(372 days)
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 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.
The CoSense ETCO Monitor is a carbon monoxide (CO) monitor that 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.
Here's an analysis of its acceptance criteria and the study that proves it:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Predicate Device K121768) | Reported Device Performance (Subject Device K130036) | Reference Predicate (K974805) |
|---|---|---|---|
| Accuracy | +/- 10% or +/-0.5ppm, whichever is greater | +/- 10% or +/-0.5ppm, whichever is greater | +/- 10% or +/-0.3ppm (whichever is greater) at 8-60 bpm |
| CO Measurement Range | 1.0 - 25.0ppm | 1.0 - 25.0ppm | 0-25 ppm |
| Resolution | 0.1 ppm | 0.1 ppm | 0.1 ppm |
2. Sample Size and Data Provenance:
- Test Set Sample Size: Not explicitly reported as a human test set. The submission relies on the identical performance specifications of its predicate device, K121768, and a clinical data analysis of published studies on other FDA-cleared CO monitoring devices.
- Data Provenance: The study performed an "analysis of published clinical data" on "uses of other FDA-cleared CO monitoring devices." This suggests the data is retrospective and collected from existing literature and studies, likely covering various clinical sites and geographical locations if the published data is diverse. No specific country of origin is mentioned for this retrospective analysis.
3. Number of Experts and Qualifications:
- Not applicable for establishing ground truth for a test set, as the study relied on an analysis of published clinical data on other devices and the identical performance specifications to a predicate device. The performance specifications themselves would have been established through engineering and laboratory testing, rather than expert interpretation of a specific test set.
4. Adjudication Method:
- Not applicable as the study did not involve a human-in-the-loop test set requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. The submission does not describe an MRMC comparative effectiveness study for the subject device. It focuses on demonstrating equivalence to predicate devices and analyzing existing published clinical data.
6. Standalone Performance:
- Yes. The device's performance specifications (accuracy, range, resolution) are presented as "identical" to its predicate (Capnia CoSense CO Monitor K121768) and "similar" to a reference predicate (Natus CO-STAT End Tidal Breath Analyzer K974805), indicating a standalone assessment of the device's technical specifications. The submission states, "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."
7. Type of Ground Truth Used:
- The ground truth for the performance specifications (accuracy, range, resolution) are established through objective measurements against known standards, typical for medical device engineering and testing.
- For the "analysis of published clinical data," the "ground truth" would be the clinical outcomes and CO measurements reported in those studies, which are assumed to be established by the methodologies used in the respective published research. The submission states this analysis provides "objective evidence that the functional and performance specifications of CoSense device are similar to the devices in the published studies."
8. Sample Size for the Training Set:
- Not applicable. This device is primarily hardware with established performance specifications. The "software algorithms" are stated to be "identical" to the predicate, implying they were developed and "trained" (if machine learning was involved, which is unlikely for this type of device based on the description) during the development of the predicate device. No details are provided on a specific training set for the subject device.
9. How Ground Truth for the Training Set Was Established:
- Not applicable, as no training set for the subject device is described. The ground truth for the underlying performance of the electrochemical sensor and capnometer would have been established through precise laboratory calibration and gas measurement standards.
{0}------------------------------------------------
14130036
JAN 1 4 2014
5.0 510(k) Summary
| Submitter: | Capnia, Inc.2445 Faber Place, Suite 250Palo Alto CA 94303(650) 213-8444 phone(650) 213-8383 fax |
|---|---|
| Contact Person: | Julie BlacklockDirector Quality and Regulatory Affairs(650) 213-8444 ext 41julie@capnia.com |
| Date Prepared: | 01/13/2014 |
| Trade Name: | CoSense™ ETCO Monitor |
| Common Name: | Carbon Monoxide Monitor |
| Classification Name: | Carbon Monoxide Gas Analyzer(21 CFR 868.1430, Product Code CCJ) |
| Predicate Devices: | CoSense™ CO Monitor (K121768) andCO-STATTM End Tidal Breath Analyzer (K974805)(reference predicate) |
| Device Description: | The CoSense ETCO Monitor is a battery-operated carbonmonoxide (CO) monitor. It uses an infrared capnometer todetect the end-tidal portion of the breath and anelectrochemical carbon monoxide sensor to measure theend-tidal breath CO concentration. The device consists ofa portable unit with software controlled menu (date, time,patient identification, measurement time of monitoring),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 CoSenseETCO Monitor(Subject Device) | Capnia CoSense COMonitor(Predicate Device) | Natus CO-STAT, EndTidal Breath Analyzer(Reference PredicateDevice) | |
|---|---|---|---|
| 510(k)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 forUse | The CoSense ETCOMonitor is indicatedfor the monitoringof carbon monoxidefrom endogenoussources (includinghemolysis) andexogenous sources | The CoSense COMonitor is indicatedfor the monitoring ofCarbon Monoxidefrom endogenous andexogenous sources inexhaled breath. It isfor use in smoking | The Natus Breath Analyzeris intended for non-invasive, quantitativemeasurement of respiratoryrate, end tidal carbondioxide concentration, andend tidal carbon monoxide(corrected for background |
| Capnia CoSenseETCO Monitor(Subject Device) | Capnia CoSense COMonitor(Predicate Device) | Natus CO-STAT EndTidal Breath Analyzer(Reference PredicateDevice) | |
| (including COpoisoning andsmoke inhalation)in exhaled breath.The end tidalcarbon monoxidelevel can be usedfor the monitoringof carbon monoxidein medicalconditions in whichthe rate ofhemolysis may berelevant. It is alsofor use in smokingcessation programsand can be used forthe screening of COpoisoning andsmoke inhalation. | cessation programsand can be used forthe screening of COpoisoning and smokeinhalation. It is for useby healthprofessionals. | carbon monoxide)concentration in the breath.The analyzer is intended foruse with neonates, children,and adults breathingspontaneously.The analyzer measures thecarbon monoxideconcentration in end tidalbreath, as an indicator ofthe blood level of COHb.The level of COHb (andconsequently theconcentration of carbonmonoxide in the end tidalbreath) can be affected byendogenous sources (forexample the rate ofhemolysis), exogenoussources (for example,combustion engineexhaust), or in some casesboth. The COHb level,elevated or normal, can beused in the diagnosis ofmedical conditions inwhich the rate of hemolysismay be relevant, and in themonitoring of patientpopulations affected by therate of hemolysis. Theanalyzer is also indicatedfor use in respiratory statusevaluation, whenevermeasurement of respiratoryrate and end tidal carbondioxide concentration aredesired.The analyzer is intended foruse under the direction of aphysician in hospitals and avariety of health caresettings. |
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 CoSenseETCO Monitor(Subject Device) | Capnia CoSense COMonitor(Predicate Device) | Natus CO-STAT EndTidal Breath Analyzer(Reference PredicateDevice) | |
|---|---|---|---|
| PatientInterface | Nasal cannula | Nasal cannula | Nasal cannula |
| Dimensions(LxWxH) | 246mm x 197mm x68mm | 244mm x 183mm x58mm | 222mm x 292mm x 152mm |
| Weight | 3.3lbs | 2.3lbs | 12lbs |
| Materials | |||
| CO SensorCell Type | Electrochemical | Electrochemical | Electrochemical |
| Cannula | Non-DEHP PVC | Non-DEHP PVC | Not Available |
| Battery | Li-Ion | Li-Ion | AC Power connected to UPS |
| PerformanceSpecifications | |||
| Accuracy | +/- 10% or +/-0.5ppmwhichever is greater | +/- 10% or +/-0.5ppmwhichever is greater | +/- 10% or +/-0.3ppm(whichever is greater) at8-60 bpm |
| COMeasurementRange | 1.0 - 25.0ppm | 1.0 - 25.0ppm | 0-25 ppm |
| Resolution | 0.1 ppm | 0.1 ppm | 0.1 ppm |
| MeasurementTime | Less than 5 minutes | Less than 5 minutes | 90% of final reading in 30seconds; total timeunknown |
| SampleCollection | Collection of a normalbreath using adisposable nasalcannula | Collection of a normalbreath using adisposable nasalcannula | Collection of a normalbreath using a disposablenasal cannula |
| Modes | Expired | Expired | Expired |
| Device ShelfLife | 1 year before servicing | 1 year before servicing | 1 year before servicing |
| CO SensorShelf Life | 6 months | 6 months | 30 days before calibration |
| Cannula ShelfLife | 8 months | 8 months | Not Available |
| Screen | LCD | LCD | Not Available |
| Software/Hardware | Analog and digitalelectronics withmicroprocessor | Analog and digitalelectronics withmicroprocessor | Not Available |
Capnia, Inc.
CONFIDENTIAL K 130036 Pre-Market Notification for the CoSense ETCO Monitor
{4}------------------------------------------------
| Capnia CoSenseETCO Monitor(Subject Device) | Capnia CoSense COMonitor(Predicate Device) | Natus CO-STAT EndTidal Breath Analyzer(Reference PredicateDevice) | |
|---|---|---|---|
| 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)
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.
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)
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement on last page.
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.
THE ONLY FOR FOR THE SERVED A FOR FOR FOR FOR FOR FOR FOR FOR 이 가지 이용 대한민국 대학 Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Image /page/7/Picture/13 description: The image shows the name "Nayan J. Patel" in bold, black font. Below the name is the date and time "2014.01.13 18:05:50 -05'00'" also in bold, black font. There is a logo to the right of the name and date.
4-2
FORM FDA 3881 (1/14)
{8}------------------------------------------------
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
§ 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).