EMMA ANALYZER (KPA) AND (MMHG); EMMA MONITOR (KPA) AND (MMHG)

K063167 · Phasein AB · CCK · Feb 6, 2007 · Anesthesiology

Device Facts

• Record ID: K063167
• Device Name: EMMA ANALYZER (KPA) AND (MMHG); EMMA MONITOR (KPA) AND (MMHG)
• Applicant: Phasein AB
• Product Code: CCK · Anesthesiology
• Decision Date: Feb 6, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1400
• Device Class: Class 2
• Attributes: Pediatric

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 and pediatric 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 and pediatric patients.

Device Story

EMMA Emergency Capnometer is a miniature mainstream infrared gas analysis bench with integrated user interface. Device attaches to breathing circuit via disposable airway adapter. Measures CO2 concentration and respiratory rate; displays data for clinician review. Used in OR, ICU, patient rooms, clinics, emergency medicine, and transport. Provides real-time monitoring to assist clinical decision-making during anesthesia and respiratory care. Benefits include enhanced portability and immediate access to respiratory gas data.

Clinical Evidence

Bench testing only. Performance compared to predicate devices using calibrated gas samples and legally marketed anesthesia and ventilation devices across the operating range. No clinical data presented.

Technological Characteristics

Mainstream infrared gas analyzer. Integrated user interface. Disposable single-patient-use airway adapters. Miniature form factor. Advanced electronics for signal processing.

Indications for Use

Indicated for adult and pediatric patients requiring monitoring of carbon dioxide concentration and respiratory rate during anesthesia, recovery, and respiratory care in clinical, emergency, or transport settings.

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

• Tidal Wave Model 610, Novametrix Medical Systems Inc. (K963327)
• VEO Multigas Monitor for Pocket PC, Phasein AB (K051857)

Submission Summary (Full Text)

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K063167

## 510(k) SUMMARY

- 510(k) Owner Name and Address: 1. PHASEIN AB Svärdvägen 15 182 33 Danderyd Sweden Telephone: [phone] Fax: [phone]
- Contact Person: 2. David Weissburg Weissburg Associates Madison, Wisconsin Telephone: [phone]

- 3. Date: 28 December 2006
- 6 2007 FEB
- Trade Name: EMMA Emergency Capnometer 4.
- Common Name: Carbon Dioxide Gas Analyzer ട.
- 6. Classification Names:
- a. Carbon dioxide gas analyzer (21 CFR 868.1400, Product Code CCK)
- 7. Substantially equivalent to:
- a. Tidal Wave Model 610, Novametrix Medical Systems Inc. (K963327)
- VEO Multigas Monitor for Pocket PC, Phasein AB. (K051857) ﻗ
- 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.
- ക 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 and pediatric 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 and pediatric patients.

- 10. Comparison to predicates: The EMMA Emergency Capnometer combines carbon dioxide measurement capabilities and enhanced portability. The EMMA Emergency Capnometer uses the same basic technology concepts of the predicate devices, while adding improvements derived from advanced electronics and miniaturization. The intended use of the EMMA Emergency Capnometer and its predicates are equivalent. All the devices utilize disposable single-patient-use airway adapters to interface with gases in the breathing circuit. Labeling and materials used are equivalent.
- 11. 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.
- 12. 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Phasein AB C/O Mr. David Weissburg Weissburg Associates 4213 Winnequah Drive Madison. Wisconsin 53716

FEB 6 2007

Re: K063167

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: January 3, 2007 Received: January 10, 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 (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.

Sincerely vours,

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: _

EMMA Emergency Capnometer Device Name:

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 and pediatric 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 and pediatric patients.

Prescription Use (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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

K063167

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