ENDOPATH LINEAR CUTTERS AND STAPLERS AND ECHELON60 ENDOSCOPIC LINEAR CUTTERS AND STAPLERS (AND RELOADS)

K070887 · Ethicon Endo-Surgery, LLC · GDW · May 25, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K070887
• Device Name: ENDOPATH LINEAR CUTTERS AND STAPLERS AND ECHELON60 ENDOSCOPIC LINEAR CUTTERS AND STAPLERS (AND RELOADS)
• Applicant: Ethicon Endo-Surgery, LLC
• Product Code: GDW · General, Plastic Surgery
• Decision Date: May 25, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4750
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The ENDOPATH ETS Endoscopic Linear Cutter and ETS-Flex Endoscopic Articulating Linear Cutter has application in general, gynecologic, and thoracic surgery for transcction, resection, and/or creation of anastomoses. The instruments may also be used for transcotion and resection of liver parcnchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen. The ENDOPATH ETS45 Endoscopic Linear Cutters, the ETS-Flex45 Endoscopic Articulating Linear Cutters, and the ETS Compact-Flex45 Articulating 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 transcetion and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen. The ENDOPATII ETS-Flex45 No-Knife Endoscopic Articulating Linear Staplers and the ETS Compact-Flex45 No-Knife Articulating Linear Staplers 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 parcnchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen. The ENDOPATH ETS Flex60 Endoscopic Articulating Long Lincar Cutter is intended for transection, rescction, and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general, gynecologic, thoracic, and pediatric surgical procedures. It can be used with staple line or tissue buttressing materials. The instrument may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and splecn. The ENDOPATH E745 Endoscopic Linear Cutter has application in multiple open and other minimally invasive surgical procedures for transection, and/or creation of anastomoses. 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. The ENDOPATH EZ45 No-Knife Endoscopic Linear Stapler has application in multiple open or other minimally invasive surgical procedures for transection. They can be used with staple line or tissue buttressing matcrials. The instruments may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen. The ENDOPATH EZ45 Thoracic Endoscopic Linear Cutter has application in thoracic surgery or other minimally invasive surgical procedures for transection, and/or creation of anastomoses. They can be used with staple line buttressing matcrials. The instruments may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen. The Echelon60 Endoscopic Linear Cutter is intended for transection, and/or creation, 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 instrument may also be used for transection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.

Device Story

ENDOPATH and Echelon Linear Cutters/Staplers are manual surgical instruments used for tissue transection, resection, and anastomosis creation. Operated by surgeons in OR settings during open or minimally invasive procedures. Devices utilize mechanical stapling mechanisms to deploy staples into tissue; some models include integrated cutting blades; others are 'No-Knife' variants for stapling only. Compatible with staple line or tissue buttressing materials. Provides mechanical tissue approximation and ligation; assists in managing hepatic, biliary, pancreatic, renal, and splenic structures. No electronic, software, or algorithmic components involved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual mechanical surgical staplers and cutters. Materials include medical-grade plastics and metals typical for surgical instrumentation. Energy source is manual (hand-operated). No software, electronics, or connectivity features.

Indications for Use

Indicated for patients undergoing open or minimally invasive general, gynecologic, urologic, thoracic, or pediatric surgical procedures requiring transection, resection, or creation of anastomoses, including 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.

Submission Summary (Full Text)

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAY 2 5 2007

Ethicon Endo-Surgery, LLC % Ethicon Endo-Surgery, Inc. Mr. Dennis Hahn Director, Regulatory Affairs 4545 Creek Road Cincinnati, Ohio 45242

Re: K070887

Trade/Device Name: ENDOPATH and Echelon Linear Cutter and Staplers Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: March 29, 2007 Received: March 30, 2007

Dear Mr. Hahn:

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 such 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); good manufacturing practice requirements as set

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Page 2 - Mr. Dennis Hahn

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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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. Milliken

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# 510(k) Number (if known): Ko70887

# Device Name: ENDOPATII and Echelon Linear Cutters and Staplers

# ENDOPATH® ETS Endoscopic Linear Cutter, ETS-Flex Endoscopic Articulating Linear Cutter (and Reloads):

The ENDOPATH ETS Endoscopic Linear Cutter and ETS-Flex Endoscopic Articulating Lincar Cutter has application in general, gynecologic, and thoracic surgery for transcction, resection, and/or creation of anastomoses. The instruments may also be used for transcotion and resection of liver parcnchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.

# ENDOPATH® ETS45 Endoscopic Linear Cutter, ETS-Flex45 Endoscopic Articulating Linear Cutter, ETS Compact Flex45 Articulating Linear Cutters (and Reloads):

The ENDOPATH ETS45 Endoscopic Linear Cutters, the ETS-Flex45 Endoscopic Articulating Linear Cutters, and the ETS Compact-Flex45 Articulating 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 transcetion and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.

## ENDOPATH® ETS-Flex45 No-Knife Endoscopic Articulating Linear Stapler, ETS Compact-Flex45 No-Knife Articulating Linear Stapler (and Reloads):

The ENDOPATII ETS-Flex45 No-Knife Articulating Linear Staplers and the ETS Compact-Flex45 No-Knife Articulating Linear Staplers 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 linc or tissue buttressing materials. The instruments may also be used for transection and resection of liver parcnchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.

#### ENDOPATH® ETS-Flex60 Endoscopic Articulating Long Linear Cutter and Reloads:

The ENDOPATH ETS Flex60 Endoscopic Articulating Long Lincar Cutter is intended for transection, rescction, and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general, gynecologic, thoracic, and pediatric surgical procedures. It can be used with staple line or tissue buttressing materials. The instrument may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and splecn.

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# Indications for Use

510(k) Number (if known): K070867

# Device Name: ENDOPATH and Echelon Linear Cutters and Staplers

#### ENDOPATH® EZ45 Endoscopic Linear Cutter (and Reloads):

The ENDOPATH E745 Endoscopic Linear Cutter has application in multiple open and other minimally invasive surgical procedures for transection, and/or creation of anastomoses. 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.

#### ENDOPATH® EZ45 No-Knife Endoscopic Linear Stapler (and Reloads):

The ENDOPATH EZ45 No-Knife Endoscopic Linear Stapler has application in multiple open or other minimally invasive surgical procedures for transection. They can be used with staple line or tissue buttressing matcrials. The instruments may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.

#### ENDOPATH® Thoracic Endoscopic Linear Cutter (and Reloads):

The ENDOPATH EZ45 Thoracic Endoscopic Linear Cutter has application in thoracic surgery or other minimally invasive surgical procedures for transection, and/or creation of anastomoses. They can be used with staple line buttressing matcrials. The instruments may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.

#### Echelon60 Endoscopic Linear Cutters and Reloads:

The Echelon60 Endoscopic Linear Cutter is intended for transection, and/or creation, 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 instrument may also be used for transection 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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluat

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ffice of Device Evaluation (ODE)
Mark A. Milliron

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

**510(k) Number** KO 70