(121 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 AlcoHAWK® PT500 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 AlcoHAWK® PT500 has been tested and uses a blow time of 5 seconds to capture an accurate deep lung sample. The AlcoHAWK® PT500 sensor uses a fuel cell type of detector similar to one found on professional units. It is handheld and uses two AA alkaline batteries as a power source. The mouthpiece is replaceable Plexiglas plastic.
Here's a breakdown of the acceptance criteria and study information for the AlcoHAWK® PT500 Digital Alcohol Detector, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Measurement Range | .00-.40% |
| Accuracy | +/-0.01% |
| Blowing time | 5 seconds |
| Warm-Up Time | 10 Seconds |
| DOT Approval | DOT Approved |
Study Information
The provided document describes a "clinical trial" but does not detail it with the same rigor one might expect for a modern AI/device study. The focus is primarily on demonstrating substantial equivalence to a predicate device and user comprehension/usability.
-
Sample sized used for the test set and the data provenance:
- Sample Size: Not explicitly stated for the "clinical trial." The document mentions "user testing data" and "a clinical trial was performed," but does not provide a number of participants or samples.
- Data Provenance: Not explicitly stated. Given the context of a 510(k) summary for a US market device, it is implied to be relevant to a US population, but no specific country of origin is mentioned. It's described as a "clinical trial," suggesting prospective data collection, but details are absent.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not explicitly stated. The study aimed to show "results that were comparable to those provided by a professional unit administered by a trained observer." This implies one or more "trained observers" were involved, but their qualifications are not detailed beyond "trained observer."
- Qualifications of Experts: Only "trained observer" is mentioned for the professional unit's administration. No specific years of experience or professional titles (e.g., toxicologist, law enforcement officer) are given.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not explicitly stated. The comparison was against a "professional unit administered by a trained observer," implying a direct comparison rather than a multi-reader adjudication process for ground truth.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a standalone breath alcohol detector, not an AI-assisted diagnostic tool that would typically involve human "readers" or "interpreters" whose performance is analyzed.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, the "clinical trial" assessed the standalone performance of the AlcoHAWK® PT500 in the hands of an "over the counter purchaser" (human-in-the-loop, but measuring the device's output) and compared it to a "professional unit administered by a trained observer." The primary goal was to show the device itself provides comparable results and that users can operate it correctly. The device's measurement function is algorithmic/automated once the breath sample is provided.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth was established by a "professional unit administered by a trained observer." This implies that the readings from a "professional unit" (likely an evidentiary-type breath alcohol tester) served as the reference standard against which the AlcoHAWK® PT500's readings were compared.
-
The sample size for the training set:
- Not applicable/Not mentioned. This device is a measurement device, not an AI or machine learning algorithm that typically requires a distinct training set. Its function is based on a fuel cell sensor and established physiological principles (Henry's law), not trained data.
-
How the ground truth for the training set was established:
- Not applicable. As noted above, there is no mention of a training set for an AI/ML algorithm.
{0}------------------------------------------------
EXHIBIT 2
510(k) Summary for K080848
JUL 2 5 2008
03 INNOVATIONS LLC 2349 Jamestown Ave., Suite #4 Independence, IA 50644 USA Tclephone: 888.399.1687 (Toll Free) 319.334.3412 (Corporate Office) Facsimile: 319.334.3421 Date prepared: July 18, 2008 Contact: Brian C. Eddy, CEO
-
- Identification of the Device: Proprietary-Trade Name: AlcoHAWK® PT500 Digital Alcohol Detector Classification Name: Device, breath trapping, alcohol, DJZ Common/Usual Name: Breath-alcohol test system
-
- Equivalent legally marketed devices K043188 AlcoHAWK® Precision Alcohol Detector, O3 Innovations LLC
-
- Indications for Use (intended usc): This device is intended to measure alcohol in human breath. Measurcments obtained by this device are used in the diagnosis of alcohol intoxication.
-
- Description of the Device: The AlcoHAWK® PT500 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 AlcoHAWK® PT500 has been tested and uses a blow time of 5 seconds to capture an accurate deep lung sample. The AlcoHAWK® PT500 sensor uses a fuel cell type of detector similar to one found on professional units. It is handheld and uses two AA alkaline batteries as a power source. The mouthpiece is replaceable Plexiglas plastic.
-
- Safety and Effectiveness, comparison to predicate device. The results of bonch, laboratory and user 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, as well as perform comparably to an evidentiary type of breath alcohol tester.
{1}------------------------------------------------
6. Substantial Equivalence Chart
| Feature | K043188 AlcoHAWK® Precision | AlcoHAWK® PT500 |
|---|---|---|
| INDICATION OF USE | The AlcoHAWK® Precision ™ Digital Alcohol Detector is intended to measure alcohol in human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication. | This device is intended to measure alcohol in human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication. (SAME) |
| MODE | Breath Alcohol Concentration | SAME |
| PRACTITIONER USE | Over the Counter | SAME |
| Blowing time | 5 Seconds | 5 seconds (SAME) |
| DISPLAY | 4 Digit LED | 4 Digit LCD (with temperature display) |
| POWER SOURCE | 9 Volt Alkaline Battery or auto cigar lighter (Optional) | 2 - AA Alkaline |
| BATTERY LIFE | 100-200 Tests | 200 Tests |
| Measurement Range | .00-.40% | SAME |
| Accuracy | +/-0.01% | SAME |
| TYPE OF SENSOR | Semiconductor-Oxide Sensor | Fuel Cell Sensor (similar to evidentiary device.) |
| ANATOMICAL SITE | Mouth | SAME |
| Mouthpiece | Replaceable | SAME |
| Warm Up Time | 15-60 seconds | 10 Seconds |
| DOT | DOT Approved | DOT Approved (SAME) |
| Construction | Plastic case with internal circuit board | SAME |
| SIZE | 4.25" x 2.75" | 5 in x 2.63 in x 1.25 in |
| WEIGHT | 130 grams. | 3.6 oz (102 g) without batteries, 5.2 oz (147 g) with batteries |
-
- Conclusion
After analyzing bench tests, a risk analysis, EMC, and user testing data, it is the conclusion of Q3 Innovations, LLC that the AlcoHAWK® PT500 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 pcrformed 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 thosc provided by a professional unit administered by a trained observer.
- Conclusion
{2}------------------------------------------------
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 its wings spread, facing left. The eagle is black and composed of thick, curved lines. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Q3 Innovations, LLC Kamm & Associates c/o Mr. Daniel Kamm Principal Consultant P.O. Box 7007 Deerfield, IL 60015
'JUL 2 5 2008
Re: K080848
Trade/Device Name: AlcoHAWK® PT500 Digital Alcohol Detector Regulation Number: 21 CFR 862.3050 Regulation Name: Breath-alcohol test system. Regulatory Class: Class I, Reserved Product Codes: DJZ Dated: July 2, 2008 Received: July 8, 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).
{3}------------------------------------------------
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.
Yéan 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
{4}------------------------------------------------
Indications for Use
510(k) Number (If Known) K080948
Device Name: AlcoHAWK® PT500 Digital Alcohol Detector
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)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K080842
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.