BACTRACK SELECT BREATHALYZER, MODEL S80 by KHN SOLUTIONS, LLC

The BACTRACK® Select Breathalyzer is an alcohol screening device, used for the detection of alcohol in the breath. The BACTRACK® provides a digital result, indicating the approximate BAC (Blood Alcohol Content) of the test subject. The BACTRACK® is powered by two AA batteries and is very easy to use. The device employs a fuel cell sensor of the same type commonly used in evidentiary breathalyzers. This results in generally better accuracy and longer battery life than silicon sensor units. The units are factory calibrated but the product should be recalibrated at least every six to twelve months. If the product is used every day, it may need to be recalibrated as frequently as every month.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the Bactrack® Select Breathalyzer Model S80. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and comprehensive performance data.

However, based on the available information, I can extract the following:

1. Table of Acceptance Criteria and Reported Device Performance

The device claims to meet the performance of the predicate device, the AlcoHAWK PT500. Therefore, the predicate's performance serves as an implicit acceptance criterion.

Feature	Acceptance Criteria (from Predicate Device)	Reported Device Performance (Bactrack® Select Breathalyzer: S80)
Accuracy	$\pm$ 0.01% BAC at 0.10% BAC	+/- 0.01 %BAC @ 0.02 %BAC
Blowing time	5 Seconds	SAME (5 Seconds)
Response time	3 Seconds	SAME (3 Seconds)
Measurement Range	0.000% to 0.400% BAC	SAME (0.000% to 0.400% BAC)
Battery Life	200 tests	Up to 1500 tests
Warm Up Time	10-20 seconds	SAME (10-20 seconds)
DOT	DOT Approved	Meets DOT requirements

Note on Accuracy: The accuracy specification for the Bactrack® Select Breathalyzer is shown as "C +/- 0.01 %BAC @ 0.02 %BAC" while the predicate's is "$\pm$ 0.01% BAC at 0.10% BAC". This implies the Bactrack® specifies its accuracy at a lower BAC level (0.02% BAC) compared to the predicate (0.10% BAC) while maintaining the same absolute tolerance of $\pm$0.01% BAC. Without further context or test results, it's difficult to directly compare these as equivalent or superior/inferior at all BAC levels. However, in the context of a 510(k), meeting or exceeding predicate performance is generally expected. The text states "few technological differences" and "as safe and effective," suggesting this difference in accuracy specification is considered acceptable for substantial equivalence.

2. Sample Size Used for the Test Set and the Data Provenance

The document mentions "clinical testing data" and a "clinical trial performed." However, no specific sample size (number of subjects or tests) for this clinical trial is provided.

The data provenance is not explicitly stated (e.g., country of origin). The submission is to the US FDA, so it's likely US-based, but this is an assumption. The data is prospective, as it describes a clinical trial that was "performed."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not provided in the document. The text only states that the clinical trial showed "obtain results that were comparable to those provided by a professional unit administered by a trained observer." It does not specify the qualifications of this "trained observer" or if multiple experts were involved in establishing ground truth for the device accuracy itself.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method for the test set.

5. 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

An MRMC comparative effectiveness study was not done. This device is a breathalyzer, not an AI-assisted diagnostic tool for human readers. The clinical trial focused on the ability of an "over the counter purchaser" to use the device and obtain comparable results to a "professional unit administered by a trained observer."

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, the primary evaluation of this device is in a standalone capacity. The device itself (the "algorithm only," in this context, referring to its measurement mechanism) is being assessed for its ability to accurately measure alcohol in breath. The clinical trial additionally assessed the human factor of the "over the counter purchaser" correctly using the device, but the core performance is the device's standalone measurement.

7. The Type of Ground Truth Used

The ground truth for the clinical trial appears to be established by comparison to "a professional unit administered by a trained observer." This implies a reference standard or a "gold standard" breathalyzer, likely a more sophisticated evidentiary or clinical device, against which the performance of the BACTRACK® Select Breathalyzer was compared.

8. The Sample Size for the Training Set

The document does not refer to a "training set." This type of device (a breathalyzer) typically undergoes calibration during manufacturing and recalibration at specified intervals, but it is not a machine learning or AI-driven system that would have a conventional "training set" in the context of data-driven algorithm development.

9. How the Ground Truth for the Training Set Was Established

As there is no mention of a "training set" in the context of algorithm development, this information is not applicable. The device is factory calibrated, and recalibration is recommended, implying a process of adjusting the device against known alcohol concentrations, but this isn't a "training set" in the AI sense.

Summary

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510(k) Summary 510(k) Number K090067 KHN Solutions LLC 300 Broadway, Suite 26 San Francisco, CA 94133 Phone: 415-693-9756 Fax: 415-358-8030 Email: info@khnsolutions.com Contact: Keith Nothacker, President Date Prepared: February 11, 2009

1. Identification of the Device: Proprietary-Trade Name: Bactrack@ Select Breathalyzer Model S80 Classification Name/Product Code: Devices, breath trapping, alcohol, DJZ Common/Usual Name: Breath Alcohol Tester
Equivalent legally marketed device: AlcoHAWK PT500 K080848 Q3 Innovations LLC. 2.
1. Indications for Use (intended use) This device is intended to measure alcohol in human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.
1. Description of the Device: The BACTRACK® Select Breathalyzer is an alcohol screening device, used for the detection of alcohol in the breath. The BACTRACK® provides a digital result, indicating the approximate BAC (Blood Alcohol Content) of the test subject. The BACTRACK® is powered by two AA batteries and is very easy to use. The device employs a fuel cell sensor of the same type commonly used in evidentiary breathalyzers. This results in generally better accuracy and longer battery life than silicon sensor units. The units are factory calibrated but the product should be recalibrated at least every six to twelve months. If the product is used every day, it may need to be recalibrated as frequently as every month.
1. Safety and Effectiveness, comparison to predicate device. The results of bench, test laboratory, and clinical testing indicates that the new device is as safe and effective as the predicate devices.

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6. Substantial Equivalence Chart

Feature	AlcoHAWK PT500 K080848 Q3Innovations LLC	BACTRACK® SelectBreathalyzer: S80
INDICATION OF USE	This device is intended to measurealcohol in the human breath.Measurements obtained by thisdevice are used as an aid in thedetection of alcohol intoxication.	SAME
MODE	Breath Alcohol Concentration	SAME
PRACTITIONER USE	Over the Counter	SAME
Blowing time	5 Seconds	SAME
Response time	3 Seconds	SAME
DISPLAY	4 digit LCD with backlight(orange)	SAME, backlight is green
POWER SOURCE	2 - AA Alkaline	SAME
BATTERY LIFE	200 tests	Up to 1500 tests
Measurement Range	0.000% to 0.400% BAC	SAME
Accuracy	$\pm$ 0.01% BAC at 0.10% BAC	+/- 0.01 %BAC @ 0.02 %BAC
TYPE OF SENSOR	Fuel cell electrochemical sensor	SAME
ANATOMICAL SITE	Mouth	SAME
Mouthpiece	Replaceable, polystyrene	SAME
Warm Up Time	10-20 seconds	SAME
DOT	DOT Approved	Meets DOT requirements
Construction	Plastic case with internal circuitboard	SAME
SIZE	5" x 2.63" x 1.25"(12.7 cm x 6.68 cm x 3.18 cm)	2.3 x 4.8 x 0.8 inches(5.8 x 12.2 x 2.2 cm)
WEIGHT	3.6 oz (102 g) without batteries;5.2 oz (147 g) with batteries	4.8 oz (136 g) with mouthpieceand batteries
Operating temperature	10 - 40°C (50 - 104°F)	SAME

Conclusion. After analyzing bench tests, laboratory tests, a risk analysis, EMC, and clinical testing data, it is the conclusion of KHN Solutions that the BACTRACK® Select 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 2 4 2009

KHN Solutions, LLC c/o Daniel Kamm, P.E. Kamm & Associates P.O. Box 7007 Deerfield. IL 60015

K090067 Trade/Device Name: Bactrack® Select Breathalyzer Model S80 Regulation Number: 21 CFR 862.3050 Regulation Name: Breath-alcohol test system Regulatory Class: Class I, reserved Product Code: DJZ Dated: January 5, 2009 Received: January 9, 2009

Dear Mr. Kamm:

Re:

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 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 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 (301) 594-3084. 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 toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Cout C. He

Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

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Indications for Use KOGODIa 7 510(k) Number (if known): K08

Device Name: Bactrack® Select Breathalyzer Model S80

Indications For Use:

This device is intended to measure alcohol in human breath. Measurements obtained by this device are used in the diagnosis 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)

Sign-Off

Cice of In Vitro Diagnostic Device funtion and Safety

080067

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Regulation Number and Section

§ 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.