MSD BIPOLAR FORCEPS

K061635 · Medtronic Sofamor Danek · GEI · Sep 5, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K061635
• Device Name: MSD BIPOLAR FORCEPS
• Applicant: Medtronic Sofamor Danek
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Sep 5, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MSD BIPOLAR Forceps are designed to grasp, manipulate and coagulate selected tissue. It is to be connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Bipolar Forceps must only be used with bipolar coagulation current. The MSD BIPOLAR Forceps has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.

Device Story

MSD Bipolar Forceps are surgical instruments used to grasp, manipulate, and coagulate tissue. The device connects to an electrosurgical generator via a bipolar cable. Operation involves the surgeon activating the device using a footswitch, which delivers bipolar electrosurgical current to the tissue held by the forceps. Used in general surgical settings, the device provides localized coagulation to assist in hemostasis or tissue management. The output is controlled by the surgeon's manual manipulation and footswitch activation, directly affecting tissue coagulation state.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Bipolar electrosurgical forceps. Energy source: external electrosurgical generator. Connectivity: bipolar cable. Operation: manual grasping with footswitch-activated bipolar current. No software or electronic components.

Indications for Use

Indicated for grasping, manipulating, and coagulating tissue in general surgical procedures. Contraindicated for tubal sterilization or tubal coagulation for sterilization 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

• CLARIS Non-Stick Bipolar Forceps (K051429)

Submission Summary (Full Text)

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K061635

MSD BIPOLAR Forceps 510(k) Summary June 2006

Page 1 of 1

- I. Company: Medtronic Sofamor Danek 1800 Pyramid Place Memphis, TN 38132 [phone]
# SEP - 5 2006

- Contact: Richard W. Treharne, PhD Vice President Regulatory Affairs
## II. Proprietary Trade Name: MSD BIPOLAR Forceps

- III. Classification Name: Electrosurgical Cutting and Coagulation and Accessories
- IV. Regulation Number: 878.4400

Product Code: GEI Class: Class II

## V. Product Description

The MSD BIPOLAR Forceps are intended for use in general surgical procedures. The device is connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Coagulation is achieved using electrosurgical energy generated by the electrosurgical generator unit and activated by a footswitch.

#### VII Indications

The MSD BIPOLAR Forceps are designed to grasp, manipulate and coagulate selected tissue. It is to be connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Bipolar Forceps must only be used with bipolar coagulation current. The MSD BIPOLAR Forceps has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.

#### VIII Substantial Equivalence

Documentation was provided which demonstrated the subject MSD BIPOLAR Forceps to be substantially equivalent to the CLARIS Non-Stick Bipolar Forceps previously cleared by the agency in K051429 (SE 07/29/05).

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 5 2006

Medtronic Sofamor Danek % Mr. Lee Grant Supervisor, Regulatory Affairs 1800 Pvramid Place Memphis, Tennessee 38132

Re: K061635

Trade/Device Name: MSD Bipolar Forceps Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: August 11, 2006 Received: August 15, 2006

Dear Mr. Grant:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your became as a get fie device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sured in the encrease of the enactment date of the Medical Device Amendments, or to conninered pror to rias 2017-11-11 in accordance with the provisions of the Federal Food, Drug, de necs that have been require approval of a premarket approval approval application (PMA). and Cosmetic rear (110.) that to hevice, subject to the general controls provisions of the Act. The r ou may, diererere, mains 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Lee Grant

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

661635

Device Name: MSD Bipolar Forceps

Indications for Use:

The MSD BIPOLAR Forceps are designed to grasp, manipulate and coagulate selected tissue. It is to be connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Bipolar Forceps must only be used with bipolar coagulation current. The MSD BIPOLAR Forceps has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of General, R. Boran. and Neurological Devices

510(k) Number *k011636*

000005