EMMA ANALYZER (KPA & MMHG); EMMA MONITOR (KPA & MMHG) by PHASEIN AB

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.

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.

AI/ML Overview

The provided text describes the EMMA Emergency Capnometer and states that testing was done in direct comparison to predicates throughout the operating range using calibrated gas samples and legally marketed anesthesia and ventilation devices. The conclusion was that the device demonstrated performance, safety, and effectiveness equivalent or superior to its predicates in all characteristics. However, the document does not explicitly detail specific acceptance criteria or provide a table of reported device performance against those criteria.

Given the information provided, I can only address some of your questions.

1. A table of acceptance criteria and the reported device performance

The provided text does not contain a specific table of acceptance criteria with corresponding reported device performance values. It only generally states that the device "demonstrated performance, safety and effectiveness equivalent or superior to its predicates in all characteristics."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The text mentions "calibrated gas samples" but does not specify the sample size used for the test set. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the study involved "calibrated gas samples and legally marketed anesthesia and ventilation devices" rather than human-interpreted data requiring expert consensus for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable, as there's no indication of human adjudication for the device performance testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is a capnometer, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The testing described ("Testing in direct comparison to predicates throughout the operating range was conducted using calibrated gas samples and legally marketed anesthesia and ventilation devices") inherently represents a standalone performance evaluation of the EMMA Emergency Capnometer. There is no mention of a human-in-the-loop component for the performance assessment itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth was established by "calibrated gas samples" and the performance of "legally marketed anesthesia and ventilation devices" (presumably as a reference standard for comparison with the device's measurements).

8. The sample size for the training set

The device is a hardware capnometer, not based on a machine learning algorithm that requires a training set. Therefore, a training set is not applicable or mentioned.

9. How the ground truth for the training set was established

As there is no training set for this type of device, this question is not applicable.

Summary

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510(k) SUMMARY, KOJ2813 Jevje 1 of 2

1. 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
1. Contact Person: David Weissburg Weissburg Associates Madison, Wisconsin, USA Telephone: 1-608-770-0223
Date: September 24, 2007 3.
1. 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.
- a. Tidal Wave Model 610, Novametrix Medical Systems Inc. (K963327)
- EMMA Emergency Capnometer, Phasein AB. (K063167) b.
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.
1. Intended Use:

1. 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.
1. 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.

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1. Conclusions from testing: The EMMA Emergency Capnometer demonstrated
  performance, safety and effectiveness equivalent or superior to its predicates in all characteristics.

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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.

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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:

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:

Regulation Number and Section

§ 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).