(133 days)
Not Found
No
The summary describes a breath alcohol measurement device with standard components (GPS, imager, modem) and performance studies focused on accuracy, precision, and usability. There is no mention of AI, ML, or any related algorithms used for data analysis, image processing beyond simple capture, or prediction.
No.
The device is used to measure alcohol in human breath for the diagnosis of alcohol intoxication; it does not provide any treatment or therapy.
Yes
The "Indications for Use" section explicitly states, "Measurements obtained by this device are used in the diagnosis of alcohol intoxication."
No
The device description explicitly states it is a "handheld breath alcohol measurement device with integrated GPS, digital imager, and cellular modem," indicating it includes significant hardware components beyond just software.
Based on the provided information, the Soberlink Cellular Device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "quantitatively measure alcohol in human breath." This involves analyzing a biological sample (breath) outside of the body.
- Indications for Use: The indications for use state that the measurements are "used in the diagnosis of alcohol intoxication." This directly links the device's output to a diagnostic purpose.
- Device Description: The description confirms it takes a "deep lung sample of the User's breath" and calculates "Blood Alcohol Level (BAC)," which is a measurement derived from the breath sample.
While the device has other features like GPS and imaging, the core function of measuring alcohol in breath for diagnostic purposes aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Soberlink Cellular Device is intended to quantitatively measure alcohol in human breath. Measurements obtained by this Device are used in the diagnosis of alcohol intoxication. For Prescription use and OTC use.
Product codes
DJZ
Device Description
The Soberlink Cellular Device is a handheld breath alcohol measurement device with integrated GPS, digital imager, and cellular modem. It is designed to take a deep lung sample of the User's breath, calculate their Blood Alcohol Level (BAC), and send the BAC reading, physical location, and digital image of the User to the Sober Sky Web Portal and Device screen for review.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Human breath
Indicated Patient Age Range
Not Found
Intended User / Care Setting
For Prescription use and OTC 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
Accuracy: The sponsor performed a study with forty-three (43) participants who consumed alcohol to determine if intended (lay) users – untrained study participants - could correctly use and interpret the device using only the supplied instructions for use. Results were compared to an evidential breath alcohol tester (the BACtrack S80 Pro). Participants took their breath alcohol reading with the candidate device and recorded the result. Immediately afterward, the participants were administered a breath alcohol test using the evidential device. There were neither device performance failures nor any subject who could not provide a BAC test from each device. Soberlink (M=0.0426, SD = 0.0278) and BACtrack (M = 0.0417, SD = 0.0262) displayed an average difference of -0.0009 (SD = 0.0047). Regression results indicated a non-significant difference of -0.001 between the two measures with a level of agreement of ß = 0.987 and R2 = 0.974.
Precision/Reproducibility: DOT Testing was conducted in accordance to the NHTSA Docket No. 2008-0030 published in 73 FR 16956. This testing included accuracy and repeatability of the Soberlink Cellular Device in comparison to the predicate device, the PAS Alcovisor Satellite.
Interfering Substances: Bench testing included cigarette smoke interference, high and low ambient temperature, air blank reading, and vibration. The Soberlink Cellular Device "passed" all testing.
Clinical Performance Data: Randomized clinical trials are not applicable. A Usability Study was conducted to determine the impact of human factors. The results indicate that users can comprehend the instructions for use and packaging without additional support in order to utilize the product correctly and safely, and produce a breath sample.
Key Metrics
Accuracy: Average difference of -0.0009 (SD = 0.0047) between Soberlink and BACtrack. Regression results showed a non-significant difference of -0.001, with a level of agreement of ß = 0.987 and R2 = 0.974.
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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads facing to the right. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 14, 2016
SOBERLINK HEALTHCARE LLC C/O ELISA MALDONADO-HOLMERTZ OBELIX CONSULTING, LLC 12416 FAIRFAX RIDGE PLACE AUSTIN TX 78738
Re: K160613
Trade/Device Name: Soberlink Cellular Device Regulation Number: 21 CFR 862.3050 Regulation Name: Breath-alcohol test system Regulatory Class: I, Reserved Product Code: DJZ Dated: June 10, 2016 Received: June 13, 2016
Dear Elisa Maldonado-Holmertz:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Katherine Serrano -S
For : Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K160613
Device Name Soberlink Cellular Device
Indications for Use (Describe)
The Soberlink Cellular Device is intended to quantitatively measure alcohol in human breath. Measurements obtained by this Device are used in the diagnosis of alcohol intoxication.
For Prescription use and OTC use.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the Soberlink logo. The logo consists of a geometric shape made up of blue cubes on the left, followed by the word "SOBERLINK" in black and blue letters. The "SOBER" part of the word is in black, while the "LINK" part is in blue.
Soberlink Healthcare LLC Traditional 510(k) Premarket Submission Soberlink Cellular Device
510(k) Summary
for
Soberlink Cellular Device
1. Submission Sponsor
Soberlink Healthcare LLC 16787 Beach Boulevard #211 Huntington Beach, CA 92647 USA Jenna Costa Strategic Director Email: jenna@soberlink.com Office number: 714.975.7200
2. Submission Correspondent
Obelix Consulting, LLC 12416 Fairfax Ridge Place Austin, TX 78738 USA Elisa Maldonado-Holmertz RA/QA Consultant Email: elisamh@obelixconsult.com Cellphonenumber: 512.431.6069
3. Date Prepared
10 June 2016
4. Device Identification
Trade/Proprietary Name: Soberlink Cellular Device Common/Usual Name: Alcohol Breath Analyzer Classification Name: Devices, breath trapping, alcohol Classification Regulation: 862.3050 – Breath-alcohol test system Product Code: DJZ Device Class: Class I Classification Panel: Toxicology
5. Legally Marketed Predicate Device(s)
K123470 - PAS Breath Analyzer
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Image /page/4/Picture/0 description: The image shows the text "Soberlink Healthcare LLC" on the first line, followed by "Traditional 510(k) Premarket Submission" on the second line, and "Soberlink Cellular Device" on the third line. The text appears to be part of a document or presentation. The text is left-aligned and in a clear, readable font.
Image /page/4/Picture/1 description: The image shows the Soberlink logo. The logo consists of a geometric shape on the left and the word "SOBERLINK" on the right. The geometric shape is made up of several smaller shapes in shades of blue. The word "SOBERLINK" is in a sans-serif font, with the letters "SOBER" in black and the letters "LINK" in blue.
6. Device Description
The Soberlink Cellular Device is a handheld breath alcohol measurement device with integrated GPS, digital imager, and cellular modem. It is designed to take a deep lung sample of the User's breath, calculate their Blood Alcohol Level (BAC), and send the BAC reading, physical location, and digital image of the User to the Sober Sky Web Portal and Device screen for review.
7. Intended Use and Indications for Use Statement
Intended Use
The Soberlink Cellular Device is intended to quantitatively measure alcohol in human breath.
Indications for Use
Measurements obtained by this device are used in the diagnosis of alcohol intoxication.
For Prescription use and OTC use.
8. Substantial Equivalence Discussion
The following table compares the Soberlink Cellular Device and Sober Sky Web Portal to the predicate device with respect to intended use, technological characteristics, and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.
| Manufacturer | Soberlink | PREDICATE |
|---|---|---|
| Trade Name | Soberlink Cellular Device | PAS Alcovisor Satellite Breath |
| Alcohol Analyzer | ||
| 510(k) Number | None | K123470 |
| Product Code | DJZ | DJZ |
| Regulation Number | 862.3050 | 862.3050 |
| Regulation Name | Breath-alcohol test system. | Breath-alcohol test system. |
| Indications for Use | Intended Use | |
| The Soberlink Cellular Device is | ||
| intended to quantitatively measure | ||
| alcohol in human breath. |
Indications for Use
Measurements obtained by this
device are used in the diagnosis of
alcohol intoxication. | The PAS Alcovisor Satellite
Breath Alcohol Analyzer is
intended to measure alcohol in
human breath.
Measurements obtained by
this device are used in the
diagnosis of alcohol
intoxication. |
| RX and OTC | For Prescription use and OTC use. | OTC |
| Mouth Piece | Multiple use disposable | Single use disposable |
| Display | LCD | LCD |
| Sensor | Electrochemical Fuel Cell | Electrochemical Fuel Cell |
| Table 3A - Comparison of Characteristics | ||
|---|---|---|
| -- | -- | ------------------------------------------ |
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Image /page/5/Picture/0 description: The image shows the Soberlink logo. The logo consists of a blue geometric shape on the left and the word "SOBERLINK" in black and blue on the right. The geometric shape is made up of several smaller cubes, and the word "SOBERLINK" is written in a bold, sans-serif font.
Soberlink Healthcare LLC Traditional 510(k) Premarket Submission Soberlink Cellular Device
| Calibration | after every 1500 tests | every 250 tests or every 12 months |
|---|---|---|
| Traceability | Each device is calibrated to .038 | |
| +/-0.002 BAC (103ppm) dry | ||
| gas which is traceable by lot | ||
| number associated with a | ||
| certificate of analysis from the | ||
| manufacturer of the dry gas. | Each device is calibrated to a | |
| 0.100% certified wet bath | ||
| simulator solution which is | ||
| traceable by lot number | ||
| associated with a certificate of | ||
| analysis from the manufacturer | ||
| of the solution. | ||
| Detection Range | 0.000 - 0.400 BAC | 0.000 - 0.400 BAC |
| Exhalation Time | 4 seconds | 3-5 seconds |
| External Material | Medical grade plastics | Medical grade plastics |
| Sterile | No | No |
| Single-Use | No | No |
| AC Powered | No | Yes - 3 AA Batteries and |
| rechargeable battery | ||
| USB Charger (compliant to EN60950, UL and CE) | Yes | No |
| Battery Life | 5-7 days | 500 test on full charge |
| DOT Tested | Yes | Yes |
| LED Tested (compliant to IEC 62471) | Yes | No |
| Complies with ISO 10993-1 | Yes | Yes |
| 60601, EMC & Electrical Safety Testing Passed | Yes | Yes |
9. Non-Clinical Performance Data
Accuracy
The sponsor performed a study to determine if intended (lay) users – untrained study participants - who had consumed alcohol could correctly use and interpret the device using only the supplied instructions for use. Results were compared to an evidential breath alcohol tester (the BACtrack S80 Pro).
Forty-three (43) participants took their breath alcohol reading with the candidate device and recorded the result. Immediately afterward, the participants were administered a breath alcohol test using the evidential device. There were neither device performance failures nor any subject who could not provide a BAC test from each device. Soberlink (M=0.0426, SD = 0.0278) and BACtrack (M = 0.0417, SD = 0.0262) displayed an average difference of -0.0009 (SD = 0.0047). Regression results indicated a non-significant difference of -0.001 between the two measures with a level of agreement of ß = 0.987 and R2 = 0.974.
Precision/Reproducibility
DOT Testing was conducted in accordance to the NHTSA Docket No. 2008-0030 published in 73 FR 16956. This testing included accuracy and repeatability of the Soberlink Cellular Device in comparison to the predicate device, the PAS Alcovisor Satellite.
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Image /page/6/Picture/0 description: The image shows the logo for Soberlink. The logo consists of a blue geometric shape on the left and the word "SOBERLINK" in black letters on the right. The letters "SOBER" are in black, while the letters "LINK" are in a lighter blue color. The geometric shape is made up of several smaller blue shapes.
Soberlink Healthcare LLC Traditional 510(k) Premarket Submission Soberlink Cellular Device
Interfering Substances
Additionally, the bench testing included cigarette smoke interference, high and low ambient temperature, air blank reading, and vibration. The Soberlink Cellular Device "passed" all testing.
As part of demonstrating safety and effectiveness of Soberlink Cellular Device and in showing substantial equivalence to the predicate device that is subject to this 510(k) submission, Soberlink completed a number of tests. The Soberlink Cellular Device meets all the requirements for overall design, EMC testing and electrical safety confirms that the output meets the design inputs and specifications. The Soberlink Cellular Device passed all testing stated above as shown by the acceptable results obtained.
10. Clinical Performance Data
Randomized clinical trials are not applicable as the innovative aspects introduced are well established. Alcohol breathalyzers have been on the market for many years with no significant incidents of safety or efficacy for the predicate devices. The design, development and testing of Soberlink Cellular Device has not resulted in the need for any randomized clinical trials; however a Usability Study was conducted to determine the impact of human factors. The results indicate that users can comprehend the instructions for use and packaging without additional support in order to utilize the product correctly and safely, and produce a breath sample.
11. Statement of Substantial Equivalence
Based upon the 510(k) summary, 510(k) statements (21 CFR 807) and the information provided herein, we conclude that the subject device is substantially equivalent to the predicate device under the Federal Food, Drug, and Cosmetics Act.
lt has been shown in this 510(k) submission that the difference between the Soberlink Cellular Device and Sober Sky Web Portal and the predicate device do not raise any questions regarding its safetyand effectiveness. The Soberlink Cellular Device, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate device.