CORDIS STEER-IT DEFLECTING TIP GUIDEWIRE

{0}------------------------------------------------ # DEC 1 7 2004 # XIV. 510(k) Summary of Substantial Equivalence: # CLASSIFICATION NAME Common/Usual Name: Cordis Steerable Guidewire Cordis STEER-IT Deflecting Tip Guidewire Proprietary Name: # SPONSOR Cordis Corporation 14201 NW 60th Avenue Miami Lakes, Florida 33014 #### CLASSIFICATION Catheter guidewires have been placed in Class II, 21 CFR 870.1330, Cathether Guide Wire. # NAME OF PREDICATE DEVICES - Cordis Wizdom Steerable Guidewire (K953760) . - USCI PilotWire™ Deflectable Guide Wire with Commander™ Deflection . Handle (K934474) - Lake Region Manufacturing, Inc. Mandrel Guidewire (K011084) . - Lake Region Manufacturing, Inc. Steerable PTCA Guidewire (K011968) . - ACS High Torque Standard (K881787) . - Cordis ATW Marker Wire (K994358) . ### PERFORMANCE STANDARDS Performance standards have not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act. #### INTENDED USE OF THE DEVICE The intended use of the Cordis STEER-IT Deflecting Tip Guidewire is the same as the Cordis Wizdom Steerable Guidewire previously cleared by FDA. ## BIOCOMPATIBILITY All materials were determined to be biocompatible. {1}------------------------------------------------ # SUMMARY STATEMENT OF SUBSTANTIAL EQUIVALENCE The Cordis STEER-IT Deflecting Tip Guidewire is substantially equivalent to the following steerable guidewires: - Cordis Wizdom Steerable Guidewire (K953760) � - USCI PilotWire™ Deflectable Guide Wire with Commander™ Deflection . Handle (K934474) - Lake Region Manufacturing, Inc. Mandrel Guidewire (K011084) . - Lake Region Manufacturing, Inc. Steerable PTCA Guidewire (K011968) ● - ACS High Torque Standard (K881787) . - Cordis ATW Marker Wire (K994358) . They are all .014" diameter guidewires used to support the advancement of I hey a the coronary and peripheral vasculature. Both the indications and contraindications are the same as previous steerable guidewires cleared by FDA. #### DESIGN/MATERIALS The Cordis STEER-IT Deflecting Tip Guidewire is similar in design and materials to the Cordis Wizdom Steerable Guidewire, Lake Region Manufacturing, Inc. Mandrel Guidewire, and the Lake Region Manufacturing, Inc. Steerable PTCA Guidewire. The difference is that the STEER-IT Deflecting Tip Guidewire employs a handle mechanism, which deflects the distal tip in two directions. The handle mechanism is butted into a stainless steel hypotube, which is soldered to a nitinol hypotube. The handle mechanism is similar to the USCI Commander™ Deflection Handle, an accessory of the USCI PilotWire™ Deflectable Guide Wire. The distal end of the STEER-IT Deflecting Tip Guidewire (3mm or 7mm) of the nitinol inner core wire is flattened, looped around and joined to the nitinol hypotube. The handle mechanism operates the movement of the distal tip by gripping the inner moveable core and allowing limited movement in two directions. (See Table 1 and Figures 1 and 2, Pages 5-7 for detailed comparison of design/material differences). #### MANUFACTURING The manufacturing processes are similar to Cordis steerable guidewires and to Lake Region guidewires cleared by FDA. Component joining methods, core grinding, coil winding, etc are the same or similar processes to predicate devices. The differences in the processes are primarily related to the handle mechanism and attachment. {2}------------------------------------------------ # SPECIFICATIONS AND TESTING Specifications to ensure the safety and effectiveness of the device are similar to the specifications for the Cordis Wizdom Steerable Guidewire. Joint strength, torqueability, coating integrity, linear stiffness, turns to failure and dimensional testing have all been completed on the Cordis STEER-IT Deflecting Tip Guidewire. Additional testing, specific to the handle mechanism has been completed. The Cordis STEER-IT Deflecting Tip Guidewire passed all the established acceptance criteria. #### CONCLUSION This 510(k) submission represents an addition to the current Cordis steerable guidewire line. Both the Cordis STEER-IT Deflecting Tip Guidewire and the Cordis Wizdom Steerable Guidewire are .014" diameter guidewires used to support the advancement of devices in the coronary and peripheral vasculature. The Cordis STEER-IT Deflecting Tip Guidewire incorporates a handle mechanism, which deflects the distal tip in two directions to aid the clinician in positioning the guidewire. This aspect of the device is similar in function to the USCI Commander™ Deflection Handle, an accessory of the USCI PilotWire™ Deflectable Guide Wire. Biocompatibility and in vitro testing demonstrates no significant change to product characterization when compared to the predicate device. Product design and indications for use for the Cordis STEER-IT Deflecting Tip Guidewire are substantially equivalent' to the predicate device as cleared by FDA. A statement regarding substantial equivalence to another product is required by 21 CFR 807.87 and relates only to whether the present product can be marketed without prior reclassification or premarket approval. The present submission is therefore not related tot he coverage of any patent, and is not to be interpreted as an admission or used as evidence in a patent infringement lawsuit. As the Commissioner of the FDA has stated, " .. a determination of substantial equivalence under the federal Food Drug and Cosmetic Act relates to the fact that the product can lawfully be marketed without premarket approval or reclassification. This determination is not intended to have any bearing whatever on the resolution of patent infringement suits." 42 Fed. Reg. 45.520, et seg. (1977). {3}------------------------------------------------ Image /page/3/Picture/2 description: The image is a seal for the U.S. Department of Health & Human Services. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three wavy lines, which are meant to represent the flow of people. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC 17 2004 Cordis Corporation c/o Stephen M. Enos, RN P.O. Box 025700 Miami, FL 33102 K040592 Re: Cordis STEER-IT Deflecting Tip Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: November 1, 2004 Received: November 2, 2004 Dear Mr. Enos: We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Sectori JTQ(x) premained is substantially equivalent (for the indications referenced above and have determined the devices marketed in interstate referenced above and nave delemined the devices marketed in interstate for use stated in the enclosure) to legally marketed presidents Device Amendments for use stated in the enclosure) to legally manced producal Device Amendments, or to commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1970, the chaculted with the provisions of the Federal Food, Drug, devices that have been reclassified in accordance while approval application (PMA). and Cosmetic Act (Act) that do not require approval assessions of the Act The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The You may, therefore, market the device, subject to the generation, listing of You may, therefore, market the device, subject to the gents for annual registration, listing of general controls provisions of the Act include requires ageinst misbranding an general controls provisions of the Act merate requirement in the management misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) mio crimi on the properal tions affecting your device can may be subject to such additional controls. Tim may be subject to such additional controlis. Existing major regalato 898. In addition, FDA may be found in the Code of Federal Regulations, Title 21, Parts 500 to 898. I be found in the Code of Federal Regalations, Frid 21, 2017, 1977, 1997, 1991, 1991, 1991, 1991, 1991, 199 {4}------------------------------------------------ Page 2 -- Mr. Stephen M. Enos Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be advised that 1271 3185aanse or our device complies with other requirements of the Act that I DA has made a aver regulations administered by other Federal agencies. You must or any I cacal stututes and regainments, including, but not limited to: registration and listing (21 Comply with an the rice of requirements, in the manufacturing practice requirements as set CFN in the quality systems (DS) regulation (21 CFR Part 820); and if applicable, the electronic forul in the quant) 5) Systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro tegin marketing your device as described in your Section 510(k) I mis letter wif anow you to ought tinding of substantial equivalence of your device to a legally prematics notification. The stassification 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 If you desire specific acrioliance at (240) 276-0120. Also, please note the regulation entitled, Connact the Office of been arket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, During R. Victories A / Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ # Indications for Use 510(k) Number (if known): K040592 Device Name: Cordis STEER-IT Deflecting Tip Guidewire r Indications For Use: The Cordis STEER-IT Deflecting Tip Guidewires are intended for use in angiographic I he Cordis STEER-11 Deliecting Tip Guidentres and interventional devices within the coronary and peripheral vasculature. > Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Duane R. Richter i-om Cardiovascular Devices ber k040593 Page 1 of 1 2