EVAP-ELECTRODES TYPES 8423, 8427, 8410 & 8413 ELECTROSURGICAL VAPORIZATION OF SOFT TISSUE

K953983 · Richard Wolf Medical Instruments Corp. · FAS · Oct 2, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K953983
• Device Name: EVAP-ELECTRODES TYPES 8423, 8427, 8410 & 8413 ELECTROSURGICAL VAPORIZATION OF SOFT TISSUE
• Applicant: Richard Wolf Medical Instruments Corp.
• Product Code: FAS · Gastroenterology, Urology
• Decision Date: Oct 2, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EVAP roller electrodes can be used for removing/vaporization/ablation of soft tissue. For example; on the prostate or on myomas. The electrodes may also be used for coagulation.

Device Story

Electrosurgical device for soft tissue vaporization/ablation and coagulation; used in surgical procedures (e.g., prostate, myomas). Device consists of stainless steel, teflon, new silver, and Hytrel tubing; some versions feature gold-plated rollers. Operated by surgeons in clinical/OR settings. Device delivers high-frequency electrical energy to tissue; irrigation used to manage heat. Output is tissue effect (vaporization/coagulation). Benefits include efficient tissue removal and hemostasis.

Clinical Evidence

Canine model study performed. Coagulation depth correlated with wattage, remaining within 2-3mm range. Irrigation confirmed to reduce heat damage risk. Long-term morbidity and healing data not provided.

Technological Characteristics

Materials: medical grade stainless steel, teflon, new silver, Hytrel 8236 thermoplastic polyester elastomer. Features: grooved and gold-plated rollers. Energy: high-frequency electrosurgical. Compliance: ANSI/AAMI standard for High Frequency Devices.

Indications for Use

Indicated for soft tissue removal, vaporization, or ablation, including prostate or myoma tissue, and for coagulation.

Regulatory Classification

Identification

An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.

Predicate Devices

• ProSurg (K946377)
• ACMI/Circon (no 510(k) available)

Submission Summary (Full Text)

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Richard Wolf Medical Instruments Corporation
353 Corporate Woods Parkway
Vernon Hills, Illinois 60061
Telephone: [phone]
Fax: [phone]
OCT - 2 1996

510(k) Summary of Safety and Effectiveness

K953983

1.0 Classification Name:
Electrode, Electrosurgical

2.0 Common Name:
Roller electrode, Coagulation electrode, Electrosurgical Electrode

3.0 Trade Name:
Electrosurgical Vaporization (EVAP) electrode

4.0 Equivalence:
The EVAP electrodes are substantially equivalent to electrodes currently sold by Richard Wolf, as well as electrodes sold by ProSurg (k946377) and ACMI/Circon (no 510(k) available).

5.0 Description:
The EVAP electrode is an electrosurgical device made of medical grade stainless steel, teflon, new silver and Hytrel tubing. Some EVAP versions have gold plated rollers.

6.0 Intended Use:
The EVAP roller electrodes can be used for removing/vaporization/ablation of soft tissue. For example; on the prostate or on myomas. The electrodes may also be used for coagulation.

7.0 Technological Characteristics:
The only variation from the existing electrodes is the addition of grooves and gold plating on various versions of the roller. The insulating material has been changed to Hytrel 8236 thermoplastic polyester elastomer.

8.0 Performance Data:
Devices were tested to meet the appropriate sections of the ANSI/AAMI standard on High Frequency Devices.

RICHARD WOLF

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K95-3983 p292

# Richard Wolf Medical Instruments Corporation

## 9.0 Clinical Tests:

Using Canine Models, it has been shown that coagulation depth increases with higher wattage but does not exceed 2-3mm. Irrigation reduces the risk of heat damage. Long term morbidity and healing were not known.

## 10.0 Data Conclusion:

The Richard Wolf EVAP Electrode is equivalent to existing electrodes particularly those sold by ProSurg and ACMI/Circon.

By: Robert D. Casner
Date: July 16, 96