ECHELON 60 ENDOSCPIC LINEAR CUTTER RELOAD, WHITE

K121600 · Ethicon Endo-Surgery, LLC · GDW · Jul 16, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K121600
• Device Name: ECHELON 60 ENDOSCPIC LINEAR CUTTER RELOAD, WHITE
• Applicant: Ethicon Endo-Surgery, LLC
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Jul 16, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4750
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The ECHELON families of endoscopic linear cutters are intended for transection, resection, 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, White, is a 60mm thin-tissue staple reload for Echelon endoscopic linear cutter devices. It provides a 1.0 mm closed staple height for thin tissues like mesentery and pulmonary/renal vessels. Device features a pocket extension for improved performance, adapted from the Echelon Black reload. Used in OR settings by surgeons during open or minimally invasive procedures. Device functions as a mechanical implantable staple system; it does not involve electronic processing or software. Benefits include reliable tissue transection and resection in delicate anatomical structures.

Clinical Evidence

Bench and animal testing performed to demonstrate safety and effectiveness. No clinical data provided.

Technological Characteristics

60mm endoscopic linear cutter reload; 1.0 mm closed staple height; includes pocket extension feature. MR compatibility established via testing of larger-mass predicate (Echelon Black). Mechanical device; no energy source or software.

Indications for Use

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

• Echelon Endoscopic Linear Cutter Reload, White (K081146, K070887, K051002)
• Echelon Endoscopic Linear Cutter Reload, Black (K112056)

Submission Summary (Full Text)

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K121600

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# 510(k) Summary

JUL 16 2012

Ethicon Endo-Surgery, LLC Company 475 Calle C Guaynabo, PR 00969

Asifa Vonhof, RAC Contact Regulatory Affairs Associate II Ethicon Endo-Surgery, Inc. Telephone: [phone] Fax: [phone] Email: avonhof(@its.jnj.com

Date Prepared May 31, 2012

## Device Name

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

## Predicate Devices

Echelon Endoscopic Linear Cutter Reload. White (K081146, K070887, K051002) Echelon Endoscopic Linear Cutter Reload, Black (K112056)

### Device Description

The Echelon Endoscopic Linear Cutter Reload, White, is a thin 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 will provide a closed staple height of 1.0 mm for use in thin tissue such as mesentery and pulmonary and renal artery and vessels.

#### Indications for Use

The ECHELON families of endoscopic linear cutters are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, 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.

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K121600 page 2/2

### Technological Characteristics

The design and performance of the subject device is based on the currently marketed Echelon white reload. In addition a pocket extension feature has been added to the subject device. This feature was introduced in K112056 for the Echelon Black reload submission. MR compatibility data has been derived from the testing performed for the Echelon Black reload. The data for the Black reload represents the worst case scenario, due to its larger staple design and greater mass.

## Performance Data

Bench and Animal testing was performed to demonstrate that the device updates do not affect safety and effectiveness and that the device will perform as intended.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

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

Ethicon Endo-Surgery, LLC % Ethicon Endo-Surgery, Incorporated Ms. Asifa Vonhof, RAC Regulatory Affairs Associate II 4545 Creek Road Cincinnati. Ohio 45242

JUL 16 2012

Re: K121600

Trade/Device Name: Echelon Endoscopic Linear Cutter Reload, White Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW, GAG Dated: May 31, 2012 Received: June 01, 2012

Dear Ms. Vonhof:

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

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Page 2 - Ms. Asifa Vonhof, RAC

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 Of ice rated 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/ucm11.5809.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,

Eric D. Keith

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): _ K121600

Device Name: Echelon Endoscopic Linear Cutter Reload, White

Indications for Use:

The ECHELON families of endoscopic linear cutters are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical opon of millinary invaste goarith staple line or tissue buttressing materials. The proveduces. They our 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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Kane bu hum
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K121600

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