(173 days)
Not Found
None
No
The summary describes a semi-quantitative visualization device for CO2, with no mention of AI, ML, image processing, or data analysis techniques typically associated with AI/ML.
No.
The device is used to visualize CO2 and is described as an "adjunct in patient assessment," indicating it provides information for diagnosis or monitoring rather than directly treating a condition.
Yes
The device is used to provide a semi-quantitative visualization of CO2 in a patient's airway or exhaled gas, and is described as an "adjunct in patient assessment" to help determine "clinical signs and symptoms," which are characteristics of a diagnostic device.
No
The description refers to a "CO2 Clip Indicator," implying a physical component that interacts with the patient's airway or exhaled gas. The summary does not explicitly state it is software-only.
Based on the provided information, the BreGas AB CO2 Clip Indicator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to visualize CO2 in the patient airway or exhaled gas. This involves analyzing gas directly from the patient's respiratory system, not a sample taken from the body (like blood, urine, or tissue) that is then tested in vitro (in a lab setting).
- Mechanism: While the description is brief, the name "Clip Indicator" and the intended use suggest a device that interacts directly with the patient's airway or breathing circuit to provide a visual indication. This is a direct measurement of a physiological parameter, not an analysis of a biological sample.
- Lack of IVD Characteristics: The description doesn't mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, etc.)
- Using reagents or assays
- Performing tests in a laboratory setting
Therefore, the BreGas AB CO2 Clip Indicator appears to be a device used for monitoring a physiological parameter in vivo (within the living body), which is not the definition of an IVD.
N/A
Intended Use / 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,
Product codes
73 CCK
Device Description
Not Found
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient airway
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.1400 Carbon dioxide gas analyzer.
(a)
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.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, representing health and human services.
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 (301) 594-4646. 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 (800) 638-2041 or (301) 443-6597 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
2
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