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.

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. 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. 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.

AI/ML Overview

The provided text describes the iCOquit® Smokerlyzer® device and its comparison to a predicate device. Here's a breakdown of the acceptance criteria and the study details:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (from Subject Device)	Reported Device Performance (iCOquit® Smokerlyzer®)	Related Study/Assessment
Measurement Range: 0 – 100 PPM	0 – 100 PPM (parts per million)	Bench Testing
Accuracy: ±≤3PPM / ±≤10% of reading*	±≤3PPM / ±≤10% of reading* (whichever is greater)	Bench Testing
H2 Cross Sensitivity: ≤6%	≤6%	Bench Testing
Power Source: Lithium battery	Lithium battery (Lithium-ion coin cell)	Device Description
Battery Life: 12 months	12 months	Device Description
Operating Temperature: 15°-35° Celsius	15°-35° Celsius (59°-95° Fahrenheit)	Device Description
Operating Humidity range: 10-90% RH non-condensing	10-90% RH non-condensing	Device Description
Type of Use: Over the counter	Over the counter	Indication for Use
Sensor Technology: Electrochemical Sensor	Electrochemical Sensor	Device Description
Sensor Life: 500 breath tests/12 months	500 breath tests/12 months (Whichever occurs first)	Device Description
Connectivity: Bluetooth	Bluetooth	Device Description
Breath Hold: 15 seconds	15 seconds	Device Description
Analysis Time: <30 seconds	<30 seconds	Device Description
Interfering gas testing: Yes	Yes	Bench Testing
Patient interface: Breath Port Mouthpiece	Breath Port Mouthpiece	Device Description
Contraindications: None	None	Device Description
Performance Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11	Meets IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11	Electrical Safety, EMC, EMI Testing, Bench Testing
Ingress Protection: IXP0	IXP0	Device Description

2. Sample size used for the test set and the data provenance

The document does not specify a sample size for any clinical test set related to the device's accuracy or overall performance with human subjects. The usability/human factors study mentions a "lay user group" but does not give a specific number.

The data provenance is for nonclinical tests. The submission is from Bedfont Scientific Ltd, located in Harrietsham, Maidstone, Kent, ME17 1JA, United Kingdom. Therefore, the nonclinical testing would have been conducted in the UK or a location specified by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The studies mentioned (Biocompatibility, Electrical Safety, Software, Bench Testing, Usability/Human Factors) are primarily focused on technical specifications and user interaction with the device, not on clinical accuracy requiring expert-established ground truth for breath CO levels.

4. Adjudication method for the test set

This information is not applicable/not provided. The studies described do not involve ambiguous clinical findings that would require an adjudication method among experts.

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

There is no mention of a multi-reader multi-case (MRMC) study. The device is a direct measurement tool, not an AI-assisted diagnostic device that would involve human readers interpreting results.

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

The device itself is a standalone sensor that provides a direct measurement of CO. The "iCOquit® App" displays the reading, calculates %COHb, and asks Fagerstrom questions. The bench testing and software verification/validation would represent the "standalone" performance of the hardware and software without human input during the measurement process, beyond providing the breath sample. The document confirms the device performs "as intended" in these tests.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the technical performance aspects (e.g., measurement range, accuracy, cross-sensitivity), the ground truth would typically be established by controlled gas mixtures or calibrated reference instruments during bench testing. For biocompatibility, it's based on recognized standards (ISO 10993-1). For electrical safety and EMC, it's based on compliance with standards (ES60601-1, IEC 60601-1-2, IEC 60601-1-11). For software, it's based on verification and validation against specifications.

8. The sample size for the training set

This information is not provided as the device does not appear to utilize machine learning models that require a separate training set. Its core function relies on an electrochemical sensor.

9. How the ground truth for the training set was established

Not applicable, as no training set for a machine learning model is mentioned.

Summary

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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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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 (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

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Indications for Use

510(k) Number (if known) K211918

Device Name iCOquit® Smokerlyzer®

Indications for Use (Describe)

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: +44 (0) 1622 851122 Fax: +44 (0) 1622 854860

Contact Person: Louise Bateman, Senior QA & RA Manager

Email: louise@bedfont.com 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: +44 (0)1622 851122, Fax: +44 (0)1622 854860, Email: ask@bedfont.com 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 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:Bedfont Scientific LtdiCOquit Smokerlyzer	Predicate:Carrot SenseCarbon Monoxide Breath SensorSystem (COBSS)
510(k)		K171408
ClassificationProduct Code	CCJ - Carbon monoxide gasanalyser	CCJ - Carbon monoxide gasanalyser
RegulationNumber	CFR - 868.1430	CFR - 868.1430
Device Class	Class 2	Class 2
Indications forUse	The iCOquit Smokerlyzer breathcarbon monoxide (CO) monitor isintended for single patient use bycigarette smoking individuals,notifying the individual user of theamount of CO on their breathproduced as a consequence ofsmoking activity. The device canbe used in smoking cessationprogrammes.	The Carbon Monoxide BreathSensor System (COBSS) is a breathcarbon monoxide monitor intendedfor single-user use by cigarettesmokers in smoking cessationprograms to inform the user abouthow breath carbon monoxide levelsare affected by smoking behaviour.The device is not intended to beused 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
MeasurementRange	0 – 100 PPM (parts per million)	0 – 100 PPM (parts per million)
Accuracy	$±≤3PPM / ±≤10%$ of reading**whichever is greater	±20% or 3PPM, whichever is greater
H2 CrossSensitivity	≤6%	<6%
Power Source	Lithium battery(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)
OperatingHumidity range	10-90% RH non-condensing	10-90% non-condensing
Type of Use	Over the counter	Over the counter
SensorTechnology	Electrochemical Sensor	Electrochemical Sensor
Sensor Life	500 breath tests/12 months.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 gastesting	Yes	Yes
Patient interface	Breath Port Mouthpiece	Detachable Mouthpiece
Contraindications	None	None
Performance	IEC 60601-1IEC 60601-1-2IEC 60601-1-11	IEC 60601-1IEC 60601-1-2IEC 60601-1-11
IngressProtection	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.

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.

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).