(90 days)
The AL-6000 is intended to measure alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcoholic intoxication.
The AL-6000 Breath Alcohol Tester is a screening device for the rapid detection of alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcoholic intoxication.
The AL-6000 is a Breath Alcohol Tester designed to measure alcohol in the human breath. The AL-6000 meets or exceeds the requirements of the US DOT (Department of Transportation) and NHTSA (National Highway Traffic Safety Administration). The device takes a breath sample of at least three (3) seconds in order to capture an accurate "deep-lung air" sample. This sample is analyzed by a semiconductor-based gas sensor in order to calculate Breath Alcohol Concentration (BrAC), which is then converted to an equivalent Blood Alcohol Concentration (BAC).
Here's an analysis of the provided text regarding the AL-6000 Breath Alcohol Tester, focusing on acceptance criteria and supporting studies:
It's important to note that the provided document is a 510(k) summary, which is a premarket notification to the FDA. It primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive results from a new, standalone clinical trial. As such, some of the requested information (like detailed training set specifics, MRMC studies, or multi-expert ground truth establishment for this specific device's studies) is not typically included in such a submission.
Description of Acceptance Criteria and Studies
The AL-6000 Breath Alcohol Tester demonstrates its substantial equivalence to the predicate device, AlcoMate CA2000, by meeting similar performance specifications, particularly in measurement accuracy. The primary study proving this equivalence is a "Benchmark and safety testing, EMC/DOT testing and risk analysis, as well as practical user testing." This testing confirmed that the AL-6000 performs within the same ranges of safety and effectiveness as the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Predicate Device) | Reported Device Performance (AL-6000) |
|---|---|
| Measurement Range: 0.00% to 0.40% | Measurement Range: 0.00% to 0.40% |
| Measurement Accuracy: +/-0.01 at 0.10% BAC | Measurement Accuracy: +/-0.01 at 0.10% BAC |
| Sensor Type: Semiconductor oxide sensor | Sensor Type: Semiconductor oxide sensor |
| Certification: DOT / NHTSA | Certification: DOT / NHTSA |
Note: The FDA 510(k) process for this device type primarily focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device. The "acceptance criteria" for the AL-6000 are largely defined by matching or exceeding the performance characteristics of its predicate, the AlcoMate CA2000.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample size used for the test set during the benchmark and practical user testing. It mentions "practical user testing" but provides no further details on the number of subjects or data points.
The data provenance is not specified. It can be inferred that the testing would have been conducted by Sentech Korea Corp., likely in Korea, but this is not explicitly stated. The testing appears to be prospective as it's part of the process to demonstrate equivalence for the AL-6000.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts or their qualifications for establishing ground truth during the testing. Given that this is a breath alcohol tester, the "ground truth" for BAC measurements would typically be established by laboratory-grade reference instruments or blood tests, not necessarily by expert consensus in a subjective interpretation task.
4. Adjudication Method for the Test Set
No adjudication method is described. For devices like breath alcohol testers, the "ground truth" is typically an objective measurement from a highly accurate reference method.
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 done or described in this 510(k) summary. MRMC studies are typically performed for imaging or diagnostic interpretation tasks where human readers' performance is being evaluated, often with and without AI assistance. This device is a direct measurement tool, not an interpretive aid for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the core testing described (benchmark and practical user testing of measurement accuracy) represents a standalone assessment of the device's performance. The device directly measures Breath Alcohol Concentration (BrAC) and converts it to Blood Alcohol Concentration (BAC) without "human-in-the-loop" interpretive work as part of its primary function. Its performance is evaluated based on its direct measurements against external standards.
7. The Type of Ground Truth Used
The ground truth for this type of device would typically be:
- Laboratory-grade reference alcohol solutions/simulators: These provide precise, known alcohol concentrations for calibration and accuracy testing.
- Comparison to approved, accurate reference devices: The statement "Benchmark... testing..." implies comparison to established methods or devices with known accuracy.
- Potentially blood alcohol concentration (BAC) measurements: In a clinical validation, human breath alcohol measurements would be correlated with concurrent blood alcohol measurements.
The document states the device "meets or exceeds the requirements of the US DOT (Department of Transportation) and NHTSA (National Highway Traffic Safety Administration)." These organizations have specific protocols for testing breath alcohol devices, which would involve standardized alcohol solutions and direct comparison to a known reference.
8. Sample Size for the Training Set
The document does not mention a specific "training set" or its size. The AL-6000 uses a semiconductor-based gas sensor. While such sensors undergo calibration, the process isn't typically framed as "training" in the same way a machine learning algorithm is trained. The sensor technology has inherent characteristics, and the device's circuitry is designed to interpret sensor output based on established physical and chemical principles, not learned from a data set in the modern AI sense.
9. How the Ground Truth for the Training Set Was Established
Since a "training set" in the context of an AI/ML algorithm isn't described, the ground truth establishment for it is not applicable here. The device relies on the intrinsic properties of its semiconductor sensor and a programmed algorithm to convert sensor readings into BAC. Calibration of the device during manufacturing and periodic checks against known alcohol standards would be part of ensuring its accuracy.
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K060 343
510(k) Summary
| APPLICANT NAME: | Sentech Korea Corp. | |
|---|---|---|
| ADDRESS: | 803 Ilsan Techno Town1141-1 Bakseok-DongIlsan-gu, Goyang-SiKyeonggi-do, 411-722Republic of Korea | MAY 11 2005 |
| PHONE: | 82-31-909-8804 | |
| FAX: | 82-31-909-8803 | |
| CONTACT: | Mr. Soo Hyun Kim, Managing Director | |
| DATE: | 11/18/2005 |
1. Identification of Device
Proprietary/Trade Name: AL-6000 Breath Alcohol Tester Classification Name: Device, Breath Trapping, Alcohol, DJZ Common Name: Breath Alcohol Test System
Equivalent Legally Marketed Device 2.
AlcoMate (Model CA2000) - KHN Solutions, LLC / K041334
3. Indications for Use (Intended Use)
The AL-6000 is intended to measure alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcoholic intoxication.
4. Device Description
The AL-6000 is a Breath Alcohol Tester designed to measure alcohol in the human breath. The AL-6000 meets or exceeds the requirements of the US DOT (Department of Transportation) and NHTSA (National Highway Traffic Safety Administration). The device takes a breath sample of at least three (3) seconds in order to capture an accurate "deep-lung air" sample. This sample is analyzed by a semiconductor-based gas sensor in order to calculate Breath Alcohol Concentration (BrAC), which is then converted to an equivalent Blood Alcohol Concentration (BAC).
The STK3100 semiconductor sensor consists primarily of a sensing layer and heating element, which is formed by an n-type semiconductor powder and heater, respectively. When the heater is powered in clean air,
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oxygen molecules in the air trap electrons in the semiconducting material after which they are chemically absorbed on the surface of the powder particles. However, when the STK3100 is exposed to ethanol vapor, the absorbed oxygen (O or Oz) reacts with the gas and is reduced. By this reaction, the electrons trapped by the oxygen are released and flow through the semiconductor, which means that resistance decreases and electrical conductivity increases.
5. Substantial Equivalence Chart
| Device: AlcoMate CA2000 | Device: AL-6000 | |
|---|---|---|
| Indications for Use | Measures alcohol content inthe human breath fordetection/diagnosis ofalcoholic intoxication | Measures alcohol content inthe human breath fordetection/diagnosis ofalcoholic intoxication |
| Method | Breath alcohol concentrationto BAC | Breath alcoholconcentration to BAC |
| Measurement Range | 0.00% to 0.40% | 0.00% to 0.40% |
| Measurement Accuracy | +/-0.01 at 0.10% BAC | +/-0.01 at 0.10% BAC |
| Sensor Type | Semiconductor oxide sensor | Semiconductor oxide sensor |
| Power Source | 9V alkaline battery | Two 1.5V AA batteries |
| Testing Capacity | Approx. 300 (1 battery) | Approx. 300 (2 batteries) |
| Certification | DOT / NHTSA | DOT / NHTSA |
| Practitioner Use | Over-the-counter | Over-the-counter |
| Construction | Circuit board housed inplastic casing, replaceablemouthpieces | Circuit board housed inplastic casing, replaceablemouthpieces |
| Warmup Time | About 20 seconds | About 20 seconds |
| Display | 3-digit LED | 3-digit LED |
| Dimensions | 5" x 3¼" x 1" | 5½" x 3" x 2" |
| Weight | 171 g | 117 g |
6. Conclusion
Benchmark and safety testing, EMC/DOT testing and risk analysis, as well as practical user testing, reveal that the AL-6000 performs within the same ranges of safety and effectiveness as those of the predicate device. The AL-6000 and predicate device describe the same indications for use and similarly well-proven methods of technical analysis (breath alcohol to BAC using semiconductor oxide sensors). Results show that the devices are substantially equivalent.
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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 stylized eagle with three streams emanating from its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Sentech Korea Corp. c/o Mr. Matthew H. Son President AK Solutions USA LLC 21 Grand Ave. Suite 103 Palisades Park, NJ 07650
MAY 11 2006
K060343 Re:
Trade/Device Name: AL-6000 Alcohol Breath Tester Regulation Number: 21 CFR§862.3050 Regulation Name: Breath-alcohol test system Regulatory Class: Class I Product Code: DJZ Dated: February 10, 2006 Received: March 1, 2006
Dear Mr. Son:
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. Iisting 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 (240) 276-0484. 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/industry/support/index.html.
Sincerely yours,
Alberto Gutierrez, Ph.D.
Alberto Gutierrez, Ph.D. 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): K060343
Device Name: AL-6000 Alcohol Breath Tester
Indications For Use:
. ..
The AL-6000 Breath Alcohol Tester is a screening device for the rapid detection of alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcoholic intoxication.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
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)
CAC.n
Division Sign-Off
Office of In Vitro Dingnostic Device Evaluation and Safety
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510(k) L(060343
§ 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.