COVIDIEN ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY

K102291 · Covidien · GDW · Sep 15, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K102291
• Device Name: COVIDIEN ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY
• Applicant: Covidien
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Sep 15, 2010
• Decision: SESE
• Submission Type: Traditional
• 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 of liver substance, hepatic vasculature and biliary structures.

Device Story

Curved surgical stapler cartridge; places three staggered rows of titanium staples on either side of cut line; simultaneously divides tissue. Features Tri-Staple technology with height-progressive staple lengths (shortest near knife, longest at outer row). Compatible with Endo GIA ULTRA Universal Stapler and GIA/Endo GIA Universal Stapler handles; includes interlocks to prevent firing previously used cartridges. Used in OR by surgeons for general, abdominal, gynecologic, pediatric, and thoracic procedures; facilitates access in restricted anatomy like deep pelvis. Output is a 60mm curved transection with stapled tissue edges. Benefits include improved access to restricted anatomical spaces and reliable tissue closure/hemostasis.

Clinical Evidence

Bench and animal model performance evaluations. Bench testing: in vitro staple formation, firing force, staple line pull-apart force. Animal testing: in vivo staple formation, free bleed, burst strength, air leak, tissue grasping, and trauma. No human clinical data provided.

Technological Characteristics

Curved stapler cartridge; 60mm length; Purple 'Medium-Thick' configuration. Materials compliant with ISO 10993-1. Energy source: manual (via compatible stapler handle). Connectivity: none. Sterilization: not specified. Software: none.

Indications for Use

Indicated for patients undergoing open or minimally invasive general abdominal, gynecologic, pediatric, or thoracic surgery requiring tissue resection, transection, or anastomosis, including deep pelvic procedures like low anterior resection and liver/biliary/hepatic vasculature procedures.

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)
• Ethicon Contour Curved Cutter Stapler & Reloads (K091322)

Submission Summary (Full Text)

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K102291

## 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] | SEP 15 2010 |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| CONTACT PERSON: | Tim M. Lohnes, Manager, Regulatory Affairs | |
| DATE PREPARED: | August 10, 2010 | |
| TRADE/PROPRIETARY NAME: | Covidien Endo GIA™ Radial Reload with Tri-Staple™<br>Technology | |
| COMMON/USUAL NAME: | Surgical Stapler with Implantable Staple | |
| CLASSIFICATION NAME: | Staple, Implantable | |
| PREDICATE DEVICE(S): | Autosuture™ ENDO GIA™ Stapler (K083519),<br>Ethicon Contour Curved Cutter Stapler & Reloads (K091322) | |

### DEVICE DESCRIPTION:

The Endo GIA™ Radial Reload with Tri-Staple™ Technology is a curved stapler cartridge that places three staggered rows of staples on either side of a cut line and simultaneouly divides (cuts) the tissue between the rows.

Covidien Reloads with Tri-Staple™ Technology apply height progressive rows of titanium staples on either side of the cut line. The shortest staple length is located in the first staggered row nearest the knife, an intermediate staple length is located in the second row, and the longest staple length is located in the third (outside) staggered row.

The Endo GIA™ Radial Reload with Tri-Staple™ Technology is compatible with the Endo GIA™ ULTRA Universal Stapler and GIA™ and Endo GIA™ Universal Stapler handles, and incorporates the functionality of those handles including interlocks to prevent firing a previously fired cartridge.

## 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 of liver substance, hepatic vasculature and biliary structures.

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## TECHNOLOGICAL CHARACTERISTICS:

This 510(k) reports a modification of our currently marketed Autosuture™ Endo GIA™ Staplers (K085319), namely, the Endo GIA™ Radial Reload with Tri-Staple" Technology applies staple radial, rather than linear staple lines from a curved, rather than straight, cartridge. The subject Endo GIA™ Radial Reload with Tri-Staple™ Technology incorporates identical Tri-Staple™ Technology and uses the existing Endo GIA™ Stapler handles for operation. It will be offered in a 60 mm length as a Purple "Medium-Thick" cartridge.

The Endo GIA™ Radial Reload Purple with Tri-Staple™ Technology is identical to the predicate Autosuture™ device with regard to stapling technologies. The curved cartridge facilitates access in restricted anatomy, for example low in the pelvis during lower anterior resection (LAR) with total mesorectal excision (TME) procedures. The Endo GIA™ Radial Reloads Purple with Tri-Staple™ Technology are compatible with the existing Endo GIA ™ Stapler handles for operation and incorporate the functionality of those handles, including interlocks to prevent firing a previously fired cartridge.

The subject device is equivalent to the predicate Ethicon Contour® Curved Cutter Stapler, which applies radial staple rows on either side of a cut line and divides between them, creating a 40mm curved transection. The Endo GIA™ Radial Reload Purple with Tri-Staple™ Technology places three radial staple rows 60mm in length and simultaneouly divides (cuts) between the rows, creating a 60mm curved transection.

#### MATERIALS:

All components of the Endo GIA™ Radial Reloads with Tri-Staple™ Technology are comprised of materials that are in accordance with ISO Standard 10993-1.

## PERFORMANCE DATA:

Bench and animal model performance evaluations were completed to verify that the EndoGIA™ Radial Reload Purple with Tri-Staple™ Technology is safe and effective and performs as intended. Testing consisted of evaluation for in vitro stable formation, firing force and staple line pull-apart force, as well as in vivo staple formation, free bleed, burst strength, air leak, tissue grasping, and trauma.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

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

Covidien % Mr. Tim M. Lohnes Manager, Regulatory Affairs 60 Middleton Avenue North Haven, Connecticut 06473

SEP 1 5 2010

Re: K102291

Trade/Device Name: Covidien Endo GIA™ Radial Reload with Tri-Staple™ Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: August 10, 2010 Received: August 12, 2010

Dear Mr. Lohnes:

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 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

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Page 2 - Mr. Tim M. Lohnes

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/Resourcesfor You/Industry/default.htm

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

510(k) Number (if known):

K102291 SEP 1 5 2010

Device Name:

## Indications For Use

510(k) Number (if known): Device Name: Covidien Endo GIA™ Radial Reload with Tri-Staple™ Technology

K102291

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. Iow anterior resection.

It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.

X Prescription Use (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 Kane for MKY

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K/02291