← Product Code [JOH](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/JOH) · K970811 # DISPOSABLE CANNULA TRACHEOSTOMY TUBE, WITH INNER CANNULA;DISPOSABLE CANNULA FENESTRATED TRACHEOSTOMY TUBE, WITH INNER CN (K970811) _Pneumocare, Inc. · JOH · Nov 13, 1998 · Anesthesiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/JOH/K970811 ## Device Facts - **Applicant:** Pneumocare, Inc. - **Product Code:** [JOH](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/JOH.md) - **Decision Date:** Nov 13, 1998 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 868.5800 - **Device Class:** Class 2 - **Review Panel:** Anesthesiology - **Attributes:** Therapeutic ## Indications for Use The PneumoCare Disposable Cannula Tracheostomy Tubes are designed to provide adult tracheostomy patients with an effective airway for breathing or ventilation. ## Device Story Disposable tracheostomy tube system; includes inner and outer cannula with soft flange; available in fenestrated and standard configurations; sizes 6.0, 7.0, 8.0, and 9.0mm. Features swivel connection and rotating angled elbow to facilitate chin movement and patient comfort. Used by clinicians in hospital or clinical settings to maintain airway patency for breathing or ventilation in adult patients. ## Clinical Evidence No clinical data provided; substantial equivalence based on design and technological characteristics. ## Technological Characteristics Constructed of soft inner and outer cannula with soft flange. Features swivel connection and rotating angled elbow. Available in 6.0, 7.0, 8.0, and 9.0mm sizes. Non-powered, mechanical device. ## Regulatory Identification A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic. ## Predicate Devices - Disposable Cannula Trach Tubes ([K811447](/device/K811447.md)) - D.I.C. Tracheostomy Tubes ([K903730](/device/K903730.md)) ## 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} NOV 13 1998 K970811 # SECTION 13: SUMMARY OF SAFETY AND EFFECTIVENESS This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92. ## 13.1 SUBMITTER INFORMATION a. Company Name: PneumoCare, Inc. b. Company Address: P.O. Box 7811 Laguna Niguel, CA 92607-7811 c. Company Phone: (714) 643-2306 d. Contact Person: Joseph Bales President e. Date Summary Prepared: January 10, 1997 ## 13.2. DEVICE IDENTIFICATION a. Trade/Proprietary Name: Disposable Cannula Tracheostomy Tube Disposable Cannula Fenestrated Tracheostomy Tube b. Classification Name: Tracheostomy Tube and Tube Cuff ## 13.3 IDENTIFICATION OF PREDICATE DEVICE | Company | Device | 510(k) No. | Date Cleared | | --- | --- | --- | --- | | Mallinckrodt | Disposable Cannula Trach Tubes | K811447 | June 26, 1981 | | Concord Portex | D.I.C. Tracheostomy Tubes | K903730 | September 25,1990 | {1} 44 ## 13.4 DEVICE DESCRIPTION The PneumoCare Disposable Cannula Tracheostomy Tube is constructed of a soft inner and outer cannula and incorporates a soft flange which is attached to the outer cannula. The tracheostomy tubes are available in both the fenestrated and standard configuration. Both configurations are available in 6.0, 7.0, 8.0 and 9.0mm sizes, where the size of the tube is determined by the inner diameter of the inner cannula. The tracheostomy tubes incorporate a swivel connection and a rotating angled elbow. The features allow for increased chin movement and patient comfort. ## 13.5 SUBSTANTIAL EQUIVALENCE The PneumoCare Disposable Tracheostomy Tube is substantially equivalent to other tracheostomy tubes currently in commercial distribution by Mallinckrodt and Concord Portex in terms of the intended use of achieving a safe and effective airway for breathing or ventilation in adult tracheostomy patients. The fundamental technical characteristics are similar to those of the predicate devices and are listed on the comparison chart provided in this 510(k) submission. ## 13.6 INTENDED USE The PneumoCare Disposable Cannula Tracheostomy Tubes are designed to provide adult tracheostomy patients with an effective airway for breathing or ventilation. {2} 4 ## 13.7 TECHNOLOGICAL CHARACTERISTICS A comparison of the technological characteristics of the predicate and legally marketed devices is provided in this submission. ## 13.8 510(K) CHECKLIST This notification contains all information required by 21 CFR 807.87. A completed copy of the Premarket Notification 510(k) Reviewer’s Checklist is provided in this submission. {3} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NOV 13 1998 Mr. Joseph H. Bales PneumoCare Inc. P.O. Box 7811 Laguna Niguel, CA 92607-7811 Re: K970811 Disposable Cannula Tracheostomy Tubes Regulatory Class: II (two) Product Code: 73 JOH Dated: November 4, 1998 Received: November 9, 1998 Dear Mr. Bales: 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 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). 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. {4} Page 2 - Mr. Joseph H. Bales 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/dsma/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 {5} # SECTION 7: INDICATIONS FOR USE (Separate Page) 510(k) Number: To Be Assigned By FDA Device Name: PneumoCare Disposable Cannula Tracheostomy Tube Indications For Use: The Disposable Cannula Tracheostomy Tubes are designed to provide an adult tracheostomy patient with an effective airway for breathing and/or ventilation. PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Mark Krause (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number K970811 Prescription Use ☑ (Per 21 CFR 801.109) OR Over-The-Counter Use 14 --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/JOH/K970811](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/JOH/K970811) **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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