ECHELON ENDOPATH Staple Line Reinforcement

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September 16, 2022 Ethicon Endo-Surgery LLC Rubina Dosani Manager, Regulatory Affairs 475 Calle C Guaynabo, PR 00696 Re: K221343 Trade/Device Name: ECHELON ENDOPATH Staple Line Reinforcement Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: OXC Dated: August 17, 2022 Received: August 18, 2022 Dear Rubina Dosani: 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). 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Sincerely, for Deborah Fellhauer, RN, BSN Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K221343 #### Device Name Echelon Endopath Staple Line Reinforcement #### Indications for Use (Describe) ECHELON ENDOPATH Staple Line Reinforcement is indicated for use in surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed. ECHELON ENDOPATH Staple Line Reinforcement can be used for reinforcement of staple lines during lung resection and bariatric surgical procedures. The device can also be used for reinforcement of staple lines during gastric, small bowel, and colorectal procedures. | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------| | <span style="font-size:10pt;"> <span style="font-family:Wingdings;">X</span> </span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:10pt;"> <span style="font-family:Wingdings;">☐</span> </span> Over-The-Counter Use (21 CFR 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}------------------------------------------------ ### 510(k) Summary #### Company Ethicon Endo-Surgery, LLC 475 Calle C Guaynabo, PR 00969 ### Contact Rubina Dosani, Manager, Regulatory Affairs Ethicon Endo-Surgery, Inc. Telephone: 513.337. 3566 Email: rdosani(@its.jnj.com | Date Prepared: | September 15, 2022 | |----------------------|--------------------------------------------------------------------------------------------------------| | Trade Name: | Echelon Endopath Staple Line Reinforcement | | Common Name: | Staple Line Reinforcement Material | | Classification Name: | Surgical mesh | | Classification: | 21CFR 878.3300 | | Product Code: | OXC | | Device Class: | Class II | | Panel: | 79, General and Plastic Surgery | | Predicate Device | Echelon Endopath Staple Line Reinforcement cleared under K190937 | | Reference Device | Intuitive Surgical SureForm ^™ 60 and SureForm ^™ 60 Reloads cleared under K173721 | ### Device Description Echelon Endopath Staple Line Reinforcement is a staple line reinforcement, also known as a buttress, for use in the surgical environment for the purpose of reinforcing a staple line. The Subject Device of this 510(k) is the same as the Predicate Device with a modification to the labeling to include the addition of the Intuitive Surgical SureForm™ 60 mm Blue, Green and Black Reloads and SureForm™ 60 mm Stapler 510(k) Cleared K173721 as compatible devices. The Predicate Device is compatible with the Echelon Flex™ 60 mm Powered Plus Articulating Endoscopic Linear Cutters with Echelon Endopath 60 mm Endoscopic Linear Cutter Reloads with Gripping Surface Technology, (510k cleared K202665, K183435). There are no design or manufacturing changes associated with this submission. The Subject Device is to be used with surgical stapling devices. Surgical stapling devices place staggered rows of staples with a reinforcement material, and simultaneously divide the tissue and the reinforcement material between the stapled rows. The Subject Device is an absorbable staple {4}------------------------------------------------ line reinforcement material which is secured to both the stapler anvil and reload with a synthetic attachment material. The product consists of an applicator which includes the implantable device, one for each of the upper and lower stapler jaws. The implantable material consists of 3 materials: the Vicryl material, the Polydioxanone film and the attachment adhesive material. Echelon Endopath Staple Line Reinforcement is an implanted material which works as an adjunct to surgical staples after transection, to provide support to soft tissue during the healing process. There are no modifications to the predicate device; and the materials of the Subject Device and Predicate Device are the same. Each unit is packaged sterile in separate pouch. ## Indications for Use ECHELON ENDOPATH Staple Line Reinforcement is indicated for use in surgical procedures in which soft tissue transection with staple line reinforcement is needed. ECHELON ENDOPATH Staple Line Reinforcement can be used for reinforcement of staple lines during lung resection and bariatric surgical procedures. The device can also be used for reinforcement of staple lines during gastric, small bowel and colorectal procedures. ## Summary of Similarities and Differences in Technological Characteristics There are no technological differences between the Subject and the Predicate Device. There are no changes to the intended use, design, materials, sterilization, manufacturing or packaging between the Subject Device and Predicate Device. ## Performance Data Bench testing was performed, as appropriate for the required endpoint to demonstrate that the performance of the Subject Device with the proposed compatible Stapler and reloads (Intuitive Surgical SureForm™ 60 mm Stapler and SureForm™ 60 mm Blue. Green and Black Reloads) is substantially equivalent to the performance of the Predicate Device with the approved compatible Stapler and Reloads (Echelon Flex 60 mm Powered Plus and any Echelon Endopath 60 mm Reloads with GST Technology). Testing performed to support the change is as follows: - Device Compatibility with Stapler and Reloads - Staple Form Quality o - Staple Line Integrity O - Manipulation of device on tissue, ● - Buttress security on Surgical Stapler and Reload O - Release Force o - O Shear Force - Usability Testing ● All bench studies passed the criteria for success. {5}------------------------------------------------ ### Animal Testing No changes were made to device indications of use, function, technology or materials. Therefore, no new animal studies were needed to demonstrate substantial equivalence of the subject to the predicate device. ### Conclusion Echelon Endopath Staple Line Reinforcement maintains the same intended use, indications for use, materials, and principle of operation as its predicate device. The addition of a new compatible Stapler and reloads does not impact these product characteristics. Testing of the product for compatibility was completed using the same or similar test methods as the Predicate device. The conclusions of the testing demonstrate that Echelon Endopath Staple Line Reinforcement Subject Device is substantially equivalent to the legally marketed Echelon Endopath Staple Line Reinforcement Predicate Device. No new issues of safety and effectiveness have been identified.