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

AI/ML Overview

Here's an analysis of the provided text regarding the INOmax DSIR device, focusing on acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text describes a compatibility study rather than a traditional performance study with explicit numerical acceptance criteria for accuracy metrics. The study aims to demonstrate substantial equivalence by confirming compatibility with additional respiratory care devices. Therefore, the "acceptance criteria" are implied to be the device performing within its published specifications and meeting the four necessary requirements for compatibility.

Acceptance Criteria Category	Specific Criteria (Implied)	Reported Device Performance
Compatibility Requirements	1. O2 dilution	Performed within published specifications.
	2. Effect on delivered pressures	Performed within published specifications.
	3. INOmax DSIR® delivery accuracy	Performed within published specifications.
	4. NO2 generation	Performed within published specifications.
Overall Performance	Device performs within its own established published specifications with new ventilators.	The INOmax DSIR® performed within published specifications when used with each of the ventilators in both primary and backup delivery.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The text states, "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." It also mentions "both devices were set up and calibrated... and tested using the settings established for each respiratory care device test." The "new respiratory care devices" are the Drager Apollo Anesthesia Ventilator and the CareFusion ReVel Ventilator.
- This implies testing across different modes of ventilation (which are not specifically enumerated, but would be several for each ventilator) and these 6 concentrations for each mode, for both primary and backup delivery, across two different new ventilators.
- While specific case numbers aren't given in a medical imaging sense, the "sample size" here refers to the extensive set of configurations and parameters tested: 2 ventilators * (multiple modes) * 6 NO concentrations * 2 delivery types (primary/backup).
Data Provenance: The study is nonclinical (laboratory testing) and was conducted by the submitter (INO Therapeutics doing business as Ikaria). The country of origin is not explicitly stated but can be inferred to be the USA, where the company is based and where the 510(k) submission was made. The study is prospective as it involves active testing of the device under specific conditions.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of nonclinical, engineering-focused study does not typically involve human experts establishing "ground truth" in the way a clinical diagnostic study would. The "ground truth" in this context is the objectively measured performance of the device against its own published specifications and the expected behavior of the ventilators. The measurements would be taken by trained technicians or engineers following established protocols. No information is provided about expert qualifications or numbers beyond "manufacturer's recommendations" for setup and calibration.

4. Adjudication Method (for the test set)

No formal adjudication method (like 2+1 or 3+1 consensus) is described, as this is not a study involving human interpretation of clinical data. The "adjudication" is based on objective measurements and comparison against established specifications. "Any anomalies found" were recorded, implying a review of results by the testing personnel.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is a nonclinical, engineering compatibility test, not a clinical study involving human readers or cases.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, this was a standalone performance study in the sense that it evaluated the performance of the device (INOmax DSIR®) itself when interfaced with two specific ventilators. There was no human-in-the-loop component being evaluated for its diagnostic or therapeutic effectiveness; rather, the device's ability to maintain its intended performance characteristics in a new configuration was assessed.

7. The Type of Ground Truth Used

The ground truth used was objective performance measurements of the INOmax DSIR® against its published specifications and the expected operational parameters of the ventilators (e.g., delivered oxygen concentration, pressure, NO concentration, NO2 generation).

8. The Sample Size for the Training Set

No training set is mentioned or applicable. This is a conformance and compatibility test, not a machine learning study.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there was no training set.

Summary

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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 Ikaria2902 Dairy DriveMadison, Wisconsin 53718
Contact Person:	Robert BovyAssociate Director, Regulatory Affairs, Devices
Email:	Robert.Bovy@Ikaria.com
Telephone:	608-226-3450
FAX:	608-226-3402
Secondary Contact Person:	David Trueblood
Email:	David.Trueblood@Ikaria.com
Telephone:	608-395-3910

Identification of the Device

Device Trade Name:	INOmax DSIR® (Delivery System)
Common Name:	Nitric Oxide Administration Apparatus (primary)Nitric Oxide Administration Apparatus, Back-up SystemNitric Oxide AnalyzerNitrogen Dioxide Analyzer
Classification Name:	Apparatus, Nitric Oxide Delivery, or Apparatus, NitricOxide Backup Delivery
Device Classification:	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,K113272, K121021
Description of Device	The INOmax DSIR® uses a "dual-channel" design to ensure the safedelivery of INOmax®. The first channel has the delivery CPU, theflow controller and the injector module to ensure the accurate deliveryof NO. The second channel is the monitoring system, which includes

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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.

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.

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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 respiratorycare devices
Labeling forcompatibility withrespiratory care devices	A variety of transport,neonatal, adult/ped, highfrequency and anesthesiaventilators, nasal CPAP andnasal high flow cannulas.	Additional respiratory care devices include:Drager Apollo Anesthesia Ventilator (K081447)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.

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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.

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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 (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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

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INDICATIONS FOR USE STATEMENT বঁ

Indications for Use

K130605 510(k) Number (if known): Device Name: INOmax® DS Indications for Use:

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.

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

Regulation Number and Section

§ 868.5165 Nitric oxide administration apparatus.

(a)
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.(b)
Classification. Class II. 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.”