(122 days)
The LifeGuard and BacTrack B90 devices are intended to measure alcohol in human breath. Measurements obtained from these devices are used in the diagnosis of alcohol intoxication.
The LifeGuard and BacTrack B90 devices are intended to be used by the general adult population and by qualified personnel, such as physicians, nurses, and technicians.
The LifeGuard and BacTrack B90 devices are intended to be used by adults (age 21 and over) in measuring alcohol intoxication in themselves or others.
The LifeGuard and BacTrack B90 devices are intended to be used in both home (over-the-counter) and clinical settings.
The LifeGuard product is a breath alcohol detector designed to sample the patient's deep lung air in order to test for the presence of alcohol in the blood. The sensor used in the LifeGuard is an electrochemical fuel cell sensor. When the patient exhales into the device, after 4 seconds a sample of the breath is pumped into the fuel cell and generates an electrical current. The amount and duration of the current has a known relationship to the concentration of alcohol in the breath sample. The relationship between the alcohol concentration in the deep lung breath and in the blood is known by Henry's law with a ratio of 2100:1.
The BacTrack B90 has the same intended use, description and performance characteristics as the LifeGuard with a different physical appearance.
Both the LifeGuard and BacTrack B90 products are handheld and are used with a single-use disposable mouthpiece and a replaceable 9 volt battery.
Here's an analysis of the provided text regarding the LifeGuard and BacTrack B90 devices, focusing on the acceptance criteria and the study that proves they meet those criteria:
1. Table of Acceptance Criteria and Reported Device Performance:
The primary acceptance criterion mentioned is accuracy. The device's performance is directly compared to its predicates.
| Acceptance Criteria | LifeGuard / BacTrack B90 Performance | Predicate 1 (Drager 6510) Performance | Predicate 2 (AlcoHawk PT-500) Performance |
|---|---|---|---|
| Accuracy | +/-.005 BAC from 0 to .100 BAC. +/- 5% above .100 BAC | From 0 to 0.5 mg/l +/- .008 mg/l (approx. +/-.00168 BAC); above 0.5 mg/l +/- 1.7% of measured volume | +/- 0.005 BAC at .050 BAC |
| Measuring Range | .000 to .400 BAC | .000 to .500 BAC | 0.000-0.400 BAC |
| Compliance with Safety Standards | Compliance with applicable US and European safety standards for a medical device | (Implied for cleared predicate) | (Implied for cleared predicate) |
| Meeting User Requirements/Labeling Adequacy | Met requirements of users and labeling adequate for proper use | (Implied for cleared predicate) | (Implied for cleared predicate) |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "laboratory bench testing" and "user studies,". However, specific sample sizes for the test set or information on data provenance (e.g., country of origin, retrospective/prospective) are NOT provided in the given text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
The document does not provide information on the number or qualifications of experts used to establish ground truth for the test set.
4. Adjudication Method for the Test Set:
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study is mentioned. This device is a breathalyzer, so the concept of "human readers" interpreting images with and without AI assistance is not applicable. The device provides a direct measurement.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
The "laboratory bench testing" described for the device would represent its standalone performance, as it verifies the hardware and firmware performance against specifications. However, the exact details of this testing (e.g., specific algorithms or human intervention) are not extensively detailed, beyond its function as a breath alcohol detector.
7. The Type of Ground Truth Used:
For the accuracy testing, the ground truth would likely be established by a calibrated alcohol standard or controlled human breath samples with known alcohol concentrations. While not explicitly stated, this is the standard method for establishing ground truth in breath alcohol measurement devices. The document implies this through the accuracy claims. The statement "The relationship between the alcohol concentration in the deep lung breath and in the blood is known by Henry's law with a ratio of 2100:1" indicates the scientific basis for the measurement, further implying a quantitative ground truth for alcohol concentration.
8. The Sample Size for the Training Set:
The document does not provide any information regarding a training set or its sample size. This type of device relies on a fixed scientific principle (electrochemical fuel cell and Henry's law) rather than machine learning algorithms that typically require large training datasets.
9. How the Ground Truth for the Training Set Was Established:
As there's no mention of a training set in the context of machine learning, this question is not applicable. The device's underlying principle is a direct chemical measurement, not a learned model from data. The device's 'training' or calibration would be through manufacturing processes and in-field calibration against known alcohol standards.
Summary of Study Details Provided in the Text:
The text states that the device meets acceptance criteria through:
- Laboratory bench testing: To verify hardware and firmware performance against specifications. This would explicitly test accuracy and other technical parameters.
- NRTL safety testing: To certify compliance with US and European safety standards.
- User studies: To validate that the device met user requirements and that labeling was adequate.
The conclusion asserts that "the LifeGuard design, feature set, verification and validation results, and agency testing reports demonstrate that the LifeGuard breath alcohol tester is a safe, effective product that is substantially equivalent to other FDA cleared alcohol breath testing products." This implies that the tests conducted were sufficient to demonstrate equivalence in terms of safety and effectiveness to the predicate devices, particularly in the realm of accuracy.
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510(k) Summary
510(k) owner
LifeGuard, a division of Lifeloc Technologies 12441 W. 49th Ave. #4 Wheat Ridge, CO 80033 Phone: (720) 317-2195 Fax: (303) 431-1423
JUL 23 2009
Contact Person: Mark Lary, Vice President of Operations
Date Prepared: March 20, 2009
Device Name(s)
Proprietary or trade name: LifeGuard Alternate proprietary or trade name: BacTrack B90 Common name: Breath Alcohol Test System Regulation number: 21 CFR 862.3050 Device Classification name: Devices, Breath Trapping, Alcohol Classification product code: DJZ
Indications for Use
The LifeGuard and BacTrack B90 devices are intended to measure alcohol in human breath. Measurements obtained from these devices are used in the diagnosis of alcohol intoxication.
The LifeGuard and BacTrack B90 devices are intended to be used by the general adult population and by qualified personnel, such as physicians, nurses, and technicians.
The LifeGuard and BacTrack B90 devices are intended to be used by adults (age 21 and over) in measuring alcohol intoxication in themselves or others.
The LifeGuard and BacTrack B90 devices are intended to be used in both home (over-the-counter) and clinical settings.
Predicate Device Summary
The LifeGuard and BacTrack B90 devices are claimed to be substantially equivalent to these legally marketed devices: Drager 6510 (K063443) and AlcoHawk PT-500 (K080848).
Description of Device
The LifeGuard product is a breath alcohol detector designed to sample the patient's deep lung air in order to test for the presence of alcohol in the blood. The sensor used in the LifeGuard is an electrochemical fuel cell sensor. When the patient exhales into the device, after 4 seconds a sample of the breath is pumped into the fuel cell and
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generates an electrical current. The amount and duration of the current has a known relationship to the concentration of alcohol in the breath sample. The relationship between the alcohol concentration in the deep lung breath and in the blood is known by Henry's law with a ratio of 2100:1.
The BacTrack B90 has the same intended use, description and performance characteristics as the LifeGuard with a different physical appearance.
Both the LifeGuard and BacTrack B90 products are handheld and are used with a single-use disposable mouthpiece and a replaceable 9 volt battery.
| Device Trade Name | LifeGuardBacTrack B90 | Predicate 1Drager 6510 | Predicate 2AlcoHawk PT-500 |
|---|---|---|---|
| 510K number | K063443 | K080848 | |
| Intendeduse/Indications for use | Intended to measurealcohol in human breath.Readings from thisdevice are used todetermine alcoholintoxication. | Same | Same |
| Patient Population | General Public (Over thecounter use) and clinicalsettings | General Public (Over thecounter use) | General Public (Over the counteruse) |
| Sensor Type | Electrochemical FuelCell | Electrochemical Fuel Cell | Electrochemical Fuel Cell |
| Construction | Plastic case with internalcircuit board | Same | Same |
| Mouthpiece | Single use disposable | Single use disposable | Single use disposable |
| Power Source | 9 volt battery | 2 AA batteries or rechargeableNiMH battery | 2 AA batteries |
| Battery Life | 300 tests | ~1500 tests | ~200 tests |
| Measuring range | .000 to .400 BAC | .000 to .500 BAC | 0.000-0.400 BAC |
| Dimensions | 5 1/4" H x 2 1/2" W x 1"D | 5 1/2" H x 3 1/8 " W x 1 1/3" D | 5" x 2.63" x 1.25" |
| Weight | 140 grams | 200 grams | 147 grams |
| Warm up time | None | None | 10-20 seconds |
| Sample time | 4 seconds and 1liter ofbreath | 1.2 liters of breath. Volume andtime are adjustable. | Default 5 seconds, adjustable from3-8 seconds |
| Display | Graphic OLED | Graphic LCD | Graphic LCD |
| Accuracy | +/-.005 BAC from 0 to.100 BAC. +/- 5% above.100 BAC | reproducibility with an ethanolstandard: from 0 to 0.5 mg/l +/-.008 mg/l above .5 mg/l +/-1.7%of measured volume(from 0 to .105 BAC +/-.00168BAC, above .105 BAC +/- 1.7%) | $\pm$ 0.005 BAC at .050 BAC |
| Operating temperature | 0-50C | -5-50C | 10-40C (50-104F) |
| Calibration interval | 1 year | 6 months | Every 6-12 months, or monthlycalibration may be required if theunit is used daily |
Table 1 - Predicate Device Feature Comparison
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Safety and Effectiveness Comparison to Predicate Device
The results of laboratory bench testing, NRTL safety testing, and user studies indicate that the LifeGuard device is as safe and effective as the predicate device. . Verification testing was done to verify the device's hardware and firmware performance met the requirements stated in the device specifications. Safety testing was performed by a Nationally Recognized Test Lab to certify compliance with applicable US and European safety standards for a medical device. A usability study was done to validate that the device met the requirements of the users and that the device labeling was adequate to describe the proper use of the device.
Conclusion
The combination of the LifeGuard design, feature set, verification and validation results, and agency testing reports demonstrate that the LifeGuard breath alcohol tester is a safe, effective product that is substantially equivalent to other FDA cleared alcohol breath testing products.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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 stripes forming its body and wing. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
LifeGuard, a Division of Lifeloc Tech. c/o Mr. Mark Lary Vice President of Operations 12441 W. 49th Avenue #4 Wheat Ridge, CO 80033
JUL 2 3 2009
Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
Re: K090766
Trade Name: LifeGuard / Backtrack B90 Breath Alcohol Tester Regulation Number: 21 CFR §862.3050 Regulation Name: Breath-Alcohol Test System Regulatory Class: Class I, reserved Product Codes: DJZ Dated: July 15, 2009 Received: July 16, 2009
Dear Mr. Lary:
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
G.C.H
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
Enclosure
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Indications for Use
510(k) Number (if known): K090766
Device Name: LifeGuard BacTrack B90
Indications For Use:
The LifeGuard and BacTrack B90 devices are intended to measure alcohol in human breath. Measurements obtained from these devices are used in the diagnosis of alcohol intoxication.
The LifeGuard and BacTrack B90 devices are intended to be used by the general adult population and by qualified personnel, such as physicians, nurses, and technicians.
The LifeGuard and BacTrack B90 devices are intended to be used by adults (age 21 and over) in measuring alcohol intoxication in themselves or others.
The LifeGuard and BacTrack B90 devices are intended to be used in both home (overthe-counter) and clinical settings.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
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)
Division Sign-Off
Page 1 of
510(k)
§ 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.