Traditional 510(k) Submission
`GUIDEZILA T Guide Extension Catheter
`
`K 123765 Page 1 of 2
`
`MAR 1 9 2013
`
`Submitters
`Name and
`Address
`Contact Name
`and Information
`
`Prepared
`Proprietary
`Name
`Common Name
`Product Code
`Classification
`
`Predicate
`Devices
`Device
`Description
`
`Intended Use I
`Indications for
`Use
`
`Comparison of
`Technological
`Characteristics
`
`510(k) Summary
`per 21 CIFR §807.92
`
`Boston Scientific Corporation
`One Scimed Place
`Maple Grove, MVN 55311
`Holly Ramirez
`Phone: 763-494-2113
`Fax:
`763-494-2222
`e-mail: Holly.Holmes@BSCI.com
`06 December 2012
`GUIDEZILLA Tm Guide Extension Catheter
`
`Guide Catheter
`DQY
`Class 11, 21 CFR Part 870.1250
`
`GuideLiner@®V2 Catheter
`
`K12082
`
`01 December 2011
`
`The Boston Scientific GUIDEZILLAnA Guide Extension Catheter acts as an
`extension to a traditional guide catheter. GUIDEZILLA consists of a proximal
`stainless steel hypotube with a tab used for device identification and a distal
`guide catheter segment through which interventional devices may be
`delivered. The guide catheter segment incorporates two radiopaque marker
`bands to aid in positioning the device during the procedure. A hydrophilic
`coating is ap ,plied to the distal polymer segment of the device.
`GUIDEZILLA is a 5F catheter compatible with a 6F guide catheter. The
`effective length of the device is 145 cm.
`The GUIDEZILLA Tm 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.
`
`The GUIDEZILLA TM Guide Extension Catheter incorporates substantially
`equivalent device materials and design, packaging materials and design,
`fundamental technology, manufacturing processes, sterilization process and
`intended use as the GuideLiner® V2 (K1 12082).
`
`
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`Traditional 510(k) Submission
`GUIDEZILLA h Guide Extension Catheter
`
`K 123765 Page 2 of 2
`
`Performance
`Data
`
`Bench testing and bioconipatibility testing were performed to support a
`determination of substantial equivalence. The results of these tests provide
`reasonable assurance that the proposed device has been designed and
`tested to assure conformance to the requirements for its intended use. No
`new safety or performance issues were raised during the testing.
`The following biocompatibility tests were completed on the GUIDEZILLA h
`Guide Extension Catheter:
`Cytotoxicity
`Sensitization
`Intracutaneous Reactivity
`Acute Systemic Toxicity
`Materials Mediated Pyrogenicity
`USP Physicochemnical
`
`Direct Contact Hemolysis
`Hemolysis Extract
`Complement Activation
`Partial Thromboplastin Time
`In Vitro Hemocompatibility
`Latex
`
`The following in-vitro performance tests were completed of the GUIDEZILLA TM
`Guide Extension Catheter:
`Effective Length
`Outer Diameter
`Inner Diameter
`Full Unit Tensile
`Kink Resistance
`Tip Deflection
`Torque Strength
`
`Radiopacity
`Dye Flow
`Coating Integrity
`Particulate Evaluation
`Corrosion Resistance
`Device Compatibility
`Packaging Integrity
`
`Clinical Testing
`
`Clinical Evaluation was not required for these devices.
`
`Conclusion
`
`Based on the indications for use, technological characteristics, and safety and
`performance testing, the GUIDEZILLA Tm Guide Extension Catheter has been
`shown to be appropriate for its intended use and is considered to be
`substantially equivalent to the GuideLiner® V2 (K1 12082).
`
`
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`DEPARTMENT OF HEALTH & HUMAN SERVICES
`
`Public Health Service
`
`March 19, 2013
`
`Food and Drug Administration
`10903 New Hampshire Avenue
`Document Control Center - W066-6609
`Silver Spring, MD 20993-0002
`
`Boston Scientific Corporation
`C/O Holly Ramirez
`One Scimed Place
`Maple Grove, MIN 55311
`
`Re: K123765
`Trade/Device Name: GuidezillaTM Guide Extension Catheter
`Regulation Number: 21 CFR 870.1250
`Regulation Name: Percutaneous Catheter
`Regulatory Class: Class 1I
`Product Code: DQY
`Dated: February 15, 2013
`Received: February 19, 2013
`
`Dear Ms. Ramirez:
`
`We have reviewed your Section 5 1 0(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 11 (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
`CFI{ 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.
`
`
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`Page 2 - Ms. Holly Ramirez
`
`If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
`go to http://.wwv.fda. 20v/AboutFDA/CentersOffices/CDRH/CDRHOffiCes/ucm 115809.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" (2 1 CFR 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/ReyortaProblem/default.htm
`of Surveillance and Biometrics/Division of Postmarket Surveillance.
`
`for the CDRH's Office
`
`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) 63 8-2041 or (301) 796-7100 or at its Internet address
`http://vw-v.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm.
`
`Sincerely yours,
`
`iilbrenner
`Matthew
`for Brain Zuckerman, M.D.
`Director, Division of Cardiovascular Devices
`Office of Device Evaluation
`Center for Devices and
`Radiological Health
`
`Enclosure
`
`
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`Indications for Use
`
`510(k) Number (if known): K123765
`
`Device Name:
`
`GUIDEZILLATM Guide Extension Catheter
`
`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 __ANX/OR
`(Part 21 CFR 801 Subpart D)
`
`ANIR(21
`
`Over-The-Counter Use ___
`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 QI-Tiiiebrenner
`
`Boston Scientific Corporation
`
`Page 1 of 1
`
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