ENDOPATH EZ-RF LINEAR CUTTER AND COAGULATION

K961264 · Ethicon Endo-Surgery, Inc. · GEI · Jul 19, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K961264
• Device Name: ENDOPATH EZ-RF LINEAR CUTTER AND COAGULATION
• Applicant: Ethicon Endo-Surgery, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jul 19, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ENDOPATH® EZ-RF Linear Cutter and Coagulation device has applications in open and minimally invasive surgical procedures for coagulation, transection, and resection of tissue. The bipolar feature is to be used only with the ERBE ERBOTOM ICC 350 or the Valleylab Force 2 electrosurgical generators.

Device Story

ENDOPATH® EZ-RF Linear Cutter and Coagulation device; surgical instrument for tissue coagulation, transection, and resection. Inputs: tissue compressed to ≤2.0mm. Operation: delivers bipolar coagulation followed by two double-staggered rows of staples while simultaneously dividing tissue. Features: safety lockout in cartridge; staple retaining cap; reloadable (max 8 firings). Connectivity: connects to RF electrosurgical generator (ERBE ERBOTOM ICC 350 or Valleylab Force 2) via integrated cord. Output: visual indicator light illuminates when current exceeds reference threshold. Used in open/minimally invasive surgery by surgeons. Benefits: simultaneous hemostasis and tissue division.

Clinical Evidence

Bench testing only. Pre-clinical laboratory evaluations performed to verify design functionality; demonstrated acceptable performance in coagulation, transection, and resection of tissue.

Technological Characteristics

Bipolar electrosurgical coagulation and mechanical stapling. Reloadable instrument; 37mm coagulation/staple line; 35mm cut length. Integrated cord for RF generator connection. Indicator light for current flow monitoring. Compatible with ERBE ERBOTOM ICC 350 and Valleylab Force 2 generators.

Indications for Use

Indicated for coagulation, transection, and resection of tissue in open and minimally invasive surgical procedures. Bipolar feature restricted to use with ERBE ERBOTOM ICC 350 or Valleylab Force 2 electrosurgical generators.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

• ELC (Endoscopic Linear Cutter)
• Forceps Predicate Device

Submission Summary (Full Text)

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K 961264
JUL 19 1996
Appendices

# 510(k) Summary of Safety and Effectiveness (App. A)

## Statement

Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency’s final rule “...510(k) Summaries and 510(k) Statements...” (21 CFR §807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency.

## Device description

The ENDOPATH® EZ-RF Linear Cutter and Coagulation device:

- delivers a line of bipolar coagulation
- followed by two double-staggered rows of staples
- while simultaneously dividing the tissue.

A safety lockout feature is incorporated into the cartridge. The line of bipolar coagulation delivered is approximately 37mm long with a 37mm staple line length, and a cut length of 35mm. A staple retaining cap on the cartridge protects the staples during shipping and transportation. The instrument is reloadable with a universal cartridge and is acceptable for use on tissue which can be compressed to a thickness of 2.0mm or less. The instrument is designed to be reloaded seven times for a maximum of eight firings per instrument.

The ENDOPATH® EZ-RF Linear Cutter and Coagulation device is designed to have an integral Indicator Light on the Linear Cutter or an external Indicator Light device. The Linear Cutter connects to an RF electrosurgical generator with an integrated cord from the Linear Cutter to the generator or the external Indicator Light device. The Indicator Light device illuminates when current is flowing above a reference current threshold.

Specific generators for use with this instrument include the ERBE ERBOTOM ICC 350 and Valleylab Force 2 electrosurgical generators (see Appendix G). New generators will be added to the labeling as they pass the appropriate qualifications. Any specific instructions/details for use with additional ESG’s will also be added to the labeling.

Continued on next page

ETHICON ENDO-SURGERY, INC.
ENDOPATH® EZ-RF Linear Cutter and Coagulation device

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# 510(k) Summary of Safety and Effectiveness, Continued

| Intended use | For coagulation, transection, and resection of tissue. |
| --- | --- |
| Indications statement | The ENDOPATH® EZ-RF Linear Cutter and Coagulation device has applications in open and minimally invasive surgical procedures for coagulation, transection, and resection of tissue. The bipolar feature is to be used only with the ERBE ERBOTOM ICC 350 or the Valleylab Force 2 electrosurgical generators. |
| Technological characteristics | The technological characteristics of the New Device are the same as the ELC and Forceps Predicate Device. |
| Performance data | Pre-clinical laboratory evaluations were performed to ensure that the device can be used as designed. The studies demonstrated acceptable performance in coagulation, transection, and resection of tissue. |
| Conclusion | Based on the 510(k) summaries and 510(k) statements (21 CFR §807) and the information provided herein, we conclude that the New Device is substantially equivalent to the ELC and Forceps Predicate Devices under the Federal Food, Drug and Cosmetic Act. |
| Contact | Lorri (Jones) Chavez
Ethicon Endo-Surgery, Inc.
4545 Creek Road
Cincinnati, Ohio 45242 |
| Date | April 1, 1996 |

ETHICON ENDO-SURGERY, INC.
ENDOPATH® EZ-RF Linear Cutter and Coagulation device