EEA Circular Stapler with Tri-Staple Technology

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January 21, 2021 Covidien Katherine Choi Principal Regulatory Affairs Specialist 60 Middletown Avenue North Haven, Connecticut 06473 Re: K202507 Trade/Device Name: EEA Circular Stapler with Tri-Staple Technology Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW Dated: December 18, 2020 Received: December 22, 2020 Dear Ms. Choi: 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/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. 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 {1}------------------------------------------------ 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-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 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-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-regulatoryassistance/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, Cindy Chowdhury, Ph.D., M.B.A. 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) K202507 Device Name EEATM Circular Stapler with Tri-Staple™ Technology Indications for Use (Describe) The EEA™ circular stapler with Tri-Staple™ technology has application throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X 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." {3}------------------------------------------------ # 510(k) Summary #### Date Prepared: Jan 19, 2021 ### Submitter: Leo Chen Covidien Rooms 501, 502, 601, 602, No.3 building No.2388 Chen Hang Road Min Hang District, Shanghai, 201114, China ### Contact: Katherine Y. Choi (U.S. Agent) on behalf of Leo Chen Covidien 60 Middletown Avenue North Haven, CT 06473, USA Senior Principal Regulatory Affairs Specialist Telephone: (917) 841-6315 Fax: (203) 492-5029 Email: katherine.y.choi@medtronic.com ### Name of Device: EEATM Circular Stapler with Tri-Staple™ Technology Proprietary/Trade Name: Model Numbers: TRIEEA25MT, TRIEEA25XT, TRIEEAXL25MT, TRIEEAXL25XT Classification Name: Staple, Implantable Regulations Number: 21 CFR 878.4750 Product Codes: GDW FDA Panel Number: 79 Device Class: Class II Review Panel: General and Plastic Surgery Common Name: Surgical Stapler #### Predicate Device: Proprietary/Trade Name: 510(k) Number: Classification Name: Requlations Number: Product Codes: FDA Panel Number: Device Class: Review Panel: Common Name: EEATM Circular Stapler with Tri-Staple™ Technology K192330, K172361 Staple, Implantable 21 CFR 878.4750 GDW / GDW, GAG 79 Class II General and Plastic Surgery Surgical Stapler ## Reference Device: Proprietary/Trade Name: 510(k) Number: Classification Name: Requlations Number: EEATM Circular Stapler with DST Series™ Technology K062850 Staple, Implantable 21 CFR 878.4750 {4}------------------------------------------------ | Product Codes: | GDW, GAG | |-------------------|-----------------------------| | FDA Panel Number: | 79 | | Device Class: | Class II | | Review Panel: | General and Plastic Surgery | | Common Name: | Surgical Stapler | #### Device Description: The EEA™ circular stapler with Tri-Staple™ technology places a circular, triple staggered row of titanium staples and resects the excess tissue, creating a circular anastomosis as an end-to-end, end-to-side or side-to-side anastomosis in both open and laparoscopic surgeries. The instrument is activated by squeezing the handle firmly as far as it will go. The subject circular stapler will be offered with a medium/thick tissue range which is identified by the purple staple quide and an extra thick tissue range which is identified by the black staple guide. Staplers for medium/thick tissue deploy three height-progressive rows of 3.0 mm, 3.5 mm and 4.0 mm titanium staples. Staplers for extra thick tissue, deploy three height-progressive rows of 4.0 mm. 4.5 mm and 5.0 mm titanium staples. The subject circular staplers are available in 25mm lumen size and 2 shaft lengths; a standard 22 cm shaft and an extra (XL) 35 cm shaft. The Tilt-Top™ anvil is available on all staplers. A blunt and a sharp tipped anvil trocar accessory is provided to assist in introducing the anvil into the surgical field. Both the subject device and the predicate device (K192330 and K172361) are from the same product family Tri-Staple™ EEA™ stapler. The subject device EEA™ Circular Stapler with Tri-Staple™ Technology (lumen size 25mm) provides the surgeons a choice of additional lumen size selections to best suit the target anatomy. The subject EEA™ Circular Stapler with Tri-Staple™ Technology is manufactured with the same patient contact materials that are utilized within the predicate device (K192330 and 172361). In the same manner as the predicate device (K192330 and K172361), the subject EEA™ Circular Stapler with Tri-Staple™ Technology is a manual surgical stapling device that places a circular, triple staggered row of titanium staples and resects tissue, creating a circular anastomosis. The instrument is activated by squeezing the handle firmly as far as it will go. An audible and tactile firing indicator will provide additional feedback of firing completion. The subject EEA™ Circular Stapler with Tri-Staple™ Technology is a single-use device that is packaged and sterilized via ETO (Ethylene Oxide) with a 5-year shelf life, which is the same as the predicate device (K192330 and 172361). #### Indications for Use: The EEA™ Circular Stapler with Tri-Staple™ Technology has application throughout the alimentary tract for the creation of end-to-end, end-to-side anastomoses in both open and laparoscopic surgeries. #### Technological and Performance Characteristics: The subject device EEA™ circular stapler with Tri-Staple™ technology (lumen size 25mm) is substantially equivalent to the predicate device K192330/K172361 (lumen size 28mm, 31mm and 33mm) regarding the fundamental stapling technologies employed, intended use and indications for use. All EEA™ circular staplers with Tri-Staple™ technology are single-use manual circular staplers that have application throughout the alimentary tract for the creation of end-to-end, endto-side and side-to-side anastomoses in both open and laparoscopic surgeries. {5}------------------------------------------------ The Tri-Staple™ technology used in the subject device is fundamentally the same as the predicate device K192330/K172361. The subject circular staplers are available in 25mm lumen size, meanwhile, the predicates are available in 3 lumen sizes 28mm. 31mm and 33mm. That's why a reference device K062850 offering 25mm lumen size is to be introduced as control device in performance testing. #### Substantial Equivalent: The subject new product models have the same intended use and indications for use as the predicate device. They are same in fundamental scientific technology in that they are all sterile, single used, handheld, manual surgical instruments equipped with titanium staples intended to be used during open or laparoscopic surgical procedures of the alimentary tract, to create anastomoses (end-to-end, end-to-side, or side-to-side) via intraluminal (within the lumen) resection. The subject and predicate devices are same in design, materials and are sterilized via ethylene oxide, but different in lumen size. The below table further summarizes the similarities and differences between the subject and predicate devices. | Features | Subject Device | Predicate Device | | Reference Device | |-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | K192330 | K172361 | K062850 | | | EEA™ Circular Stapler with Tri-Staple™ Technology | | | EEA™ Circular Stapler with DST Series™ Technology | | Manufacturer | Same as predicate device. | Covidien | | Covidien | | Indications for Use | Same as predicate device. | The EEA™ Circular Stapler with Tri-Staple™ Technology has application throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries. | | The EEA™ Circular Stapler with DST Series™ Technology has application throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries. | | Operation Method | Same as predicate device. | Manual | | Manual | | Anatomical Site | Same as predicate device. | Alimentary tract | | Alimentary tract | | Surgical Approach | Same as predicate device. | Open and laparoscopic | | Open and laparoscopic | | Staple Rows | Same as predicate device. | 3 staggered rows of staples with different staple height in each staple row | | 2 staggered rows of staples with same staple height in each staple row | | Features | Subject Device | Predicate Device | | Reference Device | | | | K192330 | K172361 | K062850 | | | | EEA™ Circular Stapler with Tri-Staple™ Technology | | EEA™ Circular Stapler with DST Series™ Technology | | Staple Guide<br>Color | Black<br>Purple<br>Same as predicate<br>device. | Black | Purple | White (25mm) | | Staple Size<br>(open leg<br>height) | Black staple guide:<br>4.0mm,4.5mm,5.0mm<br>Purple staple guide:<br>3.0mm,3.5mm,4.0mm<br>Same as predicate<br>device. | Black staple guide:<br>4.0mm,4.5mm,5.0mm | Purple staple guide:<br>3.0mm,3.5mm,4.0mm | White staple (25mm)<br>guide:<br>4.8mm, 4.8mm<br>3.5m, 3.5mm | | Lumen Sizes | 25mm<br>Same as reference<br>device (25mm lumen<br>size), which is selected<br>to be the control device<br>in the performance<br>testing. | 28mm/31mm/33mm | | 25mm | | Staple Material | Same as predicate<br>device. | Titanium per ASTM F67 Grade I | | Titanium per ASTM F67<br>Grade I | | Stapler Length | Same as predicate<br>device. | Standard length: 22cm<br>Extra length XL: 35cm | | Standard length: 22cm<br>Extra length XL: 35cm | | Audible<br>Feedback | Same as predicate<br>device. | Yes | | Yes | | Anvil Head | Same as predicate<br>device. | 3 staggered rows of anvil bucket, lipless<br>design | | 2 staggered rows of anvil<br>bucket, lipped design | | Safety Lever | Same as predicate<br>device. | Red color | | White color | | Key Parts<br>Materials | Same as predicate<br>device. | Knife: Stainless Steel<br>Anvil: Stainless Steel<br>Tube: Aluminum | | Knife: Stainless Steel<br>Anvil: Stainless Steel<br>Tube: Aluminum | | Biocompatibility | Same as predicate<br>device. | Evaluated per ISO 10993-1 series and FDA<br>2016 biocompatibility guidance | | Evaluated per ISO<br>10993-1 series | | Single Use | Same as predicate<br>device. | Yes | | Yes | | Disposable | Same as predicate<br>device. | Yes | | Yes | | Sterile | Same as predicate<br>device. | Ethylene oxide | | Ethylene oxide | | Shelf Life | Same as predicate<br>device. | 5 years | | 5 years | {6}------------------------------------------------ {7}------------------------------------------------ ## Tests performed to evaluate and compare technological and performance characteristics: Non-clinical performance data - the following testing has been performed to demonstrate substantial equivalence to the predicate device. - 1. Performance Test (In-Vitro) - . Visual/Packaging Inspection - IFU Walkthrough - . Safety Lock Release Force Test - . Staple Formation on Test Medium - Anvil Retention Force Test - Anvil Attach Force Test - Anvil Detach Force Test ● - Clamping Force Test . - Unclamping Force Test ● - . Firing Force Test - 2. Performance Test (Ex-Vivo) - Ex-Vivo Firinas - Knife Cut Evaluation ● - . Leak / Burst Test - 3. Performance Test (In-Vivo) - Atraumatic Tissue Test ● - Hemostasis Test ● - . Staple Formation on Tissues The chronic animal study submitted in K172361 to evaluate the performance of the subject device and reference device shows no differences in healing metrics or anastomotic index. Clinical performance data - No clinical study is deemed necessary since the substantial equivalence has been sufficiently demonstrated by non-clinical studies. #### Conclusion: Based upon the supporting data summarized above, we concluded that the subject device EEA™ Circular Stapler with Tri-Staple™ Technology is substantially equivalent to the legally-marketed device (K192330 and K172361) and does not raise different questions or additional risks of safety and effectiveness than the predicate device.