(174 days)
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Not Found
No
The summary describes a physical mask for oxygen delivery and CO2 sampling, with no mention of AI, ML, or any computational analysis of the sampled data.
No.
The primary stated uses of the device are for the delivery of supplemental oxygen and monitoring breathing by sampling exhaled carbon dioxide, which are supportive and diagnostic functions, not directly therapeutic.
Yes
The documentation describes the device as for "monitoring non-intubated patients who are breathing spontaneously" and for "monitoring breathing by sampling exhaled carbon dioxide," which are diagnostic uses.
No
The device description clearly describes a physical mask with tubing and connectors, indicating it is a hardware device, not software-only.
Based on the provided information, the CAPNOXYGEN mask is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue) outside of the body. The CAPNOXYGEN mask is used on the patient to deliver oxygen and sample exhaled breath directly from the patient's airway.
- The intended use is for monitoring breathing and delivering oxygen. This is a direct interaction with the patient's respiratory system, not an analysis of a biological sample.
- The device description confirms it samples exhaled carbon dioxide via a tube inside the mask. This is a real-time measurement of gas being expelled by the patient, not an analysis of a collected sample.
Therefore, the CAPNOXYGEN mask falls under the category of a medical device used for patient monitoring and therapy, not an IVD.
N/A
Intended Use / Indications for Use
The CAPNOXYGEN mask is a medium concentration single-use 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 provided. The mask is intended to be used for monitoring non-intubated patients who are breathing spontaneously.
Product codes (comma separated list FDA assigned to the subject device)
73 CCK
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.
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
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Indicated Patient Age Range
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Intended User / Care Setting
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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)
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 that the two had the same accuracy with 95% confidence. Neither mask had any adverse effects.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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).
0
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:
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.
(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)
OR
Over-the-Counter Use
(Optional Format 1-2-96)
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