(138 days)
Not Found
No
The description focuses on standard sensor technology (infrared capnometer, electrochemical CO sensor) and basic software control for menu navigation and data display. There is no mention of AI/ML terms or functionalities like learning, adaptation, or complex pattern recognition beyond direct measurement.
No.
The device is indicated for monitoring carbon monoxide levels for diagnostic purposes related to smoking cessation and poisoning, rather than providing direct treatment.
Yes
The device is indicated for "screening of CO poisoning and smoke inhalation," which is a diagnostic purpose. It monitors "Carbon Monoxide from endogenous and exogenous sources in exhaled breath," providing information that can be used to diagnose a condition.
No
The device description explicitly states it is a battery-operated carbon monoxide monitor that uses an infrared capnometer and an electrochemical carbon monoxide sensor, indicating it includes significant hardware components beyond just software.
Based on the provided information, the CoSense CO Monitor is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The CoSense CO Monitor analyzes exhaled breath directly from the patient. It's a non-invasive measurement of a physiological process (exhalation) and the concentration of a substance within that breath.
- The device description focuses on sensors and monitoring. It uses an infrared capnometer and an electrochemical carbon monoxide sensor to measure the concentration of CO in the breath. This is a direct measurement, not an analysis of a sample that has been removed from the body.
- The intended use describes monitoring and screening. The device is used for monitoring CO in exhaled breath for smoking cessation, CO poisoning screening, and smoke inhalation. These are applications of a direct measurement, not the analysis of a biological sample.
In summary, the CoSense CO Monitor is a medical device that performs a direct measurement of a substance in exhaled breath. It does not analyze a sample that has been taken from the body, which is the defining characteristic of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The CoSense CO Monitor is indicated for the monitoring of Carbon Monoxide from endogenous and exogenous sources in exhaled breath. It is for use in smoking cessation programs and can be used for the screening of CO poisoning and smoke inhalation. It is for use by health professionals.
Product codes
CCJ, 868.1430
Device Description
The CoSense CO Monitor is a battery-operated carbon monoxide monitor. It uses an infrared capnometer to detect the end-tidal portion of the breath and an electrochemical carbon monoxide sensor to measure the end-tidal breath CO concentration. The device consists of a portable unit with software controlled menu (date, time, patient identification, measurement time of monitoring), single-use nasal cannula, replaceable CO Sensor, and a power supply.
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
health professionals
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)
To verify that device design meets its functional and performance requirements, representative samples of the device underwent biocompatibility, software, electrical, and mechanical testing in accordance with the following industry standards:
• AAMI/ANSI/ISO 10993-1:2009 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process
• General Principles of Software Validation; Final Guidance for Industry and FDA Staff, Version January 11, 2002
• AAMI/ANSI/IEC 60601-1:1998 Medical Electrical Equipment—Part 1: General Requirements for Safety
• AAMI/ANSI/IEC 60101-1-2:2001 Medical Electrical Equipment—Part 1-2: General Requirements for Safety-Collateral Standard: Electromagnetic Compatibility
• ASTM D4169-09 Standard Practice for Performance Testing of Shipping Containers and Systems
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
OCT 3 1 2012
510(K) SUMMARY
・
| Table 1: | 510(k) Summary | K121768 |
|---|---|---|
| Submitter: | Capnia, Inc. | |
| 2445 Faber Place, Suite 250 | ||
| Palo Alto CA 94303 | ||
| Contact Person: | Julie Blacklock | |
| Associate Director, Regulatory Affairs and Quality Assurance | ||
| (650) 213-8444 ext 41 | ||
| julie@capnia.com | ||
| Date Prepared: | 6/14/2012 | |
| Trade Name: | CoSense™ CO Monitor | |
| Common Name: | Carbon Monoxide Monitor | |
| Classification: | Class II | |
| Product Code: | CCJ, 868.1430 | |
| Predicate Device(s): | The subject device is equivalent to the following devices: | |
| • FIM Medical Tabataba CO Tester (K080278) | ||
| Device Description: | The CoSense CO Monitor is a battery-operated carbon | |
| monoxide monitor. It uses an infrared capnometer to detect the | ||
| end-tidal portion of the breath and an electrochemical carbon | ||
| monoxide sensor to measure the end-tidal breath CO | ||
| concentration. The device consists of a portable unit with | ||
| software controlled menu (date, time, patient identification, | ||
| measurement time of monitoring), single-use nasal cannula, | ||
| replaceable CO Sensor, and a power supply. | ||
| Indication for Use: | The CoSense CO Monitor is indicated for the monitoring of | |
| Carbon Monoxide from endogenous and exogenous sources in | ||
| exhaled breath. It is for use in smoking cessation programs and | ||
| can be used for the screening of CO poisoning and smoke | ||
| inhalation. It is for use by health professionals. |
1
| Functional and
Safety Testing: | To verify that device design meets its functional and performance requirements, representative samples of the device underwent biocompatibility, software, electrical, and mechanical testing in accordance with the following industry standards:
• AAMI/ANSI/ISO 10993-1:2009 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process
• General Principles of Software Validation; Final Guidance for Industry and FDA Staff, Version January 11, 2002
• AAMI/ANSI/IEC 60601-1:1998 Medical Electrical Equipment—Part 1: General Requirements for Safety
• AAMI/ANSI/IEC 60101-1-2:2001 Medical Electrical Equipment—Part 1-2: General Requirements for Safety-Collateral Standard: Electromagnetic Compatibility
• ASTM D4169-09 Standard Practice for Performance Testing of Shipping Containers and Systems |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion: | Capnia considers the CoSense device to be equivalent to the predicate device listed above. This conclusion is based upon the devices' similarities in indications for use, principles of operation, technology, and materials. |
and the comments of the comments of
and the control control of the control of
.
and the comments of the comments of the comments of the comments of
.
·
:
2
Image /page/2/Picture/1 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized depiction of an eagle with three stripes representing the three levels of government. The emblem is positioned in the center of the circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper half of the circle's perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 31 2012
Capnia, Incorporated Ms. Julie Blacklock Associate Director, Regulatory Affairs and Quality Assurance 2445 Faber Place, Suite 250 Palo Alto, California 94303
Re: K121768
Trade/Device Name: Capnia CoSense CO Monitor Regulation Number: 21 CFR 868.1430 Regulation Name: Carbon Monoxide Gas Analyzer Regulatory Class: II Product Code: CCJ Dated: October 10, 2012 Received: October 11. 2012
Dear Ms. Blacklock:
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.
3
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); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely vours.
ph for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
Device Name: Capnia CoSense CO Monitor
Indications for Use:
The CoSense CO Monitor is indicated for the monitoring of Carbon Monoxide from endogenous and exogenous sources in exhaled breath. It is for use in smoking cessation programs and can be used for the screening of CO poisoning and smoke inhalation. It is for use by health professionals.
Prescription Use X (21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L Schull
(Division Sign-Off Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: V21768