COSENSE CO MONITOR

{0}------------------------------------------------ 14130036 JAN 1 4 2014 # 5.0 510(k) Summary | Submitter: | Capnia, Inc.<br>2445 Faber Place, Suite 250<br>Palo Alto CA 94303<br>(650) 213-8444 phone<br>(650) 213-8383 fax | |----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Julie Blacklock<br>Director Quality and Regulatory Affairs<br>(650) 213-8444 ext 41<br>julie@capnia.com | | Date Prepared: | 01/13/2014 | | 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 Devices: | CoSense™ CO Monitor (K121768) and<br>CO-STATTM End Tidal Breath Analyzer (K974805)<br>(reference predicate) | | Device Description: | The CoSense ETCO Monitor is a battery-operated carbon<br>monoxide (CO) monitor. It uses an infrared capnometer to<br>detect the end-tidal portion of the breath and an<br>electrochemical carbon monoxide sensor to measure the<br>end-tidal breath CO concentration. The device consists of<br>a portable unit with software controlled menu (date, time,<br>patient identification, measurement time of monitoring),<br>single-use nasal cannula, replaceable CO Sensor, and a | Capnia, Inc. battery charger/power supply. {1}------------------------------------------------ ### Indications for Use: Technological Characteristics: 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. The CoSense ETCO Monitor uses the identical performance specifications (accuracy, range, and resolution), software algorithms, sensors, and accessories as our predicate device, the CoSense CO Monitor. The CoSense ETCO Monitor also has similar performance specifications (accuracy, range, and resolution) as the reference predicate, CO-STAT End Tidal Breath Analyzer. ### Comparison to Predicate Device (K121768) and Reference Predicate (K974805): | | Capnia CoSense<br>ETCO Monitor<br>(Subject Device) | Capnia CoSense CO<br>Monitor<br>(Predicate Device) | Natus CO-STAT, End<br>Tidal Breath Analyzer<br>(Reference Predicate<br>Device) | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k)<br>Number | K130036 | K121768 | K974805 | | Manufacturer | Capnia, Inc. | Capnia, Inc. | Natus Medical, Inc. | | Classification | Class II | Class II | Class II | | Product Code | CCJ | CCJ | CCJ | | Regulation | 21 CFR 868.1430 | 21 CFR 868.1430 | 21 CFR 868.1430 | | Indications for<br>Use | The CoSense ETCO<br>Monitor is indicated<br>for the monitoring<br>of carbon monoxide<br>from endogenous<br>sources (including<br>hemolysis) and<br>exogenous sources | The CoSense CO<br>Monitor is indicated<br>for the monitoring of<br>Carbon Monoxide<br>from endogenous and<br>exogenous sources in<br>exhaled breath. It is<br>for use in smoking | The Natus Breath Analyzer<br>is intended for non-<br>invasive, quantitative<br>measurement of respiratory<br>rate, end tidal carbon<br>dioxide concentration, and<br>end tidal carbon monoxide<br>(corrected for background | | Capnia CoSense<br>ETCO Monitor<br>(Subject Device) | Capnia CoSense CO<br>Monitor<br>(Predicate Device) | Natus CO-STAT End<br>Tidal Breath Analyzer<br>(Reference Predicate<br>Device) | | | (including CO<br>poisoning and<br>smoke inhalation)<br>in exhaled breath.<br>The end tidal<br>carbon monoxide<br>level can be used<br>for the monitoring<br>of carbon monoxide<br>in medical<br>conditions in which<br>the rate of<br>hemolysis may be<br>relevant. It is also<br>for use in smoking<br>cessation programs<br>and can be used for<br>the screening of CO<br>poisoning and<br>smoke inhalation. | cessation programs<br>and can be used for<br>the screening of CO<br>poisoning and smoke<br>inhalation. It is for use<br>by health<br>professionals. | carbon monoxide)<br>concentration in the breath.<br>The analyzer is intended for<br>use with neonates, children,<br>and adults breathing<br>spontaneously.<br>The analyzer measures the<br>carbon monoxide<br>concentration in end tidal<br>breath, as an indicator of<br>the blood level of COHb.<br>The level of COHb (and<br>consequently the<br>concentration of carbon<br>monoxide in the end tidal<br>breath) can be affected by<br>endogenous sources (for<br>example the rate of<br>hemolysis), exogenous<br>sources (for example,<br>combustion engine<br>exhaust), or in some cases<br>both. The COHb level,<br>elevated or normal, can be<br>used in the diagnosis of<br>medical conditions in<br>which the rate of hemolysis<br>may be relevant, and in the<br>monitoring of patient<br>populations affected by the<br>rate of hemolysis. The<br>analyzer is also indicated<br>for use in respiratory status<br>evaluation, whenever<br>measurement of respiratory<br>rate and end tidal carbon<br>dioxide concentration are<br>desired.<br>The analyzer is intended for<br>use under the direction of a<br>physician in hospitals and a<br>variety of health care<br>settings. | | CONFIDENTIAL K 130036 Pre-Market Notification for the CoSense ETCO Monitor {2}------------------------------------------------ Capnia, Inc. CONFIDENTIAL K 130036 Pre-Market Notification for the CoSense ETCO Monitor . {3}------------------------------------------------ | | Capnia CoSense<br>ETCO Monitor<br>(Subject Device) | Capnia CoSense CO<br>Monitor<br>(Predicate Device) | Natus CO-STAT End<br>Tidal Breath Analyzer<br>(Reference Predicate<br>Device) | |-------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------------| | Patient<br>Interface | Nasal cannula | Nasal cannula | Nasal cannula | | Dimensions<br>(LxWxH) | 246mm x 197mm x<br>68mm | 244mm x 183mm x<br>58mm | 222mm x 292mm x 152mm | | Weight | 3.3lbs | 2.3lbs | 12lbs | | Materials | | | | | CO Sensor<br>Cell Type | Electrochemical | Electrochemical | Electrochemical | | Cannula | Non-DEHP PVC | Non-DEHP PVC | Not Available | | Battery | Li-Ion | Li-Ion | AC Power connected to UPS | | Performance<br>Specifications | | | | | Accuracy | +/- 10% or +/-0.5ppm<br>whichever is greater | +/- 10% or +/-0.5ppm<br>whichever is greater | +/- 10% or +/-0.3ppm<br>(whichever is greater) at<br>8-60 bpm | | CO<br>Measurement<br>Range | 1.0 - 25.0ppm | 1.0 - 25.0ppm | 0-25 ppm | | Resolution | 0.1 ppm | 0.1 ppm | 0.1 ppm | | Measurement<br>Time | Less than 5 minutes | Less than 5 minutes | 90% of final reading in 30<br>seconds; total time<br>unknown | | Sample<br>Collection | Collection of a normal<br>breath using a<br>disposable nasal<br>cannula | Collection of a normal<br>breath using a<br>disposable nasal<br>cannula | Collection of a normal<br>breath using a disposable<br>nasal cannula | | Modes | Expired | Expired | Expired | | Device Shelf<br>Life | 1 year before servicing | 1 year before servicing | 1 year before servicing | | CO Sensor<br>Shelf Life | 6 months | 6 months | 30 days before calibration | | Cannula Shelf<br>Life | 8 months | 8 months | Not Available | | Screen | LCD | LCD | Not Available | | Software/<br>Hardware | Analog and digital<br>electronics with<br>microprocessor | Analog and digital<br>electronics with<br>microprocessor | Not Available | Capnia, Inc. CONFIDENTIAL K 130036 Pre-Market Notification for the CoSense ETCO Monitor {4}------------------------------------------------ | | Capnia CoSense<br>ETCO Monitor<br>(Subject Device) | Capnia CoSense CO<br>Monitor<br>(Predicate Device) | Natus CO-STAT End<br>Tidal Breath Analyzer<br>(Reference Predicate<br>Device) | |--------------|----------------------------------------------------|----------------------------------------------------|-------------------------------------------------------------------------------| | Power Source | Rechargeable Battery | Rechargeable Battery | AC | ## Non-clinical Performance The design and performance specifications are identical Data: to our predicate device. No additional non-clinical performance data is provided. Clinical Performance An analysis of published clinical data was conducted. Data: This analysis was performed on the uses of other FDA-cleared CO monitoring devices for measurement of CO in screening of CO poisoning, smoke inhalation and detection of hemolysis. Results provide objective evidence that the functional and performance specifications of CoSense device are similar to the devices in the published studies, specifically the CO-STAT End Tidal Breath Analyzer, and are within the range of accuracy, measurement, and resolution of the devices currently used clinically for detection of endogenous and exogenous sources of elevated CO. Conclusion: Capnia considers the revised CoSense ETCO Monitor device to be equivalent to our predicate device and the reference predicate listed above. This conclusion is based upon the devices' similarities in indications for use and identical principles of operation, technology, and performance. The accuracy, measurement range, and resolution specifications are unchanged from our predicate CoSense device. These performance specifications are similar to the CO-STAT End Tidal Breath Analyzer (reference predicate). The proposed CoSense device indication is also similar to the indication for CO-STAT End Tidal Breath Analyzer, as both indications use hemolysis as examples of endogenous CO. Published clinical data and previous design verification data demonstrate that the device is equivalent to our predicate device. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three wing-like strokes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol. The logo is presented in black and white. ## DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 14, 2014 Capnia, Incorporated Ms. Julie Blacklock Director, Quality and Regulatory Affairs 2445 Faber Place, Suite 250 Palo Alto, CA 94303 Re: K130036 Trade/Device Name: CoSense™ ETCO Monitor Regulation Number: 21 CFR 868.1430 Regulation Name: Carbon Monoxide Gas Analyzer Regulatory Class: II Product Code: CCJ Dated: December 13, 2013 Received: December 16, 2013 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. {6}------------------------------------------------ Page 2 - Ms. Blacklock 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 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" (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. Image /page/6/Picture/6 description: The image contains a signature and some text. The text reads "Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID FOR". The signature is illegible and is located to the left of the text. The text is slightly blurred. Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ### Indications for Use 510(k) Number (if known) K130036 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 tide 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. 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