GORE VIABIL Short Wire Biliary Endoprosthesis

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font and is left-aligned. The text is likely part of a document or sign. Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the most complete and the bottom profile being the least complete. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W O66-G609 Silver Spring, MD 20993-0002 May 8, 2017 W.L. Gore & Associates, Inc. Barbara L. Smith, RAC Regulatory Associate 301 Airport Road Elkton, MD 21921 Re: K170740 Trade/Device Name: GORE® VIABIL® Short Wire Biliary Endoprosthesis Regulation Number: 21 CFR§ 876.5010 Regulation Name: Biliary Catheter and Accessories Regulatory Class: II Product Code: FGE Dated: March 9, 2017 Received: March 10, 2017 Dear Barbara L. Smith: 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 and the limitations described below. 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. The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling: The safety and effectiveness of this device for use in the vascular system have not been established {1}------------------------------------------------ Furthermore, the indication for biliary use must be prominently displayed in all labeline. including pouch box, and carton labels, instructions for use, and other promotional materials, in close proximity to the trade name, of a similar point size, and in bold print. Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling. 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 devicerelated 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. {2}------------------------------------------------ You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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, # William H. Maisel -S William H. Maisel, MD, MPH Director, Office of Device Evaluation (Acting) Deputy Center Director for Science Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K170740 Device Name GORE® VIABIL® Short Wire Biliary Endoprosthesis Indications for Use (Describe) The GORE® VIABIL® Short Wire Biliary Endoprosthesis is intended for palliation of malignant strictures in the biliary tree. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------------------------|---------------------------------------------| | <span style="text-decoration: underline;"><b>X</b></span> Prescription Use (Part 21 CFR 801 Subpart D) | 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." {4}------------------------------------------------ #### 7 510(K) SUMMARY [21 CFR 807.92] #### 510(k) Submitter W. L. Gore & Associates, Inc. 301 Airport Road Elkton, Maryland 21921 Regulatory contact: Barbara L. Smith, RAC #### Date Prepared May 1, 2017 #### Device Names/Classification | Device Name: | GORE® VIABIL® Short Wire Biliary Endoprosthesis | |----------------------|-------------------------------------------------| | Common Name: | Biliary Stent | | Classification Name: | Catheter, biliary, diagnostic | | Classification: | 21CFR876.5010 – Class II | | Product Code: | FGE | #### Predicate Devices - . K081184 GORE® VIABIL® Biliary Endoprosthesis #### Device Description The GORE® VIABIL® Short Wire Biliary Endoprosthesis is a flexible endoprosthesis (stent) that is radially compressed and secured onto the distal end of a delivery catheter. The catheter provides a means for implanting the GORE® VIABIL® Short Wire Biliary Endoprosthesis at the target site in the biliary tract. The subject of this 510(k) pre-market notification is a modification to the catheter component of the endoscopic (GI) delivery system to include a guidewire exit port located near the distal end of the catheter which will allow use of a shorter length (minimum 260cm) guidewire enabling single user control of the guidewire during use. No changes have been made to the implanted endoprosthesis of the predicate GORE® VIABIL® Biliary Endoprosthesis device. {5}------------------------------------------------ The sizes of the GORE® VIABIL® Short Wire Biliary Endoprosthesis device are the same as the predicate GORE® VIABIL® Biliary Endoprosthesis as noted in the following table. | Endoprosthesis -<br>Diameter (mm) x Length<br>(cm) | Drainage Holes<br>Located at the<br>Hilar Region | |----------------------------------------------------|--------------------------------------------------| | 8 × 4 | No holes | | 8 x 6 | No holes | | 8 × 8 | No holes | | 8 x 10 | No holes | | 10 x 4 | No holes | | 10 x 6 | No holes | | 10 x 8 | No holes | | 10 x 10 | No holes | | 8 × 6 | Holes | | 8 × 8 | Holes | | 8 x 10 | Holes | | 10 x 6 | Holes | | 10 x 8 | Holes | | 10 x 10 | Holes | #### Indications for Use The GORE® VIABIL® Short Wire Biliary Endoprosthesis is intended for palliation of malignant strictures in the biliary tree. {6}------------------------------------------------ ### Comparison of Technological Characteristics The table below describes the similarities/differences between the catheter component of the subiect GORE® VIABIL® Short Wire Biliary Endoprosthesis and the catheter component of the predicate GORE® VIABIL® Biliary Endoprosthesis (K081184). | | Modified Device | Predicate Device | |-----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------| | | GORE® VIABIL® Short Wire Biliary | GORE® VIABIL® Biliary | | | Endoprosthesis | Endoprosthesis<br>K081184 | | Indications for use | No change - Same as predicate | Intended for palliation of malignant<br>strictures in the biliary tree. | | Endoprosthesis<br>(Stent device) | No change - Same as predicate | ePTFE/FEP film tube supported by<br>an FEP coated Nitinol stent. | | Deployment<br>System | No change - Same as predicate | Pull-line style deployment using an<br>ePTFE zipper | | | Single port hub | Y-arm (dual port) catheter hub | | GI Delivery<br>Catheter<br>Component -<br>Modified for use<br>with shorter<br>guidewire | Dual lumen catheter tubing<br>-Added guidewire exit port on catheter<br>shaft; 2nd catheter hub port eliminated.<br>Catheter material formulation change<br>to different durometer of same<br>material type | Dual lumen catheter tubing<br>-Guidewire exits from 2nd catheter<br>hub port | | Biocompatibility | Same as predicate | Biocompatible per ISO10993-1. | | Device Packaging | • HDPE coil with modified connector<br>• No change to sterile barrier | • HDPE coil and connector for<br>physical protection of device<br>within sterile barrier | | Sterilization<br>method/SAL | Same as predicate | Ethylene Oxide/SAL of 10-6 | | Labeling | Same as predicate<br>MR safety information<br>Update to warning statements | Complies with applicable regulations &<br>FDA guidance on MR safety | #### Summary of Performance Testing #### Non-Clinical The device specific guidance document, FDA's Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents, was consulted in determining the appropriate testing for the subject catheter modification. Testing was conducted on representative sterile, aged samples. The test samples were subjected to simulated use deployment testing, dimensional testing, tensile/bond strength testing, deployment force, accessory component compatibility, deployment accuracy, and deployment reliability. Testing demonstrated the subject Viabil device met the established acceptance criteria for up to the intended device shelf life, consistent with the predicate Viabil device. Biocompatibility testing was conducted per ISO10993-1 and confirmed the subject device, like the predicate device, is biocompatible for its intended use. Packaging testing of the subject Viabil device in the predicate Viabil device packaging system confirmed that the packaging system {7}------------------------------------------------ was acceptable for the GORE® VIABIL® Short Wire Biliary Endoprosthesis device. MR Safety testing was conducted in recognition of FDA's guidance, Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment and the results included in the device labeling. Animal study: No animal studies were required to support this submission. Clinical No clinical evaluations were required to support this submission. #### Conclusion Based on the information contained within this 510(k) premarket notification, W. L. Gore & Associates concludes that the subject GORE® VIABIL® Short Wire Biliary Endoprosthesis device is substantially equivalent to the predicate GORE® VIABIL® Biliary Endoprosthesis device in terms of indications for use, materials, biocompatibility, sterilization, packaging, labeling and performance.