(222 days)
Intended to measure alcohol in human breath. Measurements obtained by this device are used in the detection of alcohol intoxication.
The RMI® LCD Alcohol Tester 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 RMI® LCD Alcohol Tester is an alcohol screening device and uses a blowing time of 3 seconds to capture an accurate deep lung sample. The RMI® LCD Alcohol Tester contains a semiconductor sensor designed to test for the presence of alcohol. The semiconductor material is heated to a specific temperature. The resistance of sensing material changes rapidly according to gas concentration changes, thereby enabling the reading of alcohol concentration by resistance measurement. The device employs a 3 digit LCD display which shows breath alcohol readings from 0.00 to 0.20 BAC (Breath Alcohol Concentration). Readings above 0.20 will display an LCD reading of "HI." The new device is a MODIFICATION of our old device, the Connectables® Alcohol Tester (K052448). We use the same sensor, but instead of three colored LEDs as indicators, the new device has a three digit LCD display of the measured BAC (breath alcohol concentration). Instead of analog comparators, we now employ an 8 bit microprocessor for control and measurement.
The provided text is a 510(k) summary for the RMI® LCD Alcohol Tester. While it discusses the device's equivalence to a predicate device and mentions a "clinical trial" related to user understanding and device usage, it does not contain detailed acceptance criteria or a study proving the device directly meets specific performance metrics in terms of accuracy or precision against a gold standard for alcohol concentration measurement.
The primary objective of the clinical trial mentioned was to establish that users could read and understand the instructions, properly use the device, and obtain comparable results to a predicate unit administered by a trained observer. This isn't a performance study in the sense of demonstrating accuracy against a laboratory reference.
Here's an attempt to answer your request based on the limited information available in the provided document, highlighting what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Not explicitly stated for the new device's accuracy) | Reported Device Performance (Implied equivalence) |
|---|---|---|
| Accuracy of BAC measurement | Not explicitly stated in terms of a specific range (e.g., +/- 0.01% BAC) | The clinical trial showed that results were "comparable to those provided by a predicate unit administered by a trained observer." This indicates functional equivalence rather than specific accuracy data. |
| User Understanding/Proper Use | User can read and understand instructions and properly use the device. | The clinical trial showed that "the over the counter purchaser of this device could read and understand the instructions, could properly use the device." |
| Comparability of results | Results are comparable to a predicate unit administered by a trained observer. | The clinical trial showed results were "comparable to those provided by a predicate unit administered by a trained observer." |
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document only mentions "a clinical trial was performed."
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). However, clinical trials are typically prospective.
3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: The ground truth for direct alcohol concentration was likely the "predicate unit administered by a trained observer" but the qualifications of this observer are not specified.
4. Adjudication Method for the Test Set
- Not specified. Given the nature of the study (user-centric rather than expert interpretation of complex images/data), a formal adjudication method like "2+1" or "3+1" is unlikely to have been relevant or applied.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study was not described. The study focused on user interaction with the device and comparability to a single predicate unit's readings, not the improvement of human readers with AI assistance. This device is a standalone breathalyzer, not an AI-assisted diagnostic tool for interpretation by humans.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, implicitly. The device itself is a standalone algorithm (microprocessor controlled) that measures and displays BAC. The "clinical trial" assessed whether users could operate it correctly and if its readings were comparable to a predicate device, but the device's core function itself is "standalone" in that it performs its measurement without human interpretation of its internal signals.
7. Type of Ground Truth Used
- Comparison to a predicate device: The implied ground truth for the BAC measurement aspect was the "predicate unit administered by a trained observer." For the usability aspect, direct observation of user interaction and instruction comprehension would form the "ground truth."
8. Sample Size for the Training Set
- Not Applicable / Not Specified. This device is a hardware-based alcohol tester, not an AI or machine learning model that requires a training set in the conventional sense. Its "training" would involve calibration and engineering design, not data-driven model training.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. See point 8.
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APR - 9 2007
510(k) Summary
RESOURCE MANAGEMENT INTERNATIONAL, LLC
2330 Ernie Krueger Circle Waukegan, IL 60087 Telephone: 847-244-4500 Fax: 847-244-4525 March 26, 2007 Contact: John Adams
1. Identification of the Device:
Proprietary-Trade Name: RMI® LCD Alcohol Tester Classification Name: Device, breath trapping, alcohol, FDA product code DJZ Common/Usual Name: Breath-alcohol test system
-
- Indications for Use (intended use) : Intended to measure alcohol in human breath. Measurements obtained by this device are used in the detection of alcohol intoxication.
-
- Description of the Device: The RMI® LCD Alcohol Tester 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 RMI® LCD Alcohol Tester is an alcohol screening device and uses a blowing time of 3 seconds to capture an accurate deep lung sample. The RMI® LCD Alcohol Tester contains a semiconductor sensor designed to test for the presence of alcohol. The semiconductor material is heated to a specific temperature. The resistance of sensing material changes rapidly according to gas concentration changes, thereby enabling the reading of alcohol concentration by resistance measurement. The device employs a 3 digit LCD display which shows breath alcohol readings from 0.00 to 0.20 BAC (Breath Alcohol Concentration). Readings above 0.20 will display an LCD reading of "HI." The new device is a MODIFICATION of our old device, the Connectables® Alcohol Tester (K052448). We use the same sensor, but instead of three colored LEDs as indicators, the new device has a three digit LCD display of the measured BAC (breath alcohol concentration). Instead of analog comparators, we now employ an 8 bit microprocessor for control and measurement.
- Safety and Effectiveness, comparison to predicate device. The results of bench, and user న్ 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.
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6. Substantial Equivalence Chart
| Feature | AlcoMate CA2000,K041334 | Connectables® AlcoholTester K052448 | RMI LCD AlcoholTester |
|---|---|---|---|
| INDICATION ForUSE | Intended to measurealcohol in the humanbreath. Measurementsobtained by this deviceare used as an aid inthe detection of alcoholintoxication. | SAME | SAME |
| MODE | Breath AlcoholConcentration | SAME | SAME |
| PRACTITIONERUSE | Over the Counter | SAME | SAME |
| DISPLAY | 3 Digit LED | Red, Yellow, and GreenLEDs. Representingranges: BAC of greaterthan .08% (red)BAC of .04% to .08%(yellow)BAC of less than .04%(green) | 3 Digit LCD, with blueLED backlight |
| POWER SOURCE | 9 Volt Alkaline Battery | 2-AAA alkaline batteries | 2-AAA alkaline batteries |
| BATTERY LIFE | 100-300 tests | 400 Tests | 300 Tests |
| Measurement Range | 0.00-0.40% | Upper limit undefined -any concentration greaterthan 0.08% will produce ared light. | 0.00-0.20%. Above 0.2%unit indicates: HI |
| TYPE OF SENSOR | Semiconductor-OxideSensor | SAME | SAME |
| ANATOMICAL SITE | Mouth | SAME | SAME |
| Mouthpiece | Replaceable | None required | None required |
| Warm Up Time | 15-60 Seconds | 5-15 seconds | 5-15 seconds |
| Blowing Time | 5 Seconds | 3 Seconds | 3 Seconds |
| Construction | Printed circuit boardinside plastic case. | SAME | SAME |
| SIZE | 5" x 2.55" | 1.64" x 2.1" | 3.5" x 1.25" |
| WEIGHT | 120 grams | 42 grams | 35 grams |
7. Conclusion
After analyzing bench tests, a risk analysis, electrical safety, and user testing data, it is the conclusion of RESOURCE MANAGEMENT INTERNATIONAL, LLC that the RMI® LCD Alcohol Tester 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 predicate unit administered by a trained observer.
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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 stripes representing the department's mission to protect the health of all Americans and provide essential human services. 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
Resources Management International, LLC c/o Mr. Dan Kamm Kamm & Associates P.O. Box 7007 Deerfield, IL 60015
APR - 9 2007
K062545 Re:
Trade/Device Name: RMI® LCD Alcohol Detector Regulation Number: 21 CFR 862.3050 Regulation Name: Alcohol test system. Regulatory Class: Class I, reserved Product Code: DJZ Dated: March 04, 2007 Received: March 07, 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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Page 2 -
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) 276-0490. 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 toll-free number (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) K062545
Device Name: RMI® LCD Alcohol Detector
Indications for Use:
Intended to measure alcohol in the human breath. Measurements obtained by this device are 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)
William Kirk-Goff
L.vision Sign-Off
Office of In Vitro Diagnostic Device Evaluation 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.