Signia Loading Unit, Tri-Staple 2.0 Cartridge

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 29, 2015 Covidien LLC Mr. Frank Gianelli Senior Product Specialist, Regulatory Affairs 60 Middletown Avenue North Haven, Connecticut 06473 Re: K151163 Trade/Device Name: Signia Loading Units with Tri-Staple" 2.0 Cartridges Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: April 30, 2015 Received: May 1, 2015 Dear Mr. Gianelli: 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. 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 801); medical device reporting (reporting of medical {1}------------------------------------------------ device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, # David Krause -S - Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ | DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration<br>Indications for Use | Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017<br>See PRA Statement below. | |------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------| |------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------| | 510(k) Number (if known) | K151163 | |--------------------------|---------| | Device Name | | Signia Loading Units with Tri-Staple™ 2.0 cartridges #### Indications for Use (Describe) The Signia Loading Units with Tri-Staple™ 2.0 cartridges have applications in abdominal, gynecologic, pediatric and thoracie surgery for resection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and transection and resection of pancreas. 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." FORM FDA 3881 (8/14) Page 1 of 1 Par Partistang Cancer ( Just 413 411 Sant EF {3}------------------------------------------------ ## 510(k) Summary of Safety and Effectiveness #### Date Prepared: April 30, 2015 #### Submitter: Covidien 60 Middletown Avenue North Haven, CT 06473 #### Contact: Frank Gianelli Senior Regulatory Affairs Product Specialist Telephone: (203) 492-5352 Fax: (203) 492-5029 Email: frank.gianelli@covidien.com ### Name of Device: | Trade/Proprietary Name: | SigniaTM Loading Units with Tri-StapleTM 2.0 Cartridges | |-------------------------|---------------------------------------------------------| | Common Name: | Surgical Stapler with Implantable Staples | | Classification Name: | Staples, Implantable | | | a. Panel no and product code: 79 GDW | | | b. Regulation no: 21 CFR 878.4750 | #### Predicate Device: | | Trade/Proprietary Name: Endo GIA TM Reloads with Tri-Staple TM Technology | |----------------------|---------------------------------------------------------------------------| | Common Name: | Surgical Stapler with Implantable Staples | | Classification Name: | Staples, Implantable, (79 GDW, 21 CFR 878.4750) | | 510(k) Number: | K111825, K083519 | | Manufacturer: | Covidien | #### Device Description: The SigniaTM Loading Units and Tri-StapleTM 2.0 Cartridges place staggered rows of titanium staples and simultaneously divides the tissue so that three staggered rows of staples are placed on either side of the cut line. The size of the staples is determined by the selection of the following single use Tri-StapleTM 2.0 cartridges: Tri-Staple TM 2.0 cartridge, vascular/medium: - Tan- three height progressive rows of 2.0 mm, 2.5 mm, 3.0 mm titanium staples on o either side of the cut line. Tri-StapleTM 2.0 cartridge, medium/thick: - · Purple-three height progressive rows of 3.0 mm, 3.5 mm and 4.0 mm titanium staples on either side of the cut line. The Tri-StableTM 2.0 Cartridge is available in 45 mm and 60 mm lengths. The SigniaTM Loading Unit is available in articulating 45 mm and 60 mm lengths. Tri-StapleTM 2.0 Cartridges are able to be loaded into the SigniaTM Loading Unit by the User. SigniaTM Loading Units may be used up to twelve times in the same procedure. SigniaTM Loading Units with Tri-Staple TM 2.0 Cartridges, similar to the predicate devices, are compatible with Covidien's Endo GIA TM Ultra Universal manual stapler handles and iDriveTM Ultra powered stapler handle with associated Endo GIATM Adapter. #### Intended Use: The SigniaT" Loading Units with Tri-StapleT" 2.0 Cartridges have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, and creation of anastomoses. They may be used for transection of liver substance, hepatic vasculature and biliary structures and transection and resection of pancreas. {4}------------------------------------------------ - Note: The Signia™ Loading Units with Tri-StapleT" 2.0 Cartridges is intended for use with Endo GIATM Stapiers and does not carry a separate indication from the stapling devices. Technological and Performance Characteristics: SigniaTM Loading Units with Tri-StapleT• 2.0 Cartridges are substantially equivalent to the predicate Endo GIAT" Reloads with Tri-StapleTM Technology in regard to the stapling technologies employed. Qualitative and quantitative data were obtained and used to compare the SigniaTM Loading Units with Tri-StapleT" 2.0 cartridges to the predicate Endo GIAT" Reloads with Tri-StapleTM Technology. All aspects were found to be identical, with the exception of the following characteristics: - 1. Construct change: - Two-modular configuration: - · Single-use, multiple-fire Loading Unit containing the anvil and knife. - l> Loading Unit can be used up to 12 firings per procedure. - I> The marketing name of the loading unit is SigniaT•. - · Single-use, single-fire staple cartridge, - l> The marketing name of the staple Cartridge is Tri-Staple TM 2.0. - 2. Material Change Addition of an alternate stainless steel material for the anvil component of the Loading Unit. - 3. Material Change New colorant formulation in material of the "tan" staple Cartridge. - 4. New components and materials Due to the construct change, new components are used that are made of materials not used in the predicate Endo GIAT" Reloads with Tri-StapleT" Technology. The design differences were found to not affect safety or performance through applicable design verification activities that showed continued conformance to applicable technical design specifications and performance requirements, applicable medical device performance standards, and other nonclinical testing. Tests performed to evaluate and compare technological and performance characteristics: - 1. Bench tests using simulated tissue medium was performed to evaluate the following technological and performance characteristics in order to show the reliability of the Signia™ Loading Units to achieve 12 firings in a single patient procedure: - . Staple formation - Knife cutting . - . Cartridge insertion/removal forces - . Clamp forces - Firing force - . Loading Unit loading/unloading forces - Lockout force - Retraction force - Articulation Angles - Articulation Forces - 2. In vivo and ex vivo tests using porcine and canine animal models was performed to evaluate the following performance characteristics - . Acute hemostasis - . Acute air leak - Burst pressure - . Staple formation - . Tissue grasping and trauma - Use with staple line reinforcement (buttress) material {5}------------------------------------------------ - 3. Usability Tests - Biocompatibility tests in accordance with ISO Standard 10993-1 was performed to 4. confirm that all components of the SigniarM Loading Units and Tri-StaplerM 2.0 Cartridges are comprised of materials that are in accordance with ISO Standard 10993-1 for their intended patient contact profile. This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence. ## Conclusion: Through the comparison of technological and performance characteristics and the results of evaluation testing, the Signia'M Loading Units with Tri-Staple'M 2.0 Cartridges were found to be substantially equivalent to the predicate devices.