ASPIRATION/COAGULATION ELECTRODE ACE-311 & ACE-511

K955093 · Utah Medical Products, Inc. · HGI · Apr 29, 1996 · Obstetrics/Gynecology

Device Facts

• Record ID: K955093
• Device Name: ASPIRATION/COAGULATION ELECTRODE ACE-311 & ACE-511
• Applicant: Utah Medical Products, Inc.
• Product Code: HGI · Obstetrics/Gynecology
• Decision Date: Apr 29, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4120
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Aspiration/Coag Electrode is intended for use in electrosurgical procedures to provide an effective tool for allaying excessive bleeding by fulgurating and desiccating tissue damaged in electrosurgical procedures.

Device Story

Device consists of stainless steel spherical ball electrode with attached external PEBAX aspiration tube; connects to standard electrosurgical pen, electrosurgical generator, and vacuum suction system. Used by trained clinicians in clinical settings to manage bleeding during electrosurgical procedures. Device enables simultaneous or sequential tissue coagulation and fluid aspiration. Benefits include improved hemostasis and site visualization during surgery.

Clinical Evidence

Bench testing only; no clinical data provided. Biocompatibility and sterilization data maintained by manufacturer.

Technological Characteristics

Stainless steel spherical ball electrode; PEBAX aspiration tube; compatible with standard electrosurgical pens, generators, and vacuum systems. Gamma sterilization. Materials selected for biocompatibility and medical-grade standards.

Indications for Use

Indicated for use by trained clinicians during electrosurgical procedures to control bleeding via tissue fulguration and desiccation.

Regulatory Classification

Identification

A gynecologic electrocautery is a device designed to destroy tissue with high temperatures by tissue contact with an electrically heated probe. It is used to excise cervical lesions, perform biopsies, or treat chronic cervicitis under direct visual observation. This generic type of device may include the following accessories: an electrical generator, a probe, and electrical cables.

Predicate Devices

• Utah Medical Products, Inc. DBL-311 ball electrode
• Utah Medical Products, Inc. DBL-511 ball electrode
• Valleylab E2505-10FR disposable electrode

Submission Summary (Full Text)

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K955093
APR 29 1996

UTAH MEDICAL PRODUCTS INC.
U

Summary of Safety and Effectiveness

The Aspiration/Coag Electrode is substantially equivalent to Utah Medical Products, Inc.’s DBL-311 and DBL-511 ball electrodes used for coagulation, combined with aspiration of the Valleylab E2505-10FR disposable electrode. The device consists of a stainless steel spherical ball electrode and an attached external PEBAX® aspiration tube.

The posterior end of the device fits snugly into a standard electrosurgical pen which is connected to an FDA approved electrosurgical generator and standard vacuum suction system. When used according to the instructions for use, in the hands of a trained user, the device provides an effective tool for allaying excessive bleeding by fulgurating and desiccating tissue damaged in electrosurgical procedures.

Materials that comprise the Aspiration/Coag Electrode are essentially the same as those used in other similar devices, and were selected based on properties of biocompatibility, compatibility with gamma sterilization, conformance with commonly used medical grade plastics and other materials, ease of processing and low cost.

Biocompatibility and sterilization information is available from Utah Medical Products, Inc. upon request.

Kevin L. Cornwell
President & CEO