UNIPOLAR HOOK ELECTRODE (5MM .340MM)/UNIPOLAR HOOK ELECTRODE (5MM. 420MM)

K964329 · Richard Wolf Medical Instruments Corp. · GEI · May 21, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K964329
• Device Name: UNIPOLAR HOOK ELECTRODE (5MM .340MM)/UNIPOLAR HOOK ELECTRODE (5MM. 420MM)
• Applicant: Richard Wolf Medical Instruments Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: May 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The electrosurgical unipolar hook electrode is intended to be used for coagulation and cutting of tissue.

Device Story

Unipolar electrosurgical hook electrode; connects to electrosurgical generator via cable. Used by surgeons for tissue cutting and coagulation. Device features durable powder coating and 3000V isolation. Operates by delivering electrical energy to tissue at the hook tip. No clinical data; bench testing performed for electrical isolation and sterilization validation.

Clinical Evidence

No clinical tests performed. Bench testing only, specifically 3000-volt isolation testing and sterilization process validation.

Technological Characteristics

Unipolar electrosurgical hook electrode; durable powder coating; 3000V electrical isolation; gas and steam sterilizable.

Indications for Use

Indicated for coagulation and cutting of tissue during electrosurgical 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.

Predicate Devices

• Hook Electrode 8383.42 (pre-enactment)
• Hook Electrodes 8383.423, 8384.423 (existing device)

Submission Summary (Full Text)

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k964329
MAY 21 1997

# 510(k) Summary of Safety and Effectiveness

| Submitter: | | | Date of Preparation: October 25, 1996 | |
| --- | --- | --- | --- | --- |
| Company / Institution name: RICHARD WOLF MEDICAL INSTRUMENTS CORP. | | | FDA establishment registration number: 14 184 79 | |
| 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: Mr. Robert L. Casarsa | | | | |
| Contact title: Quality Assurance Manager | | | | |
| Product Information: | | | | |
| Trade name: Unipolar Electrosurgical Hook Electrode | | Model number: 8383.423, 8384.423 | | |
| Common name: Hook Electrode | | Classification name: Electrosurgical cutting and coagulation device and accessories | | |
| | | | | |
| | | | | |
| Information on devices to which substantial equivalence is claimed: | | | | |
| 510(k) Number | Trade or proprietary or model name | | Manufacturer | |
| 1 pre-enactment | 1 Hook Electrode 8383.42 | | 1 Richard Wolf Medical Instruments | |
| 2 existing device | 2 Hook Electrodes 8383.423, 8384.423 | | 2 Richard Wolf Medical Instruments | |
| 3 | 3 | | 3 | |

## 1.0 Description

The Hook Electrode is a unipolar electrosurgical device used primarily for cutting, but also usable for coagulation. The device is attached via cable to an electrosurgical generator.

## 2.0 Intended Use

The electrosurgical unipolar hook electrode is intended to be used for coagulation and cutting of tissue.

## 3.0 Technological Characteristics

- durable powder coating
- 3000 Volt isolation
- gas and steam sterilizable

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## 4.0 Substantial Equivalence

The basic design of the hook electrode is equivalent to pre enactment devices from R.Wolf and equivalent to existing competitive devices.

## 5.0 Performance Data

Tested to assure 3000 volt isolation and validation to recommended sterilization processes.

## 6.0 Clinical Tests

No clinical tests performed.

## 7.0 Conclusions Drawn

These devices are designed and tested to guarantee the safety and effectiveness, when used according to the instruction manual.

By:
Robert L. Casarsa
Quality Assurance Manager
Date: Oct 25, 1996

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
MAY 21 1997
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

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

Re: K964329
Trade Name: Electrosurgical Hook Electrodes
Regulatory Class: II
Product Code: GEI
Dated: April 18, 1997
Received: April 22, 1997

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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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.

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Page 2 - Mr. Robert L. Casarsa

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/dsmamain.html".

Sincerely yours,


Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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510(k) Number (if known): K 964329

Device Name: ELECTOSURGICAL HOOK ELECTRODES

Indications For Use:

The electrosurgical unipolar hook electrode is used for coagulation and cutting of tissue.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)


PRESCRIPTION USE (PER 21 CFR 301.109)

OR

OVER-THE-COUNTER USE