CO2 EASY

K070128 · Westmed, Inc. · CCK · Feb 15, 2007 · Anesthesiology

Device Facts

• Record ID: K070128
• Device Name: CO2 EASY
• Applicant: Westmed, Inc.
• Product Code: CCK · Anesthesiology
• Decision Date: Feb 15, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1400
• Device Class: Class 2
• Attributes: 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.

Device Story

CO2 Easy is a colorimetric carbon dioxide gas analyzer used to monitor airway patency and verify endotracheal or nasotracheal tube placement. The device is placed in-line with the patient's breathing circuit. It utilizes a chemical indicator that changes color in the presence of exhaled CO2, providing visual feedback to the clinician. It is intended for use by healthcare professionals in clinical settings. The output is a color-coded visual indicator, which assists the clinician in confirming correct tube placement or identifying airway obstruction, thereby reducing the risk of esophageal intubation or unrecognized airway loss.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and comparison of technological characteristics to the predicate device.

Technological Characteristics

Colorimetric CO2 gas analyzer; utilizes a pH-sensitive chemical indicator for CO2 detection; in-line airway circuit form factor; non-electronic/passive device; no external energy source required.

Indications for Use

Indicated for use during mask ventilation to assist in determining airway patency and for verifying the placement of endotracheal or nasotracheal tubes in patients requiring airway management.

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.

Predicate Devices

• Nellcor Easy Cap (K910666)

Submission Summary (Full Text)

{0}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is a symbol that resembles a stylized caduceus or a representation of human services, with three curved lines forming a shape that suggests movement or support.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

WestMed, Incorporated C/O Mr. Neil E. Devine, JR. Responsible Third Party Official Intertek Testing Services NA, Incorporated 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087

FEB 1 5 2007

Re: K070128

Trade/Device Name: CO2 Easy Regulation Number: 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: II Product Code: CCK Dated: February 5, 2007 Received: February 6, 2007

Dear Mr. Devine:

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.

{1}------------------------------------------------

Page 2 - Mr. Devine

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 vour 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 vours.

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

{2}------------------------------------------------

510(k) Number (if known): 灯 OZO /ス 8

Device Name: 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.

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mint Thind

(Division Sign-Off) Division of Anestheridage. General Hospital, Intection Control. I

Page 1 of 1

-5.60(k.) P. 45, 46, 47

## PAGE 13 of 56 PAGES