(167 days)
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.
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.
The provided text describes the PAS Alcovisor® Satellite™ and Mars™ Breath Alcohol Analyzers. Here's a breakdown of the acceptance criteria and the study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature | Acceptance Criteria (from predicate) | Reported Device Performance (PAS Alcovisor Satellite™ / Mars™) |
|---|---|---|
| Accuracy | 0.01% | 0.01% up to 0.100% and +/- 10% above 0.100% |
| NHTSA (DOT)-Approval | Yes | Yes |
Note: The document explicitly states the "Accuracy" and "NHTSA (DOT)-Approval" as comparable features between the predicate and the new devices. While other features like sensor type, mouthpiece, power source, dimensions, construction, weight, warm-up time, measurement site, battery life, and intended user are listed for comparison, they are described as direct equivalences or minor technological differences, rather than distinct "acceptance criteria" with specific thresholds reported for the new device. The "Accuracy" is the most direct performance metric given an acceptance range and the device's reported performance within that range.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "consumer field evaluations" for verification and "tests conducted by the US Department of Transportation (National Highway Traffic Safety Administration (NHTSA)) for approval as an Alcohol Screening Device." However, the exact number of participants or tests for these evaluations is not provided.
- Data Provenance: The tests were conducted by the US Department of Transportation (National Highway Traffic Safety Administration (NHTSA)). The nature of the "consumer field evaluations" is not further detailed, so specific countries of origin beyond the US (for NHTSA) are unknown. The evaluations appear to be prospective as they were conducted to obtain approval for the devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: The ground truth was established by the US Department of Transportation (NHTSA). While the document doesn't detail the qualifications of specific individuals, NHTSA's role implies that the tests and their interpretation were conducted by qualified personnel experienced in alcohol breath testing device evaluation and regulatory standards.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly described. The testing for NHTSA approval implies a standardized method for determining alcohol content, likely using a known standard or reference method (e.g., blood alcohol tests or calibrated alcohol solutions) that serves as the ground truth. There is no mention of a human expert consensus or multiple reader adjudication process for the test set results.
5. 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 analyzer, not an AI-assisted diagnostic tool that requires human interpretation. Therefore, the concept of human readers improving with or without AI assistance is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, a standalone performance study was done. The device's performance was evaluated by the NHTSA for approval as an Alcohol Screening Device. This implies testing of the device itself (algorithm + hardware) to accurately measure alcohol content in human breath, without a human-in-the-loop interpretation process beyond operating the device.
7. The Type of Ground Truth Used
- Ground Truth Type: The ground truth for evaluating the device's accuracy would have been based on known alcohol concentrations. This could involve:
- Calibrated alcohol standards: Using solutions or simulators with precisely known alcohol concentrations.
- Reference methods: Comparing breath readings to a validated, accurate blood alcohol concentration (BAC) measurement, which is considered the gold standard for alcohol intoxication.
- The document implies the tests were conducted for "approval as an Alcohol Screening Device" by NHTSA, which follows strict protocols for establishing accurate alcohol levels.
8. The Sample Size for the Training Set
- Not applicable. This device is a physical instrument with an electrochemical fuel cell sensor and embedded logic, not a machine learning or AI model that requires a "training set" in the conventional sense of AI development.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As the device does not rely on a machine learning "training set," there is no ground truth established for such a set. The device's underlying principles are based on the chemistry of its sensor and established physiological relationships (Henry's law) rather than data-driven learning.
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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
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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
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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 tomeasure alcoholin human breath.Measurementsobtained in thisdevice are usedin the diagnosisof alcoholintoxication. | This device isintended tomeasure alcoholon human breath.Measurementsobtained by thisdevice are used inthe diagnosis ofalcoholintoxication. | This device isintended tomeasure alcohol onhuman breath.Measurementsobtained by thisdevice are used inthe diagnosis ofalcoholintoxication. |
| Sensor | ElectrochemicalFuel Cell | ElectrochemicalFuel Cell | ElectrochemicalFuel Cell |
| Mouthpiece | Single UseDisposable | Single UseDisposable | Single UseDisposable |
Table 1: Summary of Substantial Equivalence to Predicate Device:
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| 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 0.100and +/- 10% above0.100% | 0.01% up to 0.100and +/- 10% above0.100% |
| 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.
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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 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.
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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
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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
§ 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.