Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on electrochemical sensors and basic data display, with no mention of AI/ML algorithms for data processing or interpretation beyond simple correlation and graphical representation.

Therapeutic

No.
The device is described as an "educational and motivational tool" to inform users about carbon monoxide levels, not to diagnose, treat, or prevent a disease or condition. While it may indirectly support smoking cessation, its stated purpose is informational and motivational.

Diagnostic

No

The "Intended Use" states it is an "educational and motivational tool to inform the user about how breath carbon monoxide levels are affected by smoking behavior." It is not described as being used to diagnose conditions or diseases.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "personal, portable, lithium ion battery powered breath carbon monoxide ("CO") monitoring device" with physical components like a mouthpiece, electrochemical sensors, buttons, an LCD screen, and a rechargeable battery. This indicates it is a hardware device with integrated software, not a software-only medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, the Pivot Breath Sensor is an In Vitro Diagnostic (IVD) device.

Here's why:

Measures a physiological parameter: The device measures the level of carbon monoxide (CO) in exhaled breath. While breath is expelled from the body, the measurement of a substance within that breath (CO) is considered an in vitro test.
Provides information about a physiological state: The CO level in breath is directly correlated with carboxyhemoglobin levels and cigarette smoking behavior. This measurement provides information about the user's exposure to CO from smoking, which is a physiological consequence of their behavior.
Intended for use outside the body: The breath sample is collected and analyzed by the device outside of the user's body.

The intended use as an "educational and motivational tool" does not negate its classification as an IVD, as it achieves this purpose by performing an in vitro measurement of a physiological parameter. The fact that it's for single-user, OTC use also aligns with the scope of IVD devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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.

Product codes

CCJ

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Exhaled breath

Indicated Patient Age Range

Not Found

Intended User / Care Setting

single-user use by cigarette smokers / Home, office and other Over the counter (OTC) environments

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

Bench Tests Performed:

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

Clinical Studies:

18-RP-1061A (Human Factors)
- Study Type: Prospective, open label, single center
- Sample Size: 15 subjects who self-report smoking 2 or more cigarettes each day
- Key Results: The Human Factors portion of the study 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)
- Study Type: Prospective, open label, single center
- Sample Size: 70 subjects who self-report smoking 2 or more cigarettes each day
- Key Results: 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)
- Study Type: Prospective, open label, single center
- Sample Size: 234 subjects, in 2 cohorts:
  - 40-60% who self-report smoking 10-19 cigarettes per day (CPD)
  - 40-60% who self-report smoking 20 or more CPD
- Key Results:
  - 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.

Key Metrics

Not Found

Predicate Device(s)

K171408

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

1

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

2

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
Redwood 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

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.

4

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

5

	Clinical Studies
Study
Attribute	18-RP-1061A (Human
Factors)	18-RP-1062A
(Comparative
Performance)	20-RP-1083A (Expanded
Indications)
Objective	Assess whether an
untrained lay user
group (representative
of intended users) can
operate the device
and interpret the
results correctly using
only the instructions
that will be provided
with the marketed
device.	Assess correlation between
the measured CO levels (in
ppm) of the Pivot Breath
Sensor submitted by a self-
trained user without
guidance by study
personnel and the
prescription-use CO breath
sensor submitted with
guidance by a trained
health care professional.	Assess changes in attitudes and
understanding towards quitting
smoking as well as smoking
behavior change with use of the
Pivot breath sensor.
Study
Design	Prospective, open
label, single center	Prospective, open label,
single center	Prospective, open label, single
center
Subjects	15 subjects who self-
report smoking 2 or
more cigarettes each
day	70 subjects who self-report
smoking 2 or more
cigarettes each day	234 subjects, in 2 cohorts:
• 40-60% who self-report
smoking 10-19 cigarettes per
day (CPD)
• 40-60% who self-report
smoking 20 or more CPD
Success
Criteria	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.	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.	Primary endpoint will assess
change in the proportion of
participants' Stage of Change
response at day 28 versus
baseline.
Secondary endpoints include:
the proportion of participants
who report ≥ 1 quit attempt by
day 28, and the proportion of
participants who reduce their
CPD by ≥ 50% by day 28,
compared to baseline.
Results	The Human Factors
portion of the study
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.	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.	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.

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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 Breath
Sensor | Predicate Device:
Carrot Inc. COBSS
(K171408) | Comparison |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | The Carbon Monoxide
Breath Sensor System
(COBSS) is a breath
carbon monoxide monitor
intended for single-user
use by cigarette smokers
in smoking cessation
programs 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 inhaled products. | Both devices are intended to
measure carbon monoxide
(CO) in exhaled breath of
cigarette smokers. Periodic
measurements of CO levels
educate users about their
smoking exposure and may
motivate them to quit
smoking. |
| Environment
of Use | Home, office and other Over the counter (OTC)
environments | | No difference; identical |
| Design
Features | • Non-invasively measures CO in exhaled breath
• Hand-held battery powered
• Visual and audible alarms | | No difference; identical |
| User Interface | Side and Center/Main
buttons to activate/ initiate
CO breath measurement
and to navigate menus. | Main button to
activate/initiate CO
breath measurement | The side button added has
no effect on sensor
functionality. |
| Display | Data (Device settings, CO
samples, CO trending) are
displayed to the user on
the device (sensor) itself
via LCD screen. | Data (Device settings, CO
samples, CO trending)
displayed to user within
the Breath Sensor
Application (BSA) via
smartphone. | The location of the display
has moved but it still
continues to be a digital
color display and has no
effect on sensor
functionality. |
| Power Source | Rechargeable lithium ion battery | | No difference; identical |
| Sensor
Technology | Electrochemical Sensor (1 each CO and H₂ sensor) | | No difference; identical |

Comparison of Subject and Predicate Devices

7

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