ECHELON FLEX 45 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER; ECHELON FLEX 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CU

K130653 · Ethicon Endo-Surgery, LLC · GDW · Mar 29, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K130653
• Device Name: ECHELON FLEX 45 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER; ECHELON FLEX 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CU
• Applicant: Ethicon Endo-Surgery, LLC
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Mar 29, 2013
• Decision: SESE
• Submission Type: Special
• 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, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials. The instruments may also be used for transection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.

Device Story

Sterile, single-patient-use endoscopic linear cutter/stapler; battery-powered firing system. Input: manual operation by surgeon in OR. Mechanism: integrated motor drives simultaneous tissue transection and stapling; delivers six staggered staple rows. Features: articulating shaft (up to 45° in 15° increments) for lateral access; safety lock-out prevents firing without cartridge or with used cartridge. Output: stapled and transected tissue. Benefit: facilitates minimally invasive surgical access and tissue management. Surgeon controls device; battery pack installed prior to use; staple cartridge loaded by user.

Clinical Evidence

Bench testing only. Ex-vivo tests performed to ensure device performance against design requirements, including process verification, design verification, and design validation. Biocompatibility testing conducted in accordance with AAMI/ANSI/ISO 10993-1:2009 and FDA G95-1.

Technological Characteristics

Insulated tubular shaft; ergonomic handle with integrated motor; battery-powered firing system. Articulation system adjusts end effector in 15° increments up to 45°. Materials tested per AAMI/ANSI/ISO 10993-1:2009. Sterile, single-patient-use. Mechanical safety lock-out feature.

Indications for Use

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

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 Flex Powered Articulating Endoscopic Linear Cutters (K110385)

Submission Summary (Full Text)

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Ethicon Endo-Surgery, LLC

510(k) Premarket Notification (Special) for Echelon Flex Powered Articulating Endoscopic Linear Cutters

#### 510(k) Summary

K130653

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

Carol Hubbard Contact Regulatory Affairs Associate Ethicon Endo-Surgery, Inc. [phone] Telephone: [phone] Fax: Email: [e-mail]

Date Prepared March 8, 2013

Trade Name: Echelon Flex Powered Articulating Endoscopic Linear Cutters Device Name Common or Usual Name: Cutter/Stapler Classification Name: Staple, Implantable; Stapler, Surgical

Predicate Device Echelon Flex Powered Articulating Endoscopic Linear Cutters (cleared under K110385)

Device Description The Echelon Flex Powered Articulating Endoscopic Linear Cutters are sterile, single patient use instruments that simultaneously cut and staple tissue through a battery powered firing system. The instruments deliver six staggered rows of staples, three on either side of the cut line. The instruments are available in three shaft lengths: compact, regular and long. The shaft can rotate freely in both directions and incorporates an articulation mechanism, which enables the distal portion of the shaft to pivot to facilitate lateral access to the operative site.

The instruments are packaged with a battery pack that must be installed prior to use.

The instruments are shipped without a staple cartridge and must be loaded prior to use. The instrument has a safety lock-out feature that is designed to prevent an instrument without a cartridge or a used cartridge from being fired.

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 of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.

Technological Characteristics The instrument utilizes an insulated tubular shaft, an ergonomic handle with an integrated motor, and battery power to simultaneously transect (cut) and staple tissue. The instrument also features an articulation system that can adjust the end effector in increments of 15° to a maximum of 45°.

The modification described in this submission does not affect the intended use of the device or alter the fundamental scientific technology of the device, and 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.

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Performance Data Ex-vivo tests (bench) were 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, design verification and design validation.

Testing for all materials is in accordance with the standards AAMI/ANSI/ISO 10993-1:2009 and on FDA General Program Memorandum #G95-1 : Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing."

The Ethicon Endo-Surgery Echelon Flex Powered Articulating Endoscopic Linear Conclusion Cutters are substantially equivalent to the legally marketed Predicate device based upon intended use, technological characteristics, and performance testing.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Letter dated: March 29, 2013

Ethicon Endo-Surgery, LLC % Ethicon End-Surgery, Incorporated Ms. Carol Hubbard Regulatory Affairs Associate 4545 Creek Road Cincinnati, Ohio 45242

Re: K130653

Trade/Device Name: Echelon Flex™ Powered Articulating Endoscopic Linear Cutters Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: March 08, 2013 Received: March 12, 2013

Dear Ms. Hubbard:

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.

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 - Ms. Carol Hubbard

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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

# Mark N. Melkerson -S

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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Ethicon Endo-Surgery, LLC 510(k) Premarket Notification (Special) for Echelon Flex Powered Articulating Endoscopic Linear Cutters

#### Indications for Use Form

### Indications for Use

510(k) Number (if known): K130653

Device Name: Echelon Flex™ Powered Articulating Endoscopic Linear Cutters

#### INDICATION 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. .

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

# David Kraūše

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K130653