ECHELON ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK

K131663 · Ethicon Endo-Surgery, LLC · GDW · Oct 18, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K131663
• Device Name: ECHELON ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK
• Applicant: Ethicon Endo-Surgery, LLC
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Oct 18, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4750
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The ECHELON and ECHELON FLEX families of Endoscopic Linear Cutters (articulating and straight) are intended for transection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials. The instruments may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.

Device Story

Echelon Endoscopic Linear Cutter Reload, Black is a 60mm thick-tissue reload for Echelon Endoscopic Linear Cutter devices; provides 2.3 mm closed staple height. Used in open or minimally invasive surgery; operated by surgeons. Device delivers staples into tissue during firing to facilitate transection and anastomosis. Benefits include effective tissue management in thick tissue applications like gastric, lung, and solid organs. No electronic or software components; purely mechanical surgical accessory.

Clinical Evidence

Bench testing only. Ex-vivo performance assessment conducted to verify design requirements and process verification.

Technological Characteristics

Mechanical surgical staple reload; 60mm configuration; 2.3 mm closed staple height. Designed for use with Echelon, Echelon Flex, and Echelon Powered Flex endoscopic linear cutters. No software or electronic components.

Indications for Use

Indicated for patients undergoing open or minimally invasive general, gynecologic, urologic, thoracic, or pediatric surgical procedures requiring tissue transection or anastomosis, including resection of liver parenchyma, pancreas, kidney, and spleen.

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

• Echelon Endoscopic Linear Cutter Reload, Black (K112056)

Submission Summary (Full Text)

{0}------------------------------------------------

| Company | Ethicon Endo-Surgery, LLC<br>475 Calle C<br>Guaynabo, PR 00969 |
|---------|----------------------------------------------------------------|
|---------|----------------------------------------------------------------|

Contact Christina Canter, RAC Senior Associate, Regulatory Affairs Ethicon Endo-Surgery. Inc. Telephone: [phone] Fax: [phone] Email: [e-mail]

OCT 1 8 2013

Date Prepared June 6, 2013

## Device Name

| Trade Name: | Echelon Endoscopic Linear Cutter Reload, Black |
|-----------------------|------------------------------------------------|
| Common or Usual Name: | Endoscopic and Accessory |
| Classification Name: | Staple, Implantable |

## Predicate Devices

Echelon Endoscopic Linear Cutter Reload, Black (cleared under K112056)

## Device Description

The Echelon Endoscopic Linear Cutter Reload, Black, is a thick tissue reload for use with the Echelon Endoscopic Linear Cutter devices (Echelon, Echelon Flex, Echelon Powered Flex) in a 60mm configuration. It is part of the current Echelon reload family and provides a closed staple height of 2.3 mm for use in thick tissue such as gastric, lung, and solid organ.

The Echelon Endoscopic Linear Cutter Reload, Black is loaded into an Echelon Endoscopic Linear Cutter and delivers staples into the tissue when the instrument is fired.

#### Indications for Use

The ECHELON and ECHELON FLEX families of Endoscopic Linear Cutters (articulating and straight) are intended for transection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials. The instruments may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.

#### Technological Characteristics

The design and performance of the Subject device is based on the currently marketed Echelon, Black reload. The modifications described in this submission do not affect the

{1}------------------------------------------------

intended use of the device or alter the fundamental scientific technology of the device. The summary information that results from the design control process serve as the basis for this submission along with the required elements of a 510(k) found in 21 CFR 807.87.

## Performance Data

Ex-vivo (bench) testing was performed to ensure that the devices perform as intended and meet design specifications. Device performance was assessed against the design requirements and included process verification and design verification.

## Conclusion

The Subject device, Echelon Endoscopic Linear Cutter Reload, Black, is substantially equivalent to the legally marketed Predicate device based on intended use, technological characteristics, and performance testing.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is composed of three stylized, curved lines that resemble a person embracing another person.

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

Ethicon Endo-Surgery, LLC Ethicon Endo-Surgery, Inc. Christina Canter 4545 Creek Road Cincinnati, Ohio 45242

October 18, 2013

Re: K131663

Trade/Device Name: Echelon Endoscopic Linear Cutter Reload, Black Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: September 13, 2013 Received: September 16, 2013

Dear Ms. Canter:

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

{3}------------------------------------------------

Page 2 - Christina Canter

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

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

fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm

Sincerely yours.

## Mark Nielkerson -S

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

Enclosure

{4}------------------------------------------------

## Indications for Use Form

## Indications for Use

510(k) Number (if known): K131663

Device Name: Echelon Endoscopic Linear Cutter Reload, Black

## INDICATION FOR USE

The ECHELON and ECHELON FLEX families of Endoscopic Linear Cutters (articulating and straight) are intended for transection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials. The instruments may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

# David Krause -S

Page 1 of 1

.

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K131663