INOMAX DS(DELIVERY SYSTEMS

K113272 · Ino Therapeutics, LLC/Dba Ikaria · MRN · Feb 29, 2012 · Anesthesiology

Device Facts

• Record ID: K113272
• Device Name: INOMAX DS(DELIVERY SYSTEMS
• Applicant: Ino Therapeutics, LLC/Dba Ikaria
• Product Code: MRN · Anesthesiology
• Decision Date: Feb 29, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5165
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The INOmax DS delivery system delivers INOmax® (nitric oxide 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, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with most ventilators. The INOmax DS provides continuous integrated monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system. The INOmax DS incorporates a battery that provides up to 6 hours of uninterrupted NO delivery in the absence of an external power source. The INOmax DS 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 patients breathing circuit. It may also use the INOblender for backup. The target patient population is controlled by the drug labeling for INOmax and is currently neonates. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates.

Device Story

System delivers nitric oxide (NO) gas into patient breathing circuits; utilizes injector module to track ventilator waveforms for synchronized, proportional dosing; provides constant NO concentration. Dual-channel architecture: channel one handles delivery (CPU, flow controller, injector); channel two handles monitoring (CPU, gas cells for NO, NO2, O2, user interface, alarms). Monitoring system can shut down delivery if NO concentration exceeds 100 ppm. Includes battery for 6-hour backup; secondary backup mode provides fixed 250 mL/min NO flow. Used in NICU and transport by clinicians. Output displayed to provider for therapy management; integrated alarms alert to faults. Benefits include precise, synchronized gas delivery and continuous monitoring to ensure patient safety during inhalation therapy.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing only. Compatibility testing performed with three respiratory care devices (Hamilton C2, Hamilton G5, Fisher & Paykel Bubble CPAP) to verify O2 dilution, delivery accuracy, and NO2 generation.

Technological Characteristics

Dual-channel system: delivery channel (CPU, flow controller, injector) and monitoring channel (CPU, gas cells, UI). Battery-powered (6 hours). Compatible with various ventilators. Components: delivery unit, blender, stand/cart, NO gas tanks. Software-controlled monitoring and alarm system.

Indications for Use

Indicated for neonates requiring nitric oxide inhalation therapy. Used in NICU and transport settings. Contraindications governed by INOmax drug labeling.

Regulatory Classification

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.

Special Controls

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.”

Predicate Devices

• K061901
• K070867
• K071516
• K080484
• K081691
• K090958
• K092545
• K093922
• K110344
• K110635

Reference Devices

• Hamilton C2 (K102775)
• Hamilton G5 (K070513)
• Fisher & Paykel Healthcare Bubble CPAP System (K100011)

Submission Summary (Full Text)

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11113272

510(k) Summary

FEB 2 9 2012

In accordance with 21 CFR 807.92 the following summary of information is provided: Date: November 3, 2011

> INO Therapeutics/Ikaria Submitter: 2902 Dairy Drive Madison, Wisconsin 53718

Primary Contact Person: Larry Lepley Associate Director, Regulatory Affairs INO Therapeutics/Ikaria T: 608-226-3415 F: 608-226-3402

Secondary Contact Person: David Trueblood Director, Regulatory Affairs INO Therapeutics/Ikaria T: 608-395-3910 F: 608-226-3402

INOmax® DSIR (Delivery System) Device: Trade Name:

Common/Usual Name: Nitric Oxide Administration Apparatus (primary) Nitric Oxide Administration Apparatus, Back-up System Nitric Oxide Analyzer Nitrogen Dioxide Analyzer

Apparatus, Nitric Oxide Delivery, or Apparatus, Nitric Oxide Classification Names: Backup Delivery, Class II - 21 CFR 868.5165

Product Code: MRN (Primary), MRQ, MRP

Predicate Device(s): K061901, K070867, K071516, K080484, K081691, K090958, K092545, K093922, K110344, K110635

The INOmax DSIR uses a "dual-channel" design to ensure the Device Description: safe delivery of INOmax. The first channel has the delivery CPU, the flow controller and the injector module to ensure the accurate delivery of NO. The second channel is the monitoring system, which includes a separate monitor CPU, the gas cells (NO, NO2, and O2 cells) and the user interface including the display and alarms. The dual-channel approach to delivery and monitoring permits INOmax delivery independent of monitoring but also allows the monitoring system to shutdown INOmax delivery if it detects a fault in the delivery system such that the NO concentration could become greater than 100 ppm.

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| Intended Use: | The INOmax DS delivery system delivers INOmax® (nitric<br>oxide of inhalation) therapy gas into the inspiratory limb of the<br>patient breathing circuit in a way that provides a constant<br>concentration of nitric oxide (NO), as set by the user, to the<br>patient throughout the inspired breath. It uses a specially<br>designed injector module, which enables tracking of the ventilator<br>waveforms and the delivery of a synchronized and proportional<br>dose of NO. It may be used with most ventilators.<br>The INOmax DS provides continuous integrated monitoring of<br>inspired O2, NO2, and NO, and a comprehensive alarm system.<br>The INOmax DS incorporates a battery that provides up to 6<br>hours of uninterrupted NO delivery in the absence of an external<br>power source.<br>The INOmax DS includes a backup NO delivery capability that<br>provides a fixed flow of 250 mL/min of NO which along with<br>user supplied 10 L/min of oxygen provides 20 ppm in the gas<br>flow to a patients breathing circuit. It may also use the<br>INOblender for backup.<br>The target patient population is controlled by the drug labeling<br>for INOmax and is currently neonates. The primary targeted<br>clinical setting is the Neonatal Intensive Care Unit (NICU) and<br>secondary targeted clinical setting is the transport of neonates. |
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| Technology: | All revisions of INOmax DSIR utilize component technology to<br>deliver Nitric Oxide gas to the patient. The components consist of<br>the Delivery System unit, the blender, a stand/cart and the NO gas<br>tanks. In this proposed revision the INOmax DSIR, technological<br>characteristic of design has not changed with the inclusion of<br>three additional respiratory care devices that INO<br>Therapeutics/Ikaria has tested to be compatible for use with the<br>INOmax DSIR system.<br>The three additional respiratory care devices include:<br>(K102775) Hamilton C2<br>(K070513) Hamilton G5<br>(K100011) Fisher & Paykel Healthcare Bubble CPAP System |
| Determination of<br>Substantial Equivalence: | Summary of Non-Clinical Tests:<br>The testing concluded all requirements necessary for the<br>operation of the INOmax DSIR and interface to the selected<br>respiratory care devices to be compatible:<br>The three respiratory care devices were set up and calibrated<br>according to the manufacturer's recommendations, and tested<br>using the settings established for each respiratory care device test.<br>The INOmax DSIR was set up and calibrated according to the<br>manufacturer's recommendations.<br>Six INOmax DSIR settings were used [0 (baseline), 1, 5, 20, 40, |

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The measured values on the INOmax DSIR were also recorded along with any anomalies found.

The testing concluded four requirements necessary for the operation of the INOmax DSJR and the three respiratory care devices to be compatible:

- O2 dilution
- Effect on respiratory care device
- INOmax DSB delivery accuracy
- NO2 generation

Testing Conclusion:

The INOmax DSJR performed within published specifications when used with each of the respiratory care devices.

## Summary of Clinical Tests:

The subject of this premarket submission, INOmax DSIR, interfaced to each of the selected respiratory care devices, did not require clinical studies to support substantial equivalence.

Conclusion: INO Therapeutics/Ikaria considers the INOmax DSIR to be as safe and as effective as the predicate device, with performance substantially equivalent to the predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002

Mr. Larry Lepley Associate Director, Regulatory Affairs INO Therapeutics / Ikaria 2902 Dairy Drive Madison, Wisconsin 53718

FEB 2 9 2012

Re: K113272 Trade/Device Name: INOmax DS Regulation Number: 21 CFR 868.5165 Regulation Name: Nitric Oxide Administration Apparatus Regulatory Class: II Product Code: MRN, MPQ, MRP Dated: January 27, 2012 Received: January 30, 2012

Dear Mr. Lepley:

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.

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## Page 2 - Mr. Lepley

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

hh 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

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INO Therapeutics/Ikaria Premarket Notification

510(k) Number (if known):

INOmax DS Device Name:

Indications for Use:

The INOmax DS delivery system delivers INOmax® (nitric oxide 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, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with most ventilators.

The INOmax DS provides continuous integrated monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system.

The INOmax DS incorporates a battery that provides up to 6 hours of uninterrupted NO delivery in the absence of an external power source.

The INOmax DS 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 patients breathing circuit. It may also use the INOblender for backup.

The target patient population is controlled by the drug labeling for INOmax and is currently neonates. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schultz

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

4113272 510(k) Number: