UNI/MONOPOLAR HF CABLE

K982677 · Richard Wolf Medical Instruments Corp. · GEI · Aug 31, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K982677
• Device Name: UNI/MONOPOLAR HF CABLE
• Applicant: Richard Wolf Medical Instruments Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Aug 31, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Uni/Monopolar High Frequency Cables are used to connect adequately equipped R. Wolf HF instruments to the corresponding HF devices.

Device Story

The Uni/Monopolar HF Cable is a conductive accessory designed to transmit high-frequency electrical current from an external generator to a Richard Wolf HF surgical instrument. It serves as the physical link between the power source and the surgical tool. The device is intended for use in clinical settings by trained healthcare professionals. It does not perform signal processing or automated analysis; it functions as a passive conduit for electrical energy. The cable supports a maximum recurrent peak voltage of 4000 Vp. By facilitating the delivery of HF energy, the cable enables the surgeon to perform electrosurgical procedures, such as cutting or coagulation, which are essential for various surgical interventions.

Clinical Evidence

No clinical tests performed. Compliance with ANSI/AAMI HF18 and IEC601-2-18 standards for high-frequency devices was demonstrated via bench testing.

Technological Characteristics

Maximum recurrent peak voltage: 4000 Vp. Sterilization: Steam at 134°C. Connectivity: Physical cable connection between HF generator and HF instrument. Standards: Complies with ANSI/AAMI HF18 and IEC601-2-18.

Indications for Use

Indicated for connecting Richard Wolf high-frequency (HF) surgical instruments to compatible HF electrical generators for the transmission of electrical current during surgical 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

• Bipolar Cables 8108 (K943776)
• Monopolar Cables 8106, 815 (pre-enactment)

Submission Summary (Full Text)

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353 Cerporate Woods Parkway Vernon Hills, Illinois 6006 1 Phone: \$47.913.1143 Fax: [phone]

## AUG 3 1 1998

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# 510(k) Summary of Safety and Effectiveness

| Submitter: | | Date of Preparation: | July 31, 1998 |
|--------------------------------|----------------------------------------|--------------------------------------|----------------|
| Company / Institution name: | Richard Wolf Medical Instruments Corp. | FDA establishment regulation 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/Monopolar HF Cable | Model number: | 815.xxx, 8106.xxx |
|--------------|-----------------------------|----------------------|------------------------|
| Common name: | Unipolar/Monopolar HF Cable | Classification Name: | Uni/Monopolar HF Cable |

Information on devices to which substantial equivalence is claimed:

| | 510(k) Number | Trade or proprietary or model name | Manufacturer |
|---|---------------|------------------------------------|-------------------|
| 1 | K943776 | Bipolar Cables 8108 | Richard Wolf GmbH |
| 2 | pre-enactment | Monopolar Cables 8106, 815 | Richard Wolf GmbH |
| 3 | | | |
| 4 | | | |

### 1.0 Description

The Uni/Monopolar HF Cables are used to direct a high frequency electrical current from an electrical generator made by unspecified manufacturers to a R. Wolf HF instrument.

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#### 2.0 Intended Use

The Uni/Monopolar HF Cables are used to connect adequately equipped R. Wolf HF instruments to the corresponding HF devices.

#### Technological Characteristics 3.0

TheUni/Monopolar HF Cables may be operated at a maximum recurrent peak voltage of 4000 Vp.

The cables can be sterilized by steam at 134℃.

#### 4.0 Substantial Equivalence

Uni/Monopolar HF Cables 815 and 8106 are substantially equivalent to existing pre-amendment Uni/Monopolar HF Cables 815 and 8106. The material changes have not reduced safety or effectiveness.

#### 5.0 Performance Data

No known FDA performance standard exists.

The Monopolar HF Cables were tested to comply with the appropriate sections of ANSI/AAMI standard on high frequency devices, HF18 and IEC601-2-18.

#### 6.0 Clinical Tests

No clinical tests performed.

#### 7.0 Conclusions Drawn

The devices are designed and tested to guarantee the safety and effectiveness when used according to the instruction manuals.

By: Robert J. Casasa

Robert L. Casarsa Quality Assurance Manager

Date: July 29 98

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 3 1 1998

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

Re: K982677

Trade Name: Uni/Monopolar HF Cable Regulatory Class: II Product Code: GEI Dated: July 31, 1998 Received: July 31, 1998

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 legally marketed predicate 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.

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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/dsma/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

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510(k) Number (if known):

K982677

Device Name:

Uni/Monopolar HF Cable

## Intended Use:

The Uni/Monopolar High Frequency Cables are used to connect adequately equipped R. Wolf HF instruments to the corresponding HF devices.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE)

coll

ative Devices eneral Re

Prescription Use
Per 21 CFR 801.109