← Product Code [CCK](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCK) · K971229 # CAPNOXYGEN MASK (K971229) _Medsys, Inc. · CCK · Sep 23, 1997 · Anesthesiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCK/K971229 ## Device Facts - **Applicant:** Medsys, Inc. - **Product Code:** [CCK](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCK.md) - **Decision Date:** Sep 23, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 868.1400 - **Device Class:** Class 2 - **Review Panel:** Anesthesiology - **Attributes:** Therapeutic ## Intended 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. ## Device Story Capnoxygen Mask is a single-use, medium-concentration oxygen mask; features integrated CO2 sampling tube. Device delivers supplemental oxygen while simultaneously sampling exhaled gas for capnography monitoring. Connects to external capnograph monitor via standard female Luer connector. Used in clinical settings for non-intubated, spontaneously breathing patients. Healthcare providers use the CO2 output from the monitor to assess patient respiratory status. Benefits include simultaneous oxygen therapy and real-time respiratory monitoring. ## Clinical Evidence Clinical study performed on a group of volunteers comparing CO2 measurement accuracy between the Capnoxygen mask and the predicate device. Results demonstrated equivalent accuracy within ±10% at a 95% confidence interval. No adverse effects reported. ## Technological Characteristics Medium-concentration, single-use plastic mask. Includes integrated sampling tube for CO2 gas collection. Features standard oxygen tubing connectors and a standard female Luer connector for gas sampling. No electronic components; passive sampling device. ## Regulatory 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. ## Predicate Devices - Jemsdal A-221 Capnographic Mask ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} Capnoxygen LLC 510(k) Summary Page A3 SEP 23 1997 Capnoxygen LLC 522 Powell Grove Road Lebanon, Tennessee 37090 Telephone 615-444-9536 510(k) Summary CAPNOXYGEN MASK K971229 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 Legally-marketed predicate device: Jemsdal A-221 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 {1} Capnoxygen LLC 510(k) Summary Page A4 connected to the Capnograph monitor by a standard female Luer connector. ## Intended 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. ## Technological characteristics The device has the same technological characteristics as the predicate device. Both are molded from plastic, 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 $\mathrm{CO}_{2}$ with the Capnoxygen mask and with the predicate device in a group of volunteers. The test showed that the two had the same accuracy $\pm 10\%$ with $95\%$ confidence. Neither mask had any adverse effects. ## Conclusion The tests show that the two masks are equivalent in safety and efficacy. {2} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SEP 23 1997 Mr. George H. Myers Medsys Inc. 377 Route 17 South Hasbrouck Heights, New Jersey 07601 Re: K971229 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 assumptions. Failure to comply with the GMP regulation may result in 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. {3} 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 regulation (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 regulation 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, ![img-0.jpeg](img-0.jpeg) Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4} Capnoxygen LLC 510(k) Summary Page A2 Page 1 of 1 510(k) Number (if known): _______________ Device Name: Capnoxygen Mask ## 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. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number K971229 Prescription Use ☑ (Per 21 CFR 810.109) OR Over-the-Counter Use ☐ (Optional Format 1-2-96) --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCK/K971229](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CCK/K971229) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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