(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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| 510(k) Summary | |
|---|---|
| Page 1 of 8 | K120216 |
| 23-Jan-12 |
MAY 1 6 2012
| GeNO LLC2941 Oxbow CircleCocoa, FL 32936 | T - (321) 785-2601F - (321) 785-2460 |
|---|---|
| Official Contact: | Alex ChaharomDirector of Quality Assurance |
Proprietary or Trade Name: GeNOsyl™ MV-1000
Classification / CFR / Classification Name:
| Product Code | CFR | Classification name |
|---|---|---|
| MRN | 868.5165 | Nitric oxide administration apparatus, primary delivery system |
| MRO | 868.6165 | Nitric oxide administration apparatus, backup delivery system |
| MRP | 868.2380 | Nitric oxide gas analyzer |
| MRQ | 868.2385 | Nitrogen dioxide gas analyzer |
Class:
All are Class 2
Predicate Devices:
Ikaria INOmax DS - K061901
Device Description:
GeNOsyl MV-1000 Delivery System includes four components:
-
- Nitric oxide administration apparatus, primary delivery system
-
- Nitric oxide gas analyzer
-
- Nitrogen dioxide gas analyzer
-
- 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.
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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.
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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 | |
|---|---|
| Features | GeNOsyI™ MV-1000 |
| Indications for use | The GeNOsyI™ MV-1000 delivers nitric oxide (NO) for inhalation therapy gasinto the inspiratory limb of the patient breathing circuit in a way that provides aconstant 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, andcomprehensive alarm system.It incorporates a battery that provides up to 1 hour of uninterrupted NO deliveryin the absence of an external power source.It includes a backup NO delivery capability that provides a fixed flow of 250mL/min of NO which along with user supplied 10 L/min of oxygen provides 20ppm in the gas flow to a patient's breathing circuit. |
a
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510(k) Summary Page 4 of 8
23-Jan-12
| Features | GeNOsyITM MV-1000 | |
|---|---|---|
| Environment of Use | Hospital, e.g., NICUIntra-hospital transport | |
| Patient Population | The target patient population is controlled by the drug labeling for FDAapproved NO and is currently neonates. | |
| Principle of Operation | Utilizes a source of NO gas which is injected into the patient breathing circuitas part of a ventilator circuit.Continuous in-line monitoring is performed to measure concentrations of O2,NO2, NOIn-line gas sampling is performed near the patient to measure NO₂A cartridge is placed in the inspiratory limb of the patient breathing circuit toact as a gas mixture / blender and to convert any NO₂ to NO prior to gasdelivery to the patient. This is considered an added safety feature which thepredicate does not have. | |
| System Design | Includes analyzers for:O2NO – 2 sensors providedNO,Back-up system | |
| Compliance withStandards | Guidance Document for Premarket Notification Submissions for Nitric OxideDelivery Apparatus, Nitric Oxide Analyzer and Nitrogen Dioxide Analyzer | |
| Injector Module | Delivers a constant flow which in combination with the in-line cartridgeprovides a constant and fixed level of NO.Outlet connector 15 mm / 22 mm | |
| Injection Flow | Constant | |
| Method used to mix NOgas and ventilator air | In-line cartridge design facilitates mixing / blending of NO and ventilator gasesfor a more consistent and constant NO / air mixture. The cartridge element ismade of ascorbic acid which converts any NO2 to NO and thus reduces thepotential of any transient NO2 being delivered to the patient | |
| NO Delivery shutoff | Yes | |
| Calibration Gas | NO Cal Gas 45 ppm ± 4%NO₂ Cal Gas 10 ppm ± 10% | |
| Features | GeNOsylTM MV-1000 | |
| Alarms | NO 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 sampling | Side stream gas sampling of ~ 230 ml/min which is analyzed and thenexhausted 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 pressure | 0.17 Bar to 0.66 Bar (2.5 to 9.5 psi) | |
| Maximum NO supplypressure | 0.66 Bar (9.5 psi) | |
| Minimum NO supplypressure | 0.17 Bar (2.5 psi) | |
| Range of NO InjectionFlow | 0-1 LPM | |
| Injection Flow | Constant | |
| Maximum CircuitPressure | N/A | |
| Maximum NOconcentration /Ventilator Mean Flowrate | Ventilator Mean Flow rate< 9 LPM9 - 10 LPM> 10 < 15 LPM> 15 < 20 LPM | Maximum NO Delivered80 ppm ± 20%75 ppm ± 20%55 ppm ± 20%35 ppm ± 20% |
| Maximum NO₂ whichcan be delivered to thepatient | < 3 ppmtypically < 0.5 ppm | |
| Features | GeNOsyIT™ MV-1000 | |
| Physical Dimensions | Max Weight15.9 kg (35 lbs) | |
| Max Width / Depth14 inches W x 20 inches D | ||
| Max Height9 inches | ||
| VentilatorCompatibility | Inspiratory Flow rate2 - 120 LPM | |
| Respiratory rate6 - 80 BPM | ||
| Airway Peak pressure0 - 70 cm H2O | ||
| PEEP0 - 20 cm H₂O | ||
| Bio-Med Devices CrossVent 2 – K942938 | ||
| Operating Conditions | Temperature5 to 40°C | |
| Humidity15 to 95% RH | ||
| Ambient Pressure68 to 106 kPa | ||
| Storage Conditions | Temperature-20 to 60°C | |
| Humidity15 to 95% RH | ||
| Ambient Pressure57 to 110 kPA | ||
| Electrical | Line Voltage:110V-125V | |
| Input Power110 VA | ||
| Input Fuse:3 A | ||
| ClassificationClass 1, Type B | ||
| Classification Name | Nitric oxide analyzer | |
| NO Range | 0 - 10 ppm | |
| NO Resolution | 0.1 ppm | |
| Accuracy | $\pm$ (20% of reading + 0.5) ppm | |
| NO Range | 10 - 100 ppm | |
| NO Resolution | 0.1 ppm | |
| Accuracy | $\pm$ (10% of reading + 0.5) ppm | |
| Classification Name | Nitrogen dioxide analyzer | |
| NO₂ Range | 0 - 10 ppm | |
| NO₂ Resolution | 0.1 ppm | |
| Accuracy | $\pm$ (20% of reading + 0.5) ppm | |
| Classification Name | Nitric oxide administration apparatus, Back-up system | |
| Flow rate | Fixed flow - 250 mL/min | |
| Separate system frommain delivery | Yes uses a manual resuscitation bag for ventilator support |
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510(k) Summary
23-Jan-12
{5}------------------------------------------------
Premarket Notification 510(k) Section 5 - 510(k) Summary
510(k) Summary Page 6 of 8
23-Jan-12
.
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510(k) Summary
Page 7 of 8 23-Jan-12
Performance Testing:
Testing included:
- . NO delivery apparatus
- NO analyzer
- NO2 analyzer .
- . Electrical safety
- Electromagnetic compatibility (EMC) .
- . Performance
- . Environmental
- . Mechanical safety
- . Biocompatibility
- Ventilator Compatibility .
- Endurance .
Standards and FDA Guidance:
The GeNOsyI™ MV-1000 was designed to comply with the applicable portions of the following Guidance and Standards.
- Guidance Document for Premarket Notification Submissions for Nitric Oxide Delivery . Apparatus, Nitric Oxide Analyzer and Nitrogen Dioxide Analyzer, January 24, 2000
- . IEC 60601-1: 2005 Medical Electrical Equipment - General Requirements for Basic Safety and Essential Performance
- . IEC 60601-1-1: 2000 Medical Electrical Equipment - General Requirements for Safety -Collateral Standard: Safety requirements for medical electrical systems
- . IEC 60601-1-2: 2001 Medical Electrical Equipment - General Requirements for Safety -Collateral Standard: Electro-magnetic Compatibility- Requirements and Tests (Includes AMENDMENT 1, ANSI/AAMI/IEX 60601-1-2:2001/a1:2004)Amendment 1: 2004
- . IEC 60601-1-8: 2006 Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
- . ISO 21647:2004 Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors
- IEC 62304: 2006 Medical Device Software Software Lifecycle Processes .
- EN ISO 10993-1:2003 Biological evaluation of medical devices Part 1: Evaluation and . testing (ISO 10993-1:2003)
- ISO 5356-1:2004 Anaesthetic and respiratory equipment Conical connectors: Part 1: . Cones and sockets.
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510(k) Summary Page 8 of 8 23-Jan-12
Substantial Equivalence
The GeNOsy!™ MV-1000 is viewed as substantially equivalent to the predicate device because:
Indications -
The proposed indications for use are identical to the predicate, INOmax DS (K061901).
Environment of Use -
The proposed environments of use are identical to the predicate, INOmax DS (K061901) except we are not seeking clearance for use in inter-hospital transport conditions.
Patient Population -
The proposed patient population is identical to the predicate, INOmax DS (K061901).
Technology / Design / Features -
The technology of the GeNOsyI™ NO2 analyzer is similar to the predicate, INOmax DS (K061901).
Materials -
The materials have been tested per ISO 10993 and are similar to the predicate, INOmax DS (K061901).
Performance Specifications -
The proposed device's performance and specifications are equivalent to the predicate.
Conclusion:
The GeNO LLC GeNOsyl™ MV-1000 has been demonstrated to be substantially equivalent for safety and effectiveness for its indicated use as compared to the predicate.
{8}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the eagle. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 1 6 2012
Mr. Paul Dryden Regulatory Consultant GeNO LLC 2941 Oxbow Circle Cocoa, Florida 32926
Re: K120216
Trade/Device Name: GeNOsyl™ MV - 1000 Regulation Number: 21 CFR 868.5165 Regulation Name: Nitric Oxide Administration Apparatus Regulatory Class: II Product Code: MRN Dated: May 8, 2012 Received: May 10, 2012
Dear Mr. Dryden:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{9}------------------------------------------------
Page 2 - Mr. Dryden
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Nh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
Page 1 of 1
510(k) Number:
K120216 (To be assigned)
Device Name:
GeNOsvl™ MV-1000
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.
Prescription Use XX (Part 21 CFR 801 Subpart D) or
Over-the-counter use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Schutter
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K120216
§ 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.”