(151 days)
No
The description focuses on the chemical sensing technology and established physical laws (Henry's Law) for measurement, with no mention of AI or ML algorithms for data processing or interpretation.
No.
The device is intended to measure alcohol in human breath as an aid in detecting alcohol intoxication, not to treat or alleviate a medical condition.
Yes
Explanation: The device measures alcohol in human breath to aid in the detection of alcohol intoxication, which aligns with the definition of a diagnostic device as it provides information for diagnosis.
No
The device description explicitly details the use of a tin dioxide sensor and the measurement of resistance changes, indicating a hardware component is essential for its function.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The definition of an IVD involves examining specimens such as blood, urine, tissue, etc., in vitro (outside the body).
- This device analyzes breath exhaled from the body. While breath comes from the body, the analysis is performed on the exhaled air, not a sample taken from the body in the traditional sense of an IVD.
- The mechanism of action is a sensor reacting to a gas. The description details a sensor that reacts to alcohol in the breath, which is a direct measurement of a substance in the exhaled air, not an analysis of a biological sample.
Therefore, while it's a diagnostic tool used to assess a physiological state (alcohol intoxication), it doesn't fit the definition of an In Vitro Diagnostic device. It's more accurately classified as a breath alcohol analyzer.
N/A
Intended Use / Indications for Use
This device is intended to measure alcohol in the human breath. Measurements obtained by this device are used as an aid in the detection of alcohol intoxication.
Product codes
DJZ
Device Description
The BACTRACK™ Breathalyzer is designed to measure deep lung air to test for the presence of alcohol in the blood. The relationship between alcohol in the blood and alcohol in the deep lung breath is well established by Henry's law in ratio of 2100:1 The BACTRACK™ Breathalyzer is has been tested and uses a blow time of 5 seconds to capture an accurate deep lung sample. The BACTRACK™ Breathalyzer sensor uses tin dioxide which has n-type conductivity when exposed to the atmosphere. This exposure causes a decrease in the number of electrons effecting absorbed oxygen molecules and thus increases resistance. If a specific gas (reducing gas) is presented, a reaction occurs with the absorbed oxygen which causes an increase in the electrons in the oxide molecules causing a decrease in resistance. This change in resistance can be measured and used to identify a specific gas (such as alcohol) and can be quantified into a % concentration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Mouth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over the Counter
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, and user testing indicates that the new device is as safe and effective as the predicate device. A clinical trial was performed to establish that the user could read and understand the instructions provided, and properly use the device, as well as perform comparably to an evidentiary type of breath alcohol tester.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: +/-0.01%
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3050 Breath-alcohol test system.
(a)
Identification. A breath-alcohol test system is a device intened to measure alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
K07/067
EXHIBIT 2
510(k) Summary KHN Solutions LLC 300 Broadway, Suite 26 San Francisco, CA 94133 Phone: 415-693-9756 Fax: 415-358-8030 Email: info@khnsolutions.com December 20, 2006 Contact: Keith Nothacker, President
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- Identification of the Device: Proprietary-Trade Name: BACTRACK™ Breathalyzer Digital Alcohol Detector Classification Name: Device, breath trapping, alcohol, DJZ Common/Usual Name: Breath-alcohol test system
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- Equivalent legally marketed devices KHN Solutions AlcoMate CA2000™ Digital Alcohol Detector, K041334
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- Indications for Use (intended use) : This device is intended to measure alcohol in the human breath. Measurements obtained by this device are used as an aid in the detection of alcohol intoxication..
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- Description of the Device: The BACTRACK™ Breathalyzer is designed to measure deep lung air to test for the presence of alcohol in the blood. The relationship between alcohol in the blood and alcohol in the deep lung breath is well established by Henry's law in ratio of 2100:1 The BACTRACK™ Breathalyzer is has been tested and uses a blow time of 5 seconds to capture an accurate deep lung sample. The BACTRACK™ Breathalyzer sensor uses tin dioxide which has n-type conductivity when exposed to the atmosphere. This exposure causes a decrease in the number of electrons effecting absorbed oxygen molecules and thus increases resistance. If a specific gas (reducing gas) is presented, a reaction occurs with the absorbed oxygen which causes an increase in the electrons in the oxide molecules causing a decrease in resistance. This change in resistance can be measured and used to identify a specific gas (such as alcohol) and can be quantified into a % concentration.
-
- Safety and Effectiveness, comparison to predicate device. The results of bench, and user testing indicates that the new device is as safe and effective as the predicate device. A clinical trial was performed to establish that the user could read and understand the instructions provided, and properly use the device, as well as perform comparably to an evidentiary type of breath alcohol tester.
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6. Substantial Equivalence Chart
| Feature | AlcoMate CA2000™ Digital
Alcohol Detector, K041334 | BACTRACK™ Breathalyzer |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|
| INDICATION OF USE | This device is intended to measure alcohol in the human breath.
Measurements obtained by this device are used as an aid in the detection of alcohol intoxication. | SAME |
| MODE | Breath Alcohol Concentration | SAME |
| PRACTITIONER USE | Over the Counter | SAME |
| Blowing time | 5 Seconds | SAME |
| DISPLAY | 3 Digit LED | 3 Digit LCD |
| POWER SOURCE | 9 Volt Alkaline Battery or auto cigar lighter (Optional) | 2 - AA Alkaline |
| BATTERY LIFE | 300 Tests | SAME |
| Measurement Range | .00-.40% | SAME |
| Accuracy | +/-0.01% | SAME |
| TYPE OF SENSOR | Semiconductor-Oxide Sensor | Semiconductor-Oxide Sensor |
| ANATOMICAL SITE | Mouth | SAME |
| Mouthpiece | Replaceable | No mouthpiece |
| Warm Up Time | 20 seconds | 10 Seconds |
| DOT | DOT Approved | Meets DOT requirements |
| Construction | Plastic case with internal circuit board | SAME |
| SIZE | 5" x 3 ¼" x 1.2" | 4.25" x 1.63" x 0.81"
(10.8 x 4.1 x 2.1 cm) |
| WEIGHT | 200 grams. | 1.4 oz (39.7 grams) |
7. Conclusion
After analyzing bench tests, a risk analysis, electrical safety, EMC, and user testing data, it is the conclusion of KHN Solutions that the BACTRACK™ Breathalyzer is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device. The clinical trial performed showed that the over the counter purchaser of this device could read and understand the instructions, could properly use the device, and obtain results that were comparable to those provided by a professional unit administered by a trained observer.
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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 stylized eagle with its wings forming three curved lines. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
KHN Solutions LLC c/o Mr. Daniel Kamm Kamm & Associates P.O. Box 7007 Deerfield, IL 60015
SEP 1 4 2007
K071067 Re: Trade Name: BACKTRACK™ Digital Alcohol Detector Regulation Number: 21 CFR §862.3050 Regulation Name: Breath alcohol test system Regulatory Class: Class I (reserved) Product Code: DJZ Dated: August 13, 2007 Received: August 16, 2007
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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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 10(x) marketed predicate device results in a classification for your device and thus, perceits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. 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 tolling at its tolling the (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Jean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (If Known) K071067
Bevice Name: BACTRACK™ Digital Alcohol Detector
Indications for Use:
This device is intended to measure alcohol in the human breath. Measurements obtained by this device are used as an aid in the detection of alcohol intoxication.
Prescription Use __ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (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)
Carol C. Benson
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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