DUET TRS RELOADS, DUET TRS RELOADS WITH TRI-STAPLE TECHNOLOGY, ENDO GIA UNIVERSAL AND ULTRA UNIVERSAL STAPLERS

{0}------------------------------------------------ KI20258 ## 510(k) Summary of Safety and Effectiveness FEB 2 9 2012 | SUBMITTER: | Surgical Devices, a global business unit<br>of Tyco Healthcare Group LP (d/b/a Covidien)<br>60 Middletown Avenue<br>North Haven, CT 06473<br>Tel. No.: (203) 492-5352 | |------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------| |------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------| Jennifer Brennan Manager, Regulatory Affairs DATE PREPARED: CONTACT PERSON: January 20, 2012 Duet TRS™ Reloads. TRADE/PROPRIETARY NAME: Duet TRS™ Reloads with Tri-Staple™ Technology Endo GIA™ Universal and Ultra Universal Staplers Surgical Stapler with Implantable Staples COMMON/USUAL NAME: PREDICATE DEVICE(S): Staples, Implantable CLASSIFICATION NAME: Duet TRS Reloads (K080898, K111825) Duet TRS™ Reloads with Tri-Staple™ Technology (K103263, K111825) Endo GIA ™ Universal and Ultra Universal Staplers (K111825) DEVICE DESCRIPTION: The Duet TRS™ Reloads when used with Endo GIA™ Staplers place two, triple-staggered rows of titanium staples along with two layers of absorbable tissue reinforcement material (one layer on cartridge side and one laver on anvil side) and simultaneously divides the tissue and reinforcement material between the two, triple-staggered staple rows. The Duet TRS™ Reloads with Tri-Staple™ Technology when used with Endo GIA™ Staplers places two, triple-staggered rows of titanium staples along with two layers of absorbable tissue reinforcement material (one layer on cartridge side and one layer on anvil side) and simultaneously divides the tissue and reinforcement material between the two, triple-staggered staple rows. The staple line reinforcement material is a synthetic absorbable film prepared from synthetic polyester composed of glycolide, dioxanone, and trimethylene carbonate. The staple line reinforcement material supplied on each Reload is undyed (natural) and secured to the anvil and cartridge with BIOSYN™ synthetic absorbable suture. {1}------------------------------------------------ The Endo GIA™ Universal and Ultra Universal Staplers (K111825) with associated staple cartridge reloads are articulating, disposable surgical staplers that simultaneously transect and staple various types of internal tissues. Each can be used in both endoscopic and open surgical procedures, is available in multiple sizes, is for endoscopic procedures and can be introduced and used through appropriately sized trocar endoscopic access cannulae. The Endo GIA™ Universal Staplers with Duet TRS™ reloads have applications in abdominal. gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas The Duet TRS™ Reloads with Tri-Staple™ Technology have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas Duet TRS™ Reloads and the Duet TRS™ Reloads with Tri-Staple™ Technology and the Endo GIA™ Staplers Universal and Ultra Universal are identical to the predicate devices. All components of the Duet TRS™ Reloads and the Duet TRS™ Reload with Tri-Staple™ Technology and the Endo GIA™ Staplers (Universal and Ultra Universal) are comprised of materials that are in accordance with ISO Standard 10993-1. · There have been no changes to the design of the Duet TRS™ Reloads, the Duet TRS™ Reloads with Tri-Staple™ Technology, or the Endo GIA™ Universal and Ultra Universal Staplers Performance evaluations were not required to support this labeling modification. ## INTENDED USE: TECHNOLOGICAL CHARACTERISTICS: MATERIALS: ## PERFORMANCE DATA: {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Covidien % Ms. Jennifer Brennan Manager, Regulatory Affairs 60 Middletown Avenue · North Haven, Connecticut 06473 FEB 2 9 2012 Re: K120258 Trade/Device Name: Duet TRS™ Reloads Duet TRS™ Reloads with Tri-Staple™ Technology Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: January 25, 2012 Received: January 27, 2012 Dear Ms. Brennan: 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 {3}------------------------------------------------ Page 2 - Ms. Jennifer Brennan 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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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. Sincerely vou ely yours, Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Indications for Use 510(k) Number (if known): Duet TRS™ Reloads Device Name: Duet TRS™ Reloads with Tri-Staple™ Technology Indications For Use: The Endo GIA™ Universal Staplers with Duet TRS™ reloads have applications in abdominal, The Lindo Of . . . Onliverour Station, transection and creation of anastomoses. They gyncologic and poulatio ourgery for version of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas The Duet TRS™ Reloads with Tri-Staple™ Technology have applications in abdominal, gynecologic and pediatric surgery for resection and creation of anastomoses. They gynecologic and poularle ourger resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas Prescription Use (Part 21 CFR 801 Subpart D) AND/ÓR Over-The-Counter Use (21 CFR 807 Subpart C) (Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Bail Kmefer, WXAU (Division Sign-Off) Division of Surgical, Orthopedic. and Restorative Devices 510(k) Number K120258 Page 1 of