COSENSE

K121768 · Capnia, Inc. · CCJ · Oct 31, 2012 · Anesthesiology

Device Facts

• Record ID: K121768
• Device Name: COSENSE
• Applicant: Capnia, Inc.
• Product Code: CCJ · Anesthesiology
• Decision Date: Oct 31, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1430
• Device Class: Class 2

Intended 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.

Device Story

CoSense CO Monitor is a battery-operated device for measuring carbon monoxide (CO) concentration in exhaled breath. It utilizes an infrared capnometer to detect the end-tidal portion of a breath and an electrochemical sensor to measure CO concentration. The device is a portable unit featuring a software-controlled menu for tracking patient identification, date, time, and measurement duration. It uses a single-use nasal cannula for patient interface. Operated by health professionals in clinical settings, the device provides CO concentration readings to assist in smoking cessation, CO poisoning screening, and smoke inhalation assessment. The output allows clinicians to evaluate patient CO levels and make informed clinical decisions regarding treatment or intervention.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including biocompatibility (ISO 10993-1), software validation (FDA guidance), electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and shipping container performance (ASTM D4169-09).

Technological Characteristics

Battery-operated portable monitor. Sensing: Infrared capnometer for end-tidal breath detection and electrochemical sensor for CO measurement. Components: Single-use nasal cannula, replaceable CO sensor, power supply. Software-controlled menu. Standards: ISO 10993-1 (biocompatibility), IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), ASTM D4169-09 (shipping).

Indications for Use

Indicated for monitoring endogenous and exogenous carbon monoxide in exhaled breath for smoking cessation programs, CO poisoning screening, and smoke inhalation screening. For use by health professionals.

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

• FIM Medical Tabataba CO Tester (K080278)

Submission Summary (Full Text)

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**OCT** 3 1 **2012**

## 510(K) SUMMARY

・

| Table 1: | 510(k) Summary | K121768 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Submitter: | Capnia, Inc.<br>2445 Faber Place, Suite 250<br>Palo Alto CA 94303 | |
| Contact Person: | Julie Blacklock<br>Associate Director, Regulatory Affairs and Quality Assurance<br>[phone] ext 41<br>[e-mail] | |
| 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:<br>• FIM Medical Tabataba CO Tester (K080278) | |
| Device Description: | The CoSense CO Monitor is a battery-operated carbon<br>monoxide monitor. It uses an infrared capnometer to detect the<br>end-tidal portion of the breath and an electrochemical carbon<br>monoxide sensor to measure the end-tidal breath CO<br>concentration. The device consists of a portable unit with<br>software controlled menu (date, time, patient identification,<br>measurement time of monitoring), single-use nasal cannula,<br>replaceable CO Sensor, and a power supply. | |
| Indication for Use: | The CoSense CO Monitor is indicated for the monitoring of<br>Carbon Monoxide from endogenous and exogenous sources in<br>exhaled breath. It is for use in smoking cessation programs and<br>can be used for the screening of CO poisoning and smoke<br>inhalation. It is for use by health professionals. | |

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| Functional and<br>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:<br>• AAMI/ANSI/ISO 10993-1:2009 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process<br>• General Principles of Software Validation; Final Guidance for Industry and FDA Staff, Version January 11, 2002<br>• AAMI/ANSI/IEC 60601-1:1998 Medical Electrical Equipment—Part 1: General Requirements for Safety<br>• AAMI/ANSI/IEC 60101-1-2:2001 Medical Electrical Equipment—Part 1-2: General Requirements for Safety-Collateral Standard: Electromagnetic Compatibility<br>• 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. |

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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.

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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); 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 [phone] or [phone] 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

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## 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