CAPNOXYGEN mask is a medium concentration single-use The mask intended to be used for the delivery of supplemental oxygen and monitoring breathing by sampling exhaled carbon dioxide. Standard connectors for the oxygen tubing and a standard female Luer connector for the gas sample line are The mask is intended to be used for monitoring provided. non-intubated patients who are breathing spontaneously.

Device Description

The Capnoxygen mask provides a means to sample exhaled carbon dioxide via a sample tube inside an oxygen mask, during mouth and/or nose breathing. The gas sample line is connected to the Capnograph monitor by a standard female Luer connector.

AI/ML Overview

The Capnoxygen Mask is designed to deliver supplemental oxygen and monitor breathing by sampling exhaled carbon dioxide. A clinical test was performed to compare its accuracy in measuring CO2 with a predicate device.

1. Acceptance Criteria and Device Performance:

Acceptance Criteria	Reported Device Performance
Accuracy in measuring CO2 compared to predicate device	The clinical test showed equivalent accuracy in measuring CO2 with 95% confidence when compared to the predicate device.
Safety - Absence of adverse effects	Neither the Capnoxygen mask nor the predicate device had any adverse effects during the clinical test.

2. Sample Size and Data Provenance for the Test Set:

Sample Size: The document does not specify the exact number of volunteers, only stating "a group of volunteers."
Data Provenance: The study was a prospective clinical test conducted on volunteers. The country of origin is not explicitly stated, but the submission is from Capnoxygen LLC in Lebanon, Tennessee, USA.

3. Number and Qualifications of Experts for Ground Truth (Test Set):

The document describes a comparative clinical test between the Capnoxygen mask and a predicate device for CO2 measurement. The "ground truth" here appears to be the measurements obtained by both devices rather than a separate expert interpretation of images or signals. Therefore, it does not explicitly mention the use or qualifications of experts to establish a separate ground truth. The comparison is directly between the two devices' measurements.

4. Adjudication Method (Test Set):

No adjudication method is described. The comparison was directly between the CO2 measurement accuracy of the Capnoxygen mask and the predicate device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was mentioned. The study focused on the direct comparison of device accuracy in CO2 measurement, not on how human readers' performance might improve with AI assistance.

6. Standalone (Algorithm Only) Performance:

This device is a physical mask for oxygen delivery and CO2 sampling, not an algorithm. Therefore, a standalone (algorithm only) performance study is not applicable and was not performed. The "accuracy" refers to the accuracy of the physical mask's ability to sample CO2 for measurement, likely by a connected capnograph monitor (though the monitor itself is not the subject of this 510(k)).

7. Type of Ground Truth Used:

The "ground truth" for this study was comparative performance data against a legally marketed predicate device (Jemsdal A-221 Capnographic Mask) in terms of CO2 measurement accuracy and safety (absence of adverse effects).

8. Sample Size for the Training Set:

The document does not mention a training set. This is a physical medical device, not an AI/machine learning model that would typically require a training set. The clinical test described is a validation study.

9. How Ground Truth for the Training Set Was Established:

Not applicable, as a training set is not mentioned for this device.

Summary

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K971229

Capnoxygen LLC 522 Powell Grove Road Lebanon, Tennessee 37090 Telephone 615-444-9536

SEP 2 3 1997

510 (k) Summary

CAPNOXYGEN MASK

Submitter Information

Name :

Capnoxygen LLC

Address : Capnoxygen LLC 522 Powell Grove Road Lebanon, Tennessee 37090

Telephone number: 615-444-9536

Contact Person: Dr. George Myers, 201-727-1703 Mr. R. Alan Davenport, 615-444-9536

. "

Date of preparation: March 20, 1997

Device Data

Trade Name: Capnoxygen Mask

Common Name: Oxygen mask with CO2 sampling tube

Classification Name: None

predicate Jemsdal A-221 Legally-marketed device: Capnographic Mask

Description

The Capnoxygen mask provides a means to sample exhaled carbon dioxide via a sample tube inside an oxygen mask, during mouth and/or nose breathing. The gas sample line is

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connected to the Capnograph monitor by a standard female Luer connector.

Intended Use

ी में बाद में से

The CAPNOXYGEN mask is a medium concentration singlemask intended to be used for the delivery of use supplemental oxygen and monitoring breathing by sampling exhaled carbon dioxide. Standard connectors for the oxygen tubing and a standard female Luer connector for the gas sample line are provided. The mask is intended to be used for monitoring non-intubated patients who are breathing spontaneously.

Technological characteristics

The device has the same technological characteristics the predicate device. Both are molded from plastic, as provided with a sampling tube, and used in the same way.

Non-clinical tests

The submission presents data on the biocompatibility of the plastic materials used in the mask.

Clinical Tests

A clinical test was performed comparing the accuracy in measuring CO2 with the Capnoxygen mask and with the predicate device in a group of volunteers. The test showed accuracy with 95% two had the same that the confidence. Neither mask had any adverse effects.

Conclusion

The tests show that the two masks are equivalent in safety and efficacy.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 3 1997

Mr. George H. Myers Medsys Inc. 377 Route 17 South Hasbrouck Heights, New Jersey 07601

K971229 Re: Capnoxygen Mask Regulatory Class: II (two) Product Code: 73 CCK Dated: July 9, 1997 Received: July 11, 1997

Dear Mr. Myers:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. George H. Myers

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Thomas J. Callehan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure -----------

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Page

510(k) Number (if known):

Device Name: Capnoxygen Mask

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Charle Udo L. Msc

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number

Prescription Use
(Per 21 CFR 810.109)

Over-the-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 868.1400 Carbon dioxide gas analyzer.

(a)
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.(b)
Classification. Class II (performance standards).