USGI TRANSPORT ENDOSCOPIC GUIDE

{0}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SER Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850 Comments of the comments of ## 1 5 2006 MAY Ms. Mary Lou Mooney Vice President of Clinical, Regulatory & Quality USGI Medical 1140 Calle Cordillera SAN CLEMENTE CA 92673 Re: K061216 Trade/Device Name: USGI Transport™ Endoscopic Access Device Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: KOG Dated: May 1, 2006 Received: May 2, 2006 Dear Ms. Mooney: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Image /page/0/Picture/10 description: The image shows a circular logo with the text "FDA Centennial" in the center. The logo also includes the years "1906-2006" at the top. There are three stars below the word "Centennial". The text around the circle reads "U.S. Food and Drug Administration". **Protecting and Promoting Public Health** {1}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter: | 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |-----------------|----------------------------------|--------------| | 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 892.xxxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html Sincerely yours, Nancy C. Brogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health a manager in the state the may be the may be the comments of Enclosure {2}------------------------------------------------ Special 510(k) Device Modification USGI TransPort™ Endoscopic Access Device ## Indications for Use 510(k) Number (if known): K061216 Device Name: USGI TransPort™ Endoscopic Access Device Indications For Use: The USGI TransPort Endoscopic Guide is intended to be used with an endoscope to facilitate intubation of the endoscope and as a guide for various flexible endoscopic instruments. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Nancy C'hogdon vision Sign-Off Division of Reproductive, Abdo and Radiological Devices 510(k) Number K061210 Page 1 of