DEXIDE BIPOLAR FORCEPS II ** DEVICE

K991859 · United States Surgical, A Division of Tyco Healthc · GEI · Jun 23, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K991859
• Device Name: DEXIDE BIPOLAR FORCEPS II ** DEVICE
• Applicant: United States Surgical, A Division of Tyco Healthc
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jun 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Dexide Bipolar Forceps II** device is indicated for use in laparoscopic bipolar procedures, to grasp, coagulate and transect tissues.

Device Story

Dexide Bipolar Forceps II is a laparoscopic instrument designed for grasping, coagulating, and transecting tissue. The device is inserted through a laparoscopic cannula and connects to compatible electrosurgical generators to deliver bipolar energy. It is operated by a surgeon in a clinical or OR setting. The device facilitates minimally invasive surgical procedures by providing mechanical grasping and electrical coagulation/transection capabilities, aiding in tissue management during surgery.

Clinical Evidence

Bench testing only. Compliance with ANSI/AAMI HF-18/1993 standard for electrosurgical devices and ISO 10993-1 for biocompatibility.

Technological Characteristics

Laparoscopic bipolar forceps. Materials comply with ISO 10993-1. Energy source: compatible electrosurgical generator (bipolar). Form factor: cannula-compatible instrument. Standards: ANSI/AAMI HF-18/1993.

Indications for Use

Indicated for patients undergoing laparoscopic procedures requiring tissue grasping, coagulation, and transection.

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

• Minisite* Bipolar Forceps** device (K972415)

Submission Summary (Full Text)

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JUN 23 1999

Dexide Bipolar Forceps II** Device

KG918Sq

### IX. 510(k)_Summary of Safety and Effectiveness

| SUBMITTER: | United States Surgical<br>150 Glover Avenue<br>Norwalk, CT 06856 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Christopher A. Graham |
| DATE PREPARED: | May 27, 1999 |
| CLASSIFICATION NAME: | Electrosurgical cutting and coagulation device and accessories |
| COMMON NAME: | Bipolar Forceps |
| PROPRIETARY NAME: | Dexide Bipolar Forceps II** device |
| PREDICATE DEVICES: | Minisite* Bipolar Forceps** device (K972415) |
| DEVICE DESCRIPTION: | The Dexide Bipolar Forceps II** device is a laparocopic<br>grasping, coagulating, and transecting bipolar forceps, which is<br>intended to be passed down a laparoscopic cannula. The<br>device is intended to be used with the bipolar outputs of<br>compatible electrosurgical generators. |
| INTENDED USE: | The Dexide Bipolar Forceps II** device is indicated for use in<br>laparoscopic bipolar procedures, to grasp, coagulate and<br>transect tissues. |
| MATERIALS: | All component materials of the Dexide Bipolar Forceps II**<br>device are comprised of materials which are in accordance with<br>ISO Standard # 10993-1. |
| PERFORMANCE DATA: | The Dexide Bipolar Forceps II** device is in compliance with<br>ANSI/AAMI American National Standard for Electrosurgical<br>Devices HF-18/1993. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 23 1999

Mr. Christopher A. Graham Senior Associate, Regulatory Affairs United States Surgical Corp. 150 Glover Avenue Norwalk, Connecticut 06856

Re: K991859 Trade Name: Dexide Bipolar Forceps II Regulatory Class: II Product Code: GEI Dated: May 27, 1999 Received: June 1, 1999

Dear Mr.Graham:

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.

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#### Page 2 - Mr. Christopher A. Graham

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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# Dexide Bipolar Forceps II** Device

### IV. Indications For Use:

ﺰ

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Name: Dexide Bipolar Forceps II** device

## Indications For Use:

The Dexide Bipolar Forceps II** device is indicated for use in laparoscopic bipolar procedures, to grasp, coagulate and transect tissues.

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Evaluation (ODE)

OR Over-The-Counter Use:_ Prescription Use: (Per 21 CFR §801.109)

Pocotalo

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