(86 days)
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No
The document describes a device that uses standard sensors (infrared capnometer and electrochemical CO sensor) and software for basic monitoring functions. There is no mention of AI, ML, or any related concepts in the device description, performance studies, or key metrics. The performance studies focus on standard testing like accuracy and biocompatibility, not AI/ML model validation.
No.
The device is a monitor that measures carbon monoxide levels in exhaled breath; it does not provide any treatment or therapy.
Yes
The device is indicated for monitoring carbon monoxide for medical conditions where the rate of hemolysis is relevant, for screening CO poisoning and smoke inhalation, and for use in smoking cessation programs, all of which involve identifying or monitoring a health condition.
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 all hardware components.
Based on the provided information, the CoSense ETCO Monitor is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The CoSense ETCO Monitor analyzes exhaled breath, which is a gas expelled from the body, not a sample taken from within the body (like blood, urine, tissue, etc.).
- The device description and intended use focus on analyzing a physiological output (exhaled breath) directly. It measures the concentration of carbon monoxide in this breath.
- There is no mention of analyzing biological samples. The device uses sensors to directly measure the composition of the exhaled air.
Therefore, the CoSense ETCO Monitor falls under the category of a non-invasive medical device that measures a physiological parameter (CO in exhaled breath).
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
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
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Mentions AI, DNN, or ML
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Input Imaging Modality
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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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The design and performance specifications are identical and unchanged from our predicate device. To verify that the device design met its functional and performance requirements, representative samples of the device underwent biocompatibility (Cytotoxicity, Sensitization, and Irritation), software, electrical, and mechanical testing, specifically CO Measurement accuracy. The following industry standards were used in applicable tests:
• AAMI / ANSI / ISO 10993-1 2009/(R) 2013 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
• AAMI / ANSI / ISO 10993-5 2009/(R) 2014 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
• AAMI / ANSI / ISO 10993-10 2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
• General Principles of Software Validation; Final Guidance for Industry and FDA Staff
• AAMI / ANSI / IEC 60601-1-2:2007 (R) 2012 Medical Electrical Equipment – Part 1-2: General Requirements for Safety-Collateral Standard: Electromagnetic Compatibility
• ASTM D4169-09 Standard Practice for Performance Testing of Shipping Containers and Systems
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
Breaths per Minute: 10 – 50 bpm
Sample Collection Rate: 48 mL/min + 2.0 mL/min
Measurement Time: Less than 5 minutes
Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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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)
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)
| 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 160
Redwood City, CA 94065 |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kristen Yen
Vice President, Clinical and Regulatory Affairs
Tel: (650) 353-2051
Fax: (650) 213-8383
Email: 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 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. |
| Indication 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. |
| Technological
Characteristics: | The CoSense ETCO Monitor uses the identical performance
specifications (accuracy, range, and resolution), related software
algorithms, sensors, and accessories as our predicate device, the
CoSense 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 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. | 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. |
| 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 Cell
Type | Electrochemical
(heating element in sensor housing) | Electrochemical |
| Cannula | Non-DEHP PVC | Non-DEHP PVC |
| Battery | Li-Ion | Li-Ion |
| Performance
Specifications | | |
| 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 |
| | Capnia CoSense ETCO Monitor
(Subject Device) | Capnia CoSense ETCO Monitor
(Predicate Device) |
| Measurement
Time | Less than 5 minutes | Less than 5 minutes |
| Sample
collection | Collection of a normal breath using a
disposable nasal cannula | Collection of a normal breath using a
disposable nasal cannula |
| Modes | Expired | Expired |
| Device shelf life | 1 year before servicing | 1 year before servicing |
| CO Sensor shelf
life | 6 months | 6 months |
| Cannula shelf
life | 13 months | 8 months |
| Screen | LCD | LCD |
| Software/
Hardware | Analog and digital electronics with
microprocessor | Analog and digital electronics with
microprocessor |
| Rechargeable
Battery | Yes | Yes |
| Power Source | Rechargeable Battery | Rechargeable Battery |
| Functional and
Safety Testing: | The design and performance specifications are identical and
unchanged from our predicate device. To verify that the device
design met its functional and performance requirements,
representative samples of the device underwent biocompatibility
(Cytotoxicity, Sensitization, and Irritation), software, electrical, and
mechanical testing, specifically CO Measurement accuracy. The
following industry standards were used in applicable tests:
• AAMI / ANSI / ISO 10993-1 2009/(R) 2013 Biological
evaluation of medical devices -- Part 1: Evaluation and
testing within a risk management process
• AAMI / ANSI / ISO 10993-5 2009/(R) 2014 Biological
evaluation of medical devices -- Part 5: Tests for in vitro
cytotoxicity
• AAMI / ANSI / ISO 10993-10 2010 Biological evaluation of
medical devices -- Part 10: Tests for irritation and skin
sensitization
• General Principles of Software Validation; Final Guidance
for Industry and FDA Staff
• AAMI / ANSI / IEC 60601-1-2:2007 (R) 2012 Medical
Electrical Equipment – Part 1-2: General Requirements for
Safety-Collateral Standard: Electromagnetic Compatibility
• ASTM D4169-09 Standard Practice for Performance Testing
of Shipping Containers and Systems | |
| | Capnia CoSense ETCO Monitor
(Subject Device) | Capnia CoSense ETCO Monitor
(Predicate Device) |
| Technical
Comparison of
Changes: | The modified CoSense ETCO Monitor is substantially
equivalent to the predicate device. In accordance with the FDA
Guidance document "Deciding When to Submit a 510(k) for a
Change to an Existing Device", the modifications were
thoroughly reviewed for introduction of new risks. The
differences between the subject device and predicate device
(heating element, cannula configuration, flow rate sensor, and
software updates) do not result in a change to performance
specifications or intended use of the device. | |
| Conclusion: | Capnia considers the CoSense ETCO Monitor device to be
substantially equivalent to our predicate device listed above.
This conclusion is based upon the devices' similarities in
principles of operation, performance requirements, functional
and safety testing as well as indications for use. | |
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