MINISITE*BIPOLAR FORCEPS** DEVICE by UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC

The Minisite* Bipolar Forceps** Device is a laparoscopic coagulating forceps device that is intended to be passed down a laparoscopic cannula. Coagulation is achieved using electrosurgical energy under laparoscopic visualization. The device is intended to be used with the bipolar outputs of compatible electrosurgical generators.

AI/ML Overview

The provided text does not contain information about the acceptance criteria or a study that proves the device meets specific performance metrics.

The document is a 510(k) Premarket Notification Summary for the "Minisite* Bipolar Forceps** Device" by United States Surgical Corporation. It primarily focuses on demonstrating substantial equivalence to a predicate device (Everest Medical BiCOAG Forceps K912544) for regulatory clearance.

Here's a breakdown of what the document does include:

Device Description: A laparoscopic coagulating forceps device for electrosurgical energy under laparoscopic visualization, intended for use with bipolar outputs of compatible electrosurgical generators.
Intended Use/Indications For Use: For use during laparoscopic bipolar coagulation.
Materials: Patient contact materials evaluated for biocompatibility in accordance with ISO Standard # 10993-1.
Regulatory Status: A letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market.

What is missing from the provided text, and therefore cannot be addressed in the requested format, includes:

A table of acceptance criteria and reported device performance.
Details about a study (sample size, data provenance, ground truth establishment, expert involvement, adjudication method, MRMC studies, standalone performance).
Any quantitative data on device efficacy or safety beyond biocompatibility.

In summary, the provided document is a regulatory clearance letter and summary, not a technical report detailing performance study results.

Summary

{0}------------------------------------------------

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

IX.	510(k)_Summary of Safety and Effectiveness
SUBMITTER:	United States Surgical Corporation150 Glover AvenueNorwalk, CT 06856
CONTACT PERSON:	Melissa Mazzoni
DATE PREPARED:	June 26, 1997
CLASSIFICATION NAME:	Electrosurgical cutting and coagulation device andaccessories
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 laparoscopiccoagulating forceps device that is intended to be passeddown a laparoscopic cannula. Coagulation is achievedusing electrosurgical energy under laparoscopicvisualization. The device is intended to be used with thebipolar outputs of compatible electrosurgical generators.
INTENDED USE:	The Minisite* Bipolar Forceps** Device is intended foruse during laparoscopic bipolar coagulation.
MATERIALS:	All patient contact materials of the Minisite* BipolarForceps** Device are evaluated for biocompatibility inaccordance with ISO Standard # 10993-1.

K97241

{1}------------------------------------------------

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.

{2}------------------------------------------------

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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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

{3}------------------------------------------------

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

(Division Sign Off,
Division of Device Evaluation

510(k) Number ________________

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
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.(b)
Classification. Class II.