PEDI CO2 EASY

K072220 · Westmed, Inc. · CCK · Aug 23, 2007 · Anesthesiology

Device Facts

• Record ID: K072220
• Device Name: PEDI CO2 EASY
• Applicant: Westmed, Inc.
• Product Code: CCK · Anesthesiology
• Decision Date: Aug 23, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1400
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

Use during mask ventilation to assist in the determination of a patent airway. Use to assist in the placement or verification of the location of an endotracheal or nasotracheal tube. Intended for patients weighing 1-15kg (2.2 - 33lbs)

Device Story

Pedi CO2 Easy is a colorimetric carbon dioxide detector used to assist in airway management. Device connects to an endotracheal tube or mask; utilizes chemical indicator that changes color in presence of exhaled CO2. Provides visual confirmation of tube placement or airway patency. Used by clinicians in clinical settings. Benefits include rapid verification of correct airway placement, reducing risk of esophageal intubation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Colorimetric CO2 detector; chemical indicator technology; form factor designed for pediatric patients (1-15kg); non-electronic; disposable.

Indications for Use

Indicated for pediatric patients weighing 1-15kg (2.2-33lbs) requiring mask ventilation to determine airway patency or verification of endotracheal/nasotracheal tube placement.

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

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is enclosed within a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG 2 3 2007

Westmed, Incorporated C/O Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services NA, Incorporated 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087

Re: K072220

Trade/Device Name: Pedi CO2 Easy Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: II Product Code: CCK Dated: August 7, 2007 Received: August 10, 2007

Dear Mr. Lehtonen:

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 such 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. Lehtonen

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

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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## Statement of Indications for Use

510(k) Number (if known):

Device Name: Pedi CO2 Easy

Indications for Use:

Use during mask ventilation to assist in the determination of a patent airway.

Use to assist in the placement or verification of the location of an endotracheal or nasotracheal tube.

Intended for patients weighing 1-15kg (2.2 - 33lbs)

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

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

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

ncurrence of DRH, Office of Device Evaluation (ODE)

Will Mact

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

510(k) Number: K072220