OmegaPoint Systems Personal Breath Alcohol Tester BreathKey™ Model g10 and BreathKey™ Model g30X are indicated for use to measure alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication. BreathKey™ Model g30X transmits the BAC results to an interlock receiver installed in a motor vehicle

Device Description

The OmegaPoint Systems BreathKey™ Model g10 and BreathKey™ Model g30X Personal Breath Alcohol Testers are designed to measure deep lung air to determine the level of alcohol in the blood. BreathKey™ Model g30X is identical to Model g10 except that Model g30X transmits the Blood Alcohol Content (BAC) results by way of a radio frequency signal to an interlock receiver installed in a motor vehicle.

The alcohol sensor is of the electrochemical fuel cell type. As the user's breath moves through the sensor, the sensor generates an electrical current that is proportional to the concentration of ethanol in the breath.

AI/ML Overview

The OmegaPoint Systems Personal Breath Alcohol Tester (Models g10 and g30X) was evaluated for substantial equivalence primarily through product bench testing against two predicate devices: the AlcoMate CA2000 Digital Alcohol Detector (K041334) and the Intoxilyzer S-D5. The submission also mentions a clinical trial to assess user readability and understandability of the operation manual.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly state "acceptance criteria" but rather presents a comparison table that highlights the features and performance characteristics of the OmegaPoint device against its predicates. The "reported device performance" for the OmegaPoint device is assumed to be the values listed in its column. The "accuracy" is the closest direct performance metric mentioned.

Feature	Acceptance Criteria (from predicate/DOT requirements)	Reported Device Performance (OmegaPoint Models g10 & g30X)
Accuracy	0.005% BAC @ up to 0.10% (Intoxilyzer S-D5) AND/OR +/- 0.01% BAC @ 0.10% (AlcoMate CA2000)	+/- 0.0014% BAC @ 0.80%
Sensor Type	Electrochemical fuel cell (Intoxilyzer S-D5), Semi-conductor-Oxide Sensor (AlcoMate CA2000)	Electrochemical fuel cell
Sampling Time	4 sec (Intoxilyzer S-D5), 5 sec (AlcoMate CA2000)	4 sec
Warm-up Time	20 sec (both predicates)	3 sec
Measurement Range	0.00 - 0.40% (both predicates)	0.000 - 0.200%
Intended User	General Public (AlcoMate CA2000)	General Public
Where Used	Home, In public (AlcoMate CA2000)	Home, In public
Power Source	9 Volt Alkaline Battery, replaceable (AlcoMate CA2000), 2 AAA batteries, replaceable (Intoxilyzer S-D5)	3V lithium battery, permanent
Display	3 Digit LED (both predicates)	3 Digit and 4 Characters LCD
Mouthpiece	Replaceable (both predicates)	Integral
DOT Approval	YES (Intoxilyzer S-D5 - implicit from DOT approved device, AlcoMate CA2000 explicitly stated YES)	NO

Note on Accuracy: The reported accuracy for the OmegaPoint device is given at 0.80% BAC, while the predicates are at 0.10% BAC. Without further context or direct comparison at the same BAC levels, it's difficult to directly compare these accuracy figures. However, the OmegaPoint's stated accuracy of +/- 0.0014% BAC appears to be numerically tighter than the predicates' stated accuracies.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Product bench testing" and a "clinical trial designed to assess user readability and understandability of the Operation Manual."

Bench Testing: No specific sample size for the bench test is provided. The data provenance is not specified, but it's likely conducted in the US by the manufacturer or a testing lab. The nature of bench testing implies newly generated data (prospective) for the device.
Clinical Trial for Manual Readability: No sample size is provided for this trial. The data provenance and whether it was retrospective or prospective are not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The ground truth for the bench testing would have been established by calibrated instruments for breath alcohol concentration. For the clinical trial on manual readability, the "ground truth" would likely be subjective user feedback or comprehension scores, not expert consensus on alcohol levels.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The provided text does not describe an adjudication method for measuring BAC or for the manual readability study.

5. 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
Not applicable. This device is a standalone breath alcohol tester, not an AI-assisted diagnostic tool for "human readers." No MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, a standalone performance evaluation was completed. The "Product bench testing" against predicate devices directly assesses the accuracy and other technical specifications of the OmegaPoint device itself. The device is designed for direct consumer use without a "human-in-the-loop" in the sense of interpreting complex diagnostic output.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the alcohol measurement aspect, the ground truth would typically be established by:

Calibrated alcohol-gas mixtures or solutions that simulate known blood alcohol concentrations (for bench testing).
For in-vivo testing, this would usually be confirmed blood alcohol concentration (BAC) measurements. The document refers to "deep lung air to determine the level of alcohol in the blood," implying the device infers BAC.

For the clinical trial on manual readability, the ground truth would be quantitative or qualitative assessment of user comprehension and ability to follow instructions.

8. The sample size for the training set
Not applicable. The document does not describe the development of an algorithm that would require a "training set" in the context of machine learning. This appears to be a hardware device with an embedded logic, rather than a machine learning model.

9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set.

Summary

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510(k), OmegaPoint Systems Personal Breath Alcohol Tester

DEC 9 2005

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16. 510(k) Summary

Date

July 29, 2005

Owner

OmegaPoint Systems, LLC Ed Gollar 1077 Celestial Street Suite 400 Cincinnati, OH 45202 Telephone: 513-241-7540 513-241-7050 Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax:

Trade Name

OmegaPoint Systems Personal Breath Alcohol Tester BreathKey™ Model g10 and BreathKey™ Model g30X

Common Name

Device, Breath Trapping Alcohol Medical Specialty: Toxicology Product Code: DJZ 862.3050 21 CFR:

Predicate Device(s)

AlcoMate CA2000 Digital Alcohol Detector manufactured by KHN Solutions LLC 510(k) Premarket Notification number: K041334 FDA Product Code: DJZ

Intoxilyzer S-D5, manufactured by CMI, Inc DOT approved device 69 FR 42237 (See Appendix 1.0)

Device Description

OmegaPoint Systems, LLC Proprietary and Confidential Information 1077 Celestial Street; Cincinnati, OH 45202 July 29, 2005

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Intended Use

The OmegaPoint Systems BreathKey™ Model g10 and BreathKey™ Model g30X are intended to measure alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication. BreathKey™ Model g30X transmits the BAC results to an interlock receiver installed in a motor vehicle

Substantial Equivalence Conclusion

Product bench testing indicates substantial equivalence to both predicate devices. The comparison testing of the Intoxilyzer S-D5 DOT approved device, the AlcoMate comparison teating of aint Systems BreathKey M Model g10 and BreathKey™ Model g30X with the inclusion of DOT requirements indicate equivalence to the predicates regarding safety and efficacy.

A clinical trial designed to assess user readability and understandability of the Operation Manual show safety regarding consumer use of the device.

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Summary of Substantial Equivalence	AlcoMate	Professional	OmegaPoint Personal
Feature	CA2000 K041334	Intoxilyzer ModelS-D5, EvidentialBreath AlcoholDevice	Breath Alcohol TesterModel g10 and Modelg30X
Indication for USE	Measure alcohol inthe human breath.Measurementsobtained by thisdevice are used inthe diagnosis ofalcoholintoxication.	Determiningbreath alcohollevel	Determining breathalcohol level.Measurements obtainedby this device are usedin the diagnosis ofalcohol intoxication.BreathKeyTM Modelg30X transmits the BACresults to an interlockreceiver installed in amotor vehicle.
Intended User	General Public	Law enforcement	General Public
Where Used	Home, In public	Police cruiser,police station	Home, In public
Construction	Plastic case withinternal circuitboard, display,internal circuitrywith ethanolsensor	Plastic case,button, display,internal circuitrywithmicroprocessor,and ethanol sensor	Plastic case, button,display, internalcircuitry withmicroprocessor, andethanol sensor
Sensor	Semi-conductor-Oxide Sensor	Electrochemicalfuel cell	Electrochemical fuelcell
Size	3 ½"W x 5"H	2 ½"W x 4 ¾"H x1 ¼"D	1 3/8"W x 2 3/8"H x9/16"D
Weight	200 grams	120 grams	20 grams
Sampling Time	5 sec	4 sec	4 sec
Mouthpiece	Replaceable	Replaceable	Integral
Power Source	9 Volt AlkalineBattery,replaceable	2 AAA batteries,replaceable	3V lithium battery,permanent
Warm-up Time	20 sec	20 sec	3 sec
Display	3 Digit LED	3 Digit LED	3 Digit and 4 CharactersLCD
Accuracy	+/- 0.01% BAC @0.10%	0.005% BAC @up to 0.10%	+/- 0.0014% BAC @0.80%
Measurement Site	Mouth	Mouth	Mouth
MODE	Breath AlcoholConcentration	Breath AlcoholConcentration	Breath AlcoholConcentration
Measurement Range	0.00 - 0.40%	0.00 - 0.40%	0.000 - 0.200%
DOT Approval	YES	YES	NO

of Substantial Equivalence C

OmegaPoint Systems, LLC Proprietary and Confidential Information 1077 Celestial Street; Cincinnati, OH 45202 July 29, 2005

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized symbol with three curved lines, resembling a person embracing another person. The symbol is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around it.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OmegaPoint Systems, LLC c/o Ewe Degenhardt TUV America 10040 Mesa Rim Road San Diego, CA 92121

2005 DEC #

K052804 Re:

Trade/Device Name: OmegaPoint Systems Personal Breath Alcohol Tester BreathKey™ Model g10 and Breathkey™ Model g30X

Regulation Number: 21 CFR 862.3050 Regulation Name: Breath-alcohol test system Regulatory Class: Class I Product Code: DJZ Dated: December 7, 2005 Received: December 8, 2005

Dear Mr. Degenhardt:

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) 276-0484. 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 Division 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 Gutierrez

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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Specifications for the Laser

K 052804 510(k) Number (if known):

Device Name:

OmegaPoint Systems Personal Breath Alcohol Tester BreathKey M Model g10 and BreathKey 10 Model g30X

Indications for Use:

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)

ce of In Vitro E evice Evaluatio

.510(k) K 052804

Regulation Number and Section

§ 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.