(88 days)
Not Found
No
The summary describes a standard capnometer device that measures CO2 and respiratory rate using infrared technology. There is no mention of AI, ML, or any related concepts in the intended use, device description, or performance studies.
No
The device is for monitoring carbon dioxide concentration and respiratory rate, which is a diagnostic or monitoring function, not a therapeutic intervention to treat a condition.
Yes
The device "measures, displays and monitors carbon dioxide concentration and respiratory rate," which are physiological parameters used to assess a patient's condition, thus making it a diagnostic device.
No
The device description explicitly states it is a "miniature mainstream infrared gas analysis bench with an integrated user interface" and a "transducer," indicating it is a hardware device that performs physical measurements.
Based on the provided text, the EMMA Emergency Capnometer is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- EMMA's Function: The EMMA Emergency Capnometer measures carbon dioxide concentration and respiratory rate directly from the breathing circuit. This is a measurement of gases being exhaled, not an analysis of a sample taken from the body.
- Intended Use: The intended use describes monitoring respiratory parameters during anesthesia, recovery, and respiratory care. This is a physiological monitoring function, not a diagnostic test performed on a biological sample.
Therefore, the EMMA Emergency Capnometer falls under the category of a physiological monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The EMMA Emergency Capnometer Monitor measures, displays and monitors carbon dioxide concentration and respiratory rate during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room, clinic, emergency medicine and emergency transport settings for adult, pediatric and infant patients.
The EMMA Emergency Capnometer Analyzer measures and displays carbon dioxide concentration and respiratory rate during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room, clinic, emergency medicine and emergency transport settings for adult, pediatric and infant patients.
Product codes
CCK
Device Description
The EMMA Emergency Capnometer is a miniature mainstream infrared gas analysis bench with an integrated user interface. The complete carbon dioxide analyzer is contained within a transducer that is attached to the breathing circuit via the EMMA Airway Adapter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult, pediatric and infant patients.
Intended User / Care Setting
operating suite, intensive care unit, patient room, clinic, emergency medicine and emergency transport settings
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Testing in direct comparison to predicates throughout the operating range was conducted using calibrated gas samples and legally marketed anesthesia and ventilation devices. The EMMA Emergency Capnometer demonstrated performance, safety and effectiveness equivalent or superior to its predicates in all characteristics.
Key Metrics
Not Found
Predicate Device(s)
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).
0
510(k) SUMMARY, KOJ2813 Jevje 1 of 2
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- 510(k) Owner Name and Address: PHASEIN AB Svärdvägen 15 182 33 Danderyd Sweden Telephone: 46-8-544-98-150 Fax: 46-8-544-98-169
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- Contact Person: David Weissburg Weissburg Associates Madison, Wisconsin, USA Telephone: 1-608-770-0223
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Date: September 24, 2007 3.
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- Trade Name: EMMA Emergency Capnometer
DEC 2 8 2007
- Common Name: Carbon Dioxide Gas Analyzer 5.
- Classification Names: 6.
- a. Carbon dioxide gas analyzer (21 CFR 868.1400, Product Code CCK)
- Substantially equivalent to: 7.
- Device description: The EMMA Emergency Capnometer is a miniature mainstream 8. infrared gas analysis bench with an integrated user interface. The complete carbon dioxide analyzer is contained within a transducer that is attached to the breathing circuit via the EMMA Airway Adapter.
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- Intended Use:
The EMMA Emergency Capnometer Monitor measures, displays and monitors carbon dioxide concentration and respiratory rate during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room, clinic, emergency medicine and emergency transport settings for adult, pediatric and infant patients.
The EMMA Emergency Capnometer Analyzer measures and displays carbon dioxide concentration and respiratory rate during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room, clinic, emergency medicine and emergency transport settings for adult, pediatric and infant patients.
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- Comparison to predicates: The EMMA Emergency Capnometer combines carbon dioxide measurement capabilities and enhanced portability. The EMMA Emergency Capnometer device is identical to its precursor (K063167), but with an extended indication for use that includes infant patients and the addition of the infant-specific EMMA Airway Adapter Infant, which is required when monitoring infants. The intended use of the EMMA Emergency Capnometer is equivalent to the predicate Tidal Wave Model 610 (K963327). Both devices utilize disposable single-patient-use airway adapters to interface with gases in the breathing circuit. Labeling and materials used are equivalent.
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- Testing vs. predicates: Testing in direct comparison to predicates throughout the operating range was conducted using calibrated gas samples and legally marketed anesthesia and ventilation devices.
1
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- Conclusions from testing: The EMMA Emergency Capnometer demonstrated
performance, safety and effectiveness equivalent or superior to its predicates in all characteristics.
- Conclusions from testing: The EMMA Emergency Capnometer demonstrated
2
Image /page/2/Picture/2 description: The image is a seal for the Department of Health and Human Services. The seal is circular and contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
DEC 2 8 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
PHASEIN AB C/O Mr. David Weissburg Principal Weissburg Associates 4213 Winnequah Drive Madison, Wisconsin 53716
Re: K072813
Trade/Device Name: EMMA Emergency Capnometer Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: II Product Code: CCK Dated: September 25, 2007 Received: October 1, 2007
Dear Mr. Weissburg:
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.
3
Page 2 - Mr. Weissburg
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 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 (240) 276-0120. 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/industry/support/index.html.
Sincerely yours,
Fidel F. Murphy, MD for Chun Lin, MD
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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Indications for Use
510(k) Number: K072813
Device Name: EMMA Emergency Capnometer
Indications for Use:
The EMMA Emergency Capnometer Monitor measures, displays and monitors carbon dioxide concentration and respiratory rate during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room, clinic, emergency medicine and emergency transport settings for adult, pediatric and infant patients.
The EMMA Emergency Capnometer Analyzer measures and displays carbon dioxide concentration and respiratory rate during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room, clinic, emergency medicine and emergency transport settings for adult, pediatric and infant patients.
Prescription Use X (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)
Neal A. Roth
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: