iCOquit® Smokerlyzer®

K211918 · Bedfont Scientific, Ltd. · CCJ · Dec 21, 2021 · Anesthesiology

Device Facts

• Record ID: K211918
• Device Name: iCOquit® Smokerlyzer®
• Applicant: Bedfont Scientific, Ltd.
• Product Code: CCJ · Anesthesiology
• Decision Date: Dec 21, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1430
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended Use

The iCOquit® Smokerlyzer® breath carbon monoxide (CO) monitor is intended for single patient use by cigarette smoking individuals, notifying the individual user of the amount of CO on their breath produced as a consequence of smoking activity. The device can be used in smoking cessation programmes.

Device Story

Handheld electrochemical breath CO monitor; pairs via Bluetooth to iCOquit® smartphone/tablet app. User exhales into device port; electrochemical sensor detects CO; generates electrical output; signal amplified and transmitted to app. Used in home/clinic settings by individual smokers. Provides quantitative CO measurement (0-100 ppm) to inform user of smoking-related CO levels; supports smoking cessation efforts. Powered by non-rechargeable 3v lithium-ion coin cell battery.

Clinical Evidence

Bench testing only. Includes biocompatibility (ISO 10993-1), electrical safety (ES60601-1), EMC/EMI (IEC 60601-1-2), and system validation. Summative usability testing with untrained lay users demonstrated effective comprehension and device operation.

Technological Characteristics

Handheld electrochemical CO monitor. Powered by 3v lithium-ion coin cell battery. Bluetooth connectivity to mobile app. Operating range 15°-35°C. Single-patient use. Software lifecycle per IEC 62304. Biocompatibility per ISO 10993-1. Safety/EMC per IEC 60601-1, 60601-1-11, and 60601-1-2.

Indications for Use

Indicated for single patient use by cigarette smokers in smoking cessation programs to monitor breath carbon monoxide levels as a consequence of smoking activity.

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 (COBSS) (K171408)

Submission Summary (Full Text)

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December 21, 2021

Bedfont Scientific Ltd % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K211918

Trade/Device Name: iCOquit® Smokerlyzer® Regulation Number: 21 CFR 868.1430 Regulation Name: Carbon monoxide gas analyzer Regulatory Class: Class II Product Code: CCJ Dated: October 7, 2021 Received: October 8, 2021

Dear Prithul Bom:

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.

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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 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 (QS) 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 medical devices and radiation-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

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# Indications for Use

510(k) Number (if known) K211918

Device Name iCOquit® Smokerlyzer®

Indications for Use (Describe)

The iCOquit® Smokelyzer® breath carbon monoxide (CO) monitor is intended for single patient use by cigarette smoking individuals, notifying the individual user of the amount of CO on their breath produced as a consequence of smoking activity. The device can be used in smoking cessation programmes.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Bedfont Scientific Ltd. The logo features five colorful circles in yellow, pink, orange, purple, and blue. Below the circles is the company name "bedfont" in a dark blue sans-serif font, with the "o" in "bedfont" being a lighter blue color. Underneath the company name is the text "est. 1976" in a smaller, dark blue font.

### 510(K) Number___K211918

### 510(k) Summary

This summary of 510(k) information is being submitted in accordance with the requirement of 21 CFR 807.92.

#### SUBMITTER .

Bedfont Scientific Ltd Station Road, Harrietsham, Maidstone, Kent, ME17 1JA United Kingdom

Telephone: [phone] Fax: [phone]

Contact Person: Louise Bateman, Senior QA & RA Manager

Email: [e-mail] Date of Summary: 13 May 2021

#### II. SUBJECT DEVICE

Device Name: iCOquit® Smokerlyzer® Analyzer, Gas, Carbon-monoxide, Gaseous-phase Classification Name: Regulation Description: Carbon monoxide gas analyzer Product Requlatory Class: Product Regulatory Code: CCJ Review Panel: Anesthesiology Code of Federal Regulation: 21 CFR 868.1430

#### lll. PREDICATE DEVICE

Manufacturer: Carrot Sense Inc Device Trade Name: Carbon Monoxide Breath Sensor System (COBSS) Device 510(k): K171408 Regulation Description: Carbon monoxide gas analyzer Product Regulatory Class: . Product Regulatory Code: CCJ Code of Federal Regulation: 21 CFR 868.1430

Bedfont Scientific Ltd

Station Road, Harrietsham, Maidstone, Kent, ME17 1JA, England Tel: [phone], Fax: [phone], Email: [e-mail] Registered in: England and Wales. Registered No: 1289798 Issue 3 - February 2017, Part No: MKT361

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Image /page/4/Picture/0 description: The image shows the logo for Bedfont Scientific Ltd. The logo features five colorful circles in yellow, pink, orange, purple, and blue. Below the circles is the word "bedfont" in a stylized font, with the "o" in "bedfont" being a solid blue circle. Below the word "bedfont" is the text "est. 1976".

#### IV. DEVICE DESCRIPTION

The iCOquit® Smokerlyzer® device is a hand-held breath monitor for the detection of Carbon Monoxide (CO) on the breath, using a non-invasive method of breath analysis to detect levels of Carbon Monoxide (CO).

The iCOquit® Smokerlyzer® device works in conjunction with the iCOquit® App developed for smartphone or tablet, which the user pairs to the device via Bluetooth.

The iCOquit® App works in conjunction with the iCOquit® Smokerlyzer® personal stop-smoking tool to provide visual motivation to help the user quit as track their quitting progress in real-time.

The iCOquit® Smokerlyzer® is an over-the-counter, hand-held breath monitor. It is not for use with other inhaled products. The use of exhaled CO measurements for the rapid estimation of carboxyhaemoglobin levels has been supported as an aid for smoking cessation and a breath CO monitor can be used as a motivational and educational tool in the home environment, including as part of smoking cessation programmes.

Using an electrochemical sensor designed to react specifically to carbon monoxide producing an electrical output, the sensor measures the level of carbon monoxide (CO) on the breath. The output is then amplified into a meaningful result by the device. The result is sent to the iCOquit® App wirelessly, allowing the meaningful result to be displayed on the user's smartphone or tablet.

The App displays the reading received from the iCOquit® Smokerlyzer® on the smartphone or tablet paired with the device and based on the questions the user answers within the App relating to their smoking habits and the CO reading, they will then receive a result from the Fagerstrom Test of Nicotine Dependence.

The sample method for the iCOquit® Smokerlyzer® channels the breath sample exhaled by the user into an integrated breath port on the device. This passes directly over the sensor during the test, ensuring the sensor is exposed to the gas sample for the required length of time to give an accurate reading.

The user is required to hold their breath for a 15 second countdown. This is displayed via the iCOquit® App and guides the user through the process of providing a breath sample for measurement. At the end of the breath hold, the patient shall blow gently but fully into the iCOquit, exhaling as much of the breath in their lungs as possible. The reading shown on the App is the peak reading.

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Image /page/5/Picture/0 description: The image shows the logo for Bedfont Scientific Ltd. The logo features five colorful circles in yellow, pink, orange, purple, and blue arranged in a semi-circular pattern above the company name. The company name "bedfont" is written in a dark blue, sans-serif font, with the "o" in "bedfont" stylized as a blue circle. Below the company name, the text "est. 1976" is displayed in a smaller, sans-serif font.

Once a breath test has been completed the user will be navigated to a screen where they will see their CO result in PPM (parts per million) and %COHb (Carboxyhemoglobin). The reading shown on the App is the peak reading. Users are then asked Fagerstrom questions to determine their smoking status of either low, moderate or high and the result is then saved in a graph.

The level of CO measured in PPM is also calculated as %COHB and displayed in the App. The formulas for calculating PPM as %COHb are:

- ≤91ppm: %COHb = 0.63 + 0.16 (PPM)
- >91ppm: %COHb = 15.75 / (80/CO ppm + 0.1575)

#### V. INTENDED USE / INDICATIONS FOR USE

The iCOquit® Smokerlyzer® breath carbon monoxide (CO) monitor is intended for single patient use by cigarette smoking individuals, notifying the individual user of the amount of CO on their breath produced as a consequence of smoking activity. The device can be used in smoking cessation programmes.

#### VI. COMPARISON OF TECHNOLGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

| | Proposed:<br>Bedfont Scientific Ltd<br>iCOquit Smokerlyzer | Predicate:<br>Carrot Sense<br>Carbon Monoxide Breath Sensor<br>System (COBSS) |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | | K171408 |
| Classification<br>Product Code | CCJ - Carbon monoxide gas<br>analyser | CCJ - Carbon monoxide gas<br>analyser |
| Regulation<br>Number | CFR - 868.1430 | CFR - 868.1430 |
| Device Class | Class 2 | Class 2 |
| Indications for<br>Use | The iCOquit Smokerlyzer breath<br>carbon monoxide (CO) monitor is<br>intended for single patient use by<br>cigarette smoking individuals,<br>notifying the individual user of the<br>amount of CO on their breath<br>produced as a consequence of<br>smoking activity. The device can<br>be used in smoking cessation<br>programmes. | The Carbon Monoxide Breath<br>Sensor System (COBSS) is a breath<br>carbon monoxide monitor intended<br>for single-user use by cigarette<br>smokers in smoking cessation<br>programs to inform the user about<br>how breath carbon monoxide levels<br>are affected by smoking behaviour.<br>The device is not intended to be<br>used with other inhaled products. |
| Design Features | Non-invasively measures CO in exhaled breath Handheld battery powered Connects with Smartphone or Tablet through Bluetooth App for iOS and Android operating systems | Non-invasively measures CO in exhaled breath Handheld battery powered Visual and audible alarms Connects with smartphone through Bluetooth App for iOS and Android operating systems |
| Measurement<br>Range | 0 – 100 PPM (parts per million) | 0 – 100 PPM (parts per million) |
| Accuracy | $±≤3PPM / ±≤10%$ of reading*<br>*whichever is greater | ±20% or 3PPM, whichever is greater |
| H2 Cross<br>Sensitivity | ≤6% | <6% |
| Power Source | Lithium battery<br>(Lithium-ion coin cell) | Lithium battery |
| Battery Life | 12 months | 7 days per charge |
| Operating | 15°-35° Celsius | 40°-104° Fahrenheit |
| Temperature | (59°-95° Fahrenheit) | (4°- 40° Celsius) |
| Operating<br>Humidity range | 10-90% RH non-condensing | 10-90% non-condensing |
| Type of Use | Over the counter | Over the counter |
| Sensor<br>Technology | Electrochemical Sensor | Electrochemical Sensor |
| Sensor Life | 500 breath tests/12 months.<br>Whichever occurs first | 18 months |
| Sensor Drift | Not Applicable | <5% per annum |
| Connectivity | Bluetooth | Bluetooth |
| Breath Hold | 15 seconds | 10 seconds |
| Analysis Time | <30 seconds | A few seconds |
| Interfering gas<br>testing | Yes | Yes |
| Patient interface | Breath Port Mouthpiece | Detachable Mouthpiece |
| Contraindications | None | None |
| Performance | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-11 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-11 |
| Ingress<br>Protection | IXP0 | IP22 |
| Screen | Smartphone/Tablet screen | Small integrated TFT/digital Screen |

## Table 1 - Table of Similarities and Differences between Predicate and Proposed Device

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Image /page/6/Picture/0 description: The image shows the logo for Bedfont Scientific Ltd. The logo features five colorful circles in yellow, pink, orange, purple, and blue. Below the circles is the company name "bedfont" in a dark blue, sans-serif font, with the registered trademark symbol. Underneath "bedfont" is the text "est. 1976" also in dark blue.

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Image /page/7/Picture/0 description: The image shows the logo for Bedfont Scientific Ltd. The logo features the word "bedfont" in a lowercase, sans-serif font, with the "o" in "bedfont" being a blue circle. Above the word "bedfont" are five colored circles: yellow, pink, orange, purple, and blue. Below the word "bedfont" is the text "est. 1976".

The iCOquit® Smokerlyzer® Carbon Monoxide Monitor and the Predicate Device are the same for the following reasons:

### Technology

The technological principle of the iCOquit® Smokerlyzer® Carbon Monoxide Monitor and the Predicate Device cleared under K171408 is monitoring of Carbon Monoxide (CO) on the breath. They have the following same technologically characteristics:

- An Electrochemical Sensor to detect the level of Carbon Monoxide (CO) on breath
- A non-replaceable Lithium battery power source ●
- Bluetooth connectivity for pairing the device with a Smartphone or Tablet Application
- Handheld Monitor ●
- . Non-invasive breath sample method
- CO level on breath measured in PPM (Parts Per Million) .

### Materials

The iCOquit® Smokerlyzer® Carbon Monoxide Monitor and the Predicate Device cleared under K171408 are manufactured from plastic material that has been subject to evaluation in accordance with standard ISO 10993-1 ISO 10993-1: Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process.

### Indications for Use

### Device Name: iCOquit® Smokerlyzer®

Indications for Use: The iCOquit breath carbon monoxide (CO) monitor is intended for single patient use by cigarette smoking individuals, notifying the individual user of the amount of CO on their breath produced as a consequence of smoking activity. The device can be used in smoking cessation programs.

### Predicate Device Name: Carbon Monoxide Breath Sensor System

Indications for Use: 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.

The iCOquit® Smokerlyzer® breath carbon monoxide (CO) monitor is intended for single patient use by cigarette smoking individuals, notifying the individual user of the amount of CO on their breath produced as a consequence of smoking activity. The device can be used in smoking cessation programs.

These indications are the same as the Predicate Device cleared under K171408. The Subject and Predicate device are breath carbon monoxide monitors, for single patient use by cigarette smokers. The devices offer a non-invasive method to determine and inform the user of the level of Carbon Monoxide (CO) on their breath produced as a consequence of smoking activity.

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Image /page/8/Picture/0 description: The image shows the logo for Bedfont Scientific Ltd. The logo features the word "bedfont" in a bold, sans-serif font, with the "o" in "bedfont" colored in blue. Above the word "bedfont" are five colored circles in yellow, pink, orange, purple, and blue. Below the word "bedfont" is the text "est. 1976".

### Environment of Use

The iCOquit® Smokerlyzer® Carbon Monoxide Monitor and the Predicate Device cleared under K171408 are both Over-the-Counter devices, which can be used in Smoking Cessation programs.

### Labelling

The iCOquit® Smokerlyzer® Carbon Monoxide Monitor and the Predicate Device cleared under K171408 are indicated for Over-the-Counter use and both devices include clear labelling enabling the user to understand their CO Measurement and identify appropriate warnings for safe and effective use.

Labelling of the iCOquit® Smokerlyzer® Carbon Monoxide Monitor is in compliance with the requirements of 21 CFR Part 801, as applicable.

#### VII. PERFORMANCE DATA

The following performance data was provided in support of the 510(k) application:

### Biocompatibility

The materials used in iCOquit® Smokerlyzer® Carbon Monoxide Monitor have been subject to evaluation in accordance with recognized consensus standard ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and are considered safe. After an evaluation of endpoints for consideration, the type of contact for consideration is:

- . Surface device, Intact Skin, Limited duration
A typical test with the iCOquit® Smokerlyzer® monitor is <1 minute (between 10-30 seconds). The monitor allows no more than 500 tests maximum to be performed. The predicate device(s) have been considered as also having limited duration of contact. The user only exhales through the device. After an evaluation of endpoints for consideration and the type of contact, end point testing was selected and the following tests were performed:

- Cytotoxicity
- Sensitization ●
- Irritation .

### Electrical Safety, EMC, EMI Testing

The iCOquit® Smokerlyzer® Carbon Monoxide Monitor and the Predicate Device cleared under K171408 have been evaluated in accordance with requirements of ES60601-1 and IEC 60601-1-2. The iCOquit® Smokerlyzer® Carbon Monoxide Monitor performed as intended, meeting the necessary requirements of these standards and is considered safe.

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Image /page/9/Picture/0 description: The image shows the logo for Bedfont Scientific Ltd. The logo features five colorful circles in yellow, pink, orange, blue, and purple. Below the circles is the company name "bedfont" in a stylized font, with the "o" in "bedfont" being blue. Below the company name is the text "est. 1976".

### Software Verification and Validation Testing

The software for iCOquit® Smokerlyzer® is considered a "Moderate" level of concern. Testing and documentation as specified within FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005)" has been performed and supplied.

### Bench Testing

Bench testing was performed with the iCOquit® Smokerlyzer® Carbon Monoxide Monitor to verify the performance to specifications of the proposed device. Testing includes:

- ES60601-1 ●
- IEC 60601-1-2 ●
- IEC 60601-1-11 .
- Software verification and system validation .

#### Usability/Human Factors

Human Factors validation testing was performed with the iCOquit® Smokerlyzer® Carbon Monoxide Monitor by means of summative usability testing. This assessed an untrained lay user group's ability to comprehend use of the device effectively. The group selected was carefully chosen to represent the intended user and successfully demonstrated that lay users were able to understand their CO measurement and effectively use the iCOquit® Smokerlyzer® in accordance with its Intended Use.

#### VIII. CONCLUSIONS

### Discussion of Differences

The differences and similarities between the subject and predicate device include:

- Subject device improves on the accuracy range .
- Subject and predicate device display levels of CO in breath through an App paired with . the devices. The predicate device can also relay results through an integrated screen on the handheld monitor
- Subject and Predicate performance specifications are similar ●
- Subject device offers a calculation from users PPM result in %COHb.

These differences do not raise any new concerns of safety or effectiveness and therefore the subject device can be considered similar.

### Conclusion

The iCOquit® Smokerlyzer® Carbon Monoxide Monitor and the predicate device cleared under K171408 can be considered the same in their use of technology, design, features and intended use. The conclusions drawn from the nonclinical tests demonstrate that the proposed subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.