(372 days)
No
The summary describes a device that uses standard sensors (infrared capnometer and electrochemical CO sensor) to measure end-tidal CO. There is no mention of AI or ML in the device description, intended use, or performance studies. The comparison to predicate devices also focuses on sensor technology and measurement accuracy, not advanced algorithms.
No.
The device is indicated for monitoring carbon monoxide levels for diagnostic and screening purposes, not for treating a condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for the monitoring of carbon monoxide" and "can be used for the screening of CO poisoning and smoke inhalation," which are diagnostic purposes to identify a medical condition or risk.
No
The device description explicitly states it is a battery-operated carbon monoxide monitor that uses an infrared capnometer and an electrochemical carbon monoxide sensor, along with a portable unit, nasal cannula, replaceable CO sensor, and battery charger/power supply. These are hardware components, not solely software.
Based on the provided information, the CoSense ETCO Monitor is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens taken from the human body. The CoSense ETCO Monitor analyzes exhaled breath, which is a substance expelled from the body, not a specimen taken from within the body (like blood, urine, tissue, etc.).
- The device description focuses on analyzing the composition of the breath itself. It uses sensors to measure the concentration of carbon monoxide in the exhaled air.
- The intended use describes monitoring CO levels in breath for various medical conditions and situations. This is a direct measurement of a substance in the breath, not an analysis of a biological specimen to diagnose or monitor a condition.
Therefore, while it's a medical device used for monitoring, it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
CCJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
exhaled breath
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Performance Data: The design and performance specifications are identical to our predicate device. No additional non-clinical performance data is provided.
Clinical Performance Data: An analysis of published clinical data was conducted. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: +/- 10% or +/-0.5ppm whichever is greater
CO Measurement Range: 1.0 - 25.0ppm
Resolution: 0.1 ppm
Measurement Time: Less than 5 minutes
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
14130036
JAN 1 4 2014
5.0 510(k) Summary
| Submitter: | Capnia, Inc.
2445 Faber Place, Suite 250
Palo Alto CA 94303
(650) 213-8444 phone
(650) 213-8383 fax |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Julie Blacklock
Director Quality and Regulatory Affairs
(650) 213-8444 ext 41
julie@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) and
CO-STATTM End Tidal Breath Analyzer (K974805)
(reference predicate) |
| 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 |
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
ETCO Monitor
(Subject Device) | Capnia CoSense CO
Monitor
(Predicate Device) | Natus CO-STAT, End
Tidal Breath Analyzer
(Reference Predicate
Device) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 for
Use | The CoSense ETCO
Monitor is indicated
for the monitoring
of carbon monoxide
from endogenous
sources (including
hemolysis) and
exogenous sources | 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 | The Natus Breath Analyzer
is intended for non-
invasive, quantitative
measurement of respiratory
rate, end tidal carbon
dioxide concentration, and
end tidal carbon monoxide
(corrected for background |
| Capnia CoSense
ETCO Monitor
(Subject Device) | Capnia CoSense CO
Monitor
(Predicate Device) | Natus CO-STAT End
Tidal Breath Analyzer
(Reference Predicate
Device) | |
| (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. | cessation programs
and can be used for
the screening of CO
poisoning and smoke
inhalation. It is for use
by health
professionals. | carbon monoxide)
concentration in the breath.
The analyzer is intended for
use with neonates, children,
and adults breathing
spontaneously.
The analyzer measures the
carbon monoxide
concentration in end tidal
breath, as an indicator of
the blood level of COHb.
The level of COHb (and
consequently the
concentration of carbon
monoxide in the end tidal
breath) can be affected by
endogenous sources (for
example the rate of
hemolysis), exogenous
sources (for example,
combustion engine
exhaust), or in some cases
both. The COHb level,
elevated or normal, can be
used in the diagnosis of
medical conditions in
which the rate of hemolysis
may be relevant, and in the
monitoring of patient
populations affected by the
rate of hemolysis. The
analyzer is also indicated
for use in respiratory status
evaluation, whenever
measurement of respiratory
rate and end tidal carbon
dioxide concentration are
desired.
The analyzer is intended for
use under the direction of a
physician in hospitals and a
variety of health care
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
ETCO Monitor
(Subject Device) | Capnia CoSense CO
Monitor
(Predicate Device) | Natus CO-STAT End
Tidal Breath Analyzer
(Reference Predicate
Device) |
|-------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Patient
Interface | Nasal cannula | Nasal cannula | Nasal cannula |
| Dimensions
(LxWxH) | 246mm x 197mm x
68mm | 244mm x 183mm x
58mm | 222mm x 292mm x 152mm |
| Weight | 3.3lbs | 2.3lbs | 12lbs |
| Materials | | | |
| CO Sensor
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
Specifications | | | |
| 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 |
| Measurement
Time | Less than 5 minutes | Less than 5 minutes | 90% of final reading in 30
seconds; total time
unknown |
| Sample
Collection | Collection of a normal
breath using a
disposable nasal
cannula | Collection of a normal
breath using a
disposable nasal
cannula | Collection of a normal
breath using a disposable
nasal cannula |
| Modes | Expired | Expired | Expired |
| Device Shelf
Life | 1 year before servicing | 1 year before servicing | 1 year before servicing |
| CO Sensor
Shelf Life | 6 months | 6 months | 30 days before calibration |
| Cannula Shelf
Life | 8 months | 8 months | Not Available |
| Screen | LCD | LCD | Not Available |
| Software/
Hardware | Analog and digital
electronics with
microprocessor | Analog and digital
electronics with
microprocessor | Not Available |
Capnia, Inc.
CONFIDENTIAL K 130036 Pre-Market Notification for the CoSense ETCO Monitor
4
| | Capnia CoSense
ETCO Monitor
(Subject Device) | Capnia CoSense CO
Monitor
(Predicate Device) | Natus CO-STAT End
Tidal Breath Analyzer
(Reference Predicate
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
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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.
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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.
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4-2
FORM FDA 3881 (1/14)
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