INOBLENDER

K122689 · Ino Therapeutics · MRO · Nov 7, 2012 · Anesthesiology

Device Facts

• Record ID: K122689
• Device Name: INOBLENDER
• Applicant: Ino Therapeutics
• Product Code: MRO · Anesthesiology
• Decision Date: Nov 7, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5165
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The INOblender provides user set concentrations of inhaled Nitric Oxide (NO), in a balance of nitrogen, mixed into a user settable constant flow of oxygen gas that is being delivered to a patient. The intended use for the INOblender is as a back up to a primary nitric oxide delivery system or for short term attended use when a primary delivery device cannot practicably be used. This intended use includes applications within a medical facility and transport outside of a medical facility. The INOblender is not intended for use as a primary NO delivery system for long-term use.

Device Story

INOblender is a backup nitric oxide (NO) delivery apparatus; inputs include constant oxygen gas flow (5-14 L/min) and 800 ppm NO/N2 cylinder gas; device blends gases to user-set concentrations (5-80 ppm NO) via manual control dial; used in medical facilities or transport; operated by clinicians; output is NO-enriched oxygen gas delivered to patient; provides temporary NO therapy when primary systems are unavailable; benefits patient by maintaining NO therapy continuity during transport or primary system failure.

Clinical Evidence

No clinical data; bench testing only. Testing confirmed compatibility with the Fisher & Paykel NeoPuff resuscitator by evaluating O2 dilution, impact on respiratory device function, NO dose delivery accuracy, and NO2 generation.

Technological Characteristics

Gas blending apparatus; consists of blender, regulator, and NO gas tank; inputs: 5-14 L/min O2 flow and 800 ppm NO/N2 cylinder; output: 5-80 ppm NO in O2; manual control dial; mechanical/pneumatic operation; no software or electronic components described.

Indications for Use

Indicated for patients requiring inhaled Nitric Oxide (NO) therapy as a backup to a primary delivery system or for short-term attended use when a primary device is impractical; suitable for use within medical facilities and during transport; not for long-term primary NO delivery.

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

• INOblender (K052663)

Reference Devices

• Fisher & Paykel NeoPuff (K892885)

Submission Summary (Full Text)

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INO Therapeutics/Ikaria Premarket Notification

INOblender®

NOV

7 2012

K122689

# 510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

August 31, 2012 Date:

INO Therapeutics, doing business as Ikaria Submitter: 2902 Dairy Drive Madison, Wisconsin 53718

Robert Bovy Primary Contact Associate Director, Regulatory Affairs Person: INO Therapeutics/Ikaria T: 608-226-3450 F: 608-226-3402

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

INOblender® Device Trade Name:

> Common/Usual Nitric Oxide Administration Apparatus - Back-up System

Apparatus, nitric oxide, backup delivery, Class II - 21 CFR 868.5165 Classification Names:

Product Code: MRO

Name:

Predicate Device(s): K052663

Device Description: The INOblender provides user set concentrations of inhaled Nitric Oxide (NO), in a balance of nitrogen, mixed into a user settable constant flow of oxygen gas that is being delivered to a patient.

> The INOblender is designed to take constant oxygen (02) gas flow (5 to 14 L/min) from the integrated O2 flowmeter and blend in NO at the setting on the NO blender's concentration control dial (5 to 80 ppm). The NO blender is calibrated for cylinder concentrations of 800 ppm NO in a balance of nitrogen (N2).

Intended Use:

The INOblender provides user set concentrations of inhaled Nitric Oxide (NO), in a balance of nitrogen, mixed into a user settable constant flow of oxygen gas that is being delivered to a patient. The intended use for the INOblender is as a back up to a primary nitric oxide delivery system or for short term attended use when a primary delivery device cannot practicably be used. This intended use includes applications within a medical facility and transport outside of a medical facility. The

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INOblender is not intended for use as a primary NO delivery system for long-term use.

All revisions of INOblender® utilize component technology to deliver Technology: Nitric Oxide gas to the patient. The components consist of the blender, the regulator and the NO gas tank.

Determination of Comparison to Predicate Device: Substantial The INOblender® with modified labeling has the same intended use as Equivalence: the cleared INOblender®. All features are identical except those described in the table below.

| Feature /<br>Specification | INOblender- K052663 | Modified INOblender |
|--------------------------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Labeling for<br>compatibility<br>with<br>resuscitators | • Airlife Adult Manual<br>Resuscitator with reservoir<br>tubing | • Airlife Adult Manual<br>Resuscitator with reservoir<br>tubing |
| | • Allegiance ½ L Pediatric Manual<br>Resuscitator with reservoir<br>tubing | • Allegiance ½ L Pediatric<br>Manual Resuscitator with<br>reservoir tubing<br>• Fisher & Paykel NeoPuff<br>(K892885) |

Summary of Non-Clinical Tests:

To confirm compatibility of the INOblender® with the new respiratory care device, this device was set up and calibrated according to the manufacturer's recommendations, and tested using the settings established for the device. The INOblender® was set up according to the manufacturer's recommendations.

The testing concluded four requirements necessary for the operation of the INOblender® and the respiratory care devices to be compatible:

- O2 dilution
- Effect on respiratory care device

- INOblender® NO dose delivery accuracy
- NO2 generation

## Summary of Clinical Tests:

The subject of this premarket submission, INOblender®, interfaced to the selected respiratory care device, did not require clinical studies to support substantial equivalence.

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

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Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping, abstract human figures.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

### November 7, 2012

Mr. Robert Bovy Associate Director, Regulatory Affairs INO Therapeutics 2902 Dairy Drive Madison, Wisconsin 53718

Re: K122689

Trade/Device Name: INOblender® Regulation Number: 21 CFR 868.5165 Regulation Name: Nitric Oxide Administration Apparatus Regulatory Class: II Product Code: MRO Dated: October 18, 2012 Received: October 19, 2012

Dear Mr. Bovy:

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. Bovy

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,

Kwame O. Ulmer

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure .

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K122689

510(k) Number (if known):

Device Name: INOblender®

Indications for Use:

The INOblender provides user set concentrations of inhaled Nitric Oxide (NO), in a balance of nitrogen, mixed into a user settable constant flow of oxygen gas that is being delivered to a patient. The intended use for the INOblender is as a back up to a primary nitric oxide delivery system or for short term attended use when a primary delivery device cannot practicably be used. This intended use includes applications within a medical facility and transport outside of a medical facility. The INOblender is not intended for use as a primary NO delivery system for long-term use.

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

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AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schiettecatte

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

**510(k) Number:*****_***_