Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602); Resolution Clip (M00522610); Resolution Clip (M00522611); Resolution Clip (M00522612)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters 'FDA' in white. Next to the blue square, the words 'U.S. FOOD & DRUG' are written in blue, with 'ADMINISTRATION' written in a smaller font size below. February 6, 2025 Boston Scientific Corporation Kyra McNamara Senior Regulatory Affairs Specialist 100 Boston Scientific Way Marlborough, Massachusetts 02472 Re: K250066 Trade/Device Name: Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602); Resolution Clip (M00522610); Resolution Clip (M00522611); Resolution Clip (M00522612) Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal Ligator Regulatory Class: Class II Product Code: PKL Dated: January 10, 2025 Received: January 10, 2025 Dear Kyra McNamara: 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. {1}------------------------------------------------ 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). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 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-reportingcombination-products); 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 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-device-advicecomprehensive-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-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatory {2}------------------------------------------------ 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). Sincerely, # Sivakami Venkatachalam - S for Shanil P. Haugen, Ph.D. 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 Submission Number (if known) K250066 Device Name Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602); Resolution Clip (M00522610); Resolution Clip (M00522611): Resolution Clip (M00522612) Indications for Use (Describe) The Resolution™ Clip is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of: 1. Endoscopic marking - 2. Hemostasis for: - · Mucosal/sub-mucosal defects < 3 cm - · Bleeding ulcers · Arteries < 2 mm - · Polyps < 1.5 cm in diameter - · Diverticula in the colon - · Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection 3. Anchoring to affix jejunal feeding tubes to the wall bowel; and Anchoring to affix fully covered esophageal self-expanding metal stents to the wall of the esophagus 4. As a supplemental closure method of luminal perforations < 20 mm that can be treated conservatively. Type of Use (Select one or both, as applicable) ( 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}------------------------------------------------ ## 510(k) SUMMARY ## 1. Submitter: Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Primary Contact: Kyra McNamara Senior Regulatory Affairs Specialist Telephone: (508)-382-0375 Date Prepared: January 10, 2025 #### 2. Proposed Device: | Trade Name: | Resolution Clip (M00522600); Resolution Clip<br>(M00522601); Resolution Clip (M00522602); Resolution<br>Clip (M00522610); Resolution Clip (M00522611);<br>Resolution Clip (M00522612) | |----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Classification Name: | Hemostatic Metal Clip for the GI Tract | | Regulation Number: | 876.4400 | | Product Code: | PKL | | Regulatory Class: | Class II | # 3. Predicate Device: | Trade Name: | Resolution™ Clip | |----------------------|----------------------------------------| | Manufacturer: | Boston Scientific | | 510(k) Number: | K222503 | | Classification Name: | Hemostatic Metal Clip for the GI Tract | | Regulation Number: | 876.4400 | | Product Code: | PKL | | Regulatory Class: | Class II | ## 4. Device Description: {5}------------------------------------------------ The Resolution™ Clip is a sterile device consisting of a pre-loaded, radiopaque, single-use, endoscopic clipping device consisting of two main components: the delivery system and the clip. The delivery system consists of a handle assembly and delivery catheter. The clip delivery system is offered in a 155cm and 235cm working length. The clip consists of a stainless-steel capsule and clip arms, a cobalt chrome yoke, and a styrene tension breaker. The clip is deployed from the delivery system during use. The clip jaws are engineered such that they can be opened and closed up to five times prior to deployment, aiding in repositioning of the clip at the lesion site. Re-opening and closing may be limited by clinical circumstances and patient anatomy, among other factors. The Resolution™ Clip is designed to be compatible with endoscopes with working channels equal to or greater than 2.8 mm. There are no associated accessories included with this device. ### 5. Intended use/ Indications for Use: The Resolution™ Clip is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of: - 1. Endoscopic marking - 2. Hemostasis for: - Mucosal/sub-mucosal defects < 3 cm - Bleeding ulcers Arteries < 2 mm - Polyps < 1.5 cm in diameter - · Diverticula in the colon - Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection 3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel; and Anchoring to affix fully covered esophageal self-expanding metal stents to the wall of the esophagus 4. As a supplemental closure method of luminal perforations < 20 mm that can be treated conservatively. #### 6. Technological Characteristics: The purpose of this Special 510(k) is to remove the outer sheath component from the Resolution™ Clip device. Simulated Use testing confirmed that the device without the outer sheath continues to meet existing performance requirements. The Instructions for Use (IFU) will be updated to reflect the outer sheath removal. No further modifications are being made and the indications for use will remain unchanged from the predicate K222503. #### 7. Performance Data: Non-clinical performance bench simulated use testing was completed to evaluate the design of the Resolution Clip device for the design modification to remove the outer sheath component. Bench Testing included testing for the following design requirements: - Device removal from the endoscope - Device passability within the endoscope ● - Absence of damage of the endoscope working channel {6}------------------------------------------------ All testing was passing and demonstrates the device's ability to fulfill non-clinical performance bench testing requirements. ## 8. Conclusion: Boston Scientific Corporation has demonstrated that the proposed Resolution™ Clip is substantially equivalent to the currently cleared Resolution™ Clip (K222503).