MINISITE*BIPOLAR FORCEPS** DEVICE

K972415 · United States Surgical, A Division of Tyco Healthc · GEI · Sep 19, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K972415
• Device Name: MINISITE*BIPOLAR FORCEPS** DEVICE
• Applicant: United States Surgical, A Division of Tyco Healthc
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Sep 19, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Minisite* Bipolar Forceps** Device is intended for use during laparoscopic bipolar coagulation.

Device Story

Minisite Bipolar Forceps are laparoscopic instruments designed for coagulation. The device is inserted through a laparoscopic cannula and used under laparoscopic visualization. It functions by delivering electrosurgical energy from a compatible bipolar electrosurgical generator to the target tissue. Operated by a surgeon in a clinical or surgical setting, the device enables precise coagulation during laparoscopic procedures. The output is the application of bipolar electrosurgical energy, which facilitates hemostasis or tissue coagulation, benefiting the patient by allowing for minimally invasive surgical intervention.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Laparoscopic bipolar coagulation forceps. Patient contact materials evaluated for biocompatibility per ISO 10993-1. Energy source: compatible bipolar electrosurgical generator. Form factor: laparoscopic instrument for cannula insertion.

Indications for Use

Indicated for use in laparoscopic bipolar coagulation.

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

• Everest Medical BiCOAG Forceps (K912544)

Submission Summary (Full Text)

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## United States Surgical Corporation 510(k) Premarket Notification Minisite* Bipolar Forceps** Device

| IX. | 510(k)_Summary of Safety and Effectiveness |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SUBMITTER: | United States Surgical Corporation<br>150 Glover Avenue<br>Norwalk, CT 06856 |
| CONTACT PERSON: | Melissa Mazzoni |
| DATE PREPARED: | June 26, 1997 |
| CLASSIFICATION NAME: | Electrosurgical cutting and coagulation device and<br>accessories |
| COMMON NAME: | Bipolar Forceps |
| PROPRIETARY NAME: | Trademark name not yet determined |
| PREDICATE DEVICES: | Everest Medical BiCOAG Forceps (K912544) |
| DEVICE DESCRIPTION: | The Minisite* Bipolar Forceps** Device is a laparoscopic<br>coagulating forceps device that is intended to be passed<br>down a laparoscopic cannula. Coagulation is achieved<br>using electrosurgical energy under laparoscopic<br>visualization. The device is intended to be used with the<br>bipolar outputs of compatible electrosurgical generators. |
| INTENDED USE: | The Minisite* Bipolar Forceps** Device is intended for<br>use during laparoscopic bipolar coagulation. |
| MATERIALS: | All patient contact materials of the Minisite* Bipolar<br>Forceps** Device are evaluated for biocompatibility in<br>accordance with ISO Standard # 10993-1. |

K97241

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo features the department's name encircling a symbol. The symbol is a stylized representation of a caduceus, which is a traditional symbol of medicine. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Melissa Mazzoni Regulatory Affairs Associate United States Surgical Corporation 150 Glover Avenue Norwalk, Connecticut 06856

SEP 1 9 1997

Re: K972415 Trade Name: Minisite*Bipolar Forceps**Device Regulatory Class: II Product Code: GEI Dated: June 26, 1997 Received: June 27, 1997

Dear Ms. Mazzoni:

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 (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 - Ms. Melissa Mazzoni

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,

Cynthia L. Williams, Ph.D., J.D.

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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IV. Indications For Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Minisite* Bipolar Forceps** Device

Indications For Use: The Minisite* Bipolar Forceps** Device is indicate for use in laparoscopic bipolar coagulation.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use: | <span></span> |
|--------------------------|---------------|
| (Per 21 CFR 801.109) | |
| OR Over-The-Counter Use: | |

(Division Sign Off,
Division of Device Evaluation

510(k) Number ________________

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