INOMAX DSIR (DELIVERY SYSTEM)

K130605 · Ino Therapeutics · MRN · May 2, 2013 · Anesthesiology

Device Facts

• Record ID: K130605
• Device Name: INOMAX DSIR (DELIVERY SYSTEM)
• Applicant: Ino Therapeutics
• Product Code: MRN · Anesthesiology
• Decision Date: May 2, 2013
• 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

INOmax DSIR delivers nitric oxide (NO) gas into patient breathing circuits; uses injector module to track ventilator waveforms; provides synchronized, proportional NO dosing. Dual-channel architecture: delivery channel (CPU, flow controller, injector) and monitoring channel (monitor CPU, gas cells for NO, NO2, O2). System provides continuous monitoring and alarms; includes 6-hour battery backup and manual backup delivery mode (250 mL/min NO + 10 L/min O2). Used in NICU and transport settings by clinicians. Output displayed on user interface; informs clinical titration of NO therapy. Benefits include precise, synchronized gas delivery and integrated safety monitoring to prevent excessive NO/NO2 concentrations.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing. Testing evaluated compatibility with new respiratory care devices across five settings (0, 1, 5, 20, 40, 80 ppm) and backup mode. Endpoints included O2 dilution, effect on delivered pressures, NO delivery accuracy, and NO2 generation. Results confirmed performance within published specifications.

Technological Characteristics

Dual-channel delivery and monitoring system. Components: delivery unit, blender, stand, gas tanks. Sensing: NO, NO2, and O2 gas cells. Energy: AC power and internal battery (6-hour capacity). Connectivity: interfaces with various ventilators (transport, neonatal, adult/ped, high frequency, anesthesia, nasal CPAP, high flow).

Indications for Use

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

• INOmax DSIR® (K121021)
• K061901
• K070867
• K071516
• K080484
• K081691
• K090958
• K092545
• K093922
• K110344
• K110635
• K113272

Reference Devices

• Drager Apollo Anesthesia Ventilator (K081447)
• CareFusion ReVel Ventilator (K070594)

Submission Summary (Full Text)

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

INOmax DSIR with Additional Ventilators

#### MAY 2 2013

#### 510(K) SUMMARY ડ.

# 510(k) Summary

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

# Submitter Information

| Date: | March 5, 2013 |
|---------------------------|-------------------------------------------------------------------------------------------|
| Company: | INO Therapeutics doing business as Ikaria<br>2902 Dairy Drive<br>Madison, Wisconsin 53718 |
| Contact Person: | Robert Bovy<br>Associate Director, Regulatory Affairs, Devices |
| Email: | [e-mail] |
| Telephone: | 608-226-3450 |
| FAX: | 608-226-3402 |
| Secondary Contact Person: | David Trueblood |
| Email: | [e-mail] |
| Telephone: | 608-395-3910 |

# Identification of the Device

| Device Trade Name: | INOmax DSIR® (Delivery System) |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Nitric Oxide Administration Apparatus (primary)<br>Nitric Oxide Administration Apparatus, Back-up System<br>Nitric Oxide Analyzer<br>Nitrogen Dioxide Analyzer |
| Classification Name: | Apparatus, Nitric Oxide Delivery, or Apparatus, Nitric<br>Oxide Backup Delivery |
| Device Classification: | Class II - 21 CFR 868.5165 |
| Product Code: | MRN (Primary), MRQ, MRP |
| Predicate Device(s) | K061901, K070867, K071516, K080484, K081691,<br>K090958, K092545, K093922, K110344, K110635,<br>K113272, K121021 |
| Description of Device | The INOmax DSIR® uses a "dual-channel" design to ensure the safe<br>delivery of INOmax®. The first channel has the delivery CPU, the<br>flow controller and the injector module to ensure the accurate delivery<br>of NO. The second channel is the monitoring system, which includes |

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

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. The delivery system can also shut down delivery if it detects certain serious problems with the monitoring system.

### 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.

### 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 revision of the INOmax DSIR®, the labeling has been updated.

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

# Determination of Substantial Equivalence

The INOmax DSIR® with modified labeling has the same intended use as the cleared INOmax DSIR®. All features are identical except those described in the table below.

| Feature / Specification | INOmax DSIR® - K121021 | INOmax DSIR® with additional respiratory<br>care devices |
|----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Labeling for<br>compatibility with<br>respiratory care devices | A variety of transport,<br>neonatal, adult/ped, high<br>frequency and anesthesia<br>ventilators, nasal CPAP and<br>nasal high flow cannulas. | Additional respiratory care devices include:<br>Drager Apollo Anesthesia Ventilator (K081447)<br>CareFusion ReVel Ventilator (K070594) |

# Comparison to Predicate Device

## Summary of Nonclinical Tests

To confirm compatibility with the new respiratory care devices, both 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 DSgg® 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, as well as the Backup mode.

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

The testing concluded four requirements necessary for the INOmax DSp and the two respiratory care devices to be compatible:

- 02 dilution
- Effect on delivered pressures
- INOmax DSR® delivery accuracy
- NO2 generation

Testing Conclusion:

The INOmax DSR® performed within published specifications when used with each of the ventilators in both primary and backup delivery.

## . Summary of Clinical Tests

The subject of this premarket submission, INOmax DSm , 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 DSm to be as safe and as effective as the predicate device, with performance substantially equivalent to the predicate device.

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

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the logo in a circular fashion.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

#### Public Health Service

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

May 2, 2013

Mr. Robert Bovy Associate Director, Regulatory Affairs INO Therapeutics 2902 Dairy Drive MADISON WI 53718

Re: K130605

Trade/Device Name: INOmax DSIR® (Delivery System) Regulation Number: 21 CFR 868.5165 Regulation Name: Nitric Oxide Administration Apparatus Regulatory Class: II Product Code: MRN, MRQ, MRP Dated: April 1, 2013 Received: April 2, 2013

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.

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

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
-s FDA

for

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

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

#### INDICATIONS FOR USE STATEMENT বঁ

# Indications for Use

K130605 510(k) Number (if known): Device Name: INOmax® DS 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 02, 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 (21 CFR Part 801 Subpart D)

Over the Counter Use_

(21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Lester W. Schulth 2013.04.30 15:5

(Division Sign-Off) Division of Anestheslology, General Hospital

510(k) Number:

Page 15 of 219