The Bipolar Forceps is intended for use in open and laparoscopic surgeries where grasping, coagulating, and transecting of tissue is indicated. The submitted Bipolar Forceps are indicated for both GYN and general laparoscopic procedures.

Device Description

The submitted Bipolar forceps are forceps that grasps, coagulate, and transects tissue, utilizing electrical current. The Bipolar forceps are compatible with all standard bipolar generators that have a bipolar outlet.

AI/ML Overview

This document describes a 510(k) premarket notification for Bipolar Forceps by Richard Wolf Medical Instruments Corporation. The submission claims substantial equivalence to a previously cleared device (K012279).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Safety and Effectiveness (Implied for medical devices)	"These devices are designed and tested to guarantee the safety and effectiveness, when used according to the instructions manual." (Section 7.0 Conclusions Drawn)
Material Equivalence	The submitted devices are "the same devices cleared in 510(k) K012279, April 30, 2002." (Section 3.0, 4.0, 5.0)
Intended Use Equivalence	The submitted device's intended use ("open and laparoscopic surgery where grasping, coagulating, and transecting is indicated") is implicitly equivalent to the predicate device, as confirmed by the substantial equivalence finding. (Section 2.0 & Indications for Use)
Technological Characteristics Equivalence	The submitted devices have "the same technological characteristics" as the predicate device (K012279). (Section 3.0)
Performance Equivalence	The submitted devices "perform the same as the devices cleared in 510(k) K012279." (Section 5.0)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable. The submission explicitly states "No clinical tests performed." The basis for substantial equivalence is direct comparison to an identical, previously cleared device.
Data Provenance: Not applicable. No new test data generated for this specific submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Number of Experts: Not applicable. No clinical tests were performed, and thus no expert-established ground truth was required for a new test set.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. No new test set requiring adjudication was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No, an MRMC comparative effectiveness study was not done. The submission explicitly states "No clinical tests performed."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance Study: Not applicable. This device is Bipolar Forceps, a surgical instrument, not an algorithm or AI system.

7. The Type of Ground Truth Used

Type of Ground Truth: Not applicable in the context of new performance testing. The "ground truth" for this 510(k) submission relies on the established safety and effectiveness of the predicate device (Patton Tripol Bipolar Forceps, K012279), to which the current device is claimed to be identical.

8. The Sample Size for the Training Set

Sample Size: Not applicable. This is not an AI/ML device where a training set would be used. The device is a surgical instrument.

9. How the Ground Truth for the Training Set Was Established

Ground Truth Establishment: Not applicable. As per point 8, there is no training set for this type of device.

Summary

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Image /page/0/Picture/1 description: The image is a logo for Richard Wolf Medical Instruments Corporation. The logo features the words "RICHARD WOLF" in bold, sans-serif font, with "RICHARD" stacked above "WOLF". Below the name is the text "Medical Instruments Corporation" in a smaller, regular font. To the right of the name is a square containing a stylized image of a wolf.

K0238i3

353 Corporate Woods Parkway Vernon Hills, IL 60061 Phone: 847-913-1113 Customer Service: 800-323-WOLF www.richard-wolf.com

12.0 510 (k) Summary of Safety and Effectiveness

				Date of Preparation:
				November 11, 2002
Company / Institution name:				FDA establishment registration number:
RICHARD WOLF MEDICAL INSTRUMENTS CORP.				14 184 79
Division name (if applicable):N.A.				Phone number (include area code):
				( 847 ) 913 1113
Street address:	353 Corporate Woods Parkway		FAX number (include area code):
			( 847 ) 913 0924
City:		State/Province:	Country:		ZIP / Postal Code:
Vernon Hills		Illinois	USA		IL 60061
Contact name:	Mr. Robert L. Casarsa
Contact title:	Quality Assurance Manager
Product Information:
Trade name:Bipolar Forceps			Model number:XXXX
Common name:Bipolar Forceps			Classification name:DEVICE, ELECTROSURGICAL, CUTTING &COAGULATION & ASSESSORIES
Information on devices to which substantial equivalence is claimed: same devices as cleared devices
510(k) Number	Trade or proprietary or model name			Manufacturer
1 K012279	1 Patton Tripol Bipolar Forceps			1
2	2			2
3	3			3
4	4			4
5	5			5

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1.0 Description

2.0 Intended Use

The submitted device is intended for use in open and laparoscopic surgery where grasping, coagulating, and transecting is indicated.

3.0 Technological Characteristics

The submitted devices are the same devices cleared in 510(k) K012279, April 30, 2002.

4.0 Substantial Equivalence

The submitted devices pose the same type of questions about safety or effectiveness as the existing devices. The submitted devices are the same devices cleared in 510(k) K012279, April 30, 2002.

5.0 Performance Data

The submitted devices perform the same as the devices cleared in 510(k) K012279, April 30, 2002 by Patton Medical Corporation.

6.0 Clinical Tests

No clinical tests performed.

7.0 Conclusions Drawn

These devices are designed and tested to quarantee the safety and effectiveness, when used according to the instructions manual.

By:

Robert L. Casassa

Robert L. Casarsa Quality Assurance Manager

Date: Nov 11, 2002

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings and head. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the eagle.

JAN 1 7 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Robert L. Casarsa Quality Assurance Manager Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, Illinois 60061

Re: K023813

Trade Name: Bipolar Forceps Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: II Product Code: GEI Dated: November 11, 2002 Received: November 15, 2002

Dear Mr. Casarsa:

We have reviewed your Section 510(k) premarket 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) that do not require approval of a premarket approval application (PMA). 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 (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. Casarsa

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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Miriam C. Provost

+0 Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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5.0 INDICATIONS FOR USE

510(k) Number (if known): —

Device Name: Bipolar Forceps

Indications For Use:

The Bipolar Forceps is intended for use in open and laparoscopic surgeries where grasping, coagulating, and transecting of tissue is indicated.

Indications and Application:

The submitted Bipolar Forceps are indicated for both GYN and general laparoscopic procedures.

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Mesiam C. Provost

I, Restorative

2(k) Number K023813
OR

Prescrintion Use Per 21 CFR 801.109

Over-The Counter

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.