(167 days)
Not Found
No
The device description details a straightforward electrochemical fuel cell sensor and a direct conversion of electrical current to BAC based on established principles (Henry's law). There is no mention of AI, ML, or any complex algorithms that would suggest their use. The performance studies focus on accuracy against established standards, not on training or validation of AI/ML models.
No
The device is used to diagnose alcohol intoxication by measuring alcohol in breath, not to treat a disease or condition.
Yes
The 'Intended Use / 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 that the devices are handheld devices made from durable plastic with an internal circuit board, a sensor, and an automatic pump, indicating they are hardware devices, not software-only.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the measurements obtained are "used in the diagnosis of alcohol intoxication." This is a key characteristic of an IVD, as it's used to provide information for diagnostic purposes.
- Sample Type: The device analyzes a sample of human breath, which is a biological specimen. IVDs typically analyze biological samples.
- Measurement of a Substance: The device measures the presence and amount of alcohol in the breath, which is a substance within the biological sample.
- Diagnosis: The results are used to aid in the diagnosis of a medical condition (alcohol intoxication).
While the device is used by the general public and is a handheld device, the core function of analyzing a biological sample to provide information for diagnosis aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
The PAS Alcovisor® Mars™ Breath Alcohol Analyzer is intended to measure alcohol in human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.
Product codes (comma separated list FDA assigned to the subject device)
DJZ
Device Description
The PAS Alcovisor® Satellite™ Breath Alcohol Analyzer and the PAS Alcovisor® Mars™ Breath Alcohol Analyzer are breath alcohol test systems designed to sample a user's deep lung breath in order to test for the presence of alcohol. The sensor is an electrochemical fuel cell which will only respond to alcohol. After the user blows into the device using a disposable mouthpiece, for 3-4 seconds, a small sample of breath is drawn into the fuel cell by an automatic pump and a chemical reaction between the alcohol and fuel cell occurs. This reaction generates an electrical current which is directly related to the amount of alcohol in the sample. The current is then converted to a Blood Alcohol Concentration (BAC) level and displayed for the user. The relationship between alcohol in a person's deep lung breath and in their blood is well established using Henry's law, which gives a ratio of 2100:1.
The Satellite™ and Mars™ are handheld devices made from durable plastic with an internal circuit board. The Satellite™ uses an internal rechargeable battery and the Mars™ uses three AAA batteries.
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
General 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 safety and effectiveness of the PAS Alcovisor® Satellite™ and the PAS Alcovisor® Mars™ devices are inherent in the device designs and have been verified through consumer field evaluations and EMC testing. The ability of both the PAS Alcovisor® Mars™ and the PAS Alcovisor® Satellite™ to measure alcohol content accurately was demonstrated by the tests conducted by the US Department of Transportation (National Highway Traffic Safety Administration (NHTSA)) for approval as an Alcohol Screening Device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: 0.01% up to 0.100 and +/- 10% above 0.100%
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
KC 123470
Image /page/0/Picture/1 description: The image shows the logo for PAS Systems International Alcohol Sensor Systems. The logo consists of a globe on the left and the text "PAS" in large, bold letters on the right. Below the letters, the words "SYSTEMS INTERNATIONAL ALCOHOL SENSOR SYSTEMS" are written in smaller letters. The globe is a black and white image of the earth.
APR 2 9 2013
್ಸ್
Section 5: 510 (k) Summary
510 (k) Owner:
PAS Systems International, Inc 1616 Princess Anne St Fredericksburg, VA 22401 Phone: (540) 372-3431 Fax: (540) 372-7647
Contact Person: Jarel R. Kelsey, President
Date Prepared: 02-06-2013
Device Name:
Trade Name: PAS Alcovisor® Satellite™ Breath Alcohol Analyzer and PAS Alcovisor® Mars™ Breath Alcohol Analyzer Common Name: Breath Alcohol Test System Classification Name: Devices, Breath Trapping, Alcohol Regulation Number: 21 CFR 862.3050 Classification Product Code: DJZ
Indications for Use:
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.
The PAS Alcovisor® Mars™ Breath Alcohol Analyzer is intended to measure alcohol in human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.
Page 5.1
1
Predicate Device Summary:
The PAS Alcovisor® Satellite™ Breath Alcohol Analyzer and the PAS Alcovisor® Mars™ Breath Alcohol Analyzer devices are claimed to be substantially equivalent to the AlcoHawk PT500 (510 (k) Number K080848).
Device Description:
The PAS Alcovisor® Satellite™ Breath Alcohol Analyzer and the PAS Alcovisor® Mars™ Breath Alcohol Analyzer are breath alcohol test systems designed to sample a user's deep lung breath in order to test for the presence of alcohol. The sensor is an electrochemical fuel cell which will only respond to alcohol. After the user blows into the device using a disposable mouthpiece, for 3-4 seconds, a small sample of breath is drawn into the fuel cell by an automatic pump and a chemical reaction between the alcohol and fuel cell occurs. This reaction generates an electrical current which is directly related to the amount of alcohol in the sample. The current is then converted to a Blood Alcohol Concentration (BAC) level and displayed for the user. The relationship between alcohol in a person's deep lung breath and in their blood is well established using Henry's law, which gives a ratio of 2100:1.
The Satellite™ and Mars™ are handheld devices made from durable plastic with an internal circuit board. The Satellite™ uses an internal rechargeable battery and the Mars™ uses three AAA batteries.
| Feature | Predicate :
AlcoHawk PT500 | PAS Alcovisor Satellite | PAS Alcovisor Mars |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | Intended to
measure alcohol
in human breath.
Measurements
obtained in this
device are used
in the diagnosis
of alcohol
intoxication. | This device is
intended to
measure alcohol
on human breath.
Measurements
obtained by this
device are used in
the diagnosis of
alcohol
intoxication. | This device is
intended to
measure alcohol on
human breath.
Measurements
obtained by this
device are used in
the diagnosis of
alcohol
intoxication. |
| Sensor | Electrochemical
Fuel Cell | Electrochemical
Fuel Cell | Electrochemical
Fuel Cell |
| Mouthpiece | Single Use
Disposable | Single Use
Disposable | Single Use
Disposable |
Table 1: Summary of Substantial Equivalence to Predicate Device:
2
| Power Source | 2 - AA Batteries | An Internal Rechargeable Battery | 3 - AAA Batteries |
|---|---|---|---|
| Dimensions | 5 in x 2.63 in x 1.25 in | 4.75 in x 1.5 in x 1.46 in | 4.2 in x 2.0 in x 0.70 in |
| Construction | Plastic Case with internal circuit board. | Plastic Case with internal circuit board and battery | Plastic Case with internal circuit board |
| Weight | 5.2 oz (with batteries) | 4.2 oz | 4.0 oz (with batteries) |
| Warm-up Time | 10 seconds | 5 seconds | 5 seconds |
| Measurement Site | Mouth | Mouth | Mouth |
| Accuracy | 0.01% | 0.01% up to 0.100 | |
| and +/- 10% above | |||
| 0.100% | 0.01% up to 0.100 | ||
| and +/- 10% above | |||
| 0.100% | |||
| Battery Life | 200 Tests | 500 tests (on full charge) | 500 tests |
| NHTSA (DOT)- | |||
| Approval | Yes | Yes | Yes |
| Intended User | General Public | General Public | General Public |
Conclusion:
The safety and effectiveness of the PAS Alcovisor® Satellite™ and the PAS Alcovisor® Mars™ devices are inherent in the device designs and have been verified through consumer field evaluations and EMC testing. The ability of both the PAS Alcovisor® Mars™ and the PAS Alcovisor® Satellite™ to measure alcohol content accurately was demonstrated by the tests conducted by the US Department of Transportation (National Highway Traffic Safety Administration (NHTSA)) for approval as an Alcohol Screening Device. Both devices also have the same intended use, with few technological differences, as the predicate device. To ensure safe use of these devices, comprehensive operating instructions are provided as well as an 800 number with qualified customer service staff on hand to guide and answer questions. In conclusion, both the Satellite™ and Mars™ are substantially equivalent to the predicate device.
3
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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract representation of a human figure or a caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 29, 2013
PAS Systems International, Inc. C/O Jarel R. Kelsey 1616 Princess Anne Street FREDERICKSBURG VA 22401
Re: K123470
Trade/Device Name: PAS Alcovisor Satellite Breath Alcohol Analyzer PAS Alcovisor Mar Breath Alcohol Analyzer . Regulation Number: 21 CFR 862.3050
Regulation Name: Breath-alcohol test system Regulatory Class: I Product Code: DJZ Dated: February 06, 2013 Received: February 19, 2013
Dear Mr. Kelsey:
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 Part 801); 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.
4
Page 2- Jarel R. Kelsey
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Carol C. Benson -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
5
Indications for Use
510(k) Number (if known): K123470
Device Name: PAS Alcovisor Mars Breath Alcohol Analyzer PAS Alcovisor Satellite Breath Alcohol Analyzer
Indications for Use:
PAS Alcovisor Mars Breath Alcohol Analyzer
The PAS Alcovisor Mars Breath Alcohol Analyzer is intended to measure alcohol in human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.
PAS Alcovisor Satellite Breath Alcohol Analyzer
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.
Prescription Use (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use X (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Denise Johnson-lyles -S 2013.04.29 12:51:42 -04'00'
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k) K123470