The INOmax DS delivery system delivers INOmax® (nitric oxide of 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 INO Therapeutics INOmax DS represents the continuing evolution of the Datex-Ohmeda (now GE Healthcare) INOvent Delivery System design. Its published performance specifications are not significantly different from the INOvent. The INOmax DS design incorporates a reconfiguration of hardware, electronic circuitry and software resulting in a more compact, stylish, modern, user-friendly and easier manufactured product.

The INOmax DS delivery system delivers INOmax® (nitric oxide of 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 iniector 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.

AI/ML Overview

The provided text describes the INOmax DS (Delivery System), a nitric oxide administration apparatus. However, it explicitly states that clinical studies were not required to support substantial equivalence for this device. Therefore, information regarding acceptance criteria derived from clinical studies, comparative effectiveness studies, or clinical ground truth establishment is not available within the provided document.

The document primarily focuses on non-clinical tests and the device's technological equivalence to a predicate device.

Here's an analysis based only on the provided text, addressing the requested points:

Acceptance Criteria and Device Performance

Since clinical studies were not required for this 510(k) submission, there are no specific performance acceptance criteria or reported device performance metrics from clinical trials mentioned. The manufacturer's conclusion is that the INOmax DS is "as safe, as effective, and performance is substantially equivalent to the predicate device."

Acceptance Criteria Category	Reported Device Performance
Clinical Performance	Not applicable; clinical studies were not required to support substantial equivalence. Device is considered "as safe, as effective, and performance is substantially equivalent to the predicate device."
Non-Clinical Performance	The device complies with voluntary standards and underwent internal quality assurance measures: Risk Analysis, Requirements Reviews, Design Reviews, Unit-level Testing (Module verification), Integration Testing (System verification), Final Acceptance Testing (Validation), Performance Testing (Verification), Safety Testing (Verification).

Other Information

Due to the lack of clinical studies, much of the requested information is not present in the provided document.

Sample sizes used for the test set and the data provenance: Not applicable, as no clinical test set for performance evaluation is mentioned. Non-clinical testing details (e.g., number of units tested, specific data provenance) are not provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test set requiring expert ground truth is mentioned.
Adjudication method for the test set: Not applicable, as no clinical test set is mentioned.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a nitric oxide delivery system, not an AI-assisted diagnostic tool. No MRMC study was conducted or mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device for nitric oxide delivery, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no clinical ground truth establishment is mentioned. The primary basis for equivalence is technological similarity and compliance with voluntary standards and internal quality assurance measures, rather than a clinical ground truth.
The sample size for the training set: Not applicable, as this is a medical device, not an AI algorithm requiring a training set.
How the ground truth for the training set was established: Not applicable.

Summary

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510(k) SummMAR 1 0 2010

In accordance with 21 CFR 807.92 the following summary of information is provided: Date: 14 August 2009

Submitter:	INO Therapeutics2902 Dairy DriveMadison, Wisconsin 53718
Primary Contact Person:	Larry LepleyAssociate Director, Regulatory Affairs608-226-3415
Secondary Contact Person:	David TruebloodDirector, Regulatory Affairs908-608-3910
Device: Trade Name:	INOmax DS (Delivery System)
Common/Usual Name:	Nitric Oxide Administration Apparatus (primary)Nitric Oxide Administration Apparatus, Back-up SystemNitric Oxide AnalyzerNitrogen Dioxide Analyzer
Classification Names:	Class II - 21CFR868.5165, MRN (primary)Class II - 21CFR868.5165, MRO
Product Code:	Class II - 21CFR868.2380, MRPClass II - 21CFR868.2385, MRQ
Predicate Device(s):	K061901; INOmax DS (Delivery System)

Device Description:

Intended Use:

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designed iniector 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 (Delivery System) employs the same functional

Technology:

Determination of Substantial Equivalence:

scientific technology as its predicate devices.

Summary of Non-Clinical Tests:

The INOmax DS (Delivery System) and its applications comply with voluntary standards as detailed in Section 17-20 of this premarket submission. The following quality assurance measures were applied to the development of the system:

. Risk Analysis
Requirements Reviews .
. Design Reviews
Testing on unit level (Module verification) .
Integration testing (System verification) .
. Final acceptance testing (Validation)
Performance testing (Verification) .
Safety testing (Verification) .

Summary of Clinical Tests:

The subject of this premarket submission, INOmax DS (Delivery System), did not require clinical studies to support substantial equivalence.

INO Therapeutics considers the INOmax DS (Delivery System) Conclusion: to be as safe, as effective, and performance is substantially equivalent to the predicate device.

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

MAR ] 0 2010

Mr. Larry Lepley Associate Director, Regulatory Affairs INO Therapeutics 2902 Dairy Drive Madison, Wisconsin 53718

Re: K092545

Trade/Device Name: INOmax DS (Delivery System) Regulation Number: 21 CFR 868.5165 Regulation Name: Nitric Oxide Administration Apparatus Regulatory Class: II Product Code: MRN, MRO, MRP, MRP, MRQ Dated: February 5, 2010 Received: February 12, 2010

Dear Mr. Lepley:

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.

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. Lepley

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/Centers Offices/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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

ph for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices

Office of Device Evaluation

Center for Devices and

Radiological Health

Enclosure

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510(k) Number (if known):

INOmax DS (Delivery System) Device Name:

Indications for Use:

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.

Prescription Use__X___________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

L Arlin Ube

(Division Sian-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

1092541 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.”