(121 days)
Not Found
No
The description focuses on the physical components and established scientific principles (Henry's Law) for breath alcohol detection, with no mention of AI or ML algorithms for data processing or interpretation.
No
The device is used for diagnosis of alcohol intoxication by measuring alcohol in human breath, not for treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "Measurements obtained by this device are used in the diagnosis of alcohol intoxication."
No
The device description clearly states it is a handheld device with a fuel cell sensor, batteries, and a mouthpiece, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: This device measures alcohol in breath, which is a sample of air exhaled from the lungs, not a sample taken from the body in the traditional sense of an in vitro test.
- Intended Use: While the intended use mentions "diagnosis of alcohol intoxication," the method of measurement is through breath analysis, not through testing a bodily fluid or tissue sample.
Therefore, while it's a diagnostic tool, it falls under a different regulatory category than an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DJZ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Mouth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over the Counter
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: +/-0.01%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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
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- 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
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- Equivalent legally marketed devices K043188 AlcoHAWK® Precision Alcohol Detector, O3 Innovations LLC
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- 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.
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- 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
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