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 Description

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.

AI/ML Overview

The provided text describes the TABATABA® CO TESTER, a Carbon Monoxide gas analyzer, and its substantial equivalence to a predicate device (K000962. PiCO Smokerlyzer, Bedfont Scientific Ltd.). The information primarily focuses on a comparison of characteristics rather than a detailed study with specific acceptance criteria and performance metrics typically found for AI/ML devices.

Based on the provided text, a direct table of "acceptance criteria" and "reported device performance" in the context of an AI/ML study is not available. The document is a 510(k) summary for a medical device, which typically establishes substantial equivalence to a predicate device based on similar intended use, technological characteristics, and safety/effectiveness data.

Here's an analysis of the provided information, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state "acceptance criteria" in a quantitative manner for performance metrics like sensitivity, specificity, or AUC, as would be common for AI/ML studies. Instead, it relies on demonstrating substantial equivalence to a predicate device. The "performance" is implicitly demonstrated through bench, standards, and clinical testing showing it's "as safe and effective" as the predicate.

The table below reflects the comparison of characteristics, which served as the basis for the substantial equivalence claim. The "Acceptance Criteria" here are the characteristics of the predicate device that the TABATABA® CO TESTER needed to meet or be comparable to. The "Reported Device Performance" refers to the TABATABA® CO TESTER's characteristics.

Acceptance Criteria (from Predicate Device K000962)	Reported Device Performance (TABATABA® CO TESTER)
Indications for Use: 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.	SAME (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.)
Construction: Hand held battery operated device	SAME (Hand held battery operated device)
Display: LCD, 3 digit	LCD, 4 digit
Enclosure material: ABS	SAME (ABS)
Mouthpiece: Polypropylene, replaceable.	SAME (Polypropylene, replaceable.)
Power source: 2-AA Alkaline Batteries	SAME (2-AA Alkaline Batteries)
CO Measurement Range: 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.

Study Proving Device Meets Acceptance Criteria:

The document states that "The results of bench, standards, and clinical testing indicates that the new device is as safe and effective as the predicate devices," and thus supports the conclusion of substantial equivalence. However, the details of these tests are not provided in this summary.

Regarding AI/ML specific questions (which are not directly applicable to this device based on the provided information):

Sample size used for the test set and the data provenance: Not applicable as this is not an AI/ML device. The document mentions "clinical testing data" without specifying sample size or provenance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is not an AI/ML device.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as this is not an AI/ML device.
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: Not applicable as this is not an AI/ML device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an AI/ML device. The device is a direct measurement tool.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): For a CO analyzer, the "ground truth" would typically be established by highly accurate laboratory-grade CO measurement instruments. The document doesn't specify the method, but mentions "bench, standards, and clinical testing."
The sample size for the training set: Not applicable as this is not an AI/ML device.
How the ground truth for the training set was established: Not applicable as this is not an AI/ML device.

In summary: The K080278 submission is for a traditional medical device (CO analyzer) and demonstrates substantial equivalence to a predicate device. It does not involve AI/ML technology, and therefore, many of the questions related to AI/ML study design are not applicable to the information provided. The "acceptance criteria" were the characteristics and performance of the predicate device, which the new device aimed to match or improve upon while remaining substantially equivalent. The study mentioned ("bench, standards, and clinical testing") served to demonstrate this equivalence, although specific data from these studies are not detailed in this summary.

Summary

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K080278
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EXHIBIT 2 510(k) Summary

FIM Medical 30, rue Camille 69003 Lyon, France Fim@fim-medical.com 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
1. Equivalent legally marketed devices K000962. PiCO Smokerlyzer, Bedfont Scientific Ltd.
1. 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 ..
1. 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.
1. 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,Bedfont Scientific Ltd.	TABATABA® COTESTER
Indications for Use	For the monitoring of CarbonMonoxide in exhaled breath. Itis for use in smoking cessationprograms and can be used forthe screening of CO poisoningand smoke inhalation. It canalso be used for ambient airmonitoring. It is for use byhealth professionals.	SAME
Construction	Hand held battery operateddevice	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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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:

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

Regulation Number and Section

§ 868.1430 Carbon monoxide gas analyzer.

(a)
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.(b)
Classification. Class II (performance standards).