INOMAX DS(IR) (DELIVERY SYSTEM)

K110635 · Ino Therapeutics, LLC/Dba Ikaria · MRN · Jun 23, 2011 · Anesthesiology

Device Facts

• Record ID: K110635
• Device Name: INOMAX DS(IR) (DELIVERY SYSTEM)
• Applicant: Ino Therapeutics, LLC/Dba Ikaria
• Product Code: MRN · Anesthesiology
• Decision Date: Jun 23, 2011
• 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 of 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

INOmax DSIR delivers nitric oxide (NO) gas into patient breathing circuits; utilizes injector module to track ventilator waveforms for synchronized, proportional NO dosing. Dual-channel architecture: first channel manages delivery (CPU, flow controller, injector); second channel manages monitoring (CPU, gas cells for NO, NO2, O2, user interface, alarms). Provides continuous monitoring and comprehensive alarm system; includes battery for 6-hour operation and backup delivery mode (fixed 250 mL/min NO flow). Used in NICU and transport settings by clinicians. Output displayed on integrated interface; informs clinical decisions regarding gas concentration and patient respiratory support. Benefits include precise, synchronized NO delivery and integrated safety monitoring.

Clinical Evidence

No clinical data. Bench testing only. Compatibility testing performed for five additional ventilators (Newport E360, Impact EMV+, Teleflex Comfort Flo, Dräger Babylog VN500, Dräger Evita Infinity V500) across multiple settings (0, 1, 5, 20, 40, 80 ppm) to verify O2 dilution, pressure impact, delivery accuracy, NO2 generation, and backup functionality.

Technological Characteristics

Dual-channel system: delivery channel (CPU, flow controller, injector) and monitoring channel (CPU, gas cells for NO, NO2, O2). Battery-powered (6-hour capacity). Includes blender, stand/cart, and gas tanks. Synchronized, proportional delivery via ventilator waveform tracking. Backup delivery mode provides fixed 250 mL/min NO flow.

Indications for Use

Indicated for neonates requiring nitric oxide inhalation therapy. Used in NICU and during neonatal transport.

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

Reference Devices

• Newport E360 (K101803)
• Impact Instrumentation EMV+ Ventilator (K091238)
• Teleflex Comfort Flo Humidification System and Nasal Cannula (K061736)
• Dräger Babylog VN500 (K093632)
• Dräger Evita Infinity V500 (K093633)

Submission Summary (Full Text)

{0}------------------------------------------------

INO Therapeutics/Ikaria Premarket Notification

INOmax DS1R with additional Ventilators

### 510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided: Date: February 28, 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® DS (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

- Classification Names: Apparatus, Nitric Oxide Delivery, or Apparatus, Nitric Oxide Backup Delivery, Class II - 21 CFR 868.5165
- MRN (Primary), MRQ, MRP Product Code:

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

Device Description: The INOmax DSIR uses a "dual-channel" design to ensure the 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.

{1}------------------------------------------------

Intended Use:

The INOmax DS delivery system delivers INOmax® (nitric oxide of 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.

Technology: All revisions of INOmax DSIR utilize component technology to deliver Nitric Oxide gas to the patient. The components consist of the Delivery System unit, the blender, a stand/cart and the NO gas tanks. In this proposed revision the INOmax DSIR, technological characteristic of design has not changed with the inclusion of five additional respiratory care devices that Ikaria has tested to be compatible for use with the INOmax DSJR system. Also there are two duration tables added to the INOmax DSJR Operation Manual. These were added as a courtesy to the user. By providing a table, the user can quickly determine how long a cylinder will last given the set dose and ventilator flow rate. This is especially helpful during medical transport. The five additional respiratory care devices include:

(K101803) Newport E360TM

(K091238) Impact Instrumentation EMV+ Ventilator®

(K061736) Teleflex Comfort FloTM Humidification System and Nasal Cannula

(K093632) Dräger Babylog® VN500

(K093633) Dräger Evita Infinity® V500

{2}------------------------------------------------

『

| Determination of | Summary of Non-Clinical Tests: |
|--------------------------|---------------------------------------------------------------------------------------------------------------------|
| Substantial Equivalence: | The testing concluded all requirements necessary for the operation of the INOmax DSIR and interface to the selected |

ventilators to be compatible:

All five respiratory care devices were set up and calibrated according to the manufacturer's recommendations, and tested using the settings established for each respiratory care device test. The INOmax DSR was set up and calibrated according to the manufacturer's recommendations.

Five INOmax DSIR settings were used [0 (baseline), 1, 5, 20, 40, and 80 ppm] for each setting and mode of ventilation/patient cannula, as well as the Backup mode.

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

The testing concluded five requirements necessary for the operation of the INOmax DSIR and the five respiratory care devices to be compatible:

- O2 dilution
- Effect on delivered pressures
- INOmax DSIR delivery accuracy
- NO2 generation
- Backup Delivery

#### Testing Conclusion:

The INOmax DSJR performed within published specifications when used with each of the ventilators.

## 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.

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

{3}------------------------------------------------

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 with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the eagle.

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 LLC/DBA Ikaria 2902 Dairy Drive Madison, Wisconsin 53718

JUN 2 3 2011

Re: K110635

Trade/Device Name: INOmax® DS Delivery System Regulation Number: 21 CFR 868.5165 Regulation Name: Nitric Oxide Administration Apparatus Regulatory Class: II Product Code: MRN Dated: May 24, 2011 Received: May 25, 2011

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.

{4}------------------------------------------------

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 yours.

Susan Quare

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

{5}------------------------------------------------

INO Therapeutics/Ikaria Premarket Notification

INOmax DSJR with additional Ventilators

510(k) Number (if known):

Device Name: INOmax DS

Indications for Use:

The INOmax DS delivery system delivers INOmax® (nitric oxide of 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, NO3, 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____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

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)

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

510(k) Number: K110635