K Number
K120216
Device Name
GENOSYL MV-1000
Manufacturer
Date Cleared
2012-05-16

(113 days)

Product Code
Regulation Number
868.5165
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
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.
More Information

No
The description focuses on hardware components, gas analysis, and control systems based on user settings and measured gas concentrations, with no mention of AI or ML algorithms for decision-making or control.

Yes
The device delivers nitric oxide (NO) for inhalation therapy gas, which is used to treat a patient's condition (e.g., in neonates). This direct involvement in physiological treatment classifies it as a therapeutic device.

No

Explanation: The device is designed for delivering nitric oxide for inhalation therapy and monitoring gas concentrations (O2, NO2, NO) during this therapy. While it monitors certain parameters, its primary function is therapeutic delivery, not diagnosis.

No

The device description clearly outlines multiple hardware components, including a nitric oxide administration apparatus, gas analyzers, a battery, and a backup delivery system. It is a physical device that delivers and monitors gases.

Based on the provided text, the GeNOsyl™ MV-1000 is not an In Vitro Diagnostic (IVD) device.

Here's why:

  • IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
  • GeNOsyl™ MV-1000 Function: The GeNOsyl™ MV-1000 is a device that delivers nitric oxide gas for inhalation therapy directly to a patient's breathing circuit. It also monitors inspired gases (O2, NO2, NO).
  • No Specimen Analysis: The device does not collect or analyze specimens from the human body. Its function is to administer a therapeutic gas and monitor the composition of the inhaled gas.

Therefore, the GeNOsyl™ MV-1000 falls under the category of a therapeutic gas delivery and monitoring system, not an IVD.

N/A

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

MRN, MRO, MRP, MRQ

Device Description

GeNOsyl MV-1000 Delivery System includes four components:

    1. Nitric oxide administration apparatus, primary delivery system
    1. Nitric oxide gas analyzer
    1. Nitrogen dioxide gas analyzer
    1. 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

The target patient population is controlled by the drug labeling for FDA approved NO and is currently neonates.

Intended User / Care Setting

Hospital, e.g., NICU Intra-hospital transport

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Testing included:

  • . NO delivery apparatus
  • NO analyzer
  • NO2 analyzer .
  • . Electrical safety
  • Electromagnetic compatibility (EMC) .
  • . Performance
  • . Environmental
  • . Mechanical safety
  • . Biocompatibility
  • Ventilator Compatibility .
  • Endurance .

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Ikaria INOmax DS - K061901

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Bio-Med Devices CrossVent 2 – K942938

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.”

0

510(k) Summary
Page 1 of 8K120216
23-Jan-12

MAY 1 6 2012

| GeNO LLC
2941 Oxbow Circle
Cocoa, FL 32936 | T - (321) 785-2601
F - (321) 785-2460 |
|--------------------------------------------------|------------------------------------------------|
| Official Contact: | Alex Chaharom
Director of Quality Assurance |

Proprietary or Trade Name: GeNOsyl™ MV-1000

Classification / CFR / Classification Name:

Product CodeCFRClassification name
MRN868.5165Nitric oxide administration apparatus, primary delivery system
MRO868.6165Nitric oxide administration apparatus, backup delivery system
MRP868.2380Nitric oxide gas analyzer
MRQ868.2385Nitrogen dioxide gas analyzer

Class:

All are Class 2

Predicate Devices:

Ikaria INOmax DS - K061901

Device Description:

GeNOsyl MV-1000 Delivery System includes four components:

    1. Nitric oxide administration apparatus, primary delivery system
    1. Nitric oxide gas analyzer
    1. Nitrogen dioxide gas analyzer
    1. 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.

1

510(k) Summary Page 2 of 8 23-Jan-12

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.

Principle of Operation

The MV-1000 injects a constant volume of nitric oxide into the inspiratory limb of the ventilator circuit to deliver a constant concentration of nitric oxide to the patient.

The NO gas is introduced by means of a mass flow controller into the inspiratory limb of the ventilator, on the dry side of the breathing circuit.

The MV-1000 delivery system is designed to deliver nitric oxide independently from the monitoring activities. This allows the monitoring system to shutdown nitric oxide delivery if a fault is detected in the system.

The MV-1000 delivery system requires a source of pharmaceutical grade nitric oxide gas at a concentration of 800 ppm in nitrogen.

The nitric oxide enters the back of the MV-1000 delivery system and a volume of gas is injected into the inspiratory limb, on the dry side of the breathing circuit, to achieve the concentration that is set by the user. Prior to reaching the patient, the gas passes through the GeNO Cartridge, which serves two (2) functions: 1) as mixing chambers and 2) to convert any NO2 which may have been formed in the breathing circuit back to NO to deliver a constant dose of NO to the patient.

2

510(k) Summary Page 3 of 8 23-Jan-12

Indications for Use:

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.

Patient Population:

The target patient population is controlled by the drug labeling for FDA approved NO and is currently neonates.

Environment of Use:

The GeNOsyl™ MV-1000 is intended to be used in Hospital, e.g., NICU and Intra-hospital transport settings.

Comparison to Predicates
FeaturesGeNOsyI™ MV-1000
Indications for useThe GeNOsyI™ 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.
Delivers NO at a constant flow.
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
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.

a

3

510(k) Summary Page 4 of 8

23-Jan-12

FeaturesGeNOsyITM MV-1000
Environment of UseHospital, e.g., NICU
Intra-hospital transport
Patient PopulationThe target patient population is controlled by the drug labeling for FDA
approved NO and is currently neonates.
Principle of OperationUtilizes a source of NO gas which is injected into the patient breathing circuit
as part of a ventilator circuit.
Continuous in-line monitoring is performed to measure concentrations of O2,
NO2, NO
In-line gas sampling is performed near the patient to measure NO₂
A cartridge is placed in the inspiratory limb of the patient breathing circuit to
act as a gas mixture / blender and to convert any NO₂ to NO prior to gas
delivery to the patient. This is considered an added safety feature which the
predicate does not have.
System DesignIncludes analyzers for:
O2
NO – 2 sensors provided
NO,
Back-up system
Compliance with
StandardsGuidance Document for Premarket Notification Submissions for Nitric Oxide
Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen Dioxide Analyzer
Injector ModuleDelivers a constant flow which in combination with the in-line cartridge
provides a constant and fixed level of NO.
Outlet connector 15 mm / 22 mm
Injection FlowConstant
Method used to mix NO
gas and ventilator airIn-line cartridge design facilitates mixing / blending of NO and ventilator gases
for a more consistent and constant NO / air mixture. The cartridge element is
made of ascorbic acid which converts any NO2 to NO and thus reduces the
potential of any transient NO2 being delivered to the patient
NO Delivery shutoffYes
Calibration GasNO Cal Gas 45 ppm ± 4%
NO₂ Cal Gas 10 ppm ± 10%
FeaturesGeNOsylTM MV-1000
AlarmsNO Low alarm
NO High alarm
NO₂ high alarm
O₂ low alarm
O₂ high alarm
Low battery alarm
Low gas pressure alarm
High gas pressure alarm
NO Gas Leak
Sampling gas occlusion include full water trap
Sampling gas line disconnected (while dosing)
Bad NO sensor or calibration required
Injector Module Failure
Flow Sensor Cable may be disconnected
NO Internal high pressure
NO Internal low pressure
Patient gas exceeded
Hardware failure
Method of samplingSide stream gas sampling of ~ 230 ml/min which is analyzed and then
exhausted to room air
NO delivery (set)0 - 80 ppm (800 ppm cylinder)
NO Resolution (set)0.1 / 1 / 2 ppm depending upon NO range
Accuracy+ 20% or 2 ppm whichever is greater @ 21°C
NO inlet pressure0.17 Bar to 0.66 Bar (2.5 to 9.5 psi)
Maximum NO supply
pressure0.66 Bar (9.5 psi)
Minimum NO supply
pressure0.17 Bar (2.5 psi)
Range of NO Injection
Flow0-1 LPM
Injection FlowConstant
Maximum Circuit
PressureN/A
Maximum NO
concentration /
Ventilator Mean Flow
rateVentilator Mean Flow rate
10 15