GUIDEZILLA GUIDE EXTENSION CATHETER

{0}------------------------------------------------ · : 上 Traditional 510(k) Submission . GUIDEZILLA™ Guide Extension Catheter . ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ : : | | 510(k) Summary<br>per 21 CFR §807.92 | | MAR 1 | |---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|------------------| | Submitter's<br>Name and<br>Address | Boston Scientific Corporation<br>One Scimed Place<br>Maple Grove, MN 55311 | | | | Contact Name<br>and Information | Holly Ramirez<br>Phone: 763-494-2113<br>Fax: 763-494-2222<br>e-mail: Holly.Holmes@BSCI.com | | | | Prepared | 06 December 2012 | | | | Proprietary<br>Name | GUIDEZILLA™ Guide Extension Catheter | | | | Common Name | Guide Catheter | | | | Product Code | DQY | | | | Classification | Class II, 21 CFR Part 870.1250 | | | | Predicate<br>Devices | GuideLiner® V2 Catheter | K112082 | 01 December 2011 | | Device<br>Description | The Boston Scientific GUIDEZILLA™ Guide Extension Catheter acts as an<br>extension to a traditional guide catheter. GUIDEZILLA consists of a proximal<br>stainless steel hypotube with a tab used for device identification and a distal<br>guide catheter segment through which interventional devices may be<br>delivered. The guide catheter segment incorporates two radiopaque marker<br>bands to aid in positioning the device during the procedure. A hydrophilic<br>coating is applied to the distal polymer segment of the device.<br>GUIDEZILLA is a 5F catheter compatible with a 6F guide catheter. The<br>effective length of the device is 145 cm. | | | | Intended Use /<br>Indications for<br>Use | The GUIDEZILLA™ Guide Extension Catheter is intended to be used in<br>conjunction with guide catheters to access discrete regions of the coronary<br>and/or peripheral vasculature, and to facilitate placement of interventional<br>devices. | | | | Comparison of<br>Technological<br>Characteristics | The GUIDEZILLA™ Guide Extension Catheter incorporates substantially<br>equivalent device materials and design, packaging materials and design,<br>fundamental technology, manufacturing processes, sterilization process and<br>intended use as the GuideLiner® V2 (K112082). | | | ## 9 2013 {1}------------------------------------------------ ______________________________________________________________________________________________________________________________________________________________________________ ## Traditional 510(k) Submission GUIDEZILLA™ Guide Extension Catheter | Performance<br>Data | Bench testing and biocompatibility testing were performed to support a<br>determination of substantial equivalence. The results of these tests provide<br>reasonable assurance that the proposed device has been designed and<br>tested to assure conformance to the requirements for its intended use. No<br>new safety or performance issues were raised during the testing. | | | |---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|--| | | The following biocompatibility tests were completed on the GUIDEZILLA™<br>Guide Extension Catheter: | | | | | Cytotoxicity | Direct Contact Hemolysis | | | | Sensitization | Hemolysis Extract | | | | Intracutaneous Reactivity | Complement Activation | | | | Acute Systemic Toxicity | Partial Thromboplastin Time | | | | Materials Mediated Pyrogenicity | In Vitro Hemocompatibility | | | | USP Physicochemical | Latex | | | | The following in-vitro performance tests were completed of the GUIDEZILLA™<br>Guide Extension Catheter: | | | | | Effective Length | Radiopacity | | | | Outer Diameter | Dye Flow | | | | Inner Diameter | Coating Integrity | | | | Full Unit Tensile | Particulate Evaluation | | | | Kink Resistance | Corrosion Resistance | | | | Tip Deflection | Device Compatibility | | | | Torque Strength | Packaging Integrity | | | Clinical Testing | Clinical Evaluation was not required for these devices. | | | | Conclusion | Based on the indications for use, technological characteristics, and safety and<br>performance testing, the GUIDEZILLA™ Guide Extension Catheter has been<br>shown to be appropriate for its intended use and is considered to be<br>substantially equivalent to the GuideLiner® V2 (K112082). | | | . . . {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. 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March 19, 2013 Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Boston Scientific Corporation C/O Holly Ramirez One Scimed Place Maple Grove, MN 55311 Re: K123765 Trade/Device Name: Guidezilla™ Guide Extension Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: February 15, 2013 Received: February 19, 2013 Dear Ms. Ramirez: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. {3}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Matthew G. Hillebrenner for Bram Zuckerman, M.D. Director, Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Indications for Use 510(k) Number (if known): _K123765 GUIDEZILLA™ Guide Extension Catheter Device Name: Indications for Use: The Guidezilla guide extension catheter is intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices. 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) ## Matthew GJ Willebrenner