(298 days)
Not Found
No
The description focuses on basic monitoring and data recording capabilities, with no mention of AI/ML terms or functionalities.
No
The device is a carbon monoxide monitor used for diagnostic and monitoring purposes, not for treating a disease or condition.
Yes
The device is designed for monitoring carbon monoxide in exhaled breath to screen for CO poisoning and smoke inhalation, which are diagnostic purposes. It also indicates use in smoking cessation programs, where monitoring CO levels can help assess a patient's smoking status, a form of diagnosis or assessment.
No
The device description explicitly states it is a "battery operated hand held carbon monoxide monitor" and mentions hardware components like an RS232 port, indicating it is a physical device with integrated software, not software only.
Based on the provided information, the TABATABA® CO TESTER is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states it is for "monitoring of Carbon Monoxide in exhaled breath." Exhaled breath is a biological specimen taken from the human body.
- Purpose: It is used for "smoking cessation programs," "screening of CO poisoning and smoke inhalation." These are diagnostic or monitoring purposes related to a person's health status.
- Predicate Device: The predicate device, K000962. PiCO Smokerlyzer, is also a device that measures CO in exhaled breath for similar purposes, which are typically classified as IVDs.
While it also mentions "ambient air monitoring," the primary intended use and the context of its application in healthcare settings for patient monitoring and diagnosis strongly indicate its classification as an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
CCJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The results of bench, standards, and clinical testing indicates that the new device is as safe and effective as the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
-
- 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
-
- Equivalent legally marketed devices K000962. PiCO Smokerlyzer, Bedfont Scientific Ltd.
-
- 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 ..
-
- 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.
-
- 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.
1
6. Comparison to predicate:
| Characteristic | ||
|---|---|---|
| K000962. PiCO Smokerlyzer, | ||
| Bedfont Scientific Ltd. | 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 | |
| Construction | Hand held battery operated | |
| 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.
3
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
4
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