ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY

K131705 · Covidien, Formerly US Surgical A Divison of Tyco H · GDW · Jul 1, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K131705
• Device Name: ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY
• Applicant: Covidien, Formerly US Surgical A Divison of Tyco H
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Jul 1, 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

Single-use surgical stapler reload; places three radial (curved) staple rows (60mm length) on each side of cut line; simultaneously divides tissue; creates 60mm curved transection. Features height-progressive titanium staple rows. Used in open or minimally invasive abdominal, gynecologic, pediatric, and thoracic surgeries; specifically designed for deep pelvic access (e.g., low anterior resection). Compatible with Endo GIA™ Ultra Universal, Endo GIA™ Universal, GIA™ Universal, and iDrive™ Ultra handles. Operated by surgeons. Provides mechanical tissue management; facilitates resection/transection/anastomosis; benefits patients by enabling precise tissue division and closure in difficult-to-reach anatomical locations.

Clinical Evidence

Bench testing only. No clinical data provided. 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 performed per ISO 10993-1.

Technological Characteristics

Implantable surgical stapler reload; titanium staples; height-progressive staple rows; 60mm curved form factor. Compatible with manual and powered stapler handles. Materials compliant with ISO 10993-1. Mechanical actuation principle.

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 resection of liver, hepatic vasculature, biliary structures, or 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 (K102291)
• Endo GIA™ Stapler, DST Series™ GIA™ Stapler and DST Series™ TA™ Stapler (K111825)

Submission Summary (Full Text)

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# 510(k) Summary

K131705
page 1/2

| SUBMITTER: | Covidien<br>60 Middletown Avenue<br>North Haven, CT 06473<br>[phone] (T) |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | JUL 0 1 2013 |
| CONTACT PERSON: | Katherine Robertson<br>Senior Specialist, Regulatory Affairs |
| DATE PREPARED: | June 10, 2013 |
| TRADE/PROPRIETRY NAME: | Endo GIA™ Radial Reload with Tri-Staple™ Technology |
| COMMON/USUAL NAME: | Surgical Stapler with Implantable Staples |
| 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 (K102291);<br>Endo GIA™ Stapler, DST Series™ GIA™ Stapler and DST Series™<br>TA™ Stapler (K111825) |
| DEVICE DESCRIPTION: | The single use Endo GIA™ radial reload with Tri-Staple™ technology<br>places three radial (curved) staple rows 60mm in length on each side of<br>a cut line and simultaneously divides the tissue between the third and<br>fourth lines, creating a 60mm curved transection. The medium/thick<br>radial reload places height progressive titanium staple rows. The reloads<br>may be inserted through an access device such as a hand access device<br>or comparable access port. The Endo GIA™ radial reloads with Tri-<br>Staple™ Technology may be used with the Endo GIA™ Ultra Universal,<br>Endo GIA™ Universal, GIA™ Universal and iDrive™ Ultra stapler<br>handles. |
| INTENDED USE: | The Endo GIA™ Radial Reload with Tri-Staple™ Technology has<br>application in open or minimally invasive general abdominal,<br>gynecologic, pediatric and thoracic surgery for resection and transection<br>of tissue and creation of anastomosis, as well as application deep in the<br>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.

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TECHNICAL CHARACTERISTICS:

PERFORMANCE DATA:

MATERIALS:

The Endo GIA™ Radial Reload with Tri-Staple™ Technology is substantially equivalent and has not altered the fundamental scientific technology to the predicate devices with regards to stapling technologies.

All components of the Endo GIA™ Radial Reload with Tri-Staple™ Technology are identical 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 demonstrate that the subject device Endo GIA™ Radial 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 .
- Firina Force 0
- Retraction Force O
- Staple Formation 0
- In Vivo ●
- Free Bleed Evaluation o
- Air Leak Test O
- Burst Evaluation 0
- Tissue Grasping and Trauma 0

Biocompatibility .

The result of these tests demonstrates that the subject device Endo GIA™ Radial Reload with Tri-Staple Technology is substantially equivalent to the predicate device.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

July 1, 2013

Covidien % Ms. Katherine Robertson Senior Regulatory Affairs Specialist 60 Middletown Avenue North Haven, Connecticut 06473

Re: K131705

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: June 10, 2013 Received: June 11, 2013

Dear Ms. Robertson:

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

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Page 2 - Ms. Katherine Robertson

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 (2) 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 n ﺭﺑﻂ ﻳﻌﻮﺍ ﺑﺎﻟﻘﺎﺭ ﺍﻟﻤﻮﺿﻮﻉ ﺍﻟﻤﻌﺎﺭﻑ ﺍﻟﻤﺴﺎﻋﺔ ﺍﻟﻤﺴﺎﻋﺔ ﺍﻟﻤﺴﺎﻋﺔ ﺍﻟﻤﺴﺎﻋﺔ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺘ 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/defiault.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.

Sincerely yours,

FOR

Peter D. Rumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

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, 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.

Prescription Use X (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: K131705