CoSense ETCO Monitor

K151107 · Capnia, Inc. · CCJ · Jul 22, 2015 · Anesthesiology

Device Facts

• Record ID: K151107
• Device Name: CoSense ETCO Monitor
• Applicant: Capnia, Inc.
• Product Code: CCJ · Anesthesiology
• Decision Date: Jul 22, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.1430
• Device Class: Class 2

Intended Use

The CoSense ETCO Monitor is indicated for the monitoring of carbon monoxide from endogenous sources (including hemolysis) and exogenous sources (including CO poisoning and smoke inhalation) in exhaled breath. The end tidal carbon monoxide level can be used for the monitoring of carbon monoxide in medical conditions in which the rate of hemolysis may be relevant. It is also for use in smoking cessation programs and can be used for the screening of CO poisoning and smoke inhalation.

Device Story

Battery-operated monitor; uses infrared capnometer to detect end-tidal breath portion; electrochemical sensor measures CO concentration. Input: exhaled breath via single-use nasal cannula. Output: CO concentration levels displayed on LCD. Used in clinical settings; operated by healthcare professionals. Provides quantitative CO data to assist in monitoring hemolysis rates, smoking cessation progress, and screening for CO poisoning/smoke inhalation. Benefits include rapid, non-invasive assessment of CO levels.

Clinical Evidence

Bench testing only. No clinical data presented. Performance verified through biocompatibility (ISO 10993-1, -5, -10), electrical safety/EMC (IEC 60601-1-2), and mechanical shipping testing (ASTM D4169-09). CO measurement accuracy verified against performance specifications.

Technological Characteristics

Portable battery-operated device; infrared capnometer; electrochemical CO sensor with heating element. Non-DEHP PVC nasal cannula. LCD display. Microprocessor-based control. Biocompatibility per ISO 10993. Electrical safety per IEC 60601-1-2. Shipping tested per ASTM D4169.

Indications for Use

Indicated for monitoring exhaled carbon monoxide (CO) in patients to assess endogenous sources (hemolysis) and exogenous sources (CO poisoning, smoke inhalation). Also indicated for smoking cessation programs and screening for CO poisoning/smoke inhalation.

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

• CoSense ETCO Monitor (K130036)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 22, 2015

Capnia, Inc. Kristen Yen Vice President. Clinical and Regulatory Affairs 3 Twin Dolphin Drive, Suite 160 Redwood City, CA 04065

Re: K151107

Trade/Device Name: CoSense ETCO Monitor Regulation Number: 21 CFR 868.1430 Regulation Name: Carbon Monoxide Gas Analyzer Regulatory Class: Class II Product Code: CCJ Dated: June 19, 2015 Received: June 22, 2015

Dear Ms. Kristen Yen:

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

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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 devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

**Tejashri Purohit-Sheth, M.D.**

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known)

K151107

Device Name CoSense ETCO Monitor

#### Indications for Use (Describe)

The CoSense ETCO Monitor is indicated for the monitoring of carbon monoxide from endogenous sources (including hemolysis) and exogenous sources (including CO poisoning and smoke inhalation) in exhaled breath. The end tidal carbon monoxide level can be used for the monitoring of carbon monoxide in medical conditions in which the rate of hemolysis may be relevant. It is also for use in smoking cessation programs and can be used for the screening of CO poisoning and smoke inhalation.

Type of Use (Select one or both, as applicable)

| <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
|--------------------------------------------------------------------------------------|
| <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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### 510(k) Summary

| Submitter: | Capnia, Inc.<br>3 Twin Dolphin Drive, Ste 160<br>Redwood City, CA 94065 |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kristen Yen<br>Vice President, Clinical and Regulatory Affairs<br>Tel: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared: | 7/21/2015 |
| Trade Name: | CoSense® ETCO Monitor |
| Common Name: | Carbon Monoxide Monitor |
| Classification Name: | Carbon Monoxide Gas Analyzer<br>(21 CFR 868.1430, Product Code CCJ) |
| Predicate Device: | CoSense® ETCO Monitor (K130036) |
| Device Description: | The CoSense ETCO Monitor is a battery-operated carbon<br>monoxide (CO) monitor. It uses an infrared capnometer to detect<br>the end-tidal portion of the breath and an electrochemical carbon<br>monoxide sensor to measure the end-tidal breath CO concentration.<br>The device consists of a portable unit with software controlled<br>menu (date, time, patient identification, measurement time of<br>monitoring), single-use nasal cannula, replaceable CO Sensor, and<br>a battery charger / power supply. |
| Indication for Use: | The CoSense ETCO Monitor is indicated for the monitoring of<br>carbon monoxide from endogenous sources (including hemolysis)<br>and exogenous sources (including CO poisoning and smoke<br>inhalation) in exhaled breath. The end tidal carbon monoxide level<br>can be used for the monitoring of carbon monoxide in medical<br>conditions in which the rate of hemolysis may be relevant. It is also<br>for use in smoking cessation programs and can be used for the<br>screening of CO poisoning and smoke inhalation. |
| Technological<br>Characteristics: | The CoSense ETCO Monitor uses the identical performance<br>specifications (accuracy, range, and resolution), related software<br>algorithms, sensors, and accessories as our predicate device, the<br>CoSense ETCO Monitor. |

# Comparison to Predicate Device (K130036)

| | Capnia CoSense ETCO Monitor<br>(Subject Device) | Capnia CoSense ETCO Monitor<br>(Predicate Device) |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | | K130036 |
| Manufacturer | Capnia, Inc. | Capnia, Inc. |
| | Capnia CoSense ETCO Monitor<br>(Subject Device) | Capnia CoSense ETCO Monitor<br>(Predicate Device) |
| Classification | Class II | Class II |
| Product Code | CCJ | CCJ |
| Regulation | 21 CFR 868.1430 | 21 CFR 868.1430 |
| Indications for<br>Use | The CoSense ETCO Monitor is<br>indicated for the monitoring of carbon<br>monoxide from endogenous sources<br>(including hemolysis) and exogenous<br>sources (including CO poisoning and<br>smoke inhalation) in exhaled breath.<br>The end tidal carbon monoxide level<br>can be used for the monitoring of<br>carbon monoxide in medical<br>conditions in which the rate of<br>hemolysis may be relevant. It is also<br>for use in smoking cessation<br>programs and can be used for the<br>screening of CO poisoning and smoke<br>inhalation. | The CoSense ETCO Monitor is<br>indicated for the monitoring of carbon<br>monoxide from endogenous sources<br>(including hemolysis) and exogenous<br>sources (including CO poisoning and<br>smoke inhalation) in exhaled breath.<br>The end tidal carbon monoxide level<br>can be used for the monitoring of<br>carbon monoxide in medical<br>conditions in which the rate of<br>hemolysis may be relevant. It is also<br>for use in smoking cessation programs<br>and can be used for the screening of<br>CO poisoning and smoke inhalation. |
| Patient Interface | Nasal cannula | Nasal cannula |
| Dimensions<br>(LxWxH) | 246mm x 197mm x 68mm | 246mm x 197mm x 68mm |
| Weight | 3.3lbs | 3.3lbs |
| Materials | | |
| CO Sensor Cell<br>Type | Electrochemical<br>(heating element in sensor housing) | Electrochemical |
| Cannula | Non-DEHP PVC | Non-DEHP PVC |
| Battery | Li-Ion | Li-Ion |
| Performance<br>Specifications | | |
| Accuracy | +/- 10% or +/-0.5ppm<br>whichever is greater | +/- 10% or +/-0.5ppm<br>whichever is greater |
| CO<br>Measurement<br>Range | 1.0 – 25.0ppm | 1.0 – 25.0ppm |
| Resolution | 0.1 ppm | 0.1 ppm |
| Breaths per<br>Minute | 10 – 50 bpm | 10 - 50 bpm |
| Sample<br>Collection Rate | 48 mL/min + 2.0 mL/min | 48 mL/min + 2.0 mL/min |
| | Capnia CoSense ETCO Monitor<br>(Subject Device) | Capnia CoSense ETCO Monitor<br>(Predicate Device) |
| Measurement<br>Time | Less than 5 minutes | Less than 5 minutes |
| Sample<br>collection | Collection of a normal breath using a<br>disposable nasal cannula | Collection of a normal breath using a<br>disposable nasal cannula |
| Modes | Expired | Expired |
| Device shelf life | 1 year before servicing | 1 year before servicing |
| CO Sensor shelf<br>life | 6 months | 6 months |
| Cannula shelf<br>life | 13 months | 8 months |
| Screen | LCD | LCD |
| Software/<br>Hardware | Analog and digital electronics with<br>microprocessor | Analog and digital electronics with<br>microprocessor |
| Rechargeable<br>Battery | Yes | Yes |
| Power Source | Rechargeable Battery | Rechargeable Battery |
| Functional and<br>Safety Testing: | The design and performance specifications are identical and<br>unchanged from our predicate device. To verify that the device<br>design met its functional and performance requirements,<br>representative samples of the device underwent biocompatibility<br>(Cytotoxicity, Sensitization, and Irritation), software, electrical, and<br>mechanical testing, specifically CO Measurement accuracy. The<br>following industry standards were used in applicable tests:<br>• AAMI / ANSI / ISO 10993-1 2009/(R) 2013 Biological<br>evaluation of medical devices -- Part 1: Evaluation and<br>testing within a risk management process<br>• AAMI / ANSI / ISO 10993-5 2009/(R) 2014 Biological<br>evaluation of medical devices -- Part 5: Tests for in vitro<br>cytotoxicity<br>• AAMI / ANSI / ISO 10993-10 2010 Biological evaluation of<br>medical devices -- Part 10: Tests for irritation and skin<br>sensitization<br>• General Principles of Software Validation; Final Guidance<br>for Industry and FDA Staff<br>• AAMI / ANSI / IEC 60601-1-2:2007 (R) 2012 Medical<br>Electrical Equipment – Part 1-2: General Requirements for<br>Safety-Collateral Standard: Electromagnetic Compatibility<br>• ASTM D4169-09 Standard Practice for Performance Testing<br>of Shipping Containers and Systems | |
| | Capnia CoSense ETCO Monitor<br>(Subject Device) | Capnia CoSense ETCO Monitor<br>(Predicate Device) |
| Technical<br>Comparison of<br>Changes: | The modified CoSense ETCO Monitor is substantially<br>equivalent to the predicate device. In accordance with the FDA<br>Guidance document "Deciding When to Submit a 510(k) for a<br>Change to an Existing Device", the modifications were<br>thoroughly reviewed for introduction of new risks. The<br>differences between the subject device and predicate device<br>(heating element, cannula configuration, flow rate sensor, and<br>software updates) do not result in a change to performance<br>specifications or intended use of the device. | |
| Conclusion: | Capnia considers the CoSense ETCO Monitor device to be<br>substantially equivalent to our predicate device listed above.<br>This conclusion is based upon the devices' similarities in<br>principles of operation, performance requirements, functional<br>and safety testing as well as indications for use. |…