Pivot Breath Sensor

K201206 · Carrot, Inc. · CCJ · Jun 30, 2021 · Anesthesiology

Device Facts

• Record ID: K201206
• Device Name: Pivot Breath Sensor
• Applicant: Carrot, Inc.
• Product Code: CCJ · Anesthesiology
• Decision Date: Jun 30, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1430
• Device Class: Class 2

Intended Use

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 Story

Portable, lithium-ion battery-powered breath carbon monoxide (CO) monitor; used by cigarette smokers in home/OTC settings. User exhales into mouthpiece; electrochemical sensors quantify CO concentration (0-100 ppm). Device features LCD screen for direct display of CO levels, color-coded for context, and navigation buttons. Provides longitudinal tracking of CO levels to educate and motivate smoking cessation. Output informs users of smoking exposure; helps track smoking behavior changes over time. No external smartphone application required for display compared to predicate.

Clinical Evidence

Three prospective, open-label studies: 1) Human Factors (n=15) confirmed untrained users can safely operate and interpret results. 2) Comparative Performance (n=70) showed high correlation (r=0.9710) between Pivot sensor and prescription-use predicate. 3) Expanded Indications (n=234) demonstrated clinical utility: 38.9% of subjects increased motivation to quit by day 28; 28.2% made at least one quit attempt; 23.1% reduced cigarettes per day by ≥50%.

Technological Characteristics

Portable, handheld device; rechargeable lithium-ion battery. Sensing principle: electrochemical (CO and H2 sensors). Range: 0-100 ppm. Display: integrated LCD. Connectivity: standalone (no smartphone app required). Biocompatibility: ISO 10993 compliant. EMC: IEC 60601 compliant. Shelf life: 18 months.

Indications for Use

Indicated for cigarette smokers (age 18-80) as an educational/motivational tool to monitor breath carbon monoxide levels. Contraindicated for suspected carbon monoxide poisoning or smoke inhalation.

Regulatory Classification

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.

Predicate Devices

• Carbon Monoxide Breath Sensor System (K171408)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

| 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 501<br>Redwood City, CA 94063 |
| Phone: | [phone] |
| 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

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.

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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

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.

## 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 | | |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Study<br>Attribute | 18-RP-1061A (Human<br>Factors) | 18-RP-1062A<br>(Comparative<br>Performance) | 20-RP-1083A (Expanded<br>Indications) |
| Objective | Assess whether an<br>untrained lay user<br>group (representative<br>of intended users) can<br>operate the device<br>and interpret the<br>results correctly using<br>only the instructions<br>that will be provided<br>with the marketed<br>device. | Assess correlation between<br>the measured CO levels (in<br>ppm) of the Pivot Breath<br>Sensor submitted by a self-<br>trained user without<br>guidance by study<br>personnel and the<br>prescription-use CO breath<br>sensor submitted with<br>guidance by a trained<br>health care professional. | Assess changes in attitudes and<br>understanding towards quitting<br>smoking as well as smoking<br>behavior change with use of the<br>Pivot breath sensor. |
| Study<br>Design | Prospective, open<br>label, single center | Prospective, open label,<br>single center | Prospective, open label, single<br>center |
| Subjects | 15 subjects who self-<br>report smoking 2 or<br>more cigarettes each<br>day | 70 subjects who self-report<br>smoking 2 or more<br>cigarettes each day | 234 subjects, in 2 cohorts:<br>• 40-60% who self-report<br>smoking 10-19 cigarettes per<br>day (CPD)<br>• 40-60% who self-report<br>smoking 20 or more CPD |
| Success<br>Criteria | Ensure that untrained<br>lay users can properly<br>operate the device, and<br>can interpret the results<br>correctly using only the<br>labeling to be provided.<br>Validate appropriate<br>mitigations of use-<br>related hazards<br>identified in risk<br>management<br>documentation. | Based on the null<br>hypothesis that the<br>Pearson correlation<br>coefficient of prescription<br>device and Pivot Breath<br>Sensor is 0.90 and the<br>alternative hypothesis that<br>it is >0.90, passing<br>criterion is refuting the null<br>hypothesis with a power of<br>≥90% assuming an 0.05<br>alpha level. | Primary endpoint will assess<br>change in the proportion of<br>participants' Stage of Change<br>response at day 28 versus<br>baseline.<br>Secondary endpoints include:<br>the proportion of participants<br>who report ≥ 1 quit attempt by<br>day 28, and the proportion of<br>participants who reduce their<br>CPD by ≥ 50% by day 28,<br>compared to baseline. |
| Results | The Human Factors<br>portion of the study<br>found the device to be<br>safe and effective for<br>the intended users,<br>uses, and use<br>environments. All<br>participants, overall,<br>were observed to<br>safely perform critical<br>tasks. | Using regression analysis,<br>the 70 paired<br>measurements of CO from<br>Pivot Breath Sensor and<br>the prescription device<br>produced a line with a<br>slope of 0.9202, a y-<br>intercept of 0.0041 and a<br>correlation coefficient of<br>0.9710. | <b>Primary:</b> Motivation to quit<br>smoking improved in a<br>statistically significant manner,<br>with 38.9% of subjects at day 28<br>indicating they were thinking of<br>quitting in the next 30 days<br>versus 14.4% at baseline. At 28<br>days, motivation to quit smoking<br>increased in 29.6%, was<br>unchanged in 66.7%, and<br>decreased in 3.7% of subjects.<br><b>Secondary:</b> By day 28, 28.2% of<br>the intent to treat (ITT)<br>population reported making ≥ 1<br>quit attempt, and 23.1% reduced<br>their CPD by ≥ 50% compared to<br>baseline. |

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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:<br>Carrot Inc. Pivot Breath<br>Sensor | Predicate Device:<br>Carrot Inc. COBSS<br>(K171408) | Comparison |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/<br>Indications<br>for Use | The Pivot Breath Sensor is<br>a breath carbon monoxide<br>monitor intended for<br>single-user use by<br>cigarette smokers as an<br>educational and<br>motivational tool to inform<br>the user about how breath<br>carbon monoxide levels<br>are affected by smoking<br>behavior. The device is not<br>intended to be used with<br>other combustible, inhaled<br>products. | The Carbon Monoxide<br>Breath Sensor System<br>(COBSS) is a breath<br>carbon monoxide monitor<br>intended for single-user<br>use by cigarette smokers<br>in smoking cessation<br>programs to inform the<br>user about how breath<br>carbon monoxide levels<br>are affected by smoking<br>behavior. The device is not<br>intended to be used with<br>other inhaled products. | Both devices are intended to<br>measure carbon monoxide<br>(CO) in exhaled breath of<br>cigarette smokers. Periodic<br>measurements of CO levels<br>educate users about their<br>smoking exposure and may<br>motivate them to quit<br>smoking. |
| Environment<br>of Use | Home, office and other Over the counter (OTC)<br>environments | | No difference; identical |
| Design<br>Features | • Non-invasively measures CO in exhaled breath<br>• Hand-held battery powered<br>• Visual and audible alarms | | No difference; identical |
| User Interface | Side and Center/Main<br>buttons to activate/ initiate<br>CO breath measurement<br>and to navigate menus. | Main button to<br>activate/initiate CO<br>breath measurement | The side button added has<br>no effect on sensor<br>functionality. |
| Display | Data (Device settings, CO<br>samples, CO trending) are<br>displayed to the user on<br>the device (sensor) itself<br>via LCD screen. | Data (Device settings, CO<br>samples, CO trending)<br>displayed to user within<br>the Breath Sensor<br>Application (BSA) via<br>smartphone. | The location of the display<br>has moved but it still<br>continues to be a digital<br>color display and has no<br>effect on sensor<br>functionality. |
| Power Source | Rechargeable lithium ion battery | | No difference; identical |
| Sensor<br>Technology | Electrochemical Sensor (1 each CO and H₂ sensor) | | No difference; identical |

#### Comparison of Subject and Predicate Devices

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| Characteristic | Subject Device:<br>Carrot Inc. Pivot Breath<br>Sensor | Predicate Device:<br>Carrot Inc. COBSS<br>(K171408) | Comparison |
|------------------------|-------------------------------------------------------|-----------------------------------------------------|------------------------------------------------------------|
| Reported<br>Values | CO levels in parts per million | | No difference; identical |
| Concentration<br>Range | 0-100 ppm | | No difference; identical |
| Shelf Life | 18 month shelf life | 6 month shelf life | Extended shelf-life desired<br>for 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).