INSULATOR WIRE GUIDE

{0}------------------------------------------------ 510(k) Premarket Notification STU(K) Insulator Wire Guide Cook Urological 5772977 8 OCT 10 1997 #### 510(k) SUMMARY L Submitted By: Tammy Bacon Cook Urological 1100 West Morgan Street Spencer, Indiana 47460 (812) 829-4891 August 8, 1997 Device Trade Name: Proposed Classification Name: Insulator Wire Guide Electrosurgical Cutting & Coagulation Device & Accessories Predicate Devices: The Insulator Wire Guide is substantially equivalent to predicate insulated wire guides in terms of indications for use, design, construction and materials equivalence. Specifically, this device is similar to the Protector Plus manufactured by Wilson-Cook Medical Inc. ### Device Description: The Insulator Wire Guide is used either inside or alongside a urological catheter or electrosurgical catheter for catheter positioning or exchange in the urinary tract. When used with a electrosurgical catheter, the Insulator Wire Guide will decrease the risk of alternate site burns to the primary material used in this device is TFE. TFE is widely used in the medical field and biocompatibility is assured. Performance testing was performed showing the device to meet requirements for a safe and effective insulated wire guide. ### Substantial Equivalence: This device will be manufactured according to specified process controls and a Quality Assurance Program. This device will undergo packaging similar to devices currently marketed and distributed by Cook Urological. Being similar with respect to indications for use, materials and physical construction to predicate devices, this device meets the requirements for section 510(k) substantial equivalence. {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is presented in black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Tammy Bacon Regulatory Affairs Technical Writer Cook Urological, Inc. 1100 West Morgan Street Spencer, Indiana 47460 Re: K972977 Insulator Wire Guide OCT 10 1997 Dated: August 8, 1997 Received: August 11, 1997 Regulatory class: II 21 CFR §876.5130/Product code: 78 KNY Dear Ms. Bacon: 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 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 requirement, 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 Radiation Control provisions, or other Federal laws or regulations. 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 vito diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 wititled, "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. W.Liau Yu Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## PREMARKET NOTIFICATION # INDICATIONS FOR USE STATEMENT 510(k) Number (if known): Not yet assigned Device Name: Insulator Wire Guide Indications for Use: The Insulator Wire Guide will be used either inside or alongside a urological catheter or electrosurgical catheter for catheter positioning or exchange in the urinary tract. When used with an electrosurgical catheter, the Insulator Wire Guide will decrease the risk of alternate site burns to the patient. This device is intended for one-time use. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEE!DED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) (Division Sign-C Division of Reproductive, Abdominal, EN and Radiological Device 510(k) Number K972977 Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use _________