The Dräger Alcotest 6510 is an apparatus for indicating the presence of alcohol in the breath.
The Dräger Alcotest 6510 is a device intended to measure alcohol in human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.

Device Description

The Drager Alcotest 6510 is designed to measure deep lung air to determine the level of alcohol in the blood. 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

Here's an analysis of the provided text regarding the Dräger Alcotest 6510, focusing on acceptance criteria and study details:

The provided 510(k) summary for the Dräger Alcotest 6510 does not explicitly define specific numerical acceptance criteria for its performance. Instead, it relies on demonstrating substantial equivalence to a predicate device (OmegaPoint Systems Personal Breath Alcohol Tester BreathKey™ Model G10 and BreathKey™ Model G30X) and general conformance to Department of Transportation (DOT) standards. The study mentioned focuses on user understanding and proper device usage rather than quantitative performance metrics against a defined ground truth.

Therefore, a table of acceptance criteria and reported device performance as typically understood for diagnostic devices with specific sensitivity/specificity targets cannot be fully generated from this document. However, I can infer the implicit "acceptance criteria" and what was reported for overall safety and effectiveness:

Implicit Acceptance Criteria and Reported Device Performance

Criteria Category	Implicit Acceptance Criteria	Reported Device Performance
Safety	The device is safe for its intended use.	"The results of bench, DOT and user testing indicates that the new device is as safe and effective as the predicate device." "After analyzing bench tests, electrical safety...it can be concluded that Dräger Alcotest 6510 is as safe and effective as the predicate and comparative devices."
Effectiveness	The device is effective in indicating the presence of alcohol in the breath and determining the level of alcohol in the blood, comparable to the predicate device. Users should be able to read, understand, and properly use the device to obtain comparable results.	"The results of bench, DOT and user testing indicates that the new device is as safe and effective as the predicate device." "User studies showed that intended users of the device could read and understand the instructions, could properly use the device and obtain results that were comparable to those provided by a predicate device administered by a trained individual."
Substantial Equivalence	The device is substantially equivalent to the predicate device in terms of indications for use, construction, sensor type, anatomical site, test sample, and general performance (after considering differences in specific parameters like measurement range, blowing time, etc., and ensuring these differences do not raise new questions of safety or effectiveness).	Detailed comparison table provided, highlighting similarities (Indications for Use, Construction, Sensor, Anatomical Site, Test Sample, DOT approval) and differences (Where Used, Measurement Range, Blowing Time, Mouthpiece, Power source, Warm-up time, Size, Weight). The conclusion explicitly states "Dräger Alcotest 6510 is as safe and effective as the predicate and comparative devices."
User Comprehension/Usage	Intended users can understand instructions and properly operate the device.	"A clinical trial was performed to establish that the user could read and understand the instructions provided, and properly use the device." "User studies showed that intended users of the device could read and understand the instructions, could properly use the device..."

Here's the additional information based on the provided text:

Sample size used for the test set and the data provenance:
- Sample Size: The document refers to "user testing" and "user studies" and a "clinical trial" but does not specify a numerical sample size for these tests.
- Data Provenance: Not explicitly stated (e.g., country of origin). The submission is from Germany, but the testing location is not mentioned. It can be inferred as prospective given the nature of a "user testing" or "clinical trial" to establish user understanding and proper usage.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document implies that the comparison for "comparable results" was against a "predicate device administered by a trained individual." This "trained individual" or the data from the predicate device serves as an indirect form of ground truth comparison.
- However, the number and specific qualifications of experts involved in establishing a formal "ground truth" for the test set (e.g., a panel of toxicologists or law enforcement officers interpreting results) are not specified. The focus of the highlighted clinical trial was user understanding and proper usage, not an independent assessment of accuracy against a gold standard performed by multiple experts.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not describe any formal adjudication method. The "user studies" primarily assessed if users could properly use the device and obtain "comparable results" to a predicate device. This suggests a direct comparison rather than a multi-reader/multi-adjudicator approach.
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, an MRMC comparative effectiveness study was not done. This device is a standalone breath alcohol tester, not an AI-assisted diagnostic tool that would involve "human readers" or "AI assistance" in the typical sense of MRMC studies for image analysis or other complex diagnoses. The "user studies" evaluated human users' ability to operate the device, not an improvement in their diagnostic performance with AI.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The Dräger Alcotest 6510 is a standalone device without a human-in-the-loop AI component. Its performance is the algorithm (electrochemical fuel cell sensor converting breath ethanol to an electrical current, processed by an internal microprocessor) combined with the user's interaction.
- The "bench tests" and "DOT conformance testing" represent evaluations of the device's technical, standalone performance against controlled standards and specifications. The document states these results were analyzed.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The primary ground truth implied for this device's effectiveness is its ability to produce results "comparable to those provided by a predicate device administered by a trained individual" and its DOT approval. For breath alcohol, the "ground truth" (or gold standard) in regulatory contexts often involves laboratory blood alcohol concentration (BAC) measurements or highly calibrated, legally accepted evidential breath testing devices.
- For the "user testing" specifically, the ground truth was the correct operation of the device and the comprehension of instructions, likely assessed by observers or direct comparison.
The sample size for the training set:
- The document does not mention a training set in the context of machine learning or AI development. This device is based on established electrochemical fuel cell technology, not on a machine learning model that would require a separate training set.
How the ground truth for the training set was established:
- As no training set (for AI/ML) is mentioned, this question is not applicable. The device's underlying principles are physics and chemistry-based, with calibration and validation typically performed through bench testing and comparisons to established standards.

Summary

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510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

K 063 44 3 The assigned 510(k) number is: _

1. Submitter Information

Name: Dräger Safety AG & Co. KGaA Address: Revalstraße 1, Lubeck, Germany 23560 Telephone Number: +49 (0)451-882-4713 Facsimile Number: +49 (0)451-882-7-4713 Contact Person: Stefan Steinmeyer Date: November 13, 2006

2. Device Information

Trade or Proprietary Name: Dräger Alcotest® 6510 Common or Usual Name: Breath-Alcohol Test Classification Name: Devices, Breath Trapping, Alcohol (per 21 CFR section 862.3050).

3. Predicate Device

Dräger Alcotest 6510 is equivalent to the following:

OmegaPoint Systems Personal Breath Alcohol Tester BreathKey™ Model G10 and BreathKey™ Model G30X (K052804)

4. Indications for Use

The Dräger Alcotest 6510 is an apparatus for indicating the presence of alcohol in the breath.

5. Device Description

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6. Safety and Effectiveness

The results of bench, DOT 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.

7. Substantial Equivalence Determination

Comparison to Predicate Devices:

Similarities
Parameter	Dräger Alcotest6510	ProfessionalIntoxilyzer ModelS-D5	BreathkeyTM
Indications for Use	Determiningbreath alcohollevel	Determiningbreath alcohollevel	Determiningbreath alcohollevel
Construction	Plastic case,button, display,internal circuitrywithmicroprocessorand ethanolsensor	Plastic case,button, display,internal circuitrywithmicroprocessorand ethanolsensor	Plastic case,button, display,internal circuitrywithmicroprocessorand ethanolsensor
Sensor	Electrochemicalfuel cell	Electrochemicalfuel cell	Electrochemicalfuel cell
Anatomical Site	Mouth	Mouth	Mouth
Test Sample	Human Breath	Human Breath	Human Breath
DOT approval	Yes	Yes	No

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Differences
Parameter	Dräger Alcotest6510	ProfessionalIntoxilyzer ModelS-D5	Breathkey™
Where Used	Police cruiser,prison, hospital,in public	Law enforcement	General public
MeasurementRange	0.00-0.500%	0.00-0.40%	0.00-0.20%
Blowing Time	3-30 sec.	4 seconds	4 seconds
Mouthpiece	Replaceable	Replaceable	Integrated, non-replaceable
Power source	2 x 1.5V alkaline(AA) batteries,replaceable	2 AAA batteries,replaceable	3 Volt battery,non-replaceable
Warm-up time	6 seconds	20 seconds	3 seconds
Size	5 ½"W x 2 4/5 "Hx 1 ¼"D	2 ½"W x 4 ¾"H x1 ¼"D	1 3/8"W x 23/8"H x 9/16"D
Weight	195 grams	20 grams	120 grams

8. Conclusions

After analyzing bench tests, electrical safety, results of DOT conformance testing, and user testing data, it can be concluded that Dräger Alcotest 6510 is as safe and effective as the predicate and comparative devices. User studies showed that intended users of the device could read and understand the instructions, could properly use the device and obtain results that were comparable to those provided by a predicate device administered by a trained individual.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Dräger Safety c/o Ms. Eve Damiano Damiano Consulting Associates, Inc. 333 Alpine Street Emmaus, PA 18049

MAR 1 1 2008

K063443 Re:

Trade/Device Name: Dräger Alcotest 6510 Breath Alcohol Test Regulation Number: 21 CFR§862.3050 Regulation Name: Breath-alcohol test system Regulatory Class: DJZ Product Code: Class I, reserved Dated: February 09, 2008 Received: February 11, 2008

Dear Ms. Damiano:

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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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 vours.

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): K063443

Device Name: Dräger Alcotest 6510

Indications For Use:

The Dräger Alcotest 6510 is a device 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 (21 CFR 801 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

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510(k) K063443

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.