MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE

{0}------------------------------------------------ K030019 JAN 2 4 2003 # 510(K) SUMMARY | Submitter's Name: | Guidant Corporation<br>CRM Division | |----------------------|--------------------------------------------------------------------| | Submitter's Address: | 4100 Hamline Avenue<br>Mail Stop F330<br>St. Paul, Minnesota 55112 | | Telephone:<br>Fax: | (651) 582-5011<br>(651) 582-5134 | | Contact Person: | Kristine M. Teich | | Date Prepared: | January 2, 2003 | ## Device Trade Name: HI-TORQUE® WHISPER™ LS (Light Support) Guide Wire with Hydrocoat Hydrophilic Coating, Model 6726 HI-TORQUE® WHISPER™ MS (Medium Support) Guide Wire with Hydrocoat Hydrophilic Coating, Model 6737 HI-TORQUE® WHISPER™ MS CS-J (Medium Support Coronary Sinus J) Guide Wire with Hydrocoat Hydrophilic Coating, Model 6738 HI-TORQUE® WHISPER™ ES (Extra Support) Guide Wire with Hydrocoat Hydrophilic Coating, Model 4482 HI-TORQUE® WHISPER™ ES CS-J (Extra Support Coronary Sinus J) Guide Wire with Hydrocoat Hydrophilic Coating, Model 4483 HI-TORQUE® WHISPER™ DS (Distal Support) Guide Wire with Hydrocoat Hydrophilic Coating, Model 4581 HI-TORQUE® WHISPER™ DS CS-J (Distal Support Coronary Sinus J) Guide Wire with Hydrocoat Hydrophilic Coating, Model 4586 HI-TORQUE® WHISPER™ EDS (Extra Distal Support) Guide Wire with Hydrocoat Hydrophilic Coating, Model 4583 HI-TORQUE® WHISPER™ EDS CS-J (Extra Distal Support Coronary Sinus J) Guide Wire with Hydrocoat Hydrophilic Coating, Model 4588 Device Common Name: Guide Wire Device Classification Name: Catheter Guide Wire Device Classification: Class II {1}------------------------------------------------ #### Summary of Substantial Equivalence: The design, materials, method of delivery and intended use features of HI-TORQUE WHISPER LS, MS/MS CS-J, ES/ES CS-J, DS/DS CS-J, and EDS/EDS CS-J Guide Wires are substantially equivalent with regard to these features in their predicate device, the HI-TORQUE WHISPER Guide Wires (K020340/March 1, 2002, and K021285/May 2, 2002). #### Device Description: The general guide wire design consists of a stainless steel tapered core with a flexible tip, jacketed by polyurethane on the distal portion of the wire and polytetrafluoroethylene (PTFE) on the proximal portion of the wire. The polyurethane is subsequently covered with a hydrophilic coating to increase lubricity. The guide wires are available with either a straight distal tip that is shapeable, or as a pre-formed 'J' distal tip shaped specifically for accessing the coronary sinus (designated 'CS-J'). The straight tip can be manually shaped to accommodate specific patient anatomy or physician preference; the CS-J shape provides the convenience of an existing 'J' shape without manual shaping. The HI-TORQUE WHISPER LS, MS/MS CS-J, and ES/ES CS-J guide wires with Hydrocoat hydrophilic coating are guide wires with a 0.014" maximum diameter and a length of 190 cm. The HI-TORQUE WHISPER DS/DS CS-J and EDS/EDS CS-J guide wires with Hydrocoat hydrophilic coating are guide wires with a 0.0145" maximum diameter and a length of 190 cm. These guide wires are all labeled as 0.014". These wires are constructed with a high tensile (Hyten) stainless steel core wire having a nominal diameter of 0.0128" (LS/MS versions) or 0.0132" (ES versions). The distal segment of each guide wire consists of a series of unique tapers and grinds which reduce the diameter and support at the distal core, thus yielding the desired flexibility and performance characteristics. #### Intended Use: The HI-TORQUE WHISPER Guide Wire is intended to aid in the placement of a Guidant implantable coronary venous lead in the coronary venous vasculature. ## Technological Characteristics: Comparisons of the proposed and predicate device show that the technological characteristics such as materials, performance characteristics, sterilization and packaging are identical or substantially equivalent to the currently marketed device. #### Performance Data: The results of the verification testing demonstrate that the HI-TORQUE WHISPER LS, MS/MS CS-J, ES/ES CS-J, DS/DS CS-J, and EDS/EDS CS-J Guide Wires meet the established acceptance criteria and perform in a manner equivalent to the predicate device. No new safety or effectiveness issues were raised during the testing program. #### Conclusions: The Guidant CRM HI-TORQUE WHISPER LS, MS/MS CS-J, ES/ES CS-J, DS/DS CS-J, and EDS/EDS CS-J Guide Wires have the same intended use, materials, technological characteristics, performance properties, and use identical sterilization processes as the Guidant VI Whisper LS and MS (Enhanced Radiopacity) guidewires and the Guidant CRM HI-TORQUE guidewires; there are no new safety or effectiveness issues. The modified HI-TORQUE WHISPER Guide Wires are substantially equivalent to the predicate devices. {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Image /page/2/Picture/2 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which consists of a stylized caduceus with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle. JAN 2 4 2003 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Guidant Corporation c/o Ms. Kristine M. Teich Principal Regulatory Affairs Associate Cardiac Rhythm Management 4100 Hamline Avenue North St. Paul. MN 55112 Re: K030019 Trade Name: Hi-Torque Whisper DS/DS CS-J, and EDS/EDS CS-J Guide Wires with Hydrocoat Hydrophilic Coating Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II (two) Product Code: DQX Dated: January 2, 2003 Received: January 3, 2003 Dear Ms. Teich: 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 (PMA), 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. {3}------------------------------------------------ Page 2 -- Ms. Kristine M. Teich 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 (OS) 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 (301) 594-4646. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Bram D. Zuckerman, M.D. Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # 2. Indications for Use Statement | 510(k) Number (if known) | | |--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | HI-TORQUE WHISPER LS, MS/MS CS-J, ES/ES CS-J, DS/DS CS-J, and EDS/EDS CS-J Guide Wires with Hydrocoat Hydrophilic Coating | | Indications for Use | The HI-TORQUE WHISPER Guide Wire is intended to aid in the placement of a Guidant implantable coronary venous lead in the coronary venous vasculature. | PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Cardiovascular | 510(k) Number | 4030019 | |---------------|---------| |---------------|---------| | Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use | |---------------------------------------|----|----------------------| |---------------------------------------|----|----------------------| Anidat CRM HI-TORQUE WHISPER Guide Wire Guidant CRM II Octor Special 5 I0(k): Device Modification