C-CO2 COLORIMETRIC CO2 INDICATOR

K050066 · Marquest Medical Products, Inc. · CCK · Mar 1, 2005 · Anesthesiology

Device Facts

• Record ID: K050066
• Device Name: C-CO2 COLORIMETRIC CO2 INDICATOR
• Applicant: Marquest Medical Products, Inc.
• Product Code: CCK · Anesthesiology
• Decision Date: Mar 1, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1400
• Device Class: Class 2

Intended Use

The C-CO2 colorimetric carbon dioxide indicator provides a semi-quantitative visualization of the CO2 in the patient airway or in the gas exhaled from a patient. It is an adjunct to clinical assessment when verifying correct ET tube placement and respiration.

Device Story

Non-sterile, single-use, colorimetric CO2 indicator; features integral luer-lock connector for placement between tracheal tube and breathing circuit. Device utilizes pressure in breathing circuit to divert low flow of exhaled gas through indicator; colorimetric media changes color based on CO2 concentration (blue: no CO2; green: intermediate; yellow: ~5% CO2). Used in hospital and transport settings by clinicians. Provides breath-by-breath visual feedback; assists in verifying ET tube placement and monitoring patient ventilation. Permanent blue/blue-green indicates absence of exhaled CO2; permanent yellow/white indicates device damage. Does not require external power; unaffected by normal breathing gases, anesthetic gases, or water vapor.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Colorimetric chemical indicator media; luer-lock connector; single-use; non-sterile. Operates via passive gas flow driven by breathing circuit pressure. No electronic components or software.

Indications for Use

Indicated for patients with tidal volume ≥150ml, minute volume ≥3L/minute, and breathing rate ≤35 breaths per minute to verify ET tube placement and respiration.

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

• BreGas AB CO2 Clip (K023820)

Submission Summary (Full Text)

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## 510(k) SUMMARY OF SAFETY & EFFECTIVENESS

MAR 1 - 2005

January 7, 2005

| Marquest Medical Products, Inc.<br>11039 East Lansing Circle<br>Englewood, CO 80112<br>(A division of Vital Signs, Inc.) | Tel - [phone] ext. 412<br>Fax - [phone] |
|--------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
|--------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|

| Official Contact: | Tom Dielmann, Vice President of RA/QA |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary or<br>Trade Name: | <i>C-CO2</i> ^TM |
| Common/Usual Name: | Colorimetric Carbon Dioxide Indicator |
| Classification Name: | 73 CCK - Analyzer, Gas, Carbon Dioxide, Gaseous Phase<br>Subsection 868.1400 |
| Intended Device: | Colorimetric CO2 Indicator |
| Predicate Device: | BreGas AB CO2 Clip - K023820 |
| Device Description: | A non-sterile, single use, colorimetric carbon dioxide<br>indicator with integral luer-lock connector, for placement in<br>a gas sampling ported component, located between a<br>tracheal tube and the breathing circuit, to detect exhaled<br>CO2.<br>Pressure in the breathing circuit causes a low flow of<br>breathing gas to pass into and through the indicator and<br>vent to the atmosphere. The colorimetric media in the<br>center window of the device indicates the presence of<br>carbon dioxide in exhaled breath on a breath-by-breath<br>basis.<br>The colorimetric media in the center window is blue when<br>no carbon dioxide is present, green at intermediate<br>concentrations and yellow when approximately 5% carbon<br>dioxide is present. A breath-by-breath color change reflects<br>ventilation of the patient. A permanent blue or blue-green<br>color indicates absence of exhaled carbon dioxide. A<br>damaged indicator will exhibit a permanent yellow or white<br>color.<br>The indicator has a color scale against which the actual<br>color may be compared to provide an approximate carbon<br>dioxide concentration. Normal breathing gases, anesthetic<br>gases, or water vapor do not affect the indicator. |

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## 510(k) SUMMARY OF SAFETY & EFFECTIVENESS (cont.)

| Indicated Use: | The C-CO2 colorimetric carbon dioxide indicator provides<br>a semi-quantitative visualization of the CO2 in the patient<br>airway or in the gas exhaled from a patient. It is an adjunct<br>to clinical assessment when verifying correct ET tube<br>placement and respiration. |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Targeted Population: | Patients with a tidal volume greater than or equal to 150ml<br>and with a minute volume greater than or equal to<br>3L/minute, and with a breathing rate less than or equal to<br>35 breaths per minute. |
| Environment of Use: | Hospital, Transport |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and body. The eagle is facing to the right.

Public Health Service

MAR 1 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Thomas W. Dielmann Vice President, Regulatory Affairs/Quality Assurance Marquest Medical Products, Incorporated 11039 East Lansing Circle Englewood, Colorado 80112

Re: K050066

Trade/Device Name: C-CO2TM Colorimetric CO2 Indicator Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: II Product Code: CCK Dated: January 7, 2005 Received: January 14, 2005

Dear Mr. Dielmann:

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. Dielmann

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 (OS) 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.

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Sincerely yours,

Sina Russo

Chiu Lin, Ph.D.

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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| 510(K) NUMBER: | K |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME: | C-CO2 ^TM COLORIMETRIC CO2 INDICATOR |
| INDICATIONS FOR USE: | The C-CO2 colorimetric carbon dioxide indicator provides a semi-quantitative visualization of the CO2 in the patient airway or in the gas exhaled from a patient. At is an adjunct to clinical assessment when verifying correct ET tube placement and respiration. |

| Prescription Use | X | and/or | Over-The-Counter Use |
|----------------------------|---|--------|----------------------|
| (per 21 CFR 801 Subpart D) | | | |

Concurrence of CDRH, Office of Device Evaluation (ODE)


| Signature-On: | |
|----------------------------------------------|---------|
| Division of Anesthesiology General Hospital, | |
| Infection Control. Dental Devices | |
| 510(k) Number | K050066 |

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