The Pivot Breath Sensor is a breath carbon monoxide monitor intended for single-user use by cigarette smokers as an educational and motivational tool to inform the user about how breath carbon monoxide levels are affected by smoking behavior. The device is not intended to be used with other combustible, inhaled products.

Device Description

The Pivot Breath Sensor is a personal, portable, lithium ion battery powered breath carbon monoxide ("CO") monitoring device that measures the level of CO in an individual's exhaled breath. It is intended for single-user over-the-counter ("OTC") use by cigarette smokers (users) to measure CO levels in their exhaled breath. This parameter correlates closely with carboxyhemoglobin levels and with cigarette smoking behavior. Hence, the more a person smokes, the higher are their exhaled breath CO levels. The user submits a breath sample by exhaling (blowing) into the mouthpiece of the Pivot Breath Sensor which is directed over electrochemical sensors to quantify the CO level in the breath. The sensor has two buttons - a front, center button and a side button - to help with user inputs and navigation. It also has a rechargeable battery that can be charged using a micro-USB cable by plugging into USB compatible charging sources such as a computer, USB adapter for power outlet, or car USB port. The calculated CO concentration/ level of the exhaled breath is displayed to the user in whole number parts-per-million ("ppm") on the LCD screen of the sensor. The Pivot breath sensor measures and displays CO concentrations from 0 to 100 ppm. Each of the breath sample results is shown to the user with a corresponding color and a number. The color is intended to aid in giving context to the quantitative CO value, aligning with the predicate device's color coding and scientific literature. The sensor can display multiple samples as the CO log and helps to graphically show the user their relative levels of exhaled breath CO throughout the day and between days. Hence, periodic measurements of CO levels may provide users with feedback regarding their smoking exposure, thus helping them to become educated and motivated to quit smoking, as supported by reference literature.

AI/ML Overview

The provided text details the 510(k) summary for the Carrot Inc. Pivot Breath Sensor. Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The regulatory document outlines several studies and their success criteria, which act as acceptance criteria.

2. Sample Size Used for the Test Set and the Data Provenance

18-RP-1061A (Human Factors):
- Sample Size: 15 subjects.
- Data Provenance: Prospective, single-center study. The document does not specify the country of origin but implies it was conducted under the direct supervision of Carrot Inc. or a contracted research institution.
18-RP-1062A (Comparative Performance):
- Sample Size: 70 subjects.
- Data Provenance: Prospective, single-center study. No country of origin is specified.
20-RP-1083A (Expanded Indications):
- Sample Size: 234 subjects, split into two cohorts (40-60% smoking 10-19 CPD, 40-60% smoking 20+ CPD).
- Data Provenance: Prospective, single-center study. No country of origin is specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

The document does not explicitly state the number or qualifications of experts used to establish ground truth for the test sets in the same way one might describe for an imaging AI device. Instead, the "ground truth" for each study is inherent to its design:

18-RP-1061A (Human Factors): The ground truth was the observable ability of untrained lay users to operate the device and interpret results against explicit instructions, likely assessed by study personnel. No specific "experts" are mentioned for establishing ground truth in this context.
18-RP-1062A (Comparative Performance): The ground truth was established by a prescription-use CO breath sensor used with guidance by a trained health care professional. This serves as the reference standard against which the Pivot Breath Sensor's performance was compared. The number and qualifications of these healthcare professionals are not specified, but they are implied to be "trained."
20-RP-1083A (Expanded Indications): The ground truth was self-reported data from participants regarding their "Stage of Change" for quitting smoking, quit attempts, and reduction in cigarettes per day (CPD) compared to baseline. No external "experts" were used to establish this ground truth; it was based on participant responses.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (like 2+1, 3+1 consensus by multiple readers) typically found in AI imaging studies. The studies described are either:

Observational (Human Factors): Study personnel observed participants' interactions.
Comparative Measurement (Comparative Performance): Direct comparison of measurements from two devices.
Self-Reported Outcomes (Expanded Indications): Based on participant responses and observed changes.

Therefore, "none" in the traditional sense of expert adjudication for diagnostic discrepancies.

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 of human readers with vs. without AI assistance was not done. The Pivot Breath Sensor is a direct-to-consumer device that provides readings to a single user, not an AI system assisting human experts in making a diagnosis.

6. If a Standalone (i.e., algorithm only without human-in-the loop performance) was done

Yes, in the context of this device, the "standalone" performance is effectively the performance of the Pivot Breath Sensor itself.

The "Sensor Performance" bench tests (accuracy, precision, linearity, cross-sensitivity) are a direct assessment of the device's standalone algorithmic and hardware performance against controlled environments and known gas concentrations.
The 18-RP-1062A (Comparative Performance) study also assesses the standalone performance of the Pivot Breath Sensor by comparing its readings (taken by self-trained users) to a "prescription-use CO breath sensor submitted with guidance by a trained health care professional." The correlation coefficient of 0.9710 indicates a strong standalone performance in agreement with a reference standard.

7. The Type of Ground Truth Used

Bench Tests: Controlled laboratory measurements and standards for physical and electrical properties, and established ISO standards for biocompatibility.
18-RP-1061A (Human Factors): Observational data of user interaction against predefined criteria for correct operation and interpretation.
18-RP-1062A (Comparative Performance): Measurements from a "prescription-use CO breath sensor submitted with guidance by a trained health care professional." This acts as the clinical gold standard for CO breath measurement.
20-RP-1083A (Expanded Indications): Self-reported outcomes data from participants regarding their smoking behavior, motivation to quit, and quit attempts.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of an AI/ML algorithm development as one would typically see for complex learning models. Given that the device relies on electrochemical sensors, the "training" analogous to machine learning would typically involve:

Sensor calibration: Manufacturers perform extensive calibration on sensor batches using known gas concentrations. This is implied by the "Sensor Performance" bench tests covering multiple lots.
Algorithm development: The internal algorithm that converts sensor signals to ppm readings is developed and refined based on engineering principles and empirical data, not necessarily a separate "training set" in the common AI sense.

Therefore, a specific "training set sample size" as might be used for supervised machine learning is not provided or applicable in the traditional sense for this type of device.

9. How the Ground Truth for the Training Set Was Established

As explained above, a distinct "training set" with ground truth in the AI/ML sense is not described. For sensor calibration and algorithm development, the "ground truth" would be established through:

Known gas concentrations: When calibrating electrochemical sensors, the device is exposed to precise, certified concentrations of carbon monoxide (and potentially interfering gases). These known concentrations serve as the ground truth for fine-tuning the sensor's response curve and the device's internal conversion algorithm.
Engineering and chemical principles: The fundamental operation of an electrochemical sensor is based on established scientific principles, which guide the development of the algorithms that translate raw sensor signals into ppm values.

Summary

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June 30, 2021

Carrot Inc. % Jonathan Kahan Partner Hogan Lovells US LLP 555 Thirteenth Street NW Washington, District of Columbia 20004

Re: K201206

Trade/Device Name: Pivot Breath Sensor Regulation Number: 21 CFR 868.1430 Regulation Name: Carbon monoxide gas analyzer Regulatory Class: Class II Product Code: CCJ Dated: October 13, 2020 Received: October 13, 2020

Dear Jonathan Kahan:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Marianela Perez-Torres, Ph.D. Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201206

Device Name

Pivot Breath Sensor

Indications for Use (Describe)

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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510(k) SUMMARY

Carrot Inc.'s Pivot Breath Sensor

I. Submitter

Company:	Carrot Inc.
Address:	1400A Seaport Blvd, Suite 501Redwood City, CA 94063
Phone:	(717) 380-1196
Contact Person:	Sara Lippert
Date Prepared:	June 30, 2021

II. Subject Device

Company:	Carrot Inc.
Trade Name:	Carbon Monoxide Breath Sensor System
Model Name:	Pivot Breath Sensor
510(k) Number:	K201206
Classification Name:	Carbon monoxide gas analyzer
Regulation:	21 C.F.R. § 868.1430
Regulatory Class:	Class II
Product Code:	CCJ

III. Predicate Device

Company:	Carrot Inc.
Trade Name:	Carbon Monoxide Breath Sensor System
Model Name:	Carbon Monoxide Breath Sensor System
510(k) Number:	K171408
Classification Name:	Carbon monoxide gas analyzer
Regulation:	21 C.F.R. § 868.1430
Regulatory Class:	Class II
Product Code:	CCJ

IV. Device Description

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The user submits a breath sample by exhaling (blowing) into the mouthpiece of the Pivot Breath Sensor which is directed over electrochemical sensors to quantify the CO level in the breath. The sensor has two buttons - a front, center button and a side button - to help with user inputs and navigation. It also has a rechargeable battery that can be charged using a micro-USB cable by plugging into USB compatible charging sources such as a computer, USB adapter for power outlet, or car USB port.

The calculated CO concentration/ level of the exhaled breath is displayed to the user in whole number parts-per-million ("ppm") on the LCD screen of the sensor. The Pivot breath sensor measures and displays CO concentrations from 0 to 100 ppm. Each of the breath sample results is shown to the user with a corresponding color and a number. The color is intended to aid in giving context to the quantitative CO value, aligning with the predicate device's color coding and scientific literature.

The sensor can display multiple samples as the CO log and helps to graphically show the user their relative levels of exhaled breath CO throughout the day and between days. Hence, periodic measurements of CO levels may provide users with feedback regarding their smoking exposure, thus helping them to become educated and motivated to quit smoking, as supported by reference literature.

V. Intended Use / Indications for Use

VI. Summary of Performance Testing

The following tests were conducted to demonstrate the Pivot Breath Sensor's safety and effectiveness.

Bench Tests Performed	Results
Shelf Life	Passed with 18 month shelf life
Biocompatibility	Passed ISO-10993 tests for cytotoxicity, sensitization and irritation
Software Validation	Passed unit, integration and system testing of firmware
Wireless Coexistence	Passed requirements
EMC testing	Passed ISO 60601 testing requirements
Sensor Performance	Passed testing related to accuracy, precision, linearity and cross sensitivity. Testing included multiple lots at various temperature and humidity conditions.
Interfering Gases	Completed testing of interfering gases and included in labeling where applicable
Hardware Verification	Passed hardware and battery life related testing
Packaging Testing	Passed functionality testing after being subjected to ISTA 3A conditioning
Device Use Life	Passed long-term repeated use testing

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	Clinical Studies
StudyAttribute	18-RP-1061A (HumanFactors)	18-RP-1062A(ComparativePerformance)	20-RP-1083A (ExpandedIndications)
Objective	Assess whether anuntrained lay usergroup (representativeof intended users) canoperate the deviceand interpret theresults correctly usingonly the instructionsthat will be providedwith the marketeddevice.	Assess correlation betweenthe measured CO levels (inppm) of the Pivot BreathSensor submitted by a self-trained user withoutguidance by studypersonnel and theprescription-use CO breathsensor submitted withguidance by a trainedhealth care professional.	Assess changes in attitudes andunderstanding towards quittingsmoking as well as smokingbehavior change with use of thePivot breath sensor.
StudyDesign	Prospective, openlabel, single center	Prospective, open label,single center	Prospective, open label, singlecenter
Subjects	15 subjects who self-report smoking 2 ormore cigarettes eachday	70 subjects who self-reportsmoking 2 or morecigarettes each day	234 subjects, in 2 cohorts:• 40-60% who self-reportsmoking 10-19 cigarettes perday (CPD)• 40-60% who self-reportsmoking 20 or more CPD
SuccessCriteria	Ensure that untrainedlay users can properlyoperate the device, andcan interpret the resultscorrectly using only thelabeling to be provided.Validate appropriatemitigations of use-related hazardsidentified in riskmanagementdocumentation.	Based on the nullhypothesis that thePearson correlationcoefficient of prescriptiondevice and Pivot BreathSensor is 0.90 and thealternative hypothesis thatit is >0.90, passingcriterion is refuting the nullhypothesis with a power of≥90% assuming an 0.05alpha level.	Primary endpoint will assesschange in the proportion ofparticipants' Stage of Changeresponse at day 28 versusbaseline.Secondary endpoints include:the proportion of participantswho report ≥ 1 quit attempt byday 28, and the proportion ofparticipants who reduce theirCPD by ≥ 50% by day 28,compared to baseline.
Results	The Human Factorsportion of the studyfound the device to besafe and effective forthe intended users,uses, and useenvironments. Allparticipants, overall,were observed tosafely perform criticaltasks.	Using regression analysis,the 70 pairedmeasurements of CO fromPivot Breath Sensor andthe prescription deviceproduced a line with aslope of 0.9202, a y-intercept of 0.0041 and acorrelation coefficient of0.9710.	Primary: Motivation to quitsmoking improved in astatistically significant manner,with 38.9% of subjects at day 28indicating they were thinking ofquitting in the next 30 daysversus 14.4% at baseline. At 28days, motivation to quit smokingincreased in 29.6%, wasunchanged in 66.7%, anddecreased in 3.7% of subjects.Secondary: By day 28, 28.2% ofthe intent to treat (ITT)population reported making ≥ 1quit attempt, and 23.1% reducedtheir CPD by ≥ 50% compared tobaseline.

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VII. Substantial Equivalence

The subject Pivot Breath Sensor is substantially equivalent to the predicate device, the company's own Carbon Monoxide Breath Sensor System (COBSS) cleared under K171408. Both devices have the same intended use of measuring breath CO levels for single-user overthe-counter ("OTC") use by cigarette smokers (users). The subject device is also similar to the predicate device in fundamental scientific technology. Both are portable, battery powered devices that use electrochemical sensors to non-invasively monitor CO levels. The minor differences in the indications for use statement do not alter the fundamental clinical purpose of the subject device as compared to its predicate, and the minor differences in technological characteristics do not present new questions of safety or effectiveness. Moreover, performance testing demonstrates that the subject device performs as intended and is as safe and effective as the predicate. The table below provides a summary of the similarities and differences between the Pivot Breath Sensor and its predicate device.

Characteristic	Subject Device:Carrot Inc. Pivot BreathSensor	Predicate Device:Carrot Inc. COBSS(K171408)	Comparison
Intended Use/Indicationsfor Use	The Pivot Breath Sensor isa breath carbon monoxidemonitor intended forsingle-user use bycigarette smokers as aneducational andmotivational tool to informthe user about how breathcarbon monoxide levelsare affected by smokingbehavior. The device is notintended to be used withother combustible, inhaledproducts.	The Carbon MonoxideBreath Sensor System(COBSS) is a breathcarbon monoxide monitorintended for single-useruse by cigarette smokersin smoking cessationprograms to inform theuser about how breathcarbon monoxide levelsare affected by smokingbehavior. The device is notintended to be used withother inhaled products.	Both devices are intended tomeasure carbon monoxide(CO) in exhaled breath ofcigarette smokers. Periodicmeasurements of CO levelseducate users about theirsmoking exposure and maymotivate them to quitsmoking.
Environmentof Use	Home, office and other Over the counter (OTC)environments		No difference; identical
DesignFeatures	• Non-invasively measures CO in exhaled breath• Hand-held battery powered• Visual and audible alarms		No difference; identical
User Interface	Side and Center/Mainbuttons to activate/ initiateCO breath measurementand to navigate menus.	Main button toactivate/initiate CObreath measurement	The side button added hasno effect on sensorfunctionality.
Display	Data (Device settings, COsamples, CO trending) aredisplayed to the user onthe device (sensor) itselfvia LCD screen.	Data (Device settings, COsamples, CO trending)displayed to user withinthe Breath SensorApplication (BSA) viasmartphone.	The location of the displayhas moved but it stillcontinues to be a digitalcolor display and has noeffect on sensorfunctionality.
Power Source	Rechargeable lithium ion battery		No difference; identical
SensorTechnology	Electrochemical Sensor (1 each CO and H₂ sensor)		No difference; identical

Comparison of Subject and Predicate Devices

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Characteristic	Subject Device:Carrot Inc. Pivot BreathSensor	Predicate Device:Carrot Inc. COBSS(K171408)	Comparison
ReportedValues	CO levels in parts per million		No difference; identical
ConcentrationRange	0-100 ppm		No difference; identical
Shelf Life	18 month shelf life	6 month shelf life	Extended shelf-life desiredfor better user experience.

VIII. Conclusion

The subject and predicate devices have the same intended use and similar indications for use, technological characteristics, and principles of operation. The modifications to the predicate device reflected in the subject device do not alter its fundamental clinical purpose or raise different questions of safety or efficacy, and performance testing supports that the subject device is substantially equivalent to its prior iteration, the Carbon Monoxide Breath Sensor System (COBSS).

Regulation Number and Section

§ 868.1430 Carbon monoxide gas analyzer.

(a)
Identification. A carbon monoxide gas analyzer is a device intended to measure the concentration of carbon monoxide in a gas mixture to aid in determining the patient's ventilatory status. The device may use techniques such as infrared absorption or gas chromatography.(b)
Classification. Class II (performance standards).

Acceptance Criteria Study	Objective	Success Criteria	Reported Device Performance
Bench Tests
Shelf Life	Not explicitly stated, implied to ensure device remains functional for the specified duration.	Passed with 18 month shelf life	Passed with 18 month shelf life.
Biocompatibility	Ensure materials are safe for human contact.	Passed ISO-10993 tests for cytotoxicity, sensitization and irritation.	Passed ISO-10993 tests for cytotoxicity, sensitization and irritation.
Software Validation	Ensure firmware functions correctly.	Passed unit, integration and system testing of firmware.	Passed unit, integration and system testing of firmware.
Wireless Coexistence	Ensure device operates without interference.	Passed requirements.	Passed requirements.
EMC testing	Ensure electromagnetic compatibility.	Passed ISO 60601 testing requirements.	Passed ISO 60601 testing requirements.
Sensor Performance	Ensure accuracy, precision, linearity, and cross-sensitivity.	Passed testing related to accuracy, precision, linearity and cross sensitivity. Testing included multiple lots at various temperature and humidity conditions.	Passed testing related to accuracy, precision, linearity and cross sensitivity. Testing included multiple lots at various temperature and humidity conditions.
Interfering Gases	Evaluate impact of other gases on sensor readings.	Completed testing of interfering gases and included in labeling where applicable.	Completed testing of interfering gases and included in labeling where applicable.
Hardware Verification	Ensure hardware and battery life meet specifications.	Passed hardware and battery life related testing.	Passed hardware and battery life related testing.
Packaging Testing	Ensure device integrity during shipping and handling.	Passed functionality testing after being subjected to ISTA 3A conditioning.	Passed functionality testing after being subjected to ISTA 3A conditioning.
Device Use Life	Evaluate long-term performance under repeated use.	Passed long-term repeated use testing.	Passed long-term repeated use testing.
Clinical Studies
18-RP-1061A (Human Factors)	Assess whether an untrained lay user group can operate the device and interpret results correctly using only provided instructions. Validate appropriate mitigations of use-related hazards.	Ensure that untrained lay users can properly operate the device, and can interpret the results correctly using only the labeling to be provided. Validate appropriate mitigations of use-related hazards identified in risk management documentation.	Found the device to be safe and effective for the intended users, uses, and use environments. All participants, overall, were observed to safely perform critical tasks.
18-RP-1062A (Comparative Performance)	Assess correlation between measured CO levels of the Pivot Breath Sensor (self-trained user) and a prescription-use CO breath sensor (trained healthcare professional guidance).	Based on the null hypothesis that the Pearson correlation coefficient of prescription device and Pivot Breath Sensor is 0.90 and the alternative hypothesis that it is >0.90, passing criterion is refuting the null hypothesis with a power of ≥90% assuming an 0.05 alpha level.	Using regression analysis, the 70 paired measurements of CO from Pivot Breath Sensor and the prescription device produced a line with a slope of 0.9202, a y-intercept of 0.0041 and a correlation coefficient of 0.9710.
20-RP-1083A (Expanded Indications)	Assess changes in attitudes and understanding towards quitting smoking as well as smoking behavior change with use of the Pivot breath sensor.	Primary: Assess change in the proportion of participants' Stage of Change response at day 28 versus baseline.Secondary: Proportion of participants who report ≥ 1 quit attempt by day 28, and proportion of participants who reduce their CPD by ≥ 50% by day 28, compared to baseline.	Primary: Motivation to quit smoking improved in a statistically significant manner, with 38.9% of subjects at day 28 indicating they were thinking of quitting in the next 30 days versus 14.4% at baseline. At 28 days, motivation to quit smoking increased in 29.6%, was unchanged in 66.7%, and decreased in 3.7% of subjects.Secondary: By day 28, 28.2% of the intent to treat (ITT) population reported making ≥ 1 quit attempt, and 23.1% reduced their CPD by ≥ 50% compared to baseline.