TABATABA COTESTER

K080278 · Fim Medical · CCJ · Nov 28, 2008 · Anesthesiology

Device Facts

• Record ID: K080278
• Device Name: TABATABA COTESTER
• Applicant: Fim Medical
• Product Code: CCJ · Anesthesiology
• Decision Date: Nov 28, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1430
• Device Class: Class 2

Intended Use

The TABATABA® CO TESTER is for the monitoring of Carbon Monoxide in exhaled breath. It is for use in smoking cessation programs and can be used for the screening of CO poisoning and smoke inhalation. It can also be used for ambient air monitoring. It is for use by health professionals.

Device Story

Battery-operated, handheld CO analyzer; monitors CO levels in exhaled breath or ambient air. Used by health professionals in clinical settings for smoking cessation, CO poisoning screening, and smoke inhalation assessment. Device features internal menu for configuring parameters (time, date, alarm thresholds, monitoring duration). Input: exhaled breath or ambient air. Output: CO concentration displayed on 4-digit LCD. Connectivity: RS232 port for computer connection to record and analyze results. Benefits: provides objective data to aid smoking cessation and rapid screening for CO exposure.

Clinical Evidence

Bench, laboratory, and clinical testing performed. Results indicate the device is as safe and effective as the predicate. No specific clinical performance metrics (sensitivity/specificity) provided in the summary.

Technological Characteristics

Handheld, battery-operated (2-AA alkaline) CO gas analyzer. Enclosure: ABS plastic. Mouthpiece: Replaceable polypropylene. Display: 4-digit LCD. Connectivity: RS232 port. Measurement range: 0-500 ppm. Dimensions: 110 x 70 x 30 mm. Weight: 170 gm.

Indications for Use

Indicated for monitoring exhaled carbon monoxide (CO) in patients for smoking cessation programs, screening for CO poisoning, and smoke inhalation. Also indicated for ambient air monitoring. For use by health professionals.

Regulatory Classification

Identification

A carbon monoxide gas analyzer is a device intended to measure the concentration of carbon monoxide in a gas mixture to aid in determining the patient's ventilatory status. The device may use techniques such as infrared absorption or gas chromatography.

Predicate Devices

• PiCO Smokerlyzer (K000962)

Submission Summary (Full Text)

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K080278
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### EXHIBIT 2 510(k) Summary

FIM Medical 30, rue Camille 69003 Lyon, France [e-mail] Tel + 33 (0)4 72 34 89 89 Fax + 33 (0)4 72 33 43 51

NOV 2 8 2008

January 10, 2008 Contact: Eric Derei, President

- 1. Identification of the Device: Proprietary-Trade Name: TABATABA® CO TESTER Classification Names: Carbon monoxide gas analyzer. Product Code CCJ, Regulation number 868.1430 Common/Usual Name: CO Analyzer
- 2. Equivalent legally marketed devices K000962. PiCO Smokerlyzer, Bedfont Scientific Ltd.
- 3. Indications for Use (intended use) The TABATABA® CO TESTER is for the monitoring of Carbon Monoxide in exhaled breath. It is for use in smoking cessation programs and can be used for the screening of CO poisoning and smoke inhalation. It can also be used for ambient air monitoring. It is for use by health professionals ..
- 4. Description of the Device: The TABATABA is a battery operated hand held carbon monoxide monitor for use as an aid in smoking cessation programs. The TABATABA is a complete tool for the prevention of the risks of active or passive smoking. It can be carried in the pocket or on the belt. The device is parametered by an internal menu (time, date, alarm threshold, measurement time of monitoring). It can be connected to a computer via an RS232 port, to record and analyze results.
- 5. Safety and Effectiveness, comparison to predicate device. The results of bench, standards, and clinical testing indicates that the new device is as safe and effective as the predicate devices.

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#### 6. Comparison to predicate:

| Characteristic | | |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|
| K000962. PiCO Smokerlyzer,<br>Bedfont Scientific Ltd. | TABATABA® CO<br>TESTER | |
| Indications for Use | For the monitoring of Carbon<br>Monoxide in exhaled breath. It<br>is for use in smoking cessation<br>programs and can be used for<br>the screening of CO poisoning<br>and smoke inhalation. It can<br>also be used for ambient air<br>monitoring. It is for use by<br>health professionals. | SAME |
| Construction | Hand held battery operated<br>device | SAME |
| Display | LCD, 3 digit | LCD, 4 digit |
| Enclosure material | ABS | SAME |
| Mouthpiece | Polypropylene, replaceable. | SAME |
| Power source | 2-AA Alkaline Batteries | SAME |
| CO Measurement | 0-80 ppm and higher | 0-500 ppm |
| Dimensions | 120 x 75 x 45 (mm) | 110 x 70 x 30 (mm) |
| Weight | 200 gm. | 170 gm. |

## 7. Conclusion

After analyzing bench, laboratory, and clinical testing data, it is the conclusion of FIM Medical that the TABATABA® CO Tester as safe and effective as the predicate devices, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 8 2008

FIM Medical C/O Daniel Kamm, P.E. Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015

Re: K080278

Trade/Device Name: TABATABA® CO Tester Regulation Number: 21 CFR 868.1430 Regulation Name: Carbon Monoxide Gas Analyzer Regulatory Class: II Product Code: CCJ Dated: November 17, 2008 Received: November 25, 2008

Dear Mr. Kamm:

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. Kamm

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

Solite Y. Michie O.m.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 (if known):

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The TABATABA® CO TESTER is for the monitoring of Carbon Monoxide in exhaled breath. It is for use in smoking cessation programs and can be used for the screening of CO poisoning and smoke inhalation. It can also be used for ambient air monitoring. It is for use by health professionals.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Arch

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

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510(k) Number: K080278