(169 days)
This device is intended to measure alcohol in the human breath. Measurements obtained by this device are used as an aid in the detection of alcohol intoxication.
The Connectables® 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 Connectables® Alcohol Tester is an alcohol screening device and uses a blow time of 3 seconds to capture an accurate deep lung sample. The Connectables® 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 provided text describes a 510(k) summary for the Connectables® Alcohol Tester. The submission aims to establish substantial equivalence to a predicate device, the Alcohawk Precision (K043188). The study focuses on user understanding and proper use, rather than a detailed performance study with specific acceptance criteria for accuracy against a gold standard.
Here's an analysis based on the provided text, addressing your questions:
1. Table of Acceptance Criteria and Reported Device Performance
Although explicit quantitative acceptance criteria for device accuracy (e.g., specific thresholds for BAC measurement) are not provided in this summary, the study's primary objective was to demonstrate that users could operate the device correctly and obtain comparable results to a predicate device under trained observation.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| User Comprehension & Proper Use: Users can read and understand instructions and use the device correctly. | "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..." |
| Comparable Results to Predicate (User-Administered vs. Trained-Administered): The device, when used by an ordinary purchaser, yields results comparable to the predicate device administered by a trained observer. | "...and obtain results that were comparable to those provided by a predicate unit administered by a trained observer." |
2. Sample Size Used for the Test Set and Data Provenance
The exact sample size for the clinical trial (test set) is not specified. The text mentions "a clinical trial was performed," but does not provide the number of participants.
The data provenance is implied to be prospective as it describes a "clinical trial" being performed to establish user understanding and device usage. The country of origin is not explicitly stated, but given the FDA submission, it's highly likely to be the United States.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The concept of "ground truth" for alcohol concentration in the test set is not explicitly detailed as a separate, independently established reference method. Instead, the comparison is made against a "predicate unit administered by a trained observer."
Therefore:
- Number of 'Experts': One "trained observer" is mentioned as administering the predicate unit for comparison. The number of trained observers administering the investigational device (if any) is not specified, as the focus was on the "over the counter purchaser" using it.
- Qualifications of 'Experts': The term "trained observer" is used, but specific qualifications (e.g., years of experience, medical degree, certification) are not provided.
4. Adjudication Method for the Test Set
No adjudication method (e.g., 2+1, 3+1) is mentioned or implied for either the measurement by the Connectables® Alcohol Tester or the predicate device. The study focused on a direct comparison between results obtained by a user of the new device and results from a "trained observer" using the predicate.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not explicitly described or performed. The study focused on user performance and comparison to a single predicate unit administered by a trained observer, rather than evaluating multiple human readers with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No, a standalone algorithm performance study was not performed in the context of this summary. The Connectables® Alcohol Tester is a physical device with a semiconductor sensor that provides alcohol readings, not an AI algorithm. The study assessed the device's usability and the comparability of its results when used by an ordinary person.
7. The Type of Ground Truth Used
The "ground truth" in this context is the measurement provided by the predicate device (Alcohawk Precision) when administered by a trained observer. It is not pathology, outcomes data, or an expert consensus independent of a device measurement. It's a comparative ground truth against an already legally marketed device under controlled observation.
8. The Sample Size for the Training Set
The document does not describe a "training set" in the context of machine learning or algorithm development. The Connectables® Alcohol Tester uses a semiconductor sensor, not a machine learning model that requires a training set. The clinical trial described is a usability and comparability study.
9. How the Ground Truth for the Training Set was Established
As there is no "training set" in the context of machine learning, this question is not applicable to the device described.
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FEB ≥ 3 2006
510(k) Summary
CONNECTABLES® LLC 2330 Ernie Krueger Circle Waukegan, IL 60087 Telephone: 847-244-4500 Fax: 847-244-4525 February 22, 2006 Contact: John Adams
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- Identification of the Device: Proprietary-Trade Name: Connectables® Alcohol Tester Classification Name: Device, breath trapping, alcohol, DJZ Common/Usual Name: Breath-alcohol test system
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- Equivalent legally marketed device: Alcohawk Precision, K043188
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- Indications for Use (intended use) : This device is intended to measure alcohol in the human breath. Measurements obtained by this device are used as an aid in the detection of alcohol intoxication.
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- Description of the Device: The Connectables® 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 Connectables® Alcohol Tester is an alcohol screening device and uses a blow time of 3 seconds to capture an accurate deep lung sample. The Connectables® Alcohol Tester contains a semiconductor sensor designed to test for the presence of The semiconductor material is heated to a specific temperature. The resistance alcohol. of sensing material changes rapidly according to gas concentration changes, thereby enabling the reading of alcohol concentration by resistance measurement.
- Safety and Effectiveness, comparison to predicate device. The results of bench, and user 5. 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 | AlcohawkPrecision™K043188 | Connectables® AlcoholTester |
|---|---|---|
| INDICATION ForUSE | The device is intendedto measure alcohol inthe human breath.Measurements obtainedby this device are usedin the diagnosis ofalcohol intoxication. | This device is intended tomeasure alcohol in thehuman breath.Measurements obtained bythis device are used as anaid in the detection ofalcohol intoxication. |
| MODE | Breath AlcoholConcentration | SAME |
| PRACTITIONER USE | Over the Counter | SAME |
| DISPLAY | 4 Digit LED | Red, Yellow, and GreenLEDs. Representingranges: BAC of greaterthan .08% (red)BAC of .04% to .08%(yellow)BAC of less than .04%(green) |
| POWER SOURCE | 9 Volt Alkaline Battery | 2-AAA alkaline batteries |
| BATTERY LIFE | 100-300 tests | 400 Tests |
| Measurement Range | 0.00-0.40% | Upper limit undefined -any concentration greaterthan 0.08% will produce ared light. |
| TYPE OF SENSOR | Semiconductor-OxideSensor | SAME |
| ANATOMICAL SITE | Mouth | SAME |
| Mouthpiece | Replaceable | None required |
| Warm Up Time | 15-60 Seconds | 5-15 seconds |
| Blowing Time | 5 Seconds | 3 Seconds |
| Construction | Printed circuit boardinside plastic case. | SAME |
| SIZE | 4.25" x 2.75" | 1.64" x 2.1" |
| WEIGHT | 130 grams | 42 grams |
7. Conclusion
After analyzing bench tests, a risk analysis, electrical safety, and user testing data, it is the conclusion of Connectables®, LLC that the Connectables® 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 or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird-like figure.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 2 3 2006
Mr. John Adams Connectables, LLC. 2340 Ernie Krueger Circle Waukegan, IL 60087
K052448 Re: Trade/Device Name: CONNECTABLES® Alcohol Tester Regulation Number: 21 CFR§862.3050 Regulation Name: Breath-alcohol test system Regulatory Class: DJZ Product Code: Class I Dated: February 13, 2006 Received: February 14, 2006
Dear Mr. Adams:
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) I mis letter will anow you to oogin inding of substantial equivalence of your device to a legally premarket nonnounce. "The 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 of quebtons on the prometic 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 Tou may other 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 Guts
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):
Device Name: Connectables ® Alcohol Detector _________________________________________________________________________________________________________________________________
Indications For Use: This device is intended to measure alcohol in the human breath. Measurements obtained by this device are used as an aid in the detection 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)
Carol Benem
052448
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.