Protégé™ EverFlex™ Self-expanding Peripheral Stent System

{0} FDA U.S. FOOD & DRUG ADMINISTRATION September 17, 2026 Medtronic, Inc. Kim Wallner Senior Regulatory Affairs Manager 2300 Berkshire Ln. N. Plymouth, Minnesota 55441 Re: K262913 Trade/Device Name: Protégé™ EverFlex™ Self-expanding Peripheral Stent System Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: Class II Product Code: FGE Dated: August 19, 2026 Received: August 19, 2026 Dear Kim Wallner: 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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K262913 - Kim Wallner Page 2 Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). {2} K262913 - Kim Wallner Page 3 # Sincerely, **STEPHANIE COLE** **-SFDA** for Anthony C. Lee, Ph.D., M.B.A. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity, and Transplant Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} | Indications for Use | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K262913 | ? | | Please provide the device trade name(s). | | ? | | Protégé™ EverFlex™ Self-expanding Peripheral Stent System | | | | Please provide your Indications for Use below. | | ? | | The stent is intended as a palliative treatment of malignant neoplasms in the biliary tree. | | | | Please select the types of uses. | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | | Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☐ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | ? | {4} K262913 Page 1 of 2 # 510(k) Summary This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92. ## Submitter Information | Applicant/ Submitter Name and Address | Medtronic 2300 Berkshire Lane N Plymouth, MN 55441 USA | | --- | --- | | Contact Person | Kim Wallner Senior Regulatory Affairs Manager Email: kim.wallner@medtronic.com Contact Number : 763-398-7295 | | Date Prepared | September 14, 2026 | ## Device Identification | Device Trade Name | Protégé™ EverFlex™ Self-expanding Peripheral Stent System | | --- | --- | | Device Classification | Regulatory Class: II | | Classification Panel | Gastroenterology/Urology | | Regulation Name | Biliary catheter and accessories | | Regulation Number | 21 CFR 876.5010 | | Product Code | FGE | ## Predicate Device | Device Trade name | Protégé™ EverFlex™ Self-expanding Biliary Stent System | | --- | --- | | 510(K) Number / Clearance Date | K060057 / 08-Mar-2006 K072301 / 18-Mar-2008 | ## Device Description The Protégé EverFlex self-expanding peripheral stent system is a self-expanding Nitinol stent system intended for permanent implantation. The self-expanding stent is made of a nickel titanium alloy (Nitinol) and comes pre-mounted on a 6 Fr (2.0 mm), 0.035 in (0.89 mm) over-the-wire delivery system. The stent system is compatible with a 0.035 in (0.89 mm) guidewire. The stent is cut from a Nitinol tube in an open lattice design and has tantalum radiopaque markers at the proximal and distal ends of the stent. Upon deployment, the stent achieves its predetermined diameter and exerts a constant, gentle outward force to establish patency. {5} K262913 Page 2 of 2 ## Indications for Use The stent is intended as a palliative treatment of malignant neoplasms in the biliary tree. ## Substantial Equivalence The indication for use, intended use, principles of operation, and fundamental scientific technology of the subject device, Protégé EverFlex self-expanding peripheral stent system, were found to be substantially equivalent to the predicate device, Protégé EverFlex self-expanding biliary stent system (K060057 and K072301). A comparison of the Protégé EverFlex self-expanding peripheral stent system to the predicate device indicates the following similarities: - Same operating principle - Same technological, engineering, and performance characteristics - Same design features - Same sterilization requirements, methods, and parameters - Same shelf-life - Same materials of construction - Same packaging materials The differences between the predicate device and the subject device are limited to the labeling. The following modifications were made: - Addition of the following contraindication “Patients with known hypersensitivity to nickel titanium” to the IFU - The product name is being updated from “Protégé™ EverFlex™ Self-expanding Biliary Stent System” to “Protégé™ EverFlex™ Self-expanding Peripheral Stent System” The differences have been demonstrated to be substantially equivalent to the predicate device. ## Conclusion The information included in this submission is sufficient to demonstrate that the Protégé EverFlex self-expanding peripheral stent system with the added contraindication and modifications to device name is substantially equivalent to the predicate device, Protégé EverFlex self-expanding biliary stent system (K060057 and K072301), and do not raise new questions of safety or effectiveness.