Who is the manufacturer of ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY?

Covidien, LLC filed the 510(k) submission for ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY (K132493).

What is the FDA product code for ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY?

GDW. It is classified under 21 CFR 878.4750 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY?

510(k) clearance (submission type: Special).

What are the predicate devices for ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY?

Endo GIA™ Radial Reload with Tri-Staple™ Technology (K131705); Endo GIA™ Single Use Black Reload with Tri-Staple™ Technology (K093410); Endo GIA™ Single Use Tan Reload with Tri-Staple™ Technology (K101444).

Who can help prepare an FDA 510(k) submission like ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY

K132493 · Covidien, LLC · GDW · Oct 23, 2013 · General, Plastic Surgery

Device Facts

Record ID	K132493
Device Name	ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY
Applicant	Covidien, LLC
Product Code	GDW · General, Plastic Surgery
Decision Date	Oct 23, 2013
Decision	SESE
Submission Type	Special
Regulation	21 CFR 878.4750
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Intended Use

The Endo GIA™ Radial Reload with Tri-Staple™ Technology has application in open or minimally invasive general abdominal, gynecologic, pediatric and thoracic surgery for resection and transection of tissue and creation of anastomosis, as well as application deep in the pelvis, i.e. low anterior resection. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.

Device Story

Endo GIA™ Radial Reload with Tri-Staple™ Technology is a single-use, disposable surgical stapling component; compatible with Endo GIA™ Ultra Universal, Endo GIA™ Universal, GIA™ Universal, and iDrive™ Ultra handles. Device places three rows of curved titanium staples (60mm length) on each side of a cut line while simultaneously dividing tissue. Used in open or minimally invasive abdominal, gynecologic, pediatric, and thoracic surgeries; operated by surgeons. Provides curved transection capability for deep pelvic access and organ resection (liver, pancreas). Benefits include precise tissue management and anastomosis creation in restricted surgical spaces.

Clinical Evidence

Bench testing only. In vitro testing included firing force, retraction force, and staple formation. In vivo testing included free bleed evaluation, air leak test, burst evaluation, and tissue grasping/trauma assessment. Biocompatibility testing conducted per ISO 10993-1.

Technological Characteristics

Implantable titanium staples; 3-row curved cartridge geometry; 60mm staple line length. Materials compliant with ISO 10993-1. Sterilized via ethylene oxide (ETO) to SAL 10^-6. Single-use, disposable. Mechanical actuation via compatible stapler handles.

Indications for Use

Indicated for patients undergoing open or minimally invasive general abdominal, gynecologic, pediatric, and thoracic surgery requiring tissue resection, transection, and anastomosis, including deep pelvic procedures (e.g., low anterior resection) and procedures involving liver, hepatic vasculature, biliary structures, and pancreas.

Regulatory Classification

Identification

An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.

Predicate Devices

Endo GIA™ Radial Reload with Tri-Staple™ Technology (K131705)
Endo GIA™ Single Use Black Reload with Tri-Staple™ Technology (K093410)
Endo GIA™ Single Use Tan Reload with Tri-Staple™ Technology (K101444)

Related Devices

K131705 — ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY · Covidien, Formerly US Surgical A Divison of Tyco H · Jul 1, 2013
K102291 — COVIDIEN ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY · Covidien · Sep 15, 2010
K101444 — AUTOSUTURE ENDO GIA SINGLE USE TAN RELOAD WITH TRI-STAPLE TECHNOLOGY · Surgical Devices, A Global Business Unit Tyco · Jun 14, 2010
K061095 — AUTO SUTUR ENDO GIA STAPLERS · United States Surgical, A Division of Tyco Healthc · May 31, 2006
K083519 — AUTOSUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS · Covidien Lp, Formerly Registered AS United States · Apr 10, 2009

Submission Summary (Full Text)

{0}------------------------------------------------ - - ・・・ ## 510(k) Summary | SUBMITTER: | Covidien 60 Middletown Avenue North Haven, CT 06473 (203) 492-5299 (T) (203) 492-5029 (F) | |------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | CONTACT PERSON: | Katherine Kassim Senior Specialist, Regulatory Affairs | | DATE PREPARED: | August 19, 2013 | | TRADE/PROPRIETRY NAME: | Endo GIA™ Radial Reload with Tri-Staple™ Technology | | | COMMON/USUAL NAME: | | CLASSIFICATION NAME: | Staples, Implantable | | FDA PANEL NUMBER: | 79 | | PRODUCT CODE: | GDW | | CLASS CODE: | Pursuant to 21 CFR 878.4750, an implantable staple is a Class II device. | | PREDICATE DEVICE(S): | Endo GIA™ Radial Reload with Tri-Staple™ Technology (K131705); Endo GIA™ Single Use Black Reload with Tri-Staple™ Technology (K093410); Endo GIA™ Single Use Tan Reload with Tri-Staple™ Technology (K101444) | | DEVICE DESCRIPTION: | The single use Endo GIA™ Radial Reload with Tri-Staple™ Technology places three radial (curved) staple rows 60mm in length on each side of a cut line and simultaneously divides the tissue between the third and fourth lines, creating a 60mm curved transection. The radial reload places height progressive titanium staple rows. The reloads may be inserted through an access device such as a hand access device or comparable access port. The Endo GIA™ Radial Reload with Tri- Stable™ Technology may be used with the Endo GIA™ Ultra Universal, Endo GIA™ Universal, GIA™ Universal and iDrive™ Ultra stapler handles. | | INTENDED USE: | The Endo GIA™ Radial Reload with Tri-Staple™ Technology has application in open or minimally invasive general abdominal, gynecologic, pediatric and thoracic surgery for resection and transection of tissue and creation of anastomosis, as well as application deep in the pelvis, i.e. low anterior resection. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas. | ------------ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ · --- - - . . ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ · · ·- ·- ﺳﻌﺮ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍ . . . . . . . . . . . . . . ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ {1}------------------------------------------------ TECHNICAL CHARACTERISTICS: The Endo GIA™ Radial Reload with Tri-Staple™ Technology black reload and tan reload are substantially equivalent and have not altered the fundamental scientific technology to the predicate devices with regards to stapling technologies. The following summary tables show the similarities and differences between the subject device and the predicate devices. | Substantial | Endo GIA™ Radial | Endo GIA™ Radial | Endo GIA™ Single | |----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Equivalence Chart | Reload with Tri- | Reload with | Use Black Reload with | | Black Reload | Staple™ Technology | Tri-Staple™ | Tri-Staple Technology | | | Black Reload | Technology Purple | (predicate - K093410) | | | (subject devices) | Reload | | | | | (predicate - K131705 ) | | | Intended Use | The Endo GIA™ Radial Reload with Tri-Staple™ Technology has application in open and minimally invasive general abdominal, gynecologic, pediatric and thoracic surgery for resection and transection of tissue and creation of anastomosis, as well as application deep in the pelvis, i.e. low anterior resection. It may be used for transection and resection of liver substances, hepatic vasculature and biliary structures and for transection and | Same | The AutoSuture™ Endo GIA™ Staplers have application in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures. | | | resection of pancreas. | | | | Staple Line Length | 60mm | 60mm | 45mm or 60mm | | Cartridge Color | Black | Purple | Same | | Staple Sizes | 4.0mm, 4.5mm, 5.0mm | 3.0mm, 3.5mm, 4.0mm | Same | | Cartridge Geometry | Curved | Same | Straight | | Staple Rows | 3 rows | Same | Same | | Staple Material | Titanium | Same | Same | | Single Use | Yes | Same | Same | | Disposable | Yes | Same | Same | | Sterilization | The subject devices shall be sterilized via a validated ethylene oxide (ETO) cycle to a SAL of 106 | Same | Same | | Packaging | The subject devices shall be packaged in a sterile tray with Tyvek® lid. Each tray is packaged in a display | Same | Same | | Substantial Equivalence Chart for Tan Reload | Endo GIA™ Radial Reload with Tri- Staple™ Technology Tan Reload (subject device) | Endo GIA™ Radial Reload with Tri- Staple™ Technology Purple Reload (predicate K131705) | Endo GIA™ Single Use Tan Reload with Tri-Staple Technology (predicate-K101444) | | Intended Use | The Endo GIA™ Radial Reload with Tri-Staple™ Technology has application in open and minimally invasive general abdominal, gynecologic, pediatric and thoracic surgery for resection and transection of tissue and creation of anastomosis, as well as application deep in the pelvis, i.e. low anterior resection. It may be used for transection and resection of liver substances, hepatic vasculature and biliary structures and for transection and resection of pancreas. | Same | The AutoSuture™ Endo GIA™ Staplers have application in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, heptic vasculature and biliary structures. | | Staple Line Length | 60mm | 60mm | 45mm or 60mm | | Cartridge Color | Tan | Purple | Same | | Staple Sizes | 2.0mm, 2.5mm, 3.0mm | 3.0mm, 3.5mm, 4.0mm | Same | | Cartridge Geometry | Curved | Same | Straight | | Staple Rows | 3 rows | Same | Same | | Staple Material | Titanium | Same | Same | | Single Use | Yes | Same | Same | | Disposable | Yes | Same | Same | | Sterilization | The subject devices shall be sterilized via a validated ethylene oxide (ETO) cycle to a SAL of 10-6 | Same | Same | | Packaging | The subject devices shall be packaged in a sterile tray with Tyvek® lid. Each tray is packaged in a display box. | Same | Same | : {2}------------------------------------------------ . . : {3}------------------------------------------------ All components of the Endo GIA™ Radial Reload with Tri-Staple™ MATERIALS: Technology are similar to the predicate Endo GIA™ Radial Reload with Tri-Staple™ Technology. All materials are similar and are in accordance with ISO Standard 10993-1. Design verification and pre-clinical validation studies were conducted to PERFORMANCE DATA: demonstrate that the proposed devices Endo GIA™ Radial Reload with Tri-Staple™ Technology black reload and tan reload are safe and effective and perform as intended. In vitro and in vivo testing to support the intended use of this device includes: - . In Vitro - Firing Force o - Retraction Force o - Staple Formation O - In Vivo . ・ - Free Bleed Evaluation o - o Air Leak Test - o Burst Evaluation - Tissue Grasping and Trauma o - . Biocompatibility The result of these tests demonstrates that the proposed devices Endo GIA™ Radial Reload with Tri-Staple™ Technology black reload and tan reload are substantially equivalent to the predicate devices. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized image of an eagle. #### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 23, 2013 Covidien, LLC Ms. Katherine Kassim Senior Regulatory Affairs Specialist 60 Middletown Avenue North Haven, Connecticut 06473 Re: K132493 Trade/Device Name: Endo GIA" Radial Reload with Tri-Staple" Technology Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: September 23, 2013 Received: September 24, 2013 Dear Ms. Kassim: 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. Ilisting 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {5}------------------------------------------------ Page 2 - Ms. Katherine Kassim forth in the quality systems (OS) 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 Small Manufacturers. International and Consumer Assistance at its tollfree 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 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 yours, ## Mark N. Melkerson -S Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ Endo GIA™ Radial Reload with Tri-Staple™ Technology ### Indications for Use K132493 510(k) Number (if known): Device Name: Endo GIA™ Radial Reload with Tri-Staple™ Technology .. . Indications for Use: The Endo GIA™ Radial Reload with Tri-Staple™ Technology has application In open or minimally invasive general abdominal, gynecologic, pediatre and thorado surgery for resection and transection of tissue and creation of anastomosis, as well as application deep in the perior, it e. low antentiment which and may be used for transection and resection of liver substance, hepatic vasculature and billiary stuctures and for transection and resection of pancreas. Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) # David Krause -S (Division Sign-Off) Division of Surgical Devices 510(k) Number: K132493 Covidien Supplamental Information Радв 18