USGI TRANSPORT ENDOSCOPIC ACCESS DEVICE

{0}------------------------------------------------ K०724०5 ### 510(k) 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 #### SUBMITTER INFORMATION 1. | a. Company Name: | USGI Medical | |------------------|--------------| |------------------|--------------| b. Company Address: 1140 Calle Cordillera San Clemente, CA 92673 Vice President of Clinical, Regulatory & Quality Mary Lou Mooney August 24, 2007 Access Device - c. Telephone: (949) 369-3890 Fax: (949) 369-3891 d. Contact Person: e. Date Summary Prepared: #### 2. DEVICE IDENTIFICATION - a. Trade/Proprietary Name: TransPort™ Endoscopic - b. Common Name: Endoscopic Overtube c. Classification Name: Endoscope and accessories, 876.1500 #### IDENTIFICATION OF PREDICATE DEVICES 3. | TransPortTM Endoscopic Access Device | USGI Medical<br>(K061216) | |--------------------------------------|---------------------------| | ShapeLockTM Endoscopic Access Device | USGI Medical<br>(K033954) | {1}------------------------------------------------ USGI Medical Special 510(k) Device Modification USGI TransPort™ Endoscopic Access Device K 072405 Pg. 2 of 2 #### 4. DESCRIPTION OF THE DEVICE The TransPort Endoscopic Access Device is comprised of a flexible shaft that can be rigidized and locked into position, a steerable tip and multiple lumens that allow insertion and exchange of flexible instruments. It is supplied as two separately packaged components, i.e., a reusable, metal body and a strerile, single use disposable sheath. #### 5. STATEMENT OF INTENDED USE The TransPort Endoscopic Access Device is intended to be used with an endoscope to facilitate intubation of the endoscope and as a guide for various flexible instruments. ### COMPARISON WITH PREDICATE DEVICES 6. The TransPort Endoscopic Access Device is comparable to the predicate devices in terms of intended use, technology, and materials. Bench testing was conducted to ensure that the device performs as intended when used according to its instructions for use. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. ## SEP 1 8 2007 Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850 Ms. Mary Lou Moonev Vice President of Clinical, Regulatory & Quality USGI Medical 1140 Calle Cordillera SAN CLEMENTE CA 92673 Re: K072405 Trade/Device Name: USGI TransPort" Endoscopic Access Device Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Codes: FED and ODB Dated: August 24, 2007 Received: August 27, 2007 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/2/Picture/10 description: The image is a circular seal with the text "TDS-2006" at the top. The letters "FDA" are in the center of the seal, with the word "Centennial" underneath. There are three stars at the bottom of the seal. The text around the perimeter of the seal is difficult to read due to the image quality. ting and I gomoting 9 {3}------------------------------------------------ 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.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |----------------|----------------------------------|--------------| | 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 894.xxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrlv/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 Enclosure {4}------------------------------------------------ # Indications for Use 510(k) Number (if known): Ko 7 2 4 05 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 د (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) Hui Leiner Division of Reproductive, AR and Radiological Devi 510/k) Number Page 1 of