INOMAX DSIR (DELIVERY SYSTEM)

K131686 · Ino Therapeutics/Ikaria · MRN · Nov 29, 2013 · Anesthesiology

Device Facts

• Record ID: K131686
• Device Name: INOMAX DSIR (DELIVERY SYSTEM)
• Applicant: Ino Therapeutics/Ikaria
• Product Code: MRN · Anesthesiology
• Decision Date: Nov 29, 2013
• Decision: SESE
• Submission Type: Traditional
• 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 is a dual-channel nitric oxide (NO) delivery and monitoring system. Input: ventilator waveform data via injector module; gas samples for NO, NO2, and O2 monitoring. Operation: delivery channel (CPU, flow controller, injector) provides synchronized, proportional NO dosing; monitoring channel (separate CPU, gas cells) tracks concentrations and manages alarms. Output: constant NO concentration to patient breathing circuit; visual/audible alarms. Used in NICU and transport by clinicians. Features: 6-hour battery backup; manual/automatic gas cell calibration; backup delivery mode (fixed 250 mL/min NO flow). Software v3.0 adds automated calibration, guided setup wizards, and modified alarm logic for NO > 100 ppm. Output informs clinician of gas concentration levels and system status; enables precise titration of inhaled NO therapy to improve patient oxygenation.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and alarm system performance (IEC 60601-1-8). Formative usability study conducted per ANSI/AAMI HE75. Compatibility with new ventilators verified via bench testing across multiple settings (0-80 ppm) and backup mode, confirming performance within specifications.

Technological Characteristics

Dual-channel architecture (delivery vs. monitoring). Components: delivery unit, blender, stand/cart, NO gas tanks. Sensing: NO, NO2, O2 gas cells. Connectivity: interfaces with external ventilators. Power: AC/DC with 6-hour battery. Software: v3.0, rule-based logic for delivery control, alarm management, and automated calibration. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8.

Indications for Use

Indicated for neonates requiring nitric oxide inhalation therapy. Used in NICU and transport settings. Contraindications are 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 (K130605)

Reference Devices

• Hamilton C1 Ventilator (K120574)
• Hamilton T1 Ventilator (K120670)

Submission Summary (Full Text)

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#### ડ. 510(K) SUMMARY

# 510(k) Summary

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

## Submitter Information

| Date: | July 8, 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: | 608-395-3905 | |
| Secondary Contact Person: | David Trueblood | NOV 29 2013 |
| 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), MRO, MRP, MRQ |
| Predicate Device(s) | K061901, K070867, K071516, K080484, K081691,<br>K090958, K092545, K093922, K110344, K110635,<br>K113272, K121021, K130605 |
| 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 |
| | a separate monitor CPU, the gas cells (NO, NO₂, and O₂ cells) and the<br>user interface including the display and alarms. The dual-channel<br>approach to delivery and monitoring permits INOMAX® delivery<br>independent of monitoring but also allows the monitoring system to<br>shutdown INOMAX® delivery if it detects a fault in the delivery<br>system such that the NO concentration could become greater than 100<br>ppm. The delivery system can also shut down delivery if it detects<br>certain serious problems with the monitoring system. |
| Intended Use | The INOmax® DS delivery system delivers INOMAX® (nitric oxide<br>for inhalation) therapy gas into the inspiratory limb of the patient<br>breathing circuit in a way that provides a constant concentration of<br>nitric oxide (NO), as set by the user, to the patient throughout the<br>inspired breath. It uses a specially designed injector module, which<br>enables tracking of the ventilator waveforms and the delivery of a<br>synchronized and proportional dose of NO. It may be used with most<br>ventilators.<br><br>The INOmax® DS provides continuous integrated monitoring of<br>inspired O₂, NO₂, and NO, and a comprehensive alarm system.<br><br>The INOmax® DS incorporates a battery that provides up to 6 hours of<br>uninterrupted NO delivery in the absence of an external power source.<br><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 user<br>supplied 10 L/min of oxygen provides 20 ppm in the gas flow to a<br>patients breathing circuit. It may also use the INOblender® for<br>backup.<br><br>The target patient population is controlled by the drug labeling for<br>INOMAX® and is currently neonates. The primary targeted clinical<br>setting is the Neonatal Intensive Care Unit (NICU) and secondary<br>targeted clinical setting is the transport of neonates. |
| Technology | All revisions of INOmax DSIR® utilize component technology to<br>deliver Nitric Oxide gas to the patient. The components consist of the<br>Delivery System unit, the blender, a stand/cart and the NO gas tanks.<br>In this revision of the INOmax DSIR®, the software and labeling have<br>been updated. |

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## Determination of Substantial Equivalence

The INOmax DS18 modifications included an update of the software to version 3.0 and modified labeling to identify compatibility with two additional respiratory care devices. The INOmax DSIR® with software version 3.0 and additional respiratory care devices has the same intended use and uses the same device hardware as the cleared INOmax DSIR® predicate device. All features are identical except those described in the table below.

| Feature /<br>Specification | INOmax DSIR® - K130605 | INOmax DSIR® with software version 3.0<br>and additional respiratory care devices |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Low-range Gas<br>Sensor Calibration | This calibration is initiated<br>manually by the user by pressing<br>the "Low Cal" button on the<br>calibration screen. | This calibration can still be initiated manually<br>but the calibration is initiated automatically<br>when the device is turned on and is initiated<br>automatically every 12 hours while in<br>continuous operation at a constant dose. |
| Purge During Pre-<br>Use Checkout | The purge step is accomplished<br>by instructing the user to set a NO<br>dose of 40 ppm using the control<br>wheel on the device. | After the first step of the Pre-Use Checkout, the<br>user presses the "Next" button on the Pre-Use<br>Checkout wizard screen and this automatically<br>initiates the purge step. |
| Other User<br>Convenience<br>Features | The steps required for pre-use<br>checkout, gas cell calibration, use<br>of backup NO delivery mode and<br>troubleshooting of alarms are all<br>described in the device labeling. | In addition to the instructions in the device<br>labeling, wizards are available on the user<br>interface to guide the user through the required<br>steps for these functions. |
| Alarms/Alerts | Delivery Failure for NO > 100<br>ppm | This alarm has been modified so that the device<br>will stop NO delivery if the NO concentration<br>exceeds 100 ppm for 12 seconds but will<br>automatically resume NO delivery if the NO<br>concentration drops back below 100 ppm for<br>12 seconds. Previously this condition caused a<br>device shutdown and required the user to<br>restart the device to resume delivery. |
| | Delivery Failure | One system voltage condition during which<br>this alarm was triggered has been eliminated. |
| | Not Applicable | A new alarm was added for a failure during the<br>newly added automatic low-range calibration<br>and is indicated as "Low Calibration Failed".<br>This alarm was added because the automatic<br>low-range calibration can occur while the<br>device is not attended by the user, so it is<br>important to notify the user if this calibration is<br>not successful. |

## Comparison to Predicate Device

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| Feature /<br>Specification | INOmax DSIR® - K130605 | INOmax DSIR® with software version 3.0<br>and additional respiratory care devices |
|-------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Labeling for<br>compatibility with<br>respiratory care<br>devices | A variety of transport, neonatal,<br>adult/ped, high frequency and<br>anesthesia ventilators, nasal<br>CPAP and nasal high flow<br>cannulas. | Additional respiratory care devices include:<br>Hamilton C1 Ventilator (K120574)<br>Hamilton T1 Ventilator (K120670) |

#### Summary of Nonclinical Tests

The following quality assurance measures were applied to the modification of the system:

- . Risk analysis
- . Formative usability study
- Requirements reviews .
- . Design reviews
- . Testing on unit level (module verification)
- . Integration testing (system verification)
- Performance testing (verification) .
- . Safety testing (verification)

Support for the substantial equivalence of the INOmax DSIR® was provided as a result of risk management and testing which included electrical safety, performance and software tests. This testing includes conformity to the FDA recognized consensus standards and voluntary standards as follows:

- IEC 60601-1:2005: Medical electrical equipment Part 1: General requirements for basic . safety and essential performance
- IEC 60601-1-2:2007 General requirements for basic safety and essential performance -. Collateral standard: Electromagnetic compatibility - Requirements and tests
- IEC 60601-1-8:2006 General requirements for basic safety and essential performance -. Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems.

A formative usability study was conducted per ANSI/AAMI HE75 Human Factors Engineering, Design of Medical Devices, to aid in the development of requirements and software verification confirmed the INOmax DSJR® is compliant with its system level requirements and that the new/modified user convenience features and alarms function as specified.

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 DSR was set up and calibrated according to the manufacturer's recommendations.

Five INOmax DSig 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.

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The measured values on the INOmax DSR 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 DSIR® delivery accuracy
- NO2 generation

#### Testing Conclusion:

The INOmax DSm 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 DSix®, with updated software and 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 DSJR® to be as safe and as effective as the predicate device, with performance substantially equivalent to the predicate device.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring MD 20993-0002

### November 29, 2013

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

Re: K131686

Trade/Device Name: INOmax DSm® (Delivery System) Regulation Number: 21 CFR 868.5165 Regulation Name: Nitric Oxide Administration Apparatus Regulatory Class: II Product Code: MRN, MRQ, MRP Dated: October 28, 2013 Received: October 30, 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.

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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 devicerelated 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 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/Resourcesfor You/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,

Image /page/6/Picture/8 description: The image shows the text "Kwame Ulmer's" in a bold, sans-serif font. The text is arranged in two lines, with "Kwame" on the top line and "Ulmer's" on the bottom line. To the right of the text is a logo that appears to be a stylized design, possibly incorporating geometric shapes and letters.

Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation · Center for Devices and Radiological Health

for

Enclosure

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K131686

Ikaria 510(k) Premarket Notification

INOmax DSIR with Version 3.0 Software

#### INDICATIONS FOR USE STATEMENT 4.

### Indications for Use

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 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)

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