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 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).

AI/ML Overview

The provided document does not describe the acceptance criteria or a study proving the device meets acceptance criteria in the way typically associated with AI/ML diagnostic devices. This document is a 510(k) summary for a medical device called INOblender®, which is a Nitric Oxide administration apparatus.

Here's why the requested information cannot be fully provided from this document:

Device Type: The INOblender® is a physical medical device (blender for gas delivery), not an AI/ML diagnostic software or algorithm. Therefore, the concepts of "algorithm only performance," "human readers improve with AI," "ground truth establishment" of a "test set" and "training set" in the context of diagnostic accuracy are not applicable.
Study Type: The submission is primarily focused on demonstrating substantial equivalence to a predicate device, not on proving diagnostic accuracy or effectiveness through clinical trials in the sense of AI/ML performance.

However, I can extract information related to the device's non-clinical testing which serves as the "study" demonstrating its capabilities.

Here's a breakdown of the available information based on your request, adapted to the context of this physical device:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" in a quantitative table with specific targets and achieved results. Instead, it lists four requirements that were tested for compatibility with a new respiratory care device. The "reported device performance" is the conclusion that these requirements were met.

Requirement/Criterion	Reported Device Performance
O2 dilution (Compatibility with respiratory care device)	Met: Device was set up, calibrated, and tested.
Effect on respiratory care device (Compatibility)	Met: Device was set up, calibrated, and tested.
INOblender® NO dose delivery accuracy (Performance)	Met: Device was set up, calibrated, and tested.
NO2 generation (Safety/Performance)	Met: Device was set up, calibrated, and tested.

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

Sample Size for Test Set: Not applicable in the context of diagnostic data. The "test set" here refers to the device itself and its interaction with a specific new respiratory care device. The testing was conducted by setting up the INOblender® and the new respiratory care device. The number of such setups or repetitions is not specified, but it's not data in the sense of patient cases.
Data Provenance: Not applicable in the context of diagnostic data. The "testing" refers to equipment performance validation, likely conducted in a laboratory setting by the manufacturer. Details like country of origin for such engineering tests are not provided and typically not relevant for this type of submission. The tests were "non-clinical."

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

Number of Experts: Not applicable. Ground truth, in the sense of expert consensus on diagnostic interpretations, is not relevant for this type of device. The "ground truth" for these tests would be the known operational parameters and specifications of the devices themselves and the physical/chemical measurements taken during the compatibility and performance tests.
Qualifications of Experts: Not applicable. The "experts" involved would be engineers and technicians performing the physical and chemical tests, adhering to established protocols. Their specific qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations of diagnostic data. For physical device performance testing, the results are typically objectively measured and compared against predefined engineering specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human diagnostic performance, which is not the purpose of the INOblender®.
Effect Size: Not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Standalone Performance: No, a standalone performance study in the context of an algorithm's diagnostic accuracy was not done. The INOblender® is a physical device that functions to deliver gas, not an algorithm. Its "standalone" performance would relate to its ability to accurately blend and deliver gases according to its specifications. The document states "INOblender® NO dose delivery accuracy" was tested, which can be considered a standalone performance aspect for the device's primary function.

7. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" for the non-clinical tests was established by known engineering specifications, physical/chemical measurement standards, and the manufacturer's recommendations for calibration and operation. For example, "NO dose delivery accuracy" would be compared against a known, precise NO concentration generated by the device itself or measured by a calibrated external sensor.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. There is no AI/ML algorithm involved, so there is no "training set" in the context of machine learning. The device is hardware-based, relying on established physical and chemical principles.

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

Ground Truth for Training Set: Not applicable for the reasons mentioned above.

Summary of Device-Specific Information:

Device Name: INOblender®
Intended Use: To provide user-set concentrations of inhaled Nitric Oxide (NO) mixed into a constant flow of oxygen gas. Intended as a backup to a primary NO delivery system or for short-term attended use when a primary device is impractical.
Technology: Component technology (blender, regulator, NO gas tank).
Predicate Device: K052663 (another INOblender® with slightly different labeling for compatibility with resuscitators).
Non-Clinical Tests:
- O2 dilution
- Effect on respiratory care device (compatibility with Fisher & Paykel NeoPuff)
- INOblender® NO dose delivery accuracy
- NO2 generation
Clinical Tests: "The subject of this premarket submission... did not require clinical studies to support substantial equivalence." (Meaning, no clinical tests were performed for this specific submission, as it relied on non-clinical data and substantial equivalence to a predicate).

Summary

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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:

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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 /Specification	INOblender- K052663	Modified INOblender
Labeling forcompatibilitywithresuscitators	• Airlife Adult ManualResuscitator with reservoirtubing	• Airlife Adult ManualResuscitator with reservoirtubing
	• Allegiance ½ L Pediatric ManualResuscitator with reservoirtubing	• Allegiance ½ L PediatricManual Resuscitator withreservoir tubing• Fisher & Paykel NeoPuff(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 (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

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:

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

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

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:__

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.”