(483 days)
No
The description focuses on an electrochemical fuel cell sensor and does not mention any AI/ML components or algorithms.
No.
The device is used to measure alcohol in human breath for diagnosis of alcohol intoxication, not for treatment.
Yes
The "Intended Use / Indications for Use" section states: "Measurements obtained by this device are used in the diagnosis of alcohol intoxication."
No
The device description explicitly states it uses an electrochemical fuel cell sensor and measures breath, indicating it is a hardware device with a physical component for sensing.
Based on the provided information, the Dräger Alcotest 6510 is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use/Indications for Use: The description explicitly states that "Measurements obtained by this device are used in the diagnosis of alcohol intoxication." This directly aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. In this case, the specimen is breath, and the information is used for the diagnosis of alcohol intoxication.
- Device Description: The device measures alcohol in human breath, which is a biological specimen.
- Anatomical Site: The device interacts with the mouth to collect the breath sample.
While the device doesn't involve image processing, AI, or machine learning, and the training/test set details are not provided, the core function of analyzing a human specimen (breath) to aid in diagnosis (alcohol intoxication) firmly places it within the category of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
DJZ
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.
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
Police cruiser, prison, hospital, in public
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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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
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.
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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 Alcotest | ||
| 6510 | Professional | ||
| Intoxilyzer Model | |||
| S-D5 | BreathkeyTM | ||
| Indications for Use | Determining | ||
| breath alcohol | |||
| level | Determining | ||
| breath alcohol | |||
| level | Determining | ||
| breath alcohol | |||
| level | |||
| Construction | Plastic case, | ||
| button, display, | |||
| internal circuitry | |||
| with | |||
| microprocessor | |||
| and ethanol | |||
| sensor | Plastic case, | ||
| button, display, | |||
| internal circuitry | |||
| with | |||
| microprocessor | |||
| and ethanol | |||
| sensor | Plastic case, | ||
| button, display, | |||
| internal circuitry | |||
| with | |||
| microprocessor | |||
| and ethanol | |||
| sensor | |||
| Sensor | Electrochemical | ||
| fuel cell | Electrochemical | ||
| fuel cell | Electrochemical | ||
| fuel 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 Alcotest | ||
| 6510 | Professional | ||
| Intoxilyzer Model | |||
| S-D5 | Breathkey™ | ||
| Where Used | Police cruiser, | ||
| prison, hospital, | |||
| in public | Law enforcement | General public | |
| Measurement | |||
| Range | 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 "H | ||
| x 1 ¼"D | 2 ½"W x 4 ¾"H x | ||
| 1 ¼"D | 1 3/8"W x 2 | ||
| 3/8"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
Page 1 of
510(k) K063443