VALLEYLAB COATED ELECTRODES

K962044 · Valleylab, Inc. · GEI · Aug 30, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K962044
• Device Name: VALLEYLAB COATED ELECTRODES
• Applicant: Valleylab, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Aug 30, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Valleylab Coated Electrodes are intended as an alternative to uncoated stainless steel electrodes or “non-stick” coated electrodes for use in conventional monopolar electrosurgical accessories. The Coated Electrodes are intended for use in situations where monopolar electrosurgical cutting and coagulation are normally used.

Device Story

Single-use electrosurgical electrodes with non-stick coating; intended for monopolar electrosurgical cutting and coagulation. Used in surgical settings by physicians. Coating facilitates easier cleaning of eschar during surgery. Compatible with Valleylab and third-party electrosurgical pencils. Benefits include improved cleanability, durability, and consistent cutting performance compared to standard stainless steel or existing non-stick electrodes.

Clinical Evidence

Pre-clinical performance trials in swine across various surgical procedures; surgeons rated performance equal or superior to other coated blades. Bench testing confirmed cleanability, durability (90-degree bend test), and cutting consistency at various power settings.

Technological Characteristics

Stainless steel electrode base with non-stick coating; various tip configurations; single-use; compatible with standard monopolar electrosurgical pencils.

Indications for Use

Indicated for patients requiring monopolar electrosurgical cutting and coagulation during surgical procedures.

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.

Submission Summary (Full Text)

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AUG 30 1996 K962044

# SUMMARY OF SAFETY AND EFFECTIVENESS
## VALLEYLAB COATED ELECTRODES

### Intended Use

Valleylab Coated Electrodes are intended as an alternative to uncoated stainless steel electrodes or “non-stick” coated electrodes for use in conventional monopolar electrosurgical accessories. The Coated Electrodes are intended for use in situations where monopolar electrosurgical cutting and coagulation are normally used.

### Product Description

The Valleylab Coated Electrodes are modifications of Valleylab’s line of single-use electrodes that includes various tip configurations. The coating provides a non-stick surface for easier cleaning of eschar during electrosurgery.

The electrodes are intended for use with monopolar electrosurgical accessories, and will be packaged separately as well as in combination with Valleylab electrosurgical pencils. The Coated Electrodes will also fit in currently marketed electrosurgical pencils offered by other manufacturers.

### Safety and Performance

1. **Biocompatibility Testing**

The biological safety of the Valleylab Coated Electrodes has been assured through the selection of materials which demonstrate appropriate levels of biocompatibility. The components of the Coated Electrodes have incidental short term contact with patient tissues at the surgical site.

2. **Performance Testing**

Performance testing was performed on prototype Valleylab Coated Electrodes (blade configuration). This configuration is representative of the range of electrodes which will be available in a coated form.

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## Electrode Cleanability and Durability

The Valleylab Coated Blade Electrode retained its easy to clean properties for a longer period of use than other coated electrodes or standard uncoated stainless steel electrodes tested.

## Electrode Cut Performance

The Valleylab Coated Blade Electrode initiates cutting immediately and continues to cut more readily and consistently than “non-stick” coated blades at both lower and higher power settings.

## Electrode Bendability Test

The Valleylab Coated Blade Electrode was bent to a maximum of 90 degrees ten times or until failure of the steel blade, without visible cracking of the coating.

## Pre-Clinical Performance

In pre-clinical trials involving a variety of surgical procedures in swine, surgeons rated the performance of the Valleylab Coated Blade equal or superior to other coated blades tested.