AUTOSUTURE ENDO GIA SINGLE USE TAN RELOAD WITH TRI-STAPLE TECHNOLOGY

K101444 · Surgical Devices, A Global Business Unit Tyco · GDW · Jun 14, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K101444
• Device Name: AUTOSUTURE ENDO GIA SINGLE USE TAN RELOAD WITH TRI-STAPLE TECHNOLOGY
• Applicant: Surgical Devices, A Global Business Unit Tyco
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Jun 14, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4750
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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.

Device Story

Endo GIA™ Stapler with Tri-Staple™ Technology; single-use reloadable stapling device. Input: tissue to be resected/transected. Operation: places two triple-staggered rows of titanium staples; simultaneously divides tissue between rows. Tri-Staple™ design features stepped staple heights (outer row tallest, inner row shortest) to accommodate varying tissue thicknesses. Used in OR by surgeons for abdominal, gynecologic, pediatric, and thoracic procedures. Output: stapled and divided tissue. Benefit: provides hemostasis and tissue approximation during surgical resection/transection. This notification updates the upper range of the tissue thickness compression contraindication from 1.5 mm to 1.8 mm.

Clinical Evidence

Bench and in vivo performance evaluations conducted. Bench testing evaluated staple formation; in vivo testing evaluated staple formation, hemostasis, and burst strength. No clinical trial data provided.

Technological Characteristics

Titanium staples; Tri-Staple™ stepped configuration (varying heights per row). Available in 30mm, 45mm, and 60mm staple line lengths; includes curved-tip anvil options. Materials comply with ISO 10993-1. Mechanical actuation; no software or electronic components.

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)

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] |
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JUN 1 4 2010

K101444

CONTACT PERSON: Frank Gianelli Senior Associate, Regulatory Affairs

May 21, 2010 DATE PREPARED:

TRADE/PROPRIETARY NAME: Autosuture™ Endo GIA™ Staplers

COMMON/USUAL NAME: Surgical Stapler with Implantable Staples

CLASSIFICATION NAME: Staples, Implantable

Autosuture™ Endo GIA™ Stapler (K083519) PREDICATE DEVICE(S):

> The Endo GIA™ Single Use Tan Reload with Tri-Staple™ Technology when used with the Endo GIA™ Stapler places two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows.

> For the Tan reload, the staple sizes are 2.0, 2.5, and 3.0 mm for use in vascular and medium thick tissue. The Tan Reloads are available in 30mm. 45mm and 60mm staple line lengths as well as curved-tip anvil configurations.

> 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 Endo GIA™ Single Use Tan 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.

> This 510(k) reports for the previously cleared Endo GIA™ Single Use Tan Reload with Tri-Staple™ Technology a change in the upper range of the tissue thickness compression contraindication from 1.5 mm to 1.8 mm. Except for this labeling change, there are no other changes to the currently marketed device as well as no change to indications for use, or to the intended use of the device.

> Tri-Staple™ Technology means that each of the two triplestaggered rows has a stepped configuration whereby the staples in the outer row are a taller height than the staples in the middle row which in turn are a taller height than the staples in the inner row. The size of the staples is determined by the selection of the appropriate single use Reload.

## INTENDED USE:

DEVICE DESCRIPTION:

TECHNOLOGICAL CHARACTERISTICS:

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MATERIALS:

PERFORMANCE DATA:

All components of the Endo GIA™ Single Use Tan Reload with Tri-Staple™ Technology are comprised of materials that are in accordance with ISO Standard 10993-1.

Bench and in vivo performance evaluations were conducted to demonstrate that the Endo GIA™ Single Use Tan Reload with Tri-Staple™ Technology when used with the Autosuture™ Endo GIA™ Stapler is safe and effective and performs as intended.

In support of this product labeling modification, bench tests were performed to evaluate staple formation and in vivo tests were performed to evaluate staple formation, hemostasis and burst strength.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Surgical Devices, a global business unit Of Tyco Healthcare Group LP % Covidien Mr. Frank Gianelli Senior Associate, Regulatory Affairs 60 Middletown Avenue North Haven, Connecticut 06473

JUN 1 4 2010

Re: K101444

Trade/Device Name: Autosuture™ Endo GIA™ Single Use Tan Reload with Tri-Staple" Technology Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: May 21, 2010 Received: May 24, 2010

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.

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Page 2 - Mr. Frank Gianelli

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 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark A Millman

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

510(k) Number (if known): K101444

Device Name: Autosuture™ Endo GIA™ Single Use Tan Reload with Tri-Staple™ Technology

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 X (Part 21 CFR 801 Subpart D) AND/OR

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)

Daniel Kronebaumxm

Division of Surgical, Orthopedic. and Restorative Devices

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510(k) Number K101444