(138 days)
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 cessation programs and can be used for the screening of CO poisoning and smoke inhalation. It is for use by health professionals.
The CoSense CO Monitor is a battery-operated carbon monoxide 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 power supply.
The provided text describes the CoSense™ CO Monitor, its indications for use, and a 510(k) summary for its clearance. However, it does not contain details about specific acceptance criteria related to device performance (e.g., accuracy, precision) or a study that directly proves the device meets such criteria.
The document primarily focuses on:
- Regulatory Clearance: Listing the device's classification, product code, and predicate device.
- Device Description: Explaining how the monitor works.
- Intended Use: Defining its applications.
- Functional and Safety Testing: Mentioning adherence to industry standards for biocompatibility, software, electrical, and mechanical aspects. This testing verifies that the design meets its functional and performance requirements generally, but specific performance metrics (e.g., measurement accuracy against a gold standard) are not detailed here.
- Substantial Equivalence: Concluding that the device is equivalent to a predicate based on similarities in indications, operation, technology, and materials. This is a regulatory conclusion, not a performance study result.
Therefore, I cannot fulfill all parts of your request with the provided information. I will address the points that can be answered and clearly state where information is missing.
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific numerical acceptance criteria (e.g., accuracy thresholds, precision values) for the device's CO measurement performance, nor does it provide a table of reported device performance metrics in terms of CO measurement accuracy or precision that would typically be found in a performance study.
The "Acceptance Criteria" mentioned are for functional and safety testing (biocompatibility, software, electrical, and mechanical testing against specific industry standards). The reported device performance in this context is simply the conclusion that the device meets these standards.
| Type of Testing / Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: AAMI/ANSI/ISO 10993-1:2009 | Met: Representative samples of the device underwent biocompatibility testing in accordance with the standard to verify that device design meets its functional and performance requirements. |
| Software: General Principles of Software Validation; Final Guidance for Industry and FDA Staff, Version January 11, 2002 | Met: Representative samples of the device underwent software validation in accordance with the standard to verify that device design meets its functional and performance requirements. |
| Electrical Safety: AAMI/ANSI/IEC 60601-1:1998, AAMI/ANSI/IEC 60101-1-2:2001 (EMC) | Met: Representative samples of the device underwent electrical and electromagnetic compatibility testing in accordance with the standards to verify that device design meets its functional and performance requirements. |
| Mechanical Testing: ASTM D4169-09 | Met: Representative samples of the device underwent mechanical testing (for shipping containers and systems) in accordance with the standard to verify that device design meets its functional and performance requirements. |
| CO Measurement Accuracy/Precision | Not specified in the provided text. The document states the device uses an electrochemical CO sensor to measure end-tidal breath CO concentration, and concludes substantial equivalence based on principles of operation, technology, and materials to a predicate device (FIM Medical Tabataba CO Tester K080278), implying comparable performance, but no explicit performance metrics are given for the CoSense device. |
2. Sample size used for the test set and the data provenance
Not provided in the text. The document mentions "representative samples of the device underwent testing," but does not specify the number of devices, patients, or measurements used for any testing directly related to CO measurement performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided in the text. This type of information is typically relevant for medical imaging or diagnostic algorithms where expert consensus is used to establish ground truth for a disease state. For a carbon monoxide monitor measuring a physiological parameter, the "ground truth" would typically involve a reference standard CO measurement device or gas concentration, not human expert interpretation of the device's output.
4. Adjudication method for the test set
Not applicable/Not provided in the text. See point 3.
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
Not applicable/Not provided in the text. An MRMC study is not relevant for a CO monitor. The device's function is to objectively measure CO, not to assist human readers in interpreting complex medical images or data.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The device itself is a standalone monitor (algorithm only without human-in-the-loop performance in terms of interpreting its raw output). The document implies that the device's measurement capability was evaluated, but details of a specific "standalone" performance study (e.g., accuracy against a known CO source) are not detailed in the provided text. The functional and safety testing ensures the device operates correctly, but specific performance metrics are absent.
7. The type of ground truth used
For objective measurements like CO concentration, the ground truth would typically be an independent, highly accurate reference standard method for measuring CO or certified gas mixtures. The provided text does not specify what ground truth method was used for performance validation of the CO measurement capabilities, but it would not be "expert consensus" or "pathology" for this type of device.
8. The sample size for the training set
Not applicable/Not provided in the text. The CoSense CO Monitor is described as using an infrared capnometer and an electrochemical CO sensor. This suggests it's a sensor-based measurement device rather than a machine learning model that would require a "training set" in the conventional sense (e.g., for image recognition or predictive analytics). While the device has "software controlled menu," it's not explicitly stated to be an AI/ML device requiring a training set for its core measurement function.
9. How the ground truth for the training set was established
Not applicable/Not provided in the text. See point 8.
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OCT 3 1 2012
510(K) SUMMARY
・
| Table 1: | 510(k) Summary | K121768 |
|---|---|---|
| Submitter: | Capnia, Inc.2445 Faber Place, Suite 250Palo Alto CA 94303 | |
| Contact Person: | Julie BlacklockAssociate Director, Regulatory Affairs and Quality Assurance(650) 213-8444 ext 41julie@capnia.com | |
| Date Prepared: | 6/14/2012 | |
| Trade Name: | CoSense™ CO Monitor | |
| Common Name: | Carbon Monoxide Monitor | |
| Classification: | Class II | |
| Product Code: | CCJ, 868.1430 | |
| Predicate Device(s): | The subject device is equivalent to the following devices:• FIM Medical Tabataba CO Tester (K080278) | |
| Device Description: | The CoSense CO Monitor is a battery-operated carbonmonoxide monitor. It uses an infrared capnometer to detect theend-tidal portion of the breath and an electrochemical carbonmonoxide sensor to measure the end-tidal breath COconcentration. The device consists of a portable unit withsoftware controlled menu (date, time, patient identification,measurement time of monitoring), single-use nasal cannula,replaceable CO Sensor, and a power supply. | |
| Indication for Use: | The CoSense CO Monitor is indicated for the monitoring ofCarbon Monoxide from endogenous and exogenous sources inexhaled breath. It is for use in smoking cessation programs andcan be used for the screening of CO poisoning and smokeinhalation. It is for use by health professionals. |
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| Functional andSafety Testing: | To verify that device design meets its functional and performance requirements, representative samples of the device underwent biocompatibility, software, electrical, and mechanical testing in accordance with the following industry standards:• AAMI/ANSI/ISO 10993-1:2009 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process• General Principles of Software Validation; Final Guidance for Industry and FDA Staff, Version January 11, 2002• AAMI/ANSI/IEC 60601-1:1998 Medical Electrical Equipment—Part 1: General Requirements for Safety• AAMI/ANSI/IEC 60101-1-2:2001 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 |
|---|---|
| Conclusion: | Capnia considers the CoSense device to be equivalent to the predicate device listed above. This conclusion is based upon the devices' similarities in indications for use, principles of operation, technology, and materials. |
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Image /page/2/Picture/1 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized depiction of an eagle with three stripes representing the three levels of government. The emblem is positioned in the center of the circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper half of the circle's perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 31 2012
Capnia, Incorporated Ms. Julie Blacklock Associate Director, Regulatory Affairs and Quality Assurance 2445 Faber Place, Suite 250 Palo Alto, California 94303
Re: K121768
Trade/Device Name: Capnia CoSense CO Monitor Regulation Number: 21 CFR 868.1430 Regulation Name: Carbon Monoxide Gas Analyzer Regulatory Class: II Product Code: CCJ Dated: October 10, 2012 Received: October 11. 2012
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.
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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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.
ph for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
Device Name: Capnia CoSense CO Monitor
Indications for Use:
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 cessation programs and can be used for the screening of CO poisoning and smoke inhalation. It is for use by health professionals.
Prescription Use X (21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L Schull
(Division Sign-Off Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: V21768
§ 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).