E2590 - B, ARGON ACCESSORY WITH BLADE ELECTRODE AND E2590 - N, ARGON ACCESSORY WITH NEEDLE ELECTRODE

K962690 · Valleylab, Inc. · GEI · Nov 4, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K962690
• Device Name: E2590 - B, ARGON ACCESSORY WITH BLADE ELECTRODE AND E2590 - N, ARGON ACCESSORY WITH NEEDLE ELECTRODE
• Applicant: Valleylab, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Nov 4, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The E2590-B & E2590-N Argon Accessories are intended for use in open surgical procedures where argon-enhanced monopolar electrosurgery is desired.

Device Story

Argon accessories; sterile, single-use, fixed electrode devices. Function: introduce argon gas around electrosurgical pencil electrode to facilitate argon-enhanced monopolar electrosurgery. Used in open surgical procedures; operated by surgeons. Output: argon-enhanced electrosurgical current for tissue coagulation/cutting. Benefit: improved surgical precision and hemostasis via argon gas delivery.

Clinical Evidence

Bench testing only; biocompatibility testing performed; compliance with IEC 601-1, IEC 601-2-2, and ANSI/AAMI HF18 standards.

Technological Characteristics

Fixed electrode design; argon gas delivery system; compatible with Valleylab handswitching pencils. Materials selected for biocompatibility. Standards: IEC 601-1 (1988), IEC 601-2-2 (1991), ANSI/AAMI HF18 (1993). Sterilization: sterile, single-use.

Indications for Use

Indicated for use in open surgical procedures requiring argon-enhanced monopolar electrosurgery. Compatible with Valleylab Handswitching Pencils (E2515, E2516, E2525, E2550, E2555).

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)

{0}

K962690
NOV - 4 1996

# SUMMARY OF SAFETY AND EFFECTIVENESS FOR THE E2590-B & E2590-N ARGON ACCESSORIES

The E2590-B & E2590-N Argon Accessories are intended for use in open surgical procedures where argon-enhanced monopolar electrosurgery is desired.

The E2590-B & E2590-N Argon Accessories are sterile, single use, fixed electrode devices which allow for the introduction of argon gas around the electrosurgical electrode of an electrosurgical pencil. The Argon Accessories are designed for use with the following Valleylab Handswitching Pencils: E2515 & E2516, E2525, E2550 & E2555.

The biological safety of the E2590-B & E2590-N Argon Accessories has been assured through the selection of materials which demonstrate appropriate levels of biocompatibility.

The E2590-B & E2590-N Argon Accessories have been designed to conform with the applicable sections of, IEC 601-1 (1988), Medical Electrical Equipment Part 1: General Requirements for Safety, IEC 601-2-2 (1991), Medical Electrical Equipment Part 2: Particular Requirements for the Safety of High Frequency Surgical Equipment, and ANSI/AAMI HF18 (1993), Electrosurgical Devices.

9