The BiSure™ Laparoscopic Bipolar Forceps is a coagulating forceps device that is intended for laparoscopic use. Coagulation is achieved under laparoscopic visualization by applying electrosurgical energy to the forceps. The device is intended for use with bipolar outputs of compatible electrosurgical generators.

The device is comprised of a handle, inner and outer shafts, interchangeable forceps (electrodes), and connecting cable.

AI/ML Overview

This K983743 document is a 510(k) submission for the BiSure™ Laparoscopic Bipolar Forceps and does not contain information regarding studies for acceptance criteria, device performance metrics, or clinical trial data.

The document explicitly states:
"Performance testing has been performed to verify that the device functions as intended and that design specifications have been satisfied."

However, it does not provide any specific details about the acceptance criteria, the results of the performance testing, sample sizes, ground truth establishment, or any comparative effectiveness studies.

The purpose of this 510(k) submission is to demonstrate substantial equivalence to a predicate device (Olympus Bipolar Forceps K955623), primarily based on technological characteristics and intended use, rather than presenting detailed clinical performance data against specific acceptance criteria. The changes mentioned are to non-patient contacting portions of the device, implying that the core functional performance related to coagulation is considered equivalent to the predicate.

Summary

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JAN 2 1 1999

K983743

SUMMARY OF SAFETY AND EFFECTIVENESS

BiSure™ Laparoscopic Bipolar Forceps

Submitter Information I.

Valleylab, Inc. 5920 Longbow Drive Boulder, CO 80301

Contact: Jack Rogers

Telephone: (303) 530-6172 Fax: (303) 530-6313

II. Date Prepared

October 22, 1998

III. Name of Device

Proprietary Name:	BiSure™ Laparoscopic Bipolar Forceps
Common Name:	Laparoscopic Bipolar Forceps
Classification Name:	Electrosurgical Cutting & Coagulation and Accessories

IV. Predicate Device

Olympus Bipolar Forceps (K955623)

V. Device Description

The device is comprised of a handle, inner and outer shafts, interchangeable forceps (electrodes), and connecting cable.

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VI. Intended Use

The BiSure™ Laparoscopic Bipolar Forceps is intended for use during laparoscopic bipolar coagulation.

Summary of Technological Characteristics VII.

The device is identical to the Olympus Bipolar Forceps (K955623), a legally marketed device, in design, function, and component composition, except for the following changes made to non-patient contacting portions:

· The release (used when connecting or changing the forceps) and rotation (used to rotate the forceps) mechanism has been changed to incorporate both functions into a one button (knob) design on the handle. The forceps may be rotated up to 120 degrees by pushing the release/rotation knob side-to-side as much as 60° either direction from its vertical position.
· The grip portion of the handle has been re-shaped. The grip incorporates a U-shaped stainless steel spring-action mechanism similar to the predicate device.

All patient-contacting components (forceps and shafts) of the device are identical to the Olymous Bipolar Forceps in design, function, and composition. Lengths of shafts for both devices are the same (330 mm and 450 mm) and the O.D. of the outer shaft is the same (5 mm).

VIII. Performance Data

Performance testing has been performed to verify that the device functions as intended and that design specifications have been satisfied.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or movement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 1 1999

Mr. Jack Rogers Regulatory Affairs Associate Vallevlab 5920 Longbow Drive Boulder, Colorado 80301

Re: K983743

Trade Name: BiSure™ Laparoscopic Bipolar Forceps Regulatory Class: II Product Code: GEI Dated: October 22, 1998 Received: October 23, 1998

Dear Mr. Rogers:

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 Ouality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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. Jack Rogers

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,

Celia M. Witten, Ph.D., M.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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INDICATIONS FOR USE

K983743 510(k) Number (if known):

Device Name: BiSure™ Laparoscopic Bipolar Forceps

Indications For Use:

The BiSure™ Laparoscopic Bipolar Forceps is indicated for use during laparoscopic bipolar coagulation.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 2.1 CFR 801.109)
OR
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K983743
Over-The-Counter Use

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.