FASTTRACH SINGLE-PASS TRACHEAL/ESOPHAGEAL AIRWAY SYSTEM

{0} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Donald R. Gorsuch President GreenField Medical Products, Inc. 910 Boston Turnpike Shrewsbury, MA 01545 FEB 27 1998 Re: K971348 FastTrach™ Single-Pass Tracheal/Esophageal Airway System Regulatory Class: II (Two) Product Code: 73 CAO Dated: December 4, 1997 Received: December 9, 1997 Dear Mr. Gorsuch: 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. {1} Page 2 - Mr. Donald R. Gorsuch 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,  Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2} Indications For Use Page 1 of 1 510(k) Number (if known): K971348 Device Name: FastTrach Single-Pass Tracheal/Esophageal Airway System Indications For Use: 1. To establish a patent airway to provide ventilation to a patient who has undergone cardiac* and/or pulmonary arrest. 2. To establish a protected airway where a compromised or obstructed airway exists in an unconscious patient.* 3. To establish a patent airway in a conscious patient who is unable to ventilate adequately.* 4. To establish a patent airway where a rescuer is unable to ventilate the unconscious patient with conventional methods.* 5. This device is particularly indicated where standard tracheal tube intubation may be difficult or not possible. 6. Where either tracheal or esophageal obturator airway is indicated. 7. Applicable to larger children, small adult or adult depending on sizes of our product available, with applied clinical judgement required. 8. For use by a person trained and experienced in airway management and the use of this device. *Note: These four indications are modified from "Indications for Endotracheal Intubation" from the Textbook of Advanced Life Support published by the American heart Association, copyright 1994 (ISBN 0-87493-626-8) p2-3. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) M. Rup (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number K971348 Prescription Use ☑ (Per 21 CFR 801.109) OR Over-The-Counter Use ☐ (Optional Format 1-2-96)