BIPOLAR FORCEPS SET (MODULAR)

K981321 · Richard Wolf Medical Instruments Corp. · GEI · Jul 7, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K981321
• Device Name: BIPOLAR FORCEPS SET (MODULAR)
• Applicant: Richard Wolf Medical Instruments Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jul 7, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For the coagulation of tubes, tissue coagulation and vascular coagulation to stop bleedings under endoscopic vision. For therapy in connection with endoscopic accessories used in medical specialies such as urology, gynecology, surgery. Not to be used for female sterilization (coagulation of fallopian tubes). Contraindications are inflammations or bacterial contamination of wounds in the operation site. Contraindications directly related to the product are currently unknown. The attending physician must determine if the intended use is appropriate based on the yeneral condition of the patient. For further instructions, refer to the latest medical literature.

Device Story

Modular bipolar forceps set used for tissue and vascular coagulation during endoscopic procedures. Device features grasping jaws for precise tissue holding and an integrated irrigation port for site cleaning. Operated by physicians in clinical settings (urology, gynecology, surgery). Device delivers high-frequency electrical energy to target tissue to achieve hemostasis. Improved design includes more durable coated insulation on electrodes. Output allows surgeons to visualize and control bleeding during minimally invasive surgery, potentially reducing patient blood loss and improving surgical site visibility.

Clinical Evidence

No clinical data. Bench testing performed to verify compliance with ANSI/AAMI 11518 and IEC 601-1/IEC 601-2-2 standards for high-frequency surgical devices. Biocompatibility testing performed on new materials.

Technological Characteristics

Modular bipolar forceps with coated electrode insulation and integrated irrigation port. Energy source: high-frequency electrical. Standards: ANSI/AAMI 11518, IEC 601-1, IEC 601-2-2. Mechanical design allows for precise grasping and axial holding.

Indications for Use

Indicated for coagulation of tubes, tissue, and vasculature to stop bleeding during endoscopic procedures in urology, gynecology, and surgery. Contraindicated for female sterilization (fallopian tube coagulation) and in cases of inflammation or bacterial contamination at the surgical site.

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

• Kleppinger bipolar forceps 8383.21, 8384.21 (pre-enact.)

Submission Summary (Full Text)

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7 1998 JUL

8

**RICHARD WOLF**
MEDICAL INSTRUMENTS CORPORATION

981321

# 510(k) Summary of Safety and Effectiveness

| Submitter: | |
|--------------------------------|----------------------------------------|
| Company / Institution name: | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
| Division name (if applicable): | N.A. |
| Street address: | 353 Corporate Woods Parkway |
| City: | Vernon Hills |
| State/Province: | Illinois |
| Country: | USA |
| ZIP / Postal Code: | 60061 |
| Contact name: | Mr. Robert L. Casarsa |
| Contact title: | Quality Assurance Manager |

| Date of Preparation: | April 8, 1998 |
|----------------------------------------|----------------|
| FDA establishment registration number: | 1418479 |
| Phone number (include area code): | [phone] |
| FAX number (include area code): | [phone] |

Product Information:

| Trade name: | Bipolar forceps set (modular) |
|----------------------|----------------------------------------|
| Model number: | 8390.xxx, 8391.xxx, 8393.xxx, 8394.xxx |
| Common name: | Modular Bipolar forceps |
| Classification name: | Bipolar forceps |

Information on devices to which substantial equivalence is claimed:

| 510(k) Number | Trade or proprietary or model name | Manufacturer |
|---------------|---------------------------------------------|-------------------|
| 1 pre-enact. | Kleppinger bipolar forceps 8383.21, 8384.21 | Richard Wolf GmbH |
| 2 | 2 | 2 |

### 1.0 Description

The modular hipolar forcep set provides precise grasping and axial holding placement of the jaws. performs thorough hygiene, and site irrigation can be achieved without using additional instruments

# Revised 6/19/98

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#### 2.0 Intended Use

The bipolar forceps are used for coagulation of tubes, tissue coagulation, and vascular coagulation to stop bleedings under endoscopic vision.

Not to be used for female sterilization (coagulation of fallopian tubes).

#### 3.0 Technological Characteristics

There are no significant technological characteristic changes to the new devices compared to the pre-enactment devices. The insulation of the electrodes is changed to a more durable coared material. An irrigation port is added.

#### Substantial Equivalence 4.0

The submitted devices pose the same type of questions about safety or effectiveness as the compared devices. The new technological characteristics have not diminished safety or effectiveness. The submitted devices are substantially equivalent to existing pre-enactment devices sold by Richard Wolf. In addition, the submitted devices are substantially equivalent to devices sold by various competitors.

#### ડ.0 Performance Data

No known FDA performance standard exists.

The bipolar forceps were tested to meet the appropriate sections of the ANSI/ AAMI standard on high frequency devices 11518 and IEC 601-1/ 1EC 601-2-2. Device materials tests were performed to assure biocompatibility of the new material. The tests indicated that no irrigation would occur.

#### 6.0 Clinical Tests

No special clinical tests performed.

#### 7.0 Conclusions Drawn

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

By: Robert L. Casassa

Robert L. Casarsa Quality Assurance Manager

Date: 6/1/98

Revised 6/19/98

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Image /page/2/Picture/11 description: The image shows a partial view of the Department of Health & Human Services logo. The text "DEPARTMENT OF HEALTH &" is visible vertically along the left side of the image. To the right of the text is the symbol of the Department of Health & Human Services, which is a stylized representation of people.

7 1998 JUL

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

Re: K981321 Trade Name: Modular Bipolar Forceps Regulatory Class: II Product Code: GEI Dated: April 8.1998 Received: April 10, 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 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 requirement, 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.

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Page 2 - Mr. Robert Casarsa

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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13:29 9661-67-471

RICHARD MULL

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510(k) Number (if known): ______ K981321

Binolar Forceps Set (modular) Device Name:__________________________________________________________________________________________________________________________________________________________________

### Intended Use:

For the coagulation of tubes, tissue coagulation and vascular coagulation to stop bleedings under endoscopic vision.

## Indication and field of application:

For therapy in connection with endoscopic accessories used in medical specialies such as urology, gynecology, surgery.

### Contraindications:

Not to be used for female sterilization (coagulation of fallopian tubes).

Contraindications are inflammations or bacterial contamination of wounds in the operation site. Contraindications directly related to the product are currently unknown. The attending physician must determine if the intended use is appropriate based on the yeneral condition of the patient. For further instructions, refer to the latest medical literature.

(17),EASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDHED)

Daodd

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K981321

Prescription Use
Per 21 CFR 801.109

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Over-The-Counter***_***_

Revised 6/19/98