AIRWAY SUPPORT SYSTEM / AIRPORT

K131506 · Abeon Medical Corporation · CCK · Mar 6, 2014 · Anesthesiology

Device Facts

• Record ID: K131506
• Device Name: AIRWAY SUPPORT SYSTEM / AIRPORT
• Applicant: Abeon Medical Corporation
• Product Code: CCK · Anesthesiology
• Decision Date: Mar 6, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1400
• Device Class: Class 2

Intended Use

The AirPort is indicated for use in patients requiring supplemental oxygenation, patients requiring, and patients requiring non-definitive airway support. To be used in one or any combination of the preceding circumstances.

Device Story

AirPort device provides supplemental oxygenation and non-definitive airway support to patients. Device functions as a carbon dioxide gas analyzer (21 CFR 868.1400). Used in clinical settings to monitor gas levels; assists healthcare providers in managing patient airway and oxygenation status. Output informs clinical decision-making regarding respiratory support. Benefits include improved patient monitoring and airway management.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on regulatory review.

Technological Characteristics

Carbon dioxide gas analyzer; classified under 21 CFR 868.1400; Product Code CCK.

Indications for Use

Indicated for patients requiring supplemental oxygenation or non-definitive airway support. No specific age or gender restrictions provided.

Regulatory Classification

Identification

A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.

Submission Summary (Full Text)

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Public Health Service

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

March 6, 2014

Abeon Medical Corporation Allison Slaga Engineer 8000 Katherine Boulevard Brecksville, OH 44141

Re: K131506

Trade Name: AirPort Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: Class II Product Code: CCK Dated: January 30, 2014 Received: February 3, 2014

## Dear Ms. Slaga:

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 - Ms. Slaga

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 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/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Image /page/1/Picture/8 description: The image contains a signature and some text. The text includes the name "Tejashri Purohit-Sheth, M.D." and the title "Clinical Deputy Director". The acronym "DAGRID" is also present in the image. The word "FOR" is located in the bottom right corner of the image.

Erin Keith, M.S. Acting Division 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ﯿﻨﻪ ﺑﻪ ﺩﺭ ﺩﺭ ﺩﺭ ﺑﻪ ﺑﻪ

#### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

## 510(k) Number (if known)

K131506

Device Name

#### AirPort

Indications for Use (Describe)

The AirPort is indicated for use in patients requiring supplemental oxygenation, patients requiring, and patients requiring non-definitive airway support. To be used in one or any combination of the preceding circumstances.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Car Sidera

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

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