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

Device Facts

• Record ID: K093410
• Device Name: AUTOSUTURE ENDO GIA SINGLE USE BLACK RELOAD WITH TRI-STAPLE TECHNOLOGY
• Applicant: Surgical Devices, A Divsion of Tyco Healthcare
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Nov 12, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4750
• Device Class: Class 2
• 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.

Indications for Use

Indicated for patients undergoing abdominal, gynecologic, pediatric, or thoracic surgery requiring resection, transection, or anastomosis, including liver substance, hepatic vasculature, and biliary structures.

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

• Autosuture™ Endo GIA™ Stapler (K083519)
• Autosuture™ Endo GIA™ Stapler (K061095)

Submission Summary (Full Text)

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## 510(k) Summary of Safety and Effectiveness

| 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.: [phone] | K093410 |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| CONTACT PERSON: | Frank Gianelli<br>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-<br>Staple™ technology for use with the currently marketed<br>Autosuture™ Endo GIA™ Stapler as described in the predicate<br>submission K083519. The black Reload bears the identical design<br>characteristics as the Reloads with Tri-Staple™ Technology<br>described in the predicate submission with the exception that the<br>staples sizes shall be 4.0, 4.5, and 5.0 mm for use in extra thick<br>tissue. The black Reloads shall be made available in 45 mm and<br>60 mm lengths. | |
| INTENDED USE: | The Autosuture™ Endo GIA™ Staplers have applications in<br>abdominal, gynecologic, pediatric and thoracic surgery for<br>resection, transection, and creation of anastomoses. They may<br>be used for transection and resection of liver substance, hepatic<br>vasculature and biliary structures. | |
| | Note: The Autosuture™ Endo GIA™ Single Use Black Reload<br>with Tri-Staple™ Technology is intended for use with the<br>Autosuture™ Endo GIA™ Stapler and does not carry a separate<br>indication from the stapling device. | |
| TECHNOLOGICAL<br>CHARACTERISTICS: | The Endo GIA™ Single Use Black Reload with Tri-Staple™<br>Technology for use in extra thick tissue is substantially equivalent<br>to the predicate Reload cartridges with regard to the stapling<br>technologies employed. The addition of the Single Use Black<br>Reload with Tri-Staple™ Technology provides an additional<br>offering to the surgeon where thick tissue must be transected or<br>resected. | |
| MATERIALS: | All components of the Autosuture™ Endo GIA™ Single Use<br>Black Reload with Tri-Staple™ Technology are comprised of<br>materials that are in accordance with ISO Standard 10993-1. | |
| PERFORMANCE DATA: | Bench and in-vivo performance evaluations were conducted to<br>demonstrate that the new Endo GIA™ Single Use Black Reload<br>with Tri-Staple™ Technology when used with the Autosuture™<br>Endo GIA™ Stapler is safe and effective and performs as<br>intended | |

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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

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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 [phone] or [phone] 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

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## 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