(140 days)
Not Found
No
The description focuses on a simple sensor and app displaying raw data and color-coding based on predefined thresholds, with no mention of AI/ML terms or learning from data.
No
The device 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. It monitors and provides information but does not actively treat or intervene in a therapeutic manner.
No
The device is 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. It measures and displays CO levels, but it is not used to diagnose a medical condition or disease.
No
The device description explicitly states that the system is composed of a "CO Breath Sensor," which is described as a "portable, battery-powered device capable of measuring the level of CO in exhaled breath." This indicates a hardware component in addition to the software application.
Based on the provided information, the Carbon Monoxide Breath Sensor System (COBSS) is an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The device is intended to measure the level of carbon monoxide in exhaled breath. Measuring substances in bodily fluids or samples (like breath) to provide information about a person's health or condition is a core function of IVD devices.
- Device Description: It explicitly states it measures "the level of CO in exhaled breath."
- Anatomical Site: Exhaled breath is a biological sample.
- Performance Studies: The performance studies compare the device's measurements to a predicate device that is also a breath CO monitor, further indicating its function as a diagnostic tool.
While the device is intended for single-user, OTC use in smoking cessation programs and provides information to the user about how smoking affects their breath CO levels, the fundamental act of measuring a substance in a biological sample (exhaled breath) for informational purposes aligns with the definition of an IVD. The information provided helps the user understand their physiological state related to smoking.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
CCJ
Device Description
The Carbon Monoxide Breath Sensor System (COBSS) is a breath carbon monoxide ("CO") monitor intended for single-user over-the-counter ("OTC") use by smokers in smoking cessation programs. The COBSS is a portable, battery-powered device that is composed of the following:
- . CO Breath Sensor. A personal mobile breath sensor capable of measuring the level of CO in exhaled breath.
- . Breath Sensor App. A smart phone app which displays the exhaled breath CO value to the user.
The CO Breath Sensor pairs to the Breath Sensor Application ("BSA") on the smartphone via low-energy Bluetooth. Once paired, the CO Breath Sensor communicates exclusively with the user's phone and is invisible to other devices. The primary screen for the BSA is the CO Log where the most recent exhaled breath CO value in parts-per-million ("ppm") is displayed at the top of the screen. The CO measurements are color coded according to the CO level, and the length of the bar is associated with the ppm value to graphically show the user their relative levels of exhaled breath CO throughout the day and between days.
CO levels in exhaled breath of smokers correlate closely with smoking behavior, i.e., intensity, frequency, and amount. Simply put, the more a person smokes, the higher their exhaled breath CO levels tend to be. Exhaled breath CO readings can inform the user about how breath carbon monoxide levels are affected by smoking behavior.
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
Adult smokers; 18-80 years (implied from study population)
Intended User / Care Setting
Single-user, over-the-counter, home use by cigarette smokers in smoking cessation programs.
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
Sample Size: 70 lay users, comprising adult smokers, with two user groups (ages 18-49 years and 50-80 years).
Data Source: Prospective, open label, single center study.
Annotation Protocol: Study subjects participated in 60-90 minute study sessions that consisted of an introduction, simulated use, performance paired breath samples, user documentation assessment and subjective feedback and rating scales. For the comparative performance portion, measurements of CO in exhaled breath were taken by a lay user using COBSS without assistance and compared to measurements obtained from the predicate device administered by trained personnel.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Combined Human Factors and Comparative Performance Study. Prospective, open label, single center design.
Sample Size: 70 lay users (adult smokers, aged 18-49 and 50-80 years).
Key Results:
- Human Factors: Assessed whether an untrained lay user group could operate the device and interpret results correctly using the device labeling. Demonstrated that the device is safe and effective for the intended users, its intended uses, and use environments. All participants were observed to safely use all primary operating functions. No instances of close calls or hazard-related use scenarios that could have resulted in significant patient or user harm.
- Comparative Performance: Assessed the correlation between measured CO levels from the study device (COBSS) used by a self-trained user and the predicate device (Smokerlyzer) used with guidance by a healthcare professional.
- Regression analysis of 70 paired measurements of CO produced a line with a slope of 0.9289, a y-intercept of -0.0306 and a correlation coefficient of 0.9878.
- COBSS CO measurements agreed with the predicate device's category 91% (64/70) of the time.
- Agreement by CO level category:
- Green category (0-6 ppm): 18/19 (95%) paired samples.
- Orange category (7-9 ppm): 5/7 (71%).
- Red category (10 ppm or greater): 41/44 (93%).
- Overall, the study demonstrated that lay users were able to use the COBSS safely and effectively for its intended use, and that the COBSS performance was acceptable when compared to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Correlation Coefficient: 0.9878
- Agreement with predicate device's category: 91% (64/70)
- Agreement for Green category (0-6 ppm): 95% (18/19)
- Agreement for Orange category (7-9 ppm): 71% (5/7)
- Agreement for Red category (10 ppm or greater): 93% (41/44)
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 29, 2017
CARROT SENSE, INC. C/O JONATHAN KAHAN PARTNER 555 THIRTEENTH STREET NW WASHINGTON DC 20004
Re: K171408
Trade/Device Name: Carbon Monoxide Breath Sensor System (COBSS) Regulation Number: 21 CFR 868.1430 Regulation Name: Carbon monoxide gas analyzer Regulatory Class: II Product Code: CCJ Dated: August 30, 2017 Received: August 30, 2017
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kellie B. Kelm -S
for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
| Form Approved: OMB No. 0910-0120 | |
|---|---|
| Expiration Date: 06/30/2020 | |
| See PRA Statement below. |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
| 510(k) Number (if known) | K171408 |
|---|---|
| Device Name | Carbon Monoxide Breath Sensor System (COBSS) |
| Indications for Use (Describe) | 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. |
| 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) |
|---|---|
| ------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
| FORM FDA 3881 (7/17) | Page 1 of 1 |
|---|---|
| ---------------------- | ------------- |
PSC Publishing Services (301) 443-6740 EF
3
K171408
510(k) SUMMARY
Carrot Sense's Carbon Monoxide Breath Sensor System (COBSS)
Submitter
| Company: | Carrot Sense, Inc. |
|---|---|
| Address: | 1600 Seaport Blvd, Suite 150 |
| Redwood City, CA 94063 | |
| Phone: | (650) 520-3259 |
| Contact Person: | Daniel J Balbierz |
| Date Prepared: | September 27, 2017 |
Subject Device
| Name of Device: | Carbon Monoxide Breath Sensor System (COBSS) |
|---|---|
| Classification Name: | Carbon monoxide gas analyzer |
| Regulation: | 21 C.F.R. § 868.1430 |
| Regulatory Class: | Class II |
| Product Code: | CCJ |
Predicate Device
| Company: | Bedfont Scientific LTD |
|---|---|
| Device Name: | Micro+ Smokerlyzer |
| 510(k) Number: | K082315 |
| Regulation: | 868.1430 |
| Product Codes: | CCJ |
Device Description
The Carbon Monoxide Breath Sensor System (COBSS) is a breath carbon monoxide ("CO") monitor intended for single-user over-the-counter ("OTC") use by smokers in smoking cessation programs. The COBSS is a portable, battery-powered device that is composed of the following:
- . CO Breath Sensor. A personal mobile breath sensor capable of measuring the level of CO in exhaled breath.
- . Breath Sensor App. A smart phone app which displays the exhaled breath CO value to the user.
4
The CO Breath Sensor pairs to the Breath Sensor Application ("BSA") on the smartphone via low-energy Bluetooth. Once paired, the CO Breath Sensor communicates exclusively with the user's phone and is invisible to other devices. The primary screen for the BSA is the CO Log where the most recent exhaled breath CO value in parts-per-million ("ppm") is displayed at the top of the screen. The CO measurements are color coded according to the CO level, and the length of the bar is associated with the ppm value to graphically show the user their relative levels of exhaled breath CO throughout the day and between days.
CO levels in exhaled breath of smokers correlate closely with smoking behavior, i.e., intensity, frequency, and amount. Simply put, the more a person smokes, the higher their exhaled breath CO levels tend to be. Exhaled breath CO readings can inform the user about how breath carbon monoxide levels are affected by smoking behavior.
Intended Use / 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.
Substantial Equivalence
The COBSS is substantially equivalent to Bedfont Scientific's Micro+ Smokerlyzer ("Smokerlyzer") cleared under 510(k) number K082315. Both devices have the same intended use of measuring breath CO levels of smokers in smoking cessation programs. Specifically, both the subject and the predicate devices provide breath CO measurements to inform the user about how breath carbon monoxide levels are affected by smoking behavior. The COBSS' labeling provides a clear understanding of the CO measurements, appropriate precautions, and warnings. A combined human factors and comparative study demonstrated that lay users were able to adequately use the COBSS and to understand the CO measurements.
In addition, the COBSS has similar technological characteristics as the predicate device. Both are portable, battery powered devices that use electrochemical sensors to non-invasively monitor CO levels. The COBSS provides the CO measurements in a smartphone app, while the predicate uses a touch screen display. However, these minor differences in technological characteristics do not present any different issues of safety or effectiveness. In addition, analytical bench testing and the combined performance and human factors study demonstrated substantially equivalent performance between the subject and the predicate devices. Thus, the COBSS is substantially equivalent to the predicate device.
A substantial equivalence table summarizing the similarities and differences between the COBSS and the predicate device is provided in Table 1.
5
Table 1 – Comparison of Substantial Equivalence
| Similarities | ||
|---|---|---|
| Feature | Subject Device: | |
| Carrot Sense's | ||
| COBSS | Predicate Device: Bedfont | |
| Scientific's Micro+ | ||
| Smokerlyzer (K082315) | ||
| Intended Use | 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. | Intended for multipatient use | |
| by healthcare professionals in | ||
| smoking cessation programs | ||
| and as an indicator of Carbon | ||
| Monoxide poisoning in | ||
| healthcare environments. | ||
| Sensor | ||
| Technology | Same | Electrochemical Sensor |
| Sensor Drift | Same |