(169 days)
Not Found
No
The description focuses on a semiconductor sensor and resistance measurement, with no mention of AI/ML terms or concepts.
No
The device is intended to measure alcohol in human breath as an aid in detecting alcohol intoxication, not to treat or alleviate a medical condition.
Yes
This device is intended to measure alcohol in human breath to aid in the detection of alcohol intoxication, which is a diagnostic purpose.
No
The device description explicitly states it "contains a semiconductor sensor" and describes the physical process of heating the material and measuring resistance changes, indicating it includes hardware components beyond just software.
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 the breath, which is a sample taken from the body, but the measurement process itself is not performed in vitro (outside the living organism). It's a direct measurement of a substance in exhaled air.
- Intended Use: The intended use is to measure alcohol in breath as an aid in detecting alcohol intoxication. While this provides information about a physiological state, it's not a diagnostic test performed on a biological sample in vitro.
Therefore, while it's a medical device used for screening, it doesn't fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
"This device is intended to measure alcohol in the human breath. Measurements obtained by this device are used as an aid in the detection of alcohol intoxication."
Product codes (comma separated list FDA assigned to the subject device)
DJZ
Device Description
"The Connectables® Alcohol Tester 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 Connectables® Alcohol Tester is an alcohol screening device and uses a blow time of 3 seconds to capture an accurate deep lung sample. The Connectables® Alcohol Tester contains a semiconductor sensor designed to test for the presence of The semiconductor material is heated to a specific temperature. The resistance alcohol. of sensing material changes rapidly according to gas concentration changes, thereby enabling the reading of alcohol concentration by resistance measurement."
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 Use
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, 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."
"The clinical trial performed 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 those provided by a predicate unit administered by a trained observer."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
FEB ≥ 3 2006
510(k) Summary
CONNECTABLES® LLC 2330 Ernie Krueger Circle Waukegan, IL 60087 Telephone: 847-244-4500 Fax: 847-244-4525 February 22, 2006 Contact: John Adams
-
- Identification of the Device: Proprietary-Trade Name: Connectables® Alcohol Tester Classification Name: Device, breath trapping, alcohol, DJZ Common/Usual Name: Breath-alcohol test system
-
- Equivalent legally marketed device: Alcohawk Precision, K043188
-
- Indications for Use (intended use) : This device is intended to measure alcohol in the human breath. Measurements obtained by this device are used as an aid in the detection of alcohol intoxication.
-
- Description of the Device: The Connectables® Alcohol Tester 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 Connectables® Alcohol Tester is an alcohol screening device and uses a blow time of 3 seconds to capture an accurate deep lung sample. The Connectables® Alcohol Tester contains a semiconductor sensor designed to test for the presence of The semiconductor material is heated to a specific temperature. The resistance alcohol. of sensing material changes rapidly according to gas concentration changes, thereby enabling the reading of alcohol concentration by resistance measurement.
- Safety and Effectiveness, comparison to predicate device. The results of bench, and user 5. 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.
1
6. Substantial Equivalence Chart
| Feature | Alcohawk
Precision™
K043188 | Connectables® Alcohol
Tester |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| INDICATION For
USE | The device is intended
to measure alcohol in
the human breath.
Measurements obtained
by this device are used
in the diagnosis of
alcohol intoxication. | This device is intended to
measure alcohol in the
human breath.
Measurements obtained by
this device are used as an
aid in the detection of
alcohol intoxication. |
| MODE | Breath Alcohol
Concentration | SAME |
| PRACTITIONER USE | Over the Counter | SAME |
| DISPLAY | 4 Digit LED | Red, Yellow, and Green
LEDs. Representing
ranges: BAC of greater
than .08% (red)
BAC of .04% to .08%
(yellow)
BAC of less than .04%
(green) |
| POWER SOURCE | 9 Volt Alkaline Battery | 2-AAA alkaline batteries |
| BATTERY LIFE | 100-300 tests | 400 Tests |
| Measurement Range | 0.00-0.40% | Upper limit undefined -
any concentration greater
than 0.08% will produce a
red light. |
| TYPE OF SENSOR | Semiconductor-Oxide
Sensor | SAME |
| ANATOMICAL SITE | Mouth | SAME |
| Mouthpiece | Replaceable | None required |
| Warm Up Time | 15-60 Seconds | 5-15 seconds |
| Blowing Time | 5 Seconds | 3 Seconds |
| Construction | Printed circuit board
inside plastic case. | SAME |
| SIZE | 4.25" x 2.75" | 1.64" x 2.1" |
| WEIGHT | 130 grams | 42 grams |
7. Conclusion
After analyzing bench tests, a risk analysis, electrical safety, and user testing data, it is the conclusion of Connectables®, LLC that the Connectables® Alcohol Tester 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 performed 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 those provided by a predicate unit administered by a trained observer.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird-like figure.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 2 3 2006
Mr. John Adams Connectables, LLC. 2340 Ernie Krueger Circle Waukegan, IL 60087
K052448 Re: Trade/Device Name: CONNECTABLES® Alcohol Tester Regulation Number: 21 CFR§862.3050 Regulation Name: Breath-alcohol test system Regulatory Class: DJZ Product Code: Class I Dated: February 13, 2006 Received: February 14, 2006
Dear Mr. Adams:
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
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to oogin inding of substantial equivalence of your device to a legally premarket nonnounce. "The 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 of quebtons on the prometic 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 Tou may other 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 Guts
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
4
Indications for Use
510(k) Number (if known):
Device Name: Connectables ® Alcohol Detector _________________________________________________________________________________________________________________________________
Indications For Use: This device is intended to measure alcohol in the human breath. Measurements obtained by this device are used as an aid in the detection 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)
Carol Benem
052448
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