CO2 CLIP

K023820 · Bregas AB · CCK · May 7, 2003 · Anesthesiology

Device Facts

• Record ID: K023820
• Device Name: CO2 CLIP
• Applicant: Bregas AB
• Product Code: CCK · Anesthesiology
• Decision Date: May 7, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1400
• Device Class: Class 2

Intended Use

The intended use of BreGas AB CO2 Clip Indicator is to provide a semi-quantitative visualization of the CO2 in the patient airway or in the gas exhaled from a patient. It is an adjunct in patient assessment, to be used in conjunction with other methods to determine clinical signs and symptoms by or on the order of a physician,

Device Story

CO2 Clip is a semi-quantitative indicator for monitoring CO2 in patient airways or exhaled gas. Device provides visual feedback to clinicians as an adjunct to standard patient assessment methods. Used by or on the order of a physician to assist in evaluating patient respiratory status. Operates as a passive indicator; provides real-time visual information regarding presence or levels of CO2. Assists healthcare providers in clinical decision-making by offering immediate, non-invasive insight into ventilation status. Benefits include enhanced monitoring capability during patient assessment.

Clinical Evidence

No clinical data provided; device relies on established technological characteristics for CO2 gas analysis.

Technological Characteristics

Semi-quantitative CO2 indicator; gaseous phase gas analyzer; class II device; 21 CFR 868.1400.

Indications for Use

Indicated for semi-quantitative visualization of CO2 in patient airways or exhaled gas as an adjunct to clinical assessment by or on the order of a physician.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 7 2003

Dr. Paul Krill Regulatory Affairs Manager Bregas AB Ulvsundavagen 178 B SE-168 67 BROMMA Sweden

Re: K023820

Trade/Device Name: CO2 Clip Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide (gaseous phase) Gas Analyzer Regulatory Class: II Product Code: 73 CCK Dated: April 23, 2003 Received: April 25, 2003

Dear Dr. Krill:

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 - Dr. Krill

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/dsma/dsmamain.html

Sincerely vours.

Susan Kunne

Susan Runner, DDS, MA Interim 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: K023820 BreGas AB CO2 Clip Indicator Indications for Use

The intended use of BreGas AB CO2 Clip Indicator is to provide a semi-quantitative visualization of the CO2 in the patient airway or in the gas exhaled from a patient. It is an adjunct in patient assessment, to be used in conjunction with other methods to determine clinical signs and symptoms by or on the order of a physician,

Eugen Kaiser

(Division Sign-Off) Division of Dental, Infection Control, and Caral Hospital Devices 510(k) Number