BIOPOLAR BUTTON ELECTRODE, WL 150MM, W/SUCTION APPLICATOR/WL 280MM, W/SUCTION APPLICATOR(8801.451

K973295 · Richard Wolf Medical Instruments Corp. · GEI · Nov 26, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K973295
• Device Name: BIOPOLAR BUTTON ELECTRODE, WL 150MM, W/SUCTION APPLICATOR/WL 280MM, W/SUCTION APPLICATOR(8801.451
• Applicant: Richard Wolf Medical Instruments Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Nov 26, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Richard Wolf Bipolar Button Electrode with Suction Applicator is designed for use in plastic and reconstructive surgery. The device provides a method of coagulating small blood vessels that bleed as a result of blunt dissue subcutaneously. When used in conjunction with the suction applicator, smoke caused by the cauterization of issue is evacuated from the operative site,

Device Story

Bipolar electrosurgical instrument with integrated suction applicator; used in plastic and reconstructive surgery. Device delivers electrical current between two prongs at distal tip to coagulate small blood vessels; suction channel simultaneously evacuates smoke generated during cauterization. Operated by surgeons in clinical settings. Benefits include localized coagulation with reduced risk of current migration to critical facial anatomy and improved visibility via smoke evacuation.

Clinical Evidence

No clinical data. Bench testing performed, specifically abrasion/flaking testing to ensure integrity and bonding of insulation material.

Technological Characteristics

Bipolar electrode with integrated suction channel; working lengths of 150 mm and 280 mm; suction applicator diameter of 3 mm. Electrical current confined between two prongs at distal tip. Insulation material used for safety.

Indications for Use

Indicated for use in plastic and reconstructive surgery for the coagulation of small blood vessels resulting from blunt subcutaneous tissue dissection.

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

• Monopolar/Frazier Suction Probe (K945805)

Submission Summary (Full Text)

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1 F47 913 0924 Vernon I tills, Illinois 80084 Phone: 847,943,4445 Fax: [phone]

973295

L

MEDICAL INSTRUMENTS CORPORATION

| Submitter: | Date of Preparation: August 27, 1997 |
|----------------------------------------|----------------------------------------|
| 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: | Bipolar Button Electrode w/ Suction Applicator |
|----------------------|------------------------------------------------|
| Model number: | 8801.551. 8801,451 |
| Common name: | Bipolar Electrode |
| Classification name: | General and Plastic Surgery |

Information on devices to which substantial equivalence is claimed:

| 510(k) Number | Trade or proprietary or model name | Manufacturer |
|---------------|------------------------------------|--------------------|
| 1 K945805 | 1 Monopolar/Frazier Suction Probe | 1 Wells Endoscopic |
| 2 | 2 | 2 |
| 3 | 3 | 3 |
| 4 | 4 | 4 |

#### 1.0 Description

The Richard Wolf Bipolar Button Electrode with Suction Applicator consists of the suction applicator with a suction channel, a button electrode, and the bipolar connector.

#### 2.0 Intended Use

Richard Wolf Bipolar Button Electrode with Suction Applicator is designed for use in plastic and reconstructive surgery. The device provides a method of coagulating small blood vessels that bleed as a result of blunt dissue subcutaneously. When used in conjunction with the suction applicator, smoke caused by the cauterization of issue is evacuated from the operative site,

Rrvised 11/12/97 3. 3. 4

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evacuated from the operative site.

### 3.0 Technological Characteristics

- · Electrical current is confined to between the two prongs at the distal tip of the instrument which prevents the electrical current to migrate to critical anatomy in the facial area.
- · Working length of 150 mm and 280 mm
- . Suction applicator diameter is 3 mm

#### 4.0 Substantial Equivalence

The Richard Wolf Bipolar Cautery and Suction Tube has the same intended use as the Wells Endoscopic Company's Monopolar/Frazier Suction Probe.

#### 5.0 Performance Data

Abrasion/Flaking testing was performed to assure the integrity and bonding of the insulation material to the instruments.

## 6.0 Clinical Tests

None

}

ﻤﺴﺎ

#### 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. Larson

Robert L. Casarsa Quality Assurance Manager

Date: Aug 22, 92

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 26 1997

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

Re: K973295

> Trade Name: Bipolar Button Electrode w/Suction Applicator Regulatory Class: II Product Code: GEI Dated: August 27, 1997 Received: September 2, 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 current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (OS) 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. 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,

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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5 10(k) Number (if known): ___K973295

Device Name:__________________________________________________________________________________________________________________________________________________________________ Bipolar Button Electrode with Suction Applicator

comments marked the first and in which the such and the more the more has

Indications for Use:

of National Comments of the more of the country of the

# Indications for Use:

Richard Wolf Bipolar Button Electrode with Suction Applicator is designed for use in plastic and reconstructive surgery. The device provides a method of coagulating small blood vessels that bleed as a result of blunt dissection of tissue subcutaneously. When used in conjunction with the suction applicator. smoke caused by the cauterization of tissue is evacuated from the operative site.

Cla Watts

Prescription Use (Per 21 CFR 801.109)

Revised 11/12/97