The AeroNOx is intended to provide a constant controlled concentration of nitric oxide in breathing gas by delivering a constant controlled flow of nitric oxide into the inspiratory limb of a mechanical ventilator that operates using a continuous constant flow of fresh gas into the inspiratory limb of the ventilator. The AeroNOx is also intended to be used with a flow inflating manual ventilator (an AeroNOx accessory), by introducing controlled flows of nitric oxide into the fresh gas flow to the manual ventilator. It is also intended to monitor nitric oxide, nitrogen dioxide, and oxygen concentrations in the breathing gas. The AeroNOx is intended to be used within a hospital or during air or ground transport outside the hospital.

Device Description

The AeroNOx nitric oxide delivery system is specifically designed for the transmission . and control of gaseous nitric oxide (NO) in parts per million (ppm) concentrations. It is divided into two main components: the titration delivery system and the NO/NO2/O2 . analyzer. These two components are mounted into a single enclosure. The construction materials are compatible with NO and will not contaminate the gas stream. A stainless steel, two stage regulator with CGA 626 gas fittings is coupled to a calibrated, high accuracy NO mass flow meter and precision metering valve. The NO is titrated continuously via tubing nearest to the ventilator outlet circuit where it is diluted by the ventilator gas flow. Initial NO flow required to approximate a desired NO concentration is estimated by calculation and verified by the monitoring component of the system. We have also included a look-up table for specific ventilator settings, AeroNOx NO flow setting and expected NO2 production based on 100% Oxygen source, in the operating manual. The AeroNOx analyzer continuously draws a sample from the ventilator circuit on the distal point of the inspiratory circuit nearest the patient wye connection. The sensors then measure NO and NO2 concentration in parts per million and Oxygen in %. The sensors operate by electrochemical means. NO, O2 and NO2 molecules diffuse across a membrane and react in the electrolyte solution augmenting an electrical current between the anode and cathode. The augmented current is proportional to the NO, O2 and NO2 concentration. The AeroNOx analyzer has been designed so that the user can set alarm limits to ensure that deviations in NO and NO2 can be monitored. These alarms are visual and audible. An oxygen analyzer is also incorporated into the system to act as a secondary monitor to display the fractional inspired oxygen concentration.

AI/ML Overview

The provided document is a Special 510(k) submission for a device modification to the AeroNOx Nitric Oxide Titration & Monitoring System. Based on the document, no studies related to device performance or clinical claims were conducted or are presented.

The modification described is solely an update to the User Manual to include three additional ventilators in the list of validated ventilators that can be connected to the AeroNOx system. The submission explicitly states: "No device modifications have been made from the predicate device. The only modification made is to the list of ventilators that may connect to the AeroNOx in the Operator's Manual (page 22)."

Therefore, there is no information available in this document to populate the requested table or answer questions regarding acceptance criteria, device performance, sample size, ground truth, expert involvement, or study methodologies. The substantial equivalence argument is based on the device's continued use of the same intended use, operating principle, design, electronic circuitry, and materials as the predicate device.

Summary

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Special 510(k): Device Modification AeroNOx Nitric Oxide Titration & Monitoring System October 13, 2009 1093260

SECTION 2: DEVICE SUMMARY

I. Device Name:

Device Trade Name: AeroNOx Nitric Oxide Titration & Monitoring System Common/Classification Name: AeroNOx Nitric Oxide Delivery Device

1. Address and Registration Number: International Biomedical, Ltd. 8508 Cross Park Drive Austin, TX 78754 FDA Registration #: 1625392
  DEC 1 6 2009
1. Device Class:
  Nitric Oxide Delivery Apparatus are classified as Class II, Product Code MRN, Anesthesiology.
1. Predicate Device Information:
  The predicate device is the AeroNOx Nitric Oxide Titration & Monitoring System, K000653, 8/4/00.
1. Labeling:
  The product labeling has been changed to add three additional ventilators to the list of validated ventilators in the user manual. No other labeling changes have been made. A copy of the revised manual is included in the submission.
1. Intended Use:
  The AeroNOx is intended to provide a constant controlled concentration of nitric oxide in breathing gas by delivering a constant controlled flow of nitric oxide into the inspiratory limb of a mechanical ventilator that operates using a continuous constant flow of fresh gas into the inspiratory limb of the ventilator. The AeroNOx is also intended to be used with a flow inflating manual ventilator (an AeroNOx accessory), by introducing controlled flows of nitric oxide into the fresh gas flow to the manual ventilator. It is also intended to monitor nitric oxide, nitrogen dioxide, and oxygen concentrations in the breathing gas.

The AeroNOx is intended to be used within a hospital or during air or ground transport outside the hospital.

The intended use of the AeroNOx has not changed.

The indications for use statement can be found in attachment 2.

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Special 510(k): Device Modification AeroNOx Nitric Oxide Titration & Monitoring System October 13. 2009

SECTION 2: DEVICE SUMMARY

7. Device Description and Comparison:

The construction materials are compatible with NO and will not contaminate the gas stream. A stainless steel, two stage regulator with CGA 626 gas fittings is coupled to a calibrated, high accuracy NO mass flow meter and precision metering valve. The NO is titrated continuously via tubing nearest to the ventilator outlet circuit where it is diluted by the ventilator gas flow. Initial NO flow required to approximate a desired NO concentration is estimated by calculation and verified by the monitoring component of the system. We have also included a look-up table for specific ventilator settings, AeroNOx NO flow setting and expected NO2 production based on 100% Oxygen source, in the operating manual.

The AeroNOx analyzer continuously draws a sample from the ventilator circuit on the distal point of the inspiratory circuit nearest the patient wye connection. The sensors then measure NO and NO2 concentration in parts per million and Oxygen in %. The sensors operate by electrochemical means. NO, O2 and NO2 molecules diffuse across a membrane and react in the electrolyte solution augmenting an electrical current between the anode and cathode. The augmented current is proportional to the NO, O2 and NO2 concentration.

The AeroNOx analyzer has been designed so that the user can set alarm limits to ensure that deviations in NO and NO2 can be monitored. These alarms are visual and audible. An oxygen analyzer is also incorporated into the system to act as a secondary monitor to display the fractional inspired oxygen concentration.

- No device modifications have been made from the predicate device. The only modification made is to the list of ventilators that may connect to the AeroNOx in the Operator's Manual (page 22).

8. Substantial Equivalence:

The modified AeroNOx has the following similarities to the previous AeroNOx model that already has 510(k) clearance:

. The same intended use
. Use the same operating principle
Incorporate the design and electronic circuitry
. Incorporate the same materials .

In summary, the AeroNOx Nitric Oxide Titration & Monitoring System described in this submission is, in our opinion, substantially equivalent to the predicate device.

ਨ

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Special 510(k): Device Modification AeroNOx Nitric Oxide Titration & Monitoring System October 13, 2009

INDICATIONS FOR USE STATEMENT

Applicant's Name:

International Biomedical, Ltd.

510(k) Number:
K093260

Device Name:

AeroNOx Nitric Oxide Titration & Monitoring System

Indications for Use:

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it, and a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The caduceus is positioned to the right of the text, and the overall design is simple and clean.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

DEC 1 6 2009

Mrs. Amy Pieper Director of Regulatory Affairs International Biomedical, Limited 8508 Cross Park Drive Austin, Texas 78754

RE: K093260

Trade/Device Name: AeroNOx Nitric Oxide Titration & Monitoring System Regulation Number: 21CFR 868,5165 Regulation Name: Nitric Oxide Delivery System Regulatory Class: II Product Code: MRN Dated: November 18, 2009 Received: November 19, 2009

Dear Mrs. Pieper:

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 - Mrs. Pieper

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,

h for

Anthony D. Watson, BS, MS, MBA 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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Special 510(k): Device Modification AeroNOx Nitric Oxide Titration & Monitoring System October 13, 2009

INDICATIONS FOR USE STATEMENT

Applicant's Name:

International Biomedical, Ltd.

510(k) Number:
K093260

Device Name:

AeroNOx Nitric Oxide Titration & Monitoring System

Indications for Use:

The AeroNOx is intended to provide a constant controlled concentration of nitric oxide in breathing gas by delivering a constant controlled flow of nitric oxide into the inspiratory limb of a mechanical ventilator that operates using a nontinuous constant flow of fresh gas into the inspiratory limb of the ventillator. The AeroNOx is also intended to be used with a flow inflating manual ventilator (an AeroNOx accessory), by introducing controlled flows of nitric oxide into the freeh gas flow to the manual ventilator. It is also intended to monitor nitric oxide, nitrogen dioxide, and oxygen concentrations in the breathing gas. The AeroNOx is intended to be used within a hospital or during air or ground transport outside the hospital.

L. Schutte

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

510(k) Number: K093260

International Biomedical

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.”