(183 days)
Not Found
No
The description focuses on the electrochemical sensor and the app's function of displaying data and administering the Fagerstrom test, which is a standard questionnaire. There is no mention of AI or ML being used for data analysis, prediction, or personalized feedback beyond displaying the CO levels and the Fagerstrom result.
No.
The device is a monitor that detects CO levels, provides visual motivation, and tracks quitting progress for smoking cessation, but it does not directly treat or cure a disease or condition.
Yes
The device is intended to monitor the amount of CO on an individual's breath produced as a consequence of smoking activity and provide a result from the Fagerstrom Test of Nicotine Dependence, which are all diagnostic indicators related to smoking habits and nicotine dependence.
No
The device description clearly states it is a "hand-held breath monitor" that works in conjunction with a smartphone app. It uses an electrochemical sensor and integrated breath port, indicating a physical hardware component is essential for its function.
Based on the provided information, the iCOquit® Smokelyzer® breath carbon monoxide (CO) monitor is an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The device is intended for single patient use by cigarette smoking individuals to measure the amount of CO on their breath. This measurement provides information about the physiological state of the individual (CO levels in their breath as a result of smoking).
- Device Description: It uses a non-invasive method of breath analysis to detect levels of Carbon Monoxide (CO) using an electrochemical sensor. This process involves analyzing a biological sample (breath) to obtain a result.
- Measurement of a Physiological Parameter: The device measures CO in breath, which is a direct indicator of the amount of CO absorbed from smoking. This is a measurement of a physiological parameter.
- Comparison to Predicate: The predicate device, K171408 (Carbon Monoxide Breath Sensor System (COBSS)), is also a breath CO monitor, which are typically classified as IVDs.
While the device is used in conjunction with an app for tracking and motivation, the core function of measuring CO in breath for the purpose of providing information about the user's smoking activity and its impact on their body aligns with the definition of an IVD. It is performing a test on a biological sample (breath) to provide diagnostic information (CO levels).
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
CCJ
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.
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)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: ±≤3PPM / ±≤10% of reading* *whichever is greater
H2 Cross Sensitivity: ≤6%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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 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.
1
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
2
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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3
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
4
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.
5
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 Ltd
iCOquit Smokerlyzer | Predicate:
Carrot Sense
Carbon Monoxide Breath Sensor
System (COBSS) |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | | K171408 |
| Classification
Product Code | CCJ - Carbon monoxide gas
analyser | CCJ - Carbon monoxide gas
analyser |
| Regulation
Number | CFR - 868.1430 | CFR - 868.1430 |
| Device Class | Class 2 | Class 2 |
| 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. | 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 behaviour.
The device is not intended to be
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
Range | 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 Cross
Sensitivity | ≤6% |