The electrodes are used for dissection, for coagulation or removing and destroying tissue by use of unipolar high-frequency current under endoscopic view.

The electrodes are used for examination, diagnostics, and/or therapy by personnel who are qualified and suitably trained in connection with endoscopically used accessories in different medical disciplines, particularly suitable for outpatient and pediatric laproscopy.

Device Description

The electrodes are part of the MICRO and MINI instrument set for laparoscopic microsurgery. They are particularly suitable for diagnostics, smaller interventions, and out-patient and pediatric microsurgery. The electrodes have the same design and material as earlier R. Wolf devices. The closed on the submitted devices and its predecessors is the small diameter for minimally invasive laparoscopy.

AI/ML Overview

The provided text is related to a 510(k) submission for Monopolar Electrodes 3.5. This type of submission is for demonstrating substantial equivalence to pre-existing devices, rather than establishing efficacy through new clinical trials with acceptance criteria.

Based on the provided text, here's an analysis regarding your questions:

1. A table of acceptance criteria and the reported device performance

No acceptance criteria or reported device performance metrics are mentioned in the provided text. The submission explicitly states:

"No know FDA performance standards exist." (Section 5.0 Performance Data)
"No clinical tests performed." (Section 6.0 Clinical Tests)

The focus of this 510(k) is to demonstrate substantial equivalence based on design, materials, and intended use to predicate devices, rather than meeting specific performance metrics from a new study.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No test set was used because no clinical tests or performance studies measuring specific outcomes were performed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No ground truth establishment was described as no clinical tests were performed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set was used.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-powered device, and no MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a medical instrument (monopolar electrodes), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No ground truth was established, as no clinical tests were performed.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device, so there is no concept of a training set.

9. How the ground truth for the training set was established

Not applicable. There is no training set for this device.

Summary of what was done for this submission:

The submission focuses on establishing substantial equivalence to legally marketed predicate devices based on:

Design and Materials: "The electrodes have the same design and material as earlier R. Wolf devices. The closed on the submitted devices and its predecessors is the small diameter for minimally invasive laparoscopy." (Section 3.0 Technological Characteristics)
Intended Use: The intended use of the new device is consistent with the predicate devices.
Predicate Devices: Several pre-enactment and 510(k) cleared devices from Richard Wolf, Karl Storz, and Jarit are cited as substantially equivalent.

The conclusion drawn is that the devices are "designed and tested to guarantee the safety and effectiveness when used according to the instruction manual," but this is a general statement based on engineering design and prior device history, not on new clinical performance data for this specific submission.

Summary

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353 Corporate Work Parkway Vernen Hills. Whichs edde ! Phone: 847,943,1113 lax: 847,945,488

NOV 1 3 199 K 9733 4 1

RICHARD WOL MEDICAL INSTRUMENTS COR

方

510(k) Summary of Safety and Effectiveness
Submitter:			Date of Preparation:
			September 3, 1997
Company / Institution name:				FDA establishment registration number:
RICHARD WOLF MEDICAL INSTRUMENTS CORP.			14 184 79
Division name (if applicable):			Phone number (include area code):
N.A.			(847) 913-1113
Street address:				FAX number (include area code):
353 Corporate Woods Parkway				(847) 913-0924
City:		State/Province:	Country:		ZIP / Postal Code:
Vernon Hills		Illinois	USA		60061
Contact name:		Mr. Robert L. Casarsa
Contact title:
		Quality Assurance Manager
Product Information:
Trade name:			Model number:
Monopolar Electrodes 3.5				8379.452, 462, .482
Common name:				Classification name:
	Monopolar HF Electrodes			Endoscopic Electrical Surgical Unit and Accessories
		Information on devices to which substantial equivalence is claimed:
510(k) Number	Trade or proprietary or model name		Manufacturer
1 pre-enactment	1 Coagulation electrodes 394, 376		1 Richard Wolf
2	2 Pediatric Operating Instruments		2 Karl Storz
3	3 Suction Coagulators			3 Jarit
4	4			4

1.0 Description

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2.0 Intended Use

The electrodes are used for dissection, for coagulation or removing and destroying tissue by use of unipolar high-frequency current under endoscopic view.

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353 Corporate Weeds Parkway Tronan Hills Himeis occe 1 Phone: 847 - 015, 1113 F.tx. 847, 245 1488

RICHARD WOLF

MEDICAL INSTRUMENTS CORPORATION

Technological Characteristics 3.0 The electrodes have the same design and material as earlier R. Wolf devices. The I he closed on the submitted devices and its predecessors is the small diameter for

minimally invasive laparoscopy.

Substantial Equivalence 4.0

The devices are substantially equivalent to existing pre-enactment devices and 510(k) devices sold by Richard Wolf, Karl Storz, and Jarit.

Performance Data 5.0

No know FDA performance standards exist.

6.0 Clinical Tests

No clinical tests performed.

7.0 Conclusions Drawn

The devices are designed and tested to guarantee the safety and effectiveness when used according to the instruction manual.

By: Thet Hlasen

Robert L. Casarsa Quality Assurance Manager

Date: Sept 3, 92

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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized abstract design resembling an eagle or a bird in flight, composed of three curved lines. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Image /page/2/Picture/4 description: The image shows the date November 3, 1997. The month is abbreviated as NOV. The day is 3 and the year is 1997. The text is in a simple, sans-serif font.

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

Re: K973341 Trade Name: Monopolar Electrodes 3.5mm Regulatory Class: II Product Code: GEI Dated: September 3, 1997 Received: September 5, 1997

Dear Mr. Casarsa:

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 (OS) 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. Robert L. Casarsa

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. 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

17:

510(k) Number (if known):	973341
Device Name:	Unipolar electrodes

Intended Use:

The electrodes are used for dissection, for coagulation or removing and destroying tissue by use of unipolar high-frequency current under endoscopic view.

Indication:

Contraindications:

Currently there are no known contraindications directly related to the product. The physician in charge must determine whether the intended application is possible based on the patient's general condition. For further instruction and notes, refer to the latest specialized literature.

Combinations:

The electrodes are used in combination with unipolar HF devices, trocar sleeves, and operating endoscopes.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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Concurrence of CDRH Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K97334/

Prescription UsePer 21 CFR 801.109	X
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Over-The Counter
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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.