(151 days)
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.
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.
The K071067 submission describes the BACTRACK™ Breathalyzer Digital Alcohol Detector.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature | Acceptance Criteria (Predicate Device K041334) | Reported Device Performance (BACTRACK™ Breathalyzer) |
|---|---|---|
| Measurement Range | .00-.40% | .00-.40% |
| Accuracy | +/-0.01% | +/-0.01% |
2. Sample Size Used for the Test Set and Data Provenance
The submission mentions "user testing data" and a "clinical trial" but does not specify the sample size for these tests.
The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin mentioned. However, the nature of a "clinical trial" and "user testing" generally implies a prospective data collection, likely in the country where the manufacturer operates or seeks approval.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The submission states that the clinical trial aimed to: "perform comparably to an evidentiary type of breath alcohol tester." and "obtain results that were comparable to those provided by a professional unit administered by a trained observer."
This implies that the ground truth for the clinical trial was established by an "evidentiary type of breath alcohol tester" operated by a "trained observer." The number of such "observers" or "professional units" is not specified. The qualifications of these observers are limited to "trained," without further detail (e.g., years of experience, specific certifications).
4. Adjudication Method for the Test Set
The submission does not explicitly describe an adjudication method for the test set. The comparison appears to be directly against the "evidentiary type of breath alcohol tester" or "professional unit."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described focuses on comparing the BACTRACK™ Breathalyzer's performance against a "professional unit" and user's ability to operate the device, not on assessing multiple human readers or the effect of AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
Yes, a standalone performance evaluation was done in the sense that the device's accuracy was assessed independently against a reference standard. The "bench tests" and the comparison of the BACTRACK™ Breathalyzer's readings to an "evidentiary type of breath alcohol tester" represent a standalone evaluation of the device's core functionality.
7. The Type of Ground Truth Used
The ground truth used for performance validation was the measurement from an "evidentiary type of breath alcohol tester" or "professional unit." This implies a reference standard that is generally accepted as accurate for breath alcohol measurement.
8. The Sample Size for the Training Set
The submission does not mention a training set or its sample size. The BACTRACK™ Breathalyzer uses a semiconductor-oxide sensor, which suggests a physical-chemical principle of operation rather than a machine learning algorithm that typically requires a training set.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set for machine learning, there is no information provided on how ground truth for a training set was established.
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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.
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- 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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SEP 1 4 2007
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6. Substantial Equivalence Chart
| Feature | AlcoMate CA2000™ DigitalAlcohol 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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§ 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.