← Product Code [GDW](/submissions/SU/subpart-e%E2%80%94surgical-devices/GDW) · K093410 # AUTOSUTURE ENDO GIA SINGLE USE BLACK RELOAD WITH TRI-STAPLE TECHNOLOGY (K093410) _Surgical Devices, A Divsion of Tyco Healthcare · GDW · Nov 12, 2009 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDW/K093410 ## Device Facts - **Applicant:** Surgical Devices, A Divsion of Tyco Healthcare - **Product Code:** [GDW](/submissions/SU/subpart-e%E2%80%94surgical-devices/GDW.md) - **Decision Date:** Nov 12, 2009 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 878.4750 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic, Pediatric ## Intended Use The Autosuture™ Endo GIA™ Staplers have applications 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, hepatic vasculature and biliary structures. Note: The Autosuture™ Endo GIA™ Single Use Black Reload with Tri-Staple™ Technology is intended for use with the Autosuture™ Endo GIA™ Stapler and does not carry a separate indication from the stapling device. ## Device Story Autosuture™ Endo GIA™ Single Use Black Reload with Tri-Staple™ Technology is a reload cartridge for the existing Autosuture™ Endo GIA™ Stapler. Designed for extra thick tissue; features staple sizes of 4.0, 4.5, and 5.0 mm. Available in 45 mm and 60 mm lengths. Used by surgeons in OR settings for resection, transection, and anastomosis in abdominal, gynecologic, pediatric, and thoracic procedures. Device functions by delivering staples to tissue; Tri-Staple™ technology provides consistent staple formation. Benefits include improved performance in thick tissue applications. ## Clinical Evidence Bench and in-vivo performance evaluations were conducted to demonstrate safety and effectiveness. No clinical trial data provided. ## Technological Characteristics Reload cartridge for surgical stapler; utilizes Tri-Staple™ technology. Materials comply with ISO 10993-1. Staple sizes: 4.0, 4.5, 5.0 mm. Lengths: 45 mm and 60 mm. Mechanical actuation. ## Regulatory Identification An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable. ## Predicate Devices - Autosuture™ Endo GIA™ Stapler ([K083519](/device/K083519.md)) - Autosuture™ Endo GIA™ Stapler ([K061095](/device/K061095.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ p ## 510(k) Summary of Safety and Effectiveness | SUBMITTER: | Surgical Devices, a global business unit
of Tyco Healthcare Group LP (d/b/a Covidien)
60 Middletown Avenue
North Haven, CT 06473
Tel. No.: (203) 492-5352 | K093410 | |-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------| | CONTACT PERSON: | Frank Gianelli
Senior Associate, Regulatory Affairs | | | DATE PREPARED: | October 29, 2009 | NOV 12 2009 | | TRADE/PROPRIETARY NAME: | Autosuture™ Endo GIA™ Staplers | | | COMMON/USUAL NAME: | Surgical Stapler with Implantable Staples | | | CLASSIFICATION NAME: | Staples, Implantable | | | PREDICATE DEVICE(S): | Autosuture™ Endo GIA™ Stapler (K083519; K061095) | | | DEVICE DESCRIPTION: | This 510(k) shall describe a new Reload cartridge with Tri-
Staple™ technology for use with the currently marketed
Autosuture™ Endo GIA™ Stapler as described in the predicate
submission K083519. The black Reload bears the identical design
characteristics as the Reloads with Tri-Staple™ Technology
described in the predicate submission with the exception that the
staples sizes shall be 4.0, 4.5, and 5.0 mm for use in extra thick
tissue. The black Reloads shall be made available in 45 mm and
60 mm lengths. | | | INTENDED USE: | The Autosuture™ Endo GIA™ Staplers have applications 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, hepatic
vasculature and biliary structures. | | | | Note: The Autosuture™ Endo GIA™ Single Use Black Reload
with Tri-Staple™ Technology is intended for use with the
Autosuture™ Endo GIA™ Stapler and does not carry a separate
indication from the stapling device. | | | TECHNOLOGICAL
CHARACTERISTICS: | The Endo GIA™ Single Use Black Reload with Tri-Staple™
Technology for use in extra thick tissue is substantially equivalent
to the predicate Reload cartridges with regard to the stapling
technologies employed. The addition of the Single Use Black
Reload with Tri-Staple™ Technology provides an additional
offering to the surgeon where thick tissue must be transected or
resected. | | | MATERIALS: | All components of the Autosuture™ Endo GIA™ Single Use
Black Reload with Tri-Staple™ Technology are comprised of
materials that are in accordance with ISO Standard 10993-1. | | | PERFORMANCE DATA: | Bench and in-vivo performance evaluations were conducted to
demonstrate that the new Endo GIA™ Single Use Black Reload
with Tri-Staple™ Technology when used with the Autosuture™
Endo GIA™ Stapler is safe and effective and performs as
intended | | . {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing protection and strength. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", indicating the department's name and national affiliation. The seal is presented in black and white, giving it a formal and official appearance. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002 Surgical Devices Tyco Healthcare Group LP (d/b/a Covidien) % Mr. Frank Gianelli Senior Associate, Regulatory Affairs 60 Middletown Avenue North Haven, Connecticut 06473 Re: K093410 Trade/Device Name: Autosuture™ Endo GIA™Single Use Black Reload with Tri-Staple™ Technology Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: October 30, 2009 Received: November 2, 2009 NOV 12 2009 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. 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 {2}------------------------------------------------ Page 2 - Mr. Frank Gianelli 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/cdrh/mdr/ 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/cdrh/industry/support/index.html. Sincerely yours. Sincerely yours, Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications For Use K09340 510(k) Number (if known): Device Name: Autosuture™ Endo GIA™ Single Use Black Reload with Tri-Staple™ Technology Indications For Use: The Autosuture™ Endo GIA™ Staplers with Endo GIA™ Single Use Reloads have applications 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. 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) Daniel Krone for MXM (Division Sign-Of) Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K093410 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDW/K093410](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GDW/K093410) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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