ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER

K051002 · Ethicon Endo-Surgery, Inc. · GDW · May 17, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K051002
• Device Name: ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER
• Applicant: Ethicon Endo-Surgery, Inc.
• Product Code: GDW · General, Plastic Surgery
• Decision Date: May 17, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4750
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The ENDOPATH Endocutter 60 Endoscopic Linear Cutter is intended for transection, resection, 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.

Device Story

ENDOPATH Endocutter 60 is a sterile, single-patient-use mechanical surgical stapler; used in open or endoscopic procedures. Device delivers staples while simultaneously dividing tissue. Features include 60mm cartridge design, enhanced compression system, rigid anvil, E-beam, and wide jaw aperture for tissue manipulation. Available in three shaft lengths (standard, compact, long). Cartridges provided in four sizes (white, blue, gold, green) corresponding to tissue thickness. Operated manually by surgeon; one-handed design allows clamping, firing, and automatic knife return. Provides consistent staple line formation; facilitates tissue transection and anastomosis. Benefits include improved tissue positioning and ergonomic handling during surgery.

Clinical Evidence

Bench testing and preclinical laboratory evaluations were performed to demonstrate that the device will perform as intended. No clinical data provided.

Technological Characteristics

Mechanical surgical stapler; 60mm cartridge design; enhanced compression system; rigid anvil and E-beam; wide jaw aperture; ergonomic one-handed operation with automatic knife return. Available in three shaft lengths. Four cartridge sizes (white, blue, gold, green) for varying tissue thicknesses. Gold cartridge features longer staple leg length for thicker tissue. Sterile, single-patient-use.

Indications for Use

Indicated for transection, resection, and creation of anastomoses in general, gynecologic, thoracic, and pediatric surgical procedures; applicable for both open and minimally invasive surgery; compatible with staple line or tissue buttressing materials.

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

• ENDOPATH Linear Cutters and Staplers

Submission Summary (Full Text)

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Ethicon Endo-Surgery, Inc. 510(k) Premarket Notification ENDOPATH Endocutter 60 Endoscopic Linear Cutter

## 510(k) Summary

| Company | Ethicon Endo-Surgery, Inc. |
|----------------------|----------------------------|
| 4545 Creek Road | |
| Cincinnati, OH 45242 | |

Georgia C. Abernathy, MBA, RAC Contact Senior Regulatory Affairs Associate Telephone: [phone] [phone] Fax: --Email: [e-mail]

Date Prepared April 19, 2005

Trade Name: ENDOPATH® Endocutter 60 Endoscopic Linear Cutter Device Name Common or Usual Name: Linear Cutter Classification Name: Endoscope and Accessories and Implantable Staples [21 CFR 876.1500 (KOG) and 21 CFR 878.4750 (GDW)]

ENDOPATH® Linear Cutters and Staplers Predicate Device

These instruments are all mechanical surgical stapling devices. The Device Description ENDOPATH Endocutter 60 Endoscopic Linear Cutter models are sterile, single patient use instruments that deliver staples while simultaneously dividing tissue between rows. These instruments may be used in either open or endoscopic procedures. The devices will be available in three shaft lengths: standard, compact and long, and will be furnished without a cartridge. Cartridges for the Endocutter 60 devices will be available in sizes that correspond to the thickness of tissue that is to be transected or resected: white (vascular/thin), blue (standard), gold (thick, less dense) and green (thick).

Indications for Use The ENDOPATH Endocutter 60 Endoscopic Linear Cutter is intended for transection, resection, 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.

Technological Characteristics The device incorporates a new 60mm cartridge design; new enhanced compression system; rigid anvil and E-beam with robust, one-piece design; wide jaw aperture for easy tissue positioning and manipulating; and ergonomic features for onehanded use (ability to clamp, fire and release with automatic knife return). The ENDOPATH Endocutter 60 device will be available in three shaft lengths: standard, compact and long. Compatible cartridges come in four sizes to accommodate various tissue thicknesses. The gold cartridge is an additional size added to the product line. The gold cartridge staple wire diameter is identical to the existing blue cartridge staple wire diameter, with a longer staple leg length for thicker indicated tissue.

Performance Data Bench testing and preclinical laboratory evaluations were performed to demonstrate that the device will perform as intended.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 7 2005

Ms. Georgia C. Abernathy, MBA, RAC Senior Regulatory Affairs Associate Ethicon Endo-Surgery Incorporated 4545 Creek Road Cincinnati, Ohio 45242-2839

Re: K051002

Trade/Device Name: ENDOPATH® Endocutter60 Endoscopic Linear Cutter Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: April 19, 2005 Received: April 20, 2005

Dear Ms. Abernathy:

We have reviewed your Section 510(k) premarket notification of intent to market the device w t nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conniner of they 2011-12-11 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 I ou may, dierere, mains 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 it may or subject to back additions, Title 21, Parts 800 to 898. In addition, FDA can be found in ther announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r that FDA has made a determination that your device complies with other requirements of the Act that I DIT has made a and regulations administered by other Federal agencies. You must or any I ederal statutes and registents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI IT rat 0077, laooiing (21 CFR Part 820); and if applicable, the electronic forth in the qualis) 35001 provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2 - Ms. Georgia C. Abernathy, MBA, RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to oegin maneting your with a equivalence of your device to a legally prematics notification: "The PDF intentig stification 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 If you desire specific advice for your act [phone] . Also, please note the regulation entitled, Colliact the Office of Comphalled as (21 transmit (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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,

Signature

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Ethicon Endo-Surgery, Inc. Ethicon Endo-Surgery, The.
510(k) Premarket Notification ENDOPATH Endoeutter 60 Endoscopic Linear Cutter

## Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

ENDOPATH® Endocutter 60 Endoscopic Linear Cutter Device Name:

Indications for Use:

The ENDOPATH Endocutter 60 Endoscopic Linear Cutter is intended for transection, The END OF FITT Entron of anastomoses. The instrument has application in multiple open or minimally invasive general, gynecologic, thoracic, and pediatric open of millinary in were general with staple line or tissue buttressing materials.

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)

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(Posted November 13, 2003)

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