STATCO2METER, MODEL 10-55372

K031814 · Mercury Medical · CCK · Aug 14, 2003 · Anesthesiology

Device Facts

• Record ID: K031814
• Device Name: STATCO2METER, MODEL 10-55372
• Applicant: Mercury Medical
• Product Code: CCK · Anesthesiology
• Decision Date: Aug 14, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1400
• Device Class: Class 2

Intended Use

The Mercury Medical StatCO2meter™ End Tidal CO2 Detector with Integrated Airway Pressure Manometer is intended to provide a semi-quantitative visualization of the CO2 in the patient airway while measuring Airway and PEEP pressure. 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

StatCO2meter™ is a colorimetric breath indicator with an integrated airway pressure manometer. Device connects between an endotracheal tube and a breathing circuit. It processes exhaled gas to provide semi-quantitative CO2 range visualization via color comparison and measures airway/PEEP pressure. Used in hospital or transport settings by clinicians to verify proper intubation and monitor airway pressure. Output allows clinicians to assess patient status as an adjunct to other clinical signs. Benefits include improved verification of airway placement and monitoring of pressure parameters during ventilation.

Clinical Evidence

Bench testing only. Performance and specifications verified against ISO 5356-1:1987 (Anesthetic and Respiratory Equipment-Conical connectors) and ASTM F1054 (Standard Specification for Conical Fittings).

Technological Characteristics

Colorimetric CO2 indicator; integrated mechanical airway pressure manometer. Conical connectors (15mm and 22mm) compliant with ISO 5356-1:1987 and ASTM F1054. Standalone, non-powered device.

Indications for Use

Indicated for use as an adjunct in patient assessment to provide semi-quantitative visualization of CO2 in the airway and measurement of airway and PEEP pressure; intended for use 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.

Predicate Devices

• StatCO2™ (K021576)
• Airway Pressure Manometer (K954486)

Submission Summary (Full Text)

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AUG 1 4 2003

# ENCLOSURE L

K031814

Premarket Notification (510(k) - Mercury Medical StatCO2meter™ End Tidal CO2 Detector with Integrated Airway Pressure Manometer.

## Non-Confidential Summary of Safety and Effectiveness

Page 1 of 2 June 10, 2003

Mercury Enterprises, Inc./Mercury Medical 11300 49th St. N. Clearwater, FL 33762 Tel: [phone] Fax: [phone]

Official Contact: Wayne Glover QA/RA Engineer

Proprietary or Trade Name: StatCO2meter™

Common/Usual Name: End Tidal CO2 detector with Integrated Airway Pressure Manometer

Classification: Class II, CCK, 21 CFR 868.1400

Classification Name: Analyzer, Gas, Carbon Dioxide, Gaseous Phase

Device: StatCO2meter™

Predicate Devices: StatCO2™ (K021576) and Airway Pressure Manometer (K954486)

### Device Description:

The Mercury Medical StatCO2meter™ is a fast, durable colorimetric breath indicator for visualization of exhaled CO2 and also measures Airway and PEEP pressure. The StatCO2meter™ is designed to connect between an endotracheal tube and a breathing device to help verify proper intubation. Exhaled gas passes through the indicator to detect approximate ranges of end-tidal CO2 by color comparison. The detector may be used during patient transport or in locations where intubations are performed.

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Premarket Notification (510(k) - Mercury Medical StatCO2meter™ End Tidal CO2 Detector with Integrated Airway Pressure Manometer.

## Non-Confidential Summary of Safety and Effectiveness

Page 2 of 2 June 10, 2003

Intended Use:

Indicated Use: The Mercury Medical StatCO2™ End Tidal CO2 Detector with Integrated Airway Pressure Manometer provides a semi-quantitative visualization of the CO2 in the patient airway while measuring Airway and PEEP pressure. 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.

Technical Characteristics: The device has the same technical characteristics as the combination of the following Mercury Medical predicate devices:

> StatCO2™ End Tidal CO2 Detector Airway Pressure Manometer

Non-Clinical Data: Performance and specifications of the device are consistent with all requirements for this device type specified by ISO 5356-1: 1987 - Anesthetic and Respiratory Equipment-Conical connectors-Part 1: Cones and Sockets. ASTM F1054 - Standard Specification for Conical Fittings of 15mm and 22mm sizes,

Environment of Use: Hospital/Transport

Conclusions: The comparison to the predicate devices demonstrates that the proposed device is safe and effective and is substantially equivalent to the predicate devices.

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 4 2003

Mr. Wayne Glover QA/RA Engineer Mercury Medical 11300-49th Street North Clearwater, Florida 33762-4800

Re: K031814

Trade/Device Name: StatCO2meterTM Regulation Number: 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: II Product Code: CCK, CAP Dated: June 10, 2003 Received: June 12, 2003

Dear Mr. Glover:

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 brior 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. Glover

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) 594-46. 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.

Suelunse

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital. Infector Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## ENCLOSURE B

## Indications for Use

Page lof l

KO31814 510(k) Number: (To be assigned) StatCO2meter™ Device Name: The Mercury Medical StatCO2meter™ End Tidal CO2 Detector Intended Use: with Integrated Airway Pressure Manometer is intended to provide a semi-quantitative visualization of the CO2 in the patient airway while measuring Airway and PEEP pressure. 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.

Concurrence of CDRH, Office of Device Evaluation (ODE)

SAWich

510(k) Number

Prescription Use X (Per CFR 801.109)

or

Over-the-counter use