VAPORIZATION ELECTRODES

K970961 · Richard Wolf Medical Instruments Corp. · KNF · Apr 10, 1998 · Obstetrics/Gynecology

Device Facts

• Record ID: K970961
• Device Name: VAPORIZATION ELECTRODES
• Applicant: Richard Wolf Medical Instruments Corp.
• Product Code: KNF · Obstetrics/Gynecology
• Decision Date: Apr 10, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4160
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

These specific EVAP electrodes can be used for vaporization, ablation, coagulation, and or resection of soft tissue in the urology tract and/or fibroids or myomas. The electrodes can be used for endometrial ablation and endometriosis.

Device Story

EVAP electrodes are electrosurgical instruments used for soft tissue management in urology and gynecology. Constructed from medical-grade stainless steel, teflon, new silver, and Hytrel tubing, some versions feature gold-plated rollers. The device is used by clinicians to perform vaporization, ablation, coagulation, and resection of soft tissue, including fibroids, myomas, and endometriosis. Operation involves applying high-frequency electrical energy to tissue; coagulation depth is controlled via wattage adjustment and irrigation to mitigate heat damage. The device is intended for prescription use.

Clinical Evidence

Bench testing was performed to meet ANSI/AAMI standards for high-frequency devices. Clinical evidence is limited to canine model testing, which demonstrated that coagulation depth increases with higher wattage but remains within a 2-3mm range. Irrigation was shown to reduce heat damage risk. No human clinical data provided.

Technological Characteristics

Materials: medical-grade stainless steel, teflon, new silver, Hytrel tubing, optional gold-plated rollers. Principle: high-frequency electrosurgical energy for tissue ablation/coagulation. Standards: ANSI/AAMI High Frequency Devices. Form factor: electrode/roller electrode.

Indications for Use

Indicated for vaporization, ablation, coagulation, and resection of soft tissue in the urology tract, fibroids, myomas, endometrial ablation, and endometriosis.

Regulatory Classification

Identification

A unipolar endoscopic coagulator-cutter is a device designed to destroy tissue with high temperatures by directing a high frequency electrical current through the tissue between an energized probe and a grounding plate. It is used in female sterilization and in other operative procedures under endoscopic observation. This generic type of device may include the following accessories: an electrical generator, probes and electrical cables, and a patient grounding plate. This generic type of device does not include devices used to perform female sterilization under hysteroscopic observation.

Predicate Devices

• Richard Wolf (K953983)
• Circon model VE-B
• ProSurg model SB-24W

Submission Summary (Full Text)

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APR-06-1998 14:45 RICHARD WOLF GA DEPT. 1 847 913 0924 P.07
Vernon Hills, Illinois 60061
Phone: [phone]
Fax: [phone]
K970961
P192
RICHARD WOLF
MEDICAL INSTRUMENTS CORPORATION
APR 10 1998

Summary of Safety and Effectiveness

| Submitter | | Date of Preparation: April 6, 1998 | |
| --- | --- | --- | --- |
| Company / Institution Name: Richard Wolf Medical Instruments Corporation | | FDA establishment registration number: 1418479 | |
| Division Name (if applicable): N.A. | | Phone Number (include area code): [phone] | |
| Street Address: 353 Corporate Woods Parkway | | FAX number (include area code): [phone] | |
| City: Vernon Hills | State/Province: Illinois | Country: USA | ZIP/Postal Code 60061 |
| Contact Name: Robert L. Casarsa | | | |
| Contact Title: Quality Assurance Manager | | | |
| Product Information: | | | |
| Trade name: EVAP Electrodes | | Model number: | |
| Common name: Roller Electrode
Coagulation Electrode
Electrosurgical Electrode | | Classification name: Electrode, Electrosurgical | |
| Information on devices to which substantial equivalence is claimed: | | | |
| 510(k) Number | Trade or Proprietary or Model Name | Manufacturer | |
| 1. | 1. See contents of submission | 1. | |
| 2. | 2. | 2. | |
| 3. | 3. | 3. | |
| 4. | 4. | 4. | |
| 5. | 5. | 5. | |

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APR-06-1998 14:45 RICHARD WOLF QA DEPT. 1 847 913 0924 P.08 MEDICAL INSTRUMENTS CORPORATION

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1.0 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.

2.0 Intended Use
These specific EVAP electrodes can be used for vaporization, ablation, coagulation, and or resection of soft tissue in the urology tract and/or fibroids or myomas. The electrodes can be used for endometrial ablation and endometriosis.

3.0 Technological Characteristics
There are no significant technological characteristics of the new device compared to the existing device.

4.0 Substantial Equivalence
The EVAP electrodes are substantially equivalent to devices sold or previously sold by Richard Wolf Medical Instruments, Circon, and ProSurg. Specifically Richard Wolf models approved by 510(k) K953983, Circon model VE-B, and proSurg model SB-24W.

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

6.0 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.

7.0 Data Conclusions
The Richard Wolf EVAP Electrode is equivalent to existing electrodes, particularly those approved by the Richard Wolf 510(k) K953983, ProSurg, and ACMI/Circon.

By: Robert L. Casarsa
Quality Assurance Manager
Date: Apr 3, 98

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

APR 10 1998

Mr. Robert L. Casarsa
Quality Assurance Manager
Richard Wolf Medical Instruments
353 Corporate Woods Parkway
Vernon Hills, IL 60061

Re: K970961
EVAP Electrodes
Dated: January 16, 1998
Received: January 20, 1998
Regulatory Class: II
21 CFR 884.4160/Procode: 85 KNF

Dear Mr. Casarsa:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,


Lillian Yin, Ph.D.
Director, Division of Reproductive,
Abdominal, Ear, Nose and Throat
and Radiological Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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APR-06-1998 14:44 RICHARD WOLF QA DEPT. 1 847 913 0924 P.06

510(k) Number (if known): K970961

Device Name: Vaporization Electrodes

## Indications for Use:

These specific EVAP electrodes can be used for vaporization, ablation, coagulation, and or resection of soft tissue in the urology tract and/or fibroids or myomas. The electrodes can be used for endometrial ablation and endometriosis.


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Concurrence of CDRH, Office of Device Evaluation (ODF)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K970961

Prescription Use ☑ Per CFR 21 CFR 801.103

OR

Over-The Counter Use

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