance Testing" section implicitly refers to standalone performance testing (e.g., "NO delivery apparatus", "NO analyzer", "NO2 analyzer", "Electrical safety", "Performance"). These tests assess the inherent capabilities of the device without human intervention beyond setup and operation.
7. The Type of Ground Truth Used
The "ground truth" for the performance testing would be objective engineering and measurement standards. For example:
- For gas analyzers: Known concentrations of calibrant gases, verified by reference measurement devices.
- For delivery accuracy: Precise flow measurements and gas concentration measurements under controlled conditions.
- For electrical safety/EMC: Compliance with IEC standards.
- For biocompatibility: Adherence to ISO 10993 standards and material testing.
It is not based on expert consensus, pathology, or outcomes data in the typical sense of a diagnostic or therapeutic clinical study.
8. The Sample Size for the Training Set
This is not applicable. The GeNOsyl™ MV-1000 is a hardware device with embedded control software, not a machine learning or AI-based system that requires a "training set" in the context of data-driven model development.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as #8.
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