GORE Tri-Lumen Catheter

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. October 5, 2018 W.L. Gore and Associates Inc. Michael Ivey Regulatory Affairs 1505 N. Fourth St. Flagstaff, Arizona 86005 Re: K180919 Trade/Device Name: GORE Tri-Lumen Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY Dated: September 4, 2018 Received: September 5, 2018 Dear Michael Ivey: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 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/ReportaProblem/default.htm. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Michael John -S 2018.10.05 09:40:44 -04'00' Bram D. Zuckerman, M.D. for Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K180919 Device Name GORE® Tri-Lumen Catheter #### Indications for Use (Describe) The GORE® Tri-Lumen Catheter (TLC) is a multi-lumen catheter indicated for use in endovascular procedures requiring multiple guidewires and through access, in which the catheter leading tip exits the patient, for the implantation of branched stent grafts. Standard techniques for placement of vascular access sheaths, catheters, and wires should be employed. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------|----------------------------------------------------------------------| | <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510(k) Summary 510(k) Number: K180919 Device Name: GORE® Tri-Lumen Catheter ### Intended Use / Indication for Use: The GORE® Tri-Lumen Catheter (TLC) is a multi-lumen catheter indicated for use in endovascular procedures requiring multiple guidewires and through-and-through access, in which the catheter leading tip exits the patient, for the implantation of branched stent grafts. Standard techniques for placement of vascular access sheaths, catheters, and wires should be employed. ### 510(k) Owner: W. L. Gore & Associates, Inc. Medical Products Division 1505 North Fourth Street Flagstaff, Arizona 86004 - U.S.A. ### Regulatory Contact: Michael Ivey W. L. Gore & Associates, Inc 3450 Kiltie Lane Flagstaff, AZ 86005 Phone: 928-864-3790 Fax: 928-864-4303 E-Mail: mivey@wlgore.com | Trade or Proprietary Name: | GORE® Tri-Lumen Catheter | |------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------| | Common/Usual/Classification Name: | Catheter, Percutaneous | | Product Classification: | Class II | | Product Code: | DQY | | Regulation Number: | 21CFR 870.1250 | | Classification Panel: | Cardiovascular Devices | | Establishment Registration Number: | 2017233 | | Predicate Device: | K072618, Twin-Pass Dual Access Catheter,<br>Vascular Solutions, Inc.<br>(this device has not been the subject of a design-related recall) | {4}------------------------------------------------ ## Device Description The GORE® Tri-Lumen Catheter (TLC) is a 140cm long multi-lumen accessory catheter designed to assist with multiple wire introduction and control during endovascular procedures. The central lumen can accommodate one 0.035" guidewire or two 0.018" guidewires while the two auxiliary lumens can each accommodate one 0.014" quidewire. The trailing end of the device has two distinct extension tubes to assist in the introduction of the guidewires into the auxiliary lumens. The leading end of the device is radiopaque to assist in visibility under fluoroscopy. The GORE® Tri-Lumen Catheter is designed to minimize entanglement of multiple quidewires and facilitate through and through access during cardiovascular procedures with fewer snaring maneuvers. ## Indications for Use The GORE® Tri-Lumen Catheter (TLC) is a multi-lumen catheter indicated for use in endovascular procedures requiring multiple quidewires and through-and-through access, in which the catheter leading tip exits the patient, for the implantation of branched stent grafts. Standard techniques for placement of vascular access sheaths, catheters, and wires should be employed. ## Summary of Similarities and Differences in Technological Characteristics between Applicant and Predicate Devices A side-by-side comparison of the subject device to the predicate devices is provided in the table below. {5}------------------------------------------------ | Device | GORE® Tri-Lumen Catheter (TLC)<br>(SUBJECT DEVICE) | Twin-Pass Dual Access Catheter<br>(PREDICATE DEVICE) | |--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | W. L. Gore & Associates Inc. | Vascular Solutions, Inc. | | 510(k) Number | TBD | K072618 | | Product Code | DQY | DQY | | Product Class | II | II | | Intended use<br>(Clinical) | Access Peripheral and Aortic Vasculature to<br>Facilitate Guidewire Placement | Access Peripheral, Aortic, and Coronary Vasculature to Facilitate<br>Guidewire Placement | | Intended User<br>(Clinical) | Physicians trained in and/or familiar with<br>endovascular procedures and similar devices.<br>This group of physicians may include vascular<br>surgeons, interventional radiologists, and<br>interventional cardiologists from various<br>regions worldwide. | Physicians trained in and/or familiar with endovascular<br>procedures and similar devices. This group of physicians may<br>include vascular surgeons, interventional radiologists, and<br>interventional cardiologists from various regions worldwide. | | Operating<br>Principle<br>(Clinical) | The GORE® Tri-Lumen Catheter (TLC) is a<br>multi-lumen catheter designed to minimize<br>entanglement of guidewires while facilitating<br>through and through access during<br>cardiovascular procedures that require the use<br>of multiple guidewires with fewer snaring<br>maneuvers. | The Twin-Pass Dual-Access Catheter is a single use device<br>designed for use in the arterial vasculature to provide support for<br>multiple 0-014"/0.36mm guidewires during interventional<br>procedures. | | Device | GORE® Tri-Lumen Catheter (TLC)<br>(SUBJECT DEVICE) | Twin-Pass Dual Access Catheter<br>(PREDICATE DEVICE) | | Use<br>Environment<br>(Clinical) | Intended for use in an operating room, catheter<br>lab, or procedural suite which would have<br>bright lighting and ambient sounds. Personal<br>protective equipment, which are typical for the<br>sterile theatre (including gowns, gloves, caps<br>and eye protection) will be used. In addition,<br>the operating room is equipped with<br>fluoroscopy equipment, which requires the user<br>to wear lead apron during use. The device is<br>provided sterile and is intended for one time<br>(single) use. Duration of use is less than 24<br>hours. Normal disposal via hospital biological<br>waste means. | Intended for use in an operating room, catheter lab, or procedural<br>suite which would have bright lighting and ambient sounds.<br>Personal protective equipment, which are typical for the sterile<br>theatre (including gowns, gloves, caps and eye protection) will be<br>used. In addition, the operating room is equipped with<br>fluoroscopy equipment, which requires the user to wear lead<br>apron during use. The device is provided sterile and is intended<br>for one time (single) use. Duration of use is less than 24 hours.<br>Normal disposal via hospital biological waste means. | | Indication for<br>use<br>(Clinical) | Indicated for use in endovascular procedures to<br>facilitate guidewire delivery and management. | Indicated for use in conjunction with steerable guidewires in<br>order to access discrete regions of the coronary and peripheral<br>arterial vasculature, to facilitate placement of guidewires and<br>other interventional devices during two<br>guidewire procedures. | | Catheter Shaft<br>(Technical) | Tri-Lumen Design | Dual-Lumen Design | | Guidewire<br>Compatibility<br>(Technical) | Central Lumen: one 0.035" or two 0.018"<br>guidewires<br>Axillary Lumen: one 0.014" or one 0.018"<br>guidewire | Each lumen can accommodate a single 0.014" guidewire | | Overall Length<br>(Technical) | 140 cm | 135 -140 cm | | Profile<br>(Technical) | 7.5 Fr | 3.5 Fr | | Catheter<br>Compatibility<br>(Technical) | ≥ 12 Fr | ≥ 6 Fr | | Device | GORE® Tri-Lumen Catheter (TLC)<br>(SUBJECT DEVICE) | Twin-Pass Dual Access Catheter<br>(PREDICATE DEVICE) | | Radiopacity<br>(Technical) | Radiopaque Tip | Radiopaque Marker Bands | | User Interface<br>(Technical) | Single Central Lumen Tube<br>Dual Axillary Lumen Extension Tubes | Single Port with Separate Rapid Exchange Port | | Visual<br>Comparison<br>(Technical) | Image: Trailing End<br>Image: Leading End | Image: Trailing End<br>Image: Leading End | | Materials of<br>Construction<br>(Biological) | Grilamid/Pebax | Pebax / Polycarbonate | | Part of body<br>interacted with:<br>(Biological) | Iliac artery, aorta, brachial artery | Iliac artery, aorta, coronary artery | | Biocompatibility<br>(Biological) | Biocompatible per<br>ISO 10993-1 | Biocompatible per<br>ISO 10993-1 | | Sterilization<br>Method<br>(Biological) | Ethylene Oxide | Ethylene Oxide | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ ## Performance Data The GORE® Tri-Lumen Catheter is substantially equivalent to the specified predicate device based on testing of the applicant device functionality, technological characteristics, and indication for use. The device design of the GORE® Tri-Lumen Catheter has been verified by testing to the catheter requirements outlined in BS EN ISO 10555-1:2013 "Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements". These tests included: - . Guidewire Compatibility - . Catheter Tip Bond Strength - Radiopacity ● - . Device Dimensions - Device Trackability ● - Device Pushability ● - Device Flushability . Based on the comparisons and information provided in this premarket notification, W.L. Gore & Associates concludes that the GORE® Tri-Lumen Catheter is substantially equivalent to the identified predicate device in terms of indications for use, design, materials, biocompatibility, packaging, sterilization, labeling and performance. The following tests/evaluations were performed to confirm the equivalency, safety, and effectiveness of the device: - Biocompatibility . - Design Verification . - Design Validation ● - Sterilization Validation ● - Packaging Integrity ● - Product Shelf-Life . - Introducer Sheath compatibility . - Device Torqueability ● - Surface Integrity ● ## Animal Data No Animal Studies were performed as part of this 510(k) Submission. ## Clinical Data No formal clinical study was conducted to specifically evaluate the performance of the GORE® Tri-Lumen Catheter; however, the catheter was used as an accessory device during an Early Feasibility Study to evaluate the initial safety of an investigational aortic stent graft. As part of that early feasibility study, 13 patients were treated with an investigational device that required the use and management of multiple through-and-through guidewires. In each case, a GORE® Tri-Lumen Catheter was used to establish the through-and-through access of the 0.014" and 0.035" guidewires from the brachial artery to the common femoral artery. The GORE® Tri-Lumen Catheter performed this task safely and effectively with no procedural or device related events reported as a result of using the catheter. ## Conclusion W.L. Gore & Associates concludes that the subject GORE® Tri-Lumen Catheter is substantially equivalent to the predicate device.