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 Description

The CoSense ETCO Monitor is a battery-operated carbon monoxide (CO) 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 battery charger / power supply.

AI/ML Overview

This document is a 510(k) premarket notification for the Capnia CoSense ETCO Monitor. It seeks to demonstrate substantial equivalence to a predicate device (K130036), which is also a Capnia CoSense ETCO Monitor.

The submission focuses on the argument that the "design and performance specifications are identical and unchanged from our predicate device." Modifications primarily involved a heating element, cannula configuration, flow rate sensor, and software updates, which the manufacturer states do not alter performance specifications or intended use.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly states that the subject device shares "identical performance specifications (accuracy, range, and resolution)" with the predicate device. Therefore, the acceptance criteria are implicitly that the subject device maintains these identical specifications.

Acceptance Criterion (from Predicate Device)	Reported Device Performance (Subject Device)
Accuracy: +/- 10% or +/- 0.5ppm (whichever is greater)	+/- 10% or +/- 0.5ppm (whichever is greater)
CO Measurement Range: 1.0 – 25.0ppm	1.0 – 25.0ppm
Resolution: 0.1 ppm	0.1 ppm
Breaths per Minute: 10 – 50 bpm	10 – 50 bpm
Sample Collection Rate: 48 mL/min +/- 2.0 mL/min	48 mL/min +/- 2.0 mL/min
Measurement Time: Less than 5 minutes	Less than 5 minutes

2. Sample size used for the test set and the data provenance:

The document does not provide specific sample sizes for a separate test set used to evaluate the subject device's performance against the predicate. Instead, it states that "representative samples of the device underwent biocompatibility (Cytotoxicity, Sensitization, and Irritation), software, electrical, and mechanical testing, specifically CO Measurement accuracy." The provenance of this data is not specified (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided. The study appears to rely on established performance specifications rather than a new ground truth established by experts for this specific 510(k) submission.

4. Adjudication method for the test set:

This information is not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable to the CoSense ETCO Monitor. It is a carbon monoxide monitor, not an AI-assisted diagnostic imaging or interpretation device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This is not directly applicable in the context of an "algorithm only" study as it is a medical device for direct measurement. The "software" was tested, but not as a standalone AI algorithm in the typical sense. The device itself is designed for standalone operation (measuring CO in exhaled breath).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the performance specifications of the device (both subject and predicate), the implied ground truth would be precise measurements from calibrated gas analyzers for CO concentration. However, this document does not detail how these original performance specifications for the predicate were established, only that the subject device maintains them.

8. The sample size for the training set:

This is not an AI/machine learning device in the context of a "training set" as typically used for AI model development. Therefore, this information is not applicable and not provided.

9. How the ground truth for the training set was established:

Not applicable, as it's not an AI/machine learning device with a training set.

Summary

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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 (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" (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,

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)

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)

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510(k) Summary

Submitter:	Capnia, Inc.3 Twin Dolphin Drive, Ste 160Redwood City, CA 94065
Contact Person:	Kristen YenVice President, Clinical and Regulatory AffairsTel: (650) 353-2051Fax: (650) 213-8383Email: kristen@capnia.com
Date Prepared:	7/21/2015
Trade Name:	CoSense® ETCO Monitor
Common Name:	Carbon Monoxide Monitor
Classification Name:	Carbon Monoxide Gas Analyzer(21 CFR 868.1430, Product Code CCJ)
Predicate Device:	CoSense® ETCO Monitor (K130036)
Device Description:	The CoSense ETCO Monitor is a battery-operated carbonmonoxide (CO) monitor. It uses an infrared capnometer to detectthe end-tidal portion of the breath and an electrochemical carbonmonoxide sensor to measure the end-tidal breath CO concentration.The device consists of a portable unit with software controlledmenu (date, time, patient identification, measurement time ofmonitoring), single-use nasal cannula, replaceable CO Sensor, anda battery charger / power supply.
Indication for Use:	The CoSense ETCO Monitor is indicated for the monitoring ofcarbon monoxide from endogenous sources (including hemolysis)and exogenous sources (including CO poisoning and smokeinhalation) in exhaled breath. The end tidal carbon monoxide levelcan be used for the monitoring of carbon monoxide in medicalconditions in which the rate of hemolysis may be relevant. It is alsofor use in smoking cessation programs and can be used for thescreening of CO poisoning and smoke inhalation.
TechnologicalCharacteristics:	The CoSense ETCO Monitor uses the identical performancespecifications (accuracy, range, and resolution), related softwarealgorithms, sensors, and accessories as our predicate device, theCoSense ETCO Monitor.

Comparison to Predicate Device (K130036)

	Capnia CoSense ETCO Monitor(Subject Device)	Capnia CoSense ETCO Monitor(Predicate Device)
510(k) Number		K130036
Manufacturer	Capnia, Inc.	Capnia, Inc.
	Capnia CoSense ETCO Monitor(Subject Device)	Capnia CoSense ETCO Monitor(Predicate Device)
Classification	Class II	Class II
Product Code	CCJ	CCJ
Regulation	21 CFR 868.1430	21 CFR 868.1430
Indications forUse	The CoSense ETCO Monitor isindicated for the monitoring of carbonmonoxide from endogenous sources(including hemolysis) and exogenoussources (including CO poisoning andsmoke inhalation) in exhaled breath.The end tidal carbon monoxide levelcan be used for the monitoring ofcarbon monoxide in medicalconditions in which the rate ofhemolysis may be relevant. It is alsofor use in smoking cessationprograms and can be used for thescreening of CO poisoning and smokeinhalation.	The CoSense ETCO Monitor isindicated for the monitoring of carbonmonoxide from endogenous sources(including hemolysis) and exogenoussources (including CO poisoning andsmoke inhalation) in exhaled breath.The end tidal carbon monoxide levelcan be used for the monitoring ofcarbon monoxide in medicalconditions in which the rate ofhemolysis may be relevant. It is alsofor use in smoking cessation programsand can be used for the screening ofCO poisoning and smoke inhalation.
Patient Interface	Nasal cannula	Nasal cannula
Dimensions(LxWxH)	246mm x 197mm x 68mm	246mm x 197mm x 68mm
Weight	3.3lbs	3.3lbs
Materials
CO Sensor CellType	Electrochemical(heating element in sensor housing)	Electrochemical
Cannula	Non-DEHP PVC	Non-DEHP PVC
Battery	Li-Ion	Li-Ion
PerformanceSpecifications
Accuracy	+/- 10% or +/-0.5ppmwhichever is greater	+/- 10% or +/-0.5ppmwhichever is greater
COMeasurementRange	1.0 – 25.0ppm	1.0 – 25.0ppm
Resolution	0.1 ppm	0.1 ppm
Breaths perMinute	10 – 50 bpm	10 - 50 bpm
SampleCollection Rate	48 mL/min + 2.0 mL/min	48 mL/min + 2.0 mL/min
	Capnia CoSense ETCO Monitor(Subject Device)	Capnia CoSense ETCO Monitor(Predicate Device)
MeasurementTime	Less than 5 minutes	Less than 5 minutes
Samplecollection	Collection of a normal breath using adisposable nasal cannula	Collection of a normal breath using adisposable nasal cannula
Modes	Expired	Expired
Device shelf life	1 year before servicing	1 year before servicing
CO Sensor shelflife	6 months	6 months
Cannula shelflife	13 months	8 months
Screen	LCD	LCD
Software/Hardware	Analog and digital electronics withmicroprocessor	Analog and digital electronics withmicroprocessor
RechargeableBattery	Yes	Yes
Power Source	Rechargeable Battery	Rechargeable Battery
Functional andSafety Testing:	The design and performance specifications are identical andunchanged from our predicate device. To verify that the devicedesign met its functional and performance requirements,representative samples of the device underwent biocompatibility(Cytotoxicity, Sensitization, and Irritation), software, electrical, andmechanical testing, specifically CO Measurement accuracy. Thefollowing industry standards were used in applicable tests:• AAMI / ANSI / ISO 10993-1 2009/(R) 2013 Biologicalevaluation of medical devices -- Part 1: Evaluation andtesting within a risk management process• AAMI / ANSI / ISO 10993-5 2009/(R) 2014 Biologicalevaluation of medical devices -- Part 5: Tests for in vitrocytotoxicity• AAMI / ANSI / ISO 10993-10 2010 Biological evaluation ofmedical devices -- Part 10: Tests for irritation and skinsensitization• General Principles of Software Validation; Final Guidancefor Industry and FDA Staff• AAMI / ANSI / IEC 60601-1-2:2007 (R) 2012 MedicalElectrical Equipment – Part 1-2: General Requirements forSafety-Collateral Standard: Electromagnetic Compatibility• ASTM D4169-09 Standard Practice for Performance Testingof Shipping Containers and Systems
	Capnia CoSense ETCO Monitor(Subject Device)	Capnia CoSense ETCO Monitor(Predicate Device)
TechnicalComparison ofChanges:	The modified CoSense ETCO Monitor is substantiallyequivalent to the predicate device. In accordance with the FDAGuidance document "Deciding When to Submit a 510(k) for aChange to an Existing Device", the modifications werethoroughly reviewed for introduction of new risks. Thedifferences between the subject device and predicate device(heating element, cannula configuration, flow rate sensor, andsoftware updates) do not result in a change to performancespecifications or intended use of the device.
Conclusion:	Capnia considers the CoSense ETCO Monitor device to besubstantially equivalent to our predicate device listed above.This conclusion is based upon the devices' similarities inprinciples of operation, performance requirements, functionaland safety testing as well as indications for use.

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Regulation Number and Section

§ 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).