CTS MIDCAB/SVH BIPOLAR SCISSORS

K963930 · Cardiothoracic Systems, Inc. · GEI · Jan 16, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K963930
• Device Name: CTS MIDCAB/SVH BIPOLAR SCISSORS
• Applicant: Cardiothoracic Systems, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jan 16, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CTS MIDCAB/SVH Bipolar Scissors is intended to cut tissue and control bleeding through coagulation, in general and cardiothoracic surgery, including minimally invasive direct coronary artery bypass (“MIDCAB”) and saphenous vein harvesting procedures.

Device Story

Electrosurgical instrument for cutting and coagulation; consists of scissor blades, handle, and power cord. Input: electrical current from electrosurgical generator. Operation: surgeon places blades across tissue, depresses actuation lever or uses foot pedal to energize blades; current flows between stainless steel blades to cut and coagulate tissue simultaneously. Used in OR by surgeons during cardiothoracic procedures. Output: mechanical cutting and thermal coagulation of tissue. Benefits: simultaneous hemostasis and tissue division, reducing bleeding during surgery.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Bipolar electrosurgical instrument; stainless steel blades; 13-inch total length; 0.5-inch blade length; 120-inch power cord. Operates at 20-30 watts via external electrosurgical generator. Sterile, nonpyrogenic, single-use.

Indications for Use

Indicated for patients undergoing general or cardiothoracic surgery, including minimally invasive direct coronary artery bypass (MIDCAB) and saphenous vein harvesting, requiring tissue cutting and coagulation.

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

• Symbiosis Bipolar Scissors
• Everest Medical Bipolar Scissors
• Valley Forge Bi-Tech Bipolar Coagulator/Cutting System
• Valleylab Force 2 and Force 4 Electrosurgical Generators

Submission Summary (Full Text)

{0}

510(k) Premarket Notification
CTS MIDCAB/SVH Bipolar Scissors
K963930
JAN 16 1997

# 510(k) Summary

CardioThoracic Systems, Inc.
CTS MIDCAB™ /SVH™ Bipolar Scissors
510(k) Notification K 963930

## GENERAL INFORMATION

**Manufacturer:**
CardioThoracic Systems, Inc.
10600 N. Tantau Avenue
Cupertino, California
[phone]
[phone] FAX
Est. Reg. No. (awaiting issuance)

**Contact Person:**
Michael J. Billig
Vice President, Regulatory, Quality, and Clinical Research

**Date Prepared:**
September 26, 1996

## DEVICE DESCRIPTION

**Classification:**
Class II

**Trade Name:**
CTS MIDCAB™/SVH™ Bipolar Scissors

**Generic/Common Name:**
Electrosurgical cutting and coagulation device and accessories
21CFR878.4400

## PREDICATE DEVICES

1. Symbiosis Bipolar Scissors
2. Everest Medical Bipolar Scissors
3. Valley Forge Bi-Tech Bipolar Coagulator/Cutting System
4. Valleylab Force 2 and Force 4 Electrosurgical Generators

## INTENDED USE

The CTS MIDCAB/SVH Bipolar Scissors is intended to cut tissue and control bleeding through coagulation, in general and cardiothoracic surgery, including minimally invasive direct coronary artery bypass (“MIDCAB”) and saphenous vein harvesting procedures.

{1}

510(k) Premarket Notification
CTS MIDCAB/SVH Bipolar Scissors

## PRODUCT DESCRIPTION

The CTS MIDCAB/SVH Bipolar Scissors is an electrosurgical instrument which consists of a pair of scissor blades which are connected to a handle instrument and an electrosurgical generator. Electric current flows from the electrode to the stainless steel cutting surface of the blades and from the stainless steel cutting surface of one blade to the stainless steel cutting surface of the other blade. The flow of the electric current down the electrode is controlled by the power generator. The overall length of the device, which consists of the handle, tube and blades, is approximately 13 inches. The power cord connecting the handle to the power control unit is approximately 120 inches. The blades are approximately 0.5 inches in length.

The surgeon places the opened scissors across the tissue to be cut and depresses the actuation lever while moving the scissors forward against the tissue. By energizing the power control unit on the actuation lever, the surgeon can simultaneously cut and coagulate the target tissue. Alternately, the power control unit may be controlled via a foot pedal. The surgeon can vary the current flow rate according to the tissue and the amount of bleeding encountered. The power setting used for the CTS Bipolar Scissors is 20-30 watts.

The CTS Bipolar Scissors is provided sterile, nonpyrogenic and for single use.

## SUBSTANTIAL EQUIVALENCE

The CTS MIDCAB/SVH Bipolar Scissors is substantially equivalent to the above identified predicate devices. The CTS Bipolar Scissors is substantially equivalent to the predicate devices with regard to intended use, function, physical characteristics, materials and sterilization method. The CTS, Symbiosis and Everest devices are all bipolar scissors which cut tissue and coagulate soft tissue through the use of bipolar technology. All three devices are connected to the same or similar electrosurgical generators and use similar power ranges for operation.

## SUMMARY

As contained in this 510(k) summary, the CTS MIDCAB/SVH is substantially equivalent to the predicate devices identified.

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