Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip

{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 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, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue. September 14, 2022 Boston Scientific Corporation Jia Huang Principal Regulatory Affairs Specialist 100 Boston Scientific Way Marlborough, MA 01752 Re: K222503 Trade/Device Name: Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: Class II Product Code: PKL Dated: August 16, 2022 Received: August 18, 2022 Dear Jia Huang: 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/cdrh/cfdocs/cfpmn/pm.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 {1}------------------------------------------------ CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-devices/medical-device-safety/medicaldevice-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-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-advicecomprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K222503 Device Name Resolution™ Clip Resolution 360™ Clip Resolution 360™ ULTRA Clip Indications for Use (Describe) The proposed Resolution™ Clip, Resolution 360™ Clip and Resolution 360™ ULTRA Clip are 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 | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | <span style="text-decoration: underline;">X</span> Prescription Use (Part 21 CER 801 Subpart D) | Over-The-Counter Use (21 CER 801 Subpart C) | |-------------------------------------------------------------------------------------------------|---------------------------------------------| |-------------------------------------------------------------------------------------------------|---------------------------------------------| #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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}------------------------------------------------ Boston Scientific Corporation 300 Boston Scientific Way Marlborough, MA 01752-1234 (508) 683-4000 www.bostonscientific.com ### 510(k) Summary for Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip #### 1. Submitter Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Contact: Jia Huang Principal Regulatory Affairs Specialist Tel: 617-912-0826 Date Prepared: August 16, 2022 #### 2. Proposed Device Trade Name: Resolution™ Clip Classification Name: Hemostatic Metal Clip for the GI Tract Regulation Number: 876.4400 Product Code: PKL Classification: Class II Trade Name: Resolution 360™ Clip Classification Name: Hemostatic Metal Clip for the GI Tract Regulation Number: 876.4400 Product Code: PKL Classification: Class II Trade Name: Resolution 360™ ULTRA Clip Classification Name: Hemostatic Metal Clip for the GI Tract Regulation Number: 876.4400 Product Code: PKL Classification: Class II #### 3. Predicate Devices Trade Name: Resolution™ Clip Classification Name: Hemostatic Metal Clip for the GI Tract Regulation Number: 876.4400 Product Code: PKL Classification: Class II 510(k) Clearance Number: K142973 Trade Name: Resolution 360™ Clip Classification Name: Hemostatic Metal Clip for the GI Tract Regulation Number: 876.4400 Image /page/3/Picture/13 description: The image shows the logo for Boston Scientific. The logo is in blue and features the words "Boston" on top of "Scientific". The font is a serif font, and the overall design is simple and professional. {4}------------------------------------------------ K222503 Page 2 of 4 Product Code: PKL Classification: Class II 510(k) Clearance Number: K151802 Trade Name: Resolution 360™ ULTRA Clip Classification Name: Hemostatic Metal Clip for the GI Tract Regulation Number: 876.4400 Product Code: PKL Classification: Class II 510(k) Clearance Number: K193424 ### 4. Device Description The Resolution™ Clip, Resolution 360™ Clip and Resolution 360™ ULTRA Clip are sterile devices 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 delivery system of Resolution 360™ Clip and Resolution 360™ ULTRA Clip will allow for the device to rotate at the distal end. The clip delivery system is offered in a 155cm and 235cm working length for Resolution Clip and Resolution 360 Clip but only 235 cm for Resolution 360 ULTRA Clip. 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, closing, and rotation capability (only for Resolution 360 Clip and Resolution 360 ULTRA Clip) may be limited by clinical circumstances and patient anatomy. There are no associated accessories included with this device. The Resolution™ Clip, Resolution 360™ Clip and Resolution 360™ ULTRA Clip are designed to be compatible with endoscopes with working channels equal to or greater than 2.8 mm. ## 5. Indications for Use The proposed Resolution™ Clip, Resolution 360™ Clip and Resolution 360™ ULTRA Clip are 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 - · Polvps < 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 {5}------------------------------------------------ conservativelv ## 6. Technological Characteristics There is no change in intended use or design associated with this Special 510(k). The technological characteristics of the proposed Resolution™ Clip, Resolution 360™ Clip and Resolution 360™ ULTRA Clip are identical to their respective predicate devices: Resolution™ Clip (K142973), Resolution 360™ Clip (K151802) and Resolution 360™ ULTRA Clip (K193424), with the exception of the MRI safety information in Instruction for Use and Product Information for Patients. In addition, minor modifications of the clinical information was also conducted in order to clarify information. # 7. Substantial Equivalence The proposed Resolution™ Clip. Resolution 360™ Clip and Resolution 360™ ULTRA Clip do not have any change in material, design, specification, manufacturing technology, performance, biocompatibility or packaging to their respective predicate devices of Resolution™ Clip (K142973), Resolution 360™ Clip (K151802) and Resolution 360™ ULTRA Clip (K193424). The only change being introduced is to the MRI safety information in the Instruction for Use and Product Information for Patients. The changes to the MRI Safety information are based on the bench testing results of the predicate devices of Resolution™ Clip (K142973) and Resolution 360™ ULTRA Clip (K193424). The design requirements are not impacted by the labeling updates and the proposed devices are deemed substantially equivalent to the predicate devices and continues to meet the pre-defined device specification. ## 8. Performance Data Performance testing (bench) was successfully completed to demonstrate compliance to the FDA MR Safety Guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment issued on May 20, 2021. The testing included the following: - Magnetically Induced Displacement Force . ASTM F2052, Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment - Magnetically Induced Torque . ASTM F2213, Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment - . Heating by Radio Frequency (RF) Fields ASTM F2182, Standard Test Method for Measurement of Radio Frequencv Induced Heating Near Passive Implants During Magnetic Resonance Imaging - . Image Artifact ASTM F2119, Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants The testing was conducted using the predicate devices of Resolution™ Clip (K142973) and Resolution 360™ ULTRA Clip (K193424). The performance (bench) testing demonstrated {6}------------------------------------------------ that the proposed Resolution™ Clip, Resolution 360™ Clip and Resolution 360™ ULTRA Clip comply with the FDA MR Safety Guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment issued on May 20, 2021, and are considered substantially equivalent to the predicate devices. ## 9. Conclusion Boston Scientific Corporation has demonstrated that the proposed Resolution™ Clip, Resolution 360™ Clip and Resolution 360™ ULTRA Clip with updated labeling including MRI safety information are compliant with the FDA MR Safety Guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment issued on May 20, 2021, and substantially equivalent to the currently cleared predicate devices of Resolution™ Clip (K142973), Resolution 360™ Clip (K151802) and Resolution 360™ ULTRA Clip (K193424) as the performance of the proposed Resolution™ Clip, Resolution 360™ Clip and Resolution 360™ ULTRA Clip meets the requirement of the per-defined acceptance criteria and intended use.