(87 days)
This device is intended to measure alcohol in human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.
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 (two AAA batteries for model S30) and is very easy to use. The device employs a silicon sensor of the same type commonly used in handheld breathalyzers. 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.
The provided text describes the BACTRACK® Select Breathalyzer (models S30, S50, S70) and its substantial equivalence to a predicate device (AL-5000 K061922 SENTECH KOREA CORP). The device is intended to measure alcohol in human breath for the diagnosis of alcohol intoxication.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the BACTRACK® Select Breathalyzer appear to be based on demonstrating "substantial equivalence" to the predicate device, AL-5000 K061922. The key performance metric explicitly stated for both devices is accuracy.
| Feature | Acceptance Criteria (Predicate Device AL-5000 K061922) | Reported Device Performance (BACTRACK® Select) |
|---|---|---|
| Accuracy | ± 0.01% BAC at 0.10% BAC | SAME (± 0.01% BAC at 0.10% BAC) |
| Measurement Range | 0.00% to 0.40% | SAME (0.00% to 0.40%) |
| Blowing time | 5 Seconds | SAME |
| Warm Up Time | 15-25 seconds | SAME |
| Sensor Type | Semiconductor-Oxide Sensor | SAME |
| Indication of Use | Measure alcohol in human breath for diagnosis of alcohol intoxication | SAME |
The text also mentions that a "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." This implies an acceptance criterion for user comprehension and ease of use, leading to comparable results, though specific quantitative metrics are not provided.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set in the clinical trial. It vaguely refers to a "clinical trial." The data provenance is also not specified; it's unclear if the data was collected in the US or another country, or if it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document states that the clinical trial results were "comparable to those provided by a professional unit administered by a trained observer." This indicates that the ground truth was established by a "professional unit" and a "trained observer." However, the number of such observers/experts and their specific qualifications (e.g., years of experience, specific medical/technical background) are not provided.
4. Adjudication Method for the Test Set
The adjudication method for establishing ground truth in the clinical trial is not explicitly stated. It can be inferred that the "trained observer" operating a "professional unit" provided the reference measurements, implying a single expert's measurement as the ground truth without a clear adjudication process among multiple experts.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described. The study compared the device's results to a "professional unit administered by a trained observer," rather than comparing human readers with and without AI assistance. Therefore, no effect size for human readers improving with AI vs. without AI assistance can be determined from the provided text.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device is a breathalyzer, which is an instrument that directly provides a measurement. Its performance is inherently "standalone" in the sense that it provides a reading. The clinical trial focused on user comprehension and the device's ability to provide results comparable to a professional unit. Therefore, the standalone performance was assessed in terms of its accuracy and comparability to a reference standard, as indicated by the "Accuracy" row in the substantial equivalence chart and the clinical trial description.
7. The Type of Ground Truth Used
The ground truth for the clinical trial was established by a "professional unit administered by a trained observer." This implies a reference measurement obtained using a presumably more accurate or validated professional breath alcohol testing device, rather than pathology, expert consensus (among multiple experts), or outcomes data. This is a form of reference standard.
8. The Sample Size for the Training Set
The document does not provide any information about a "training set" or its sample size. This device is a sensor-based instrument, not a machine learning or AI algorithm that typically requires a training set. Its development and validation would primarily involve engineering and calibration, followed by clinical testing, rather than a machine learning training/testing paradigm.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a "training set" in the context of this device, this information is not applicable and not provided.
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K683801
MAR 1 9 2009
510(k) Summary 510(k) Number 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: December 6, 2008
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- Identification of the Device: Proprietary-Trade Name: Bactrack® Select Breathalyzer (3 models: S30, S50, S70) Classification Name/Product Code: Devices, breath trapping, alcohol, DJZ Common/Usual Name: Breath Alcohol Tester
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- Equivalent legally marketed device: AL-5000 K061922, SENTECH KOREA CORP.
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- 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.
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- 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 (two AAA batteries for model S30) and is very easy to use. The device employs a silicon sensor of the same type commonly used in handheld breathalyzers. 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.
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- 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 | AL-5000 K061922 SENTECHKOREA CORP | BACTRACK® Select: S30, S50, S70 |
|---|---|---|
| INDICATION OF USE | This device is intended tomeasure alcohol in the humanbreath. Measurements obtainedby this device are used as an aidin the detection of alcoholintoxication. | SAME |
| MODE | Breath Alcohol Concentration | SAME |
| PRACTITIONER USE | Over the Counter | SAME |
| Blowing time | 5 Seconds | SAME |
| DISPLAY | 3 Digit LED | S50: Identical to AL-5000S30: 3 Digit LCDS70: 4 Digit LCD |
| POWER SOURCE | 2 - AA Alkaline | SAME except 2-AAA for ModelS30. |
| BATTERY LIFE | "Over 200 tests" | SAME. 200-300 tests for all 3models |
| Measurement Range | 0.00% to 0.40% | SAME |
| Accuracy | $\pm$ 0.01% BAC at 0.10% BAC | SAME |
| TYPE OF SENSOR | Semiconductor-Oxide Sensor | SAME |
| ANATOMICAL SITE | Mouth | SAME |
| Mouthpiece | Replaceable, polystyrene | SAME as AL-5000 |
| Warm Up Time | 15-25 seconds | SAME |
| DOT | DOT Approved | Meets DOT requirements,approval in process |
| Construction | Plastic case with internal circuitboard | SAME |
| SIZE | 116 x 59 x 27 mm | S50: Identical to AL-5000S30: 103 x 34 x 25 mmS70: 122 x 58 x 22 mm |
| WEIGHT | 105 g. | S50: Identical to AL-5000S30: 53/77 g (without, with batteries)S70: 67/115g (without, with batteries) |
- 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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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three stripes forming its wing and tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
MAR 1 9 2009
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
KHN Solutions, LLC c/o Daniel Kamm, P.E. Kamm & Associates PO Box 7007 Deerfield, IL 60015
Re: K083801
Trade/Device Name: Bactrack® Select Breathalyzer Models S30, S50, and S70 Regulation Number: 21 CFR.862.3050 Regulation Name: Breath-alcohol test system Regulatory Class: Class I, reserved Product Code: DJZ Dated: December 16, 2008 Received: December 22, 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 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 vours.
Cort 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 510(k) Number (if known): K08 3 ૪ ౮ (
Device Name: Bactrack® Select Breathalyzer (3 models- S30, S50, S70)
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)
Kelle Ehlers
Human Sign-Off
Thee of In Vitro Diagnostic Device ation and Safety
Page 1 of 1
§ 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.