Richard Wolf Bipolar Button Electrode with Suction Applicator is designed for use in plastic and reconstructive surgery. The device provides a method of coagulating small blood vessels that bleed as a result of blunt dissection of tissue subcutaneously. When used in conjunction with the suction applicator. smoke caused by the cauterization of tissue is evacuated from the operative site.

Device Description

The Richard Wolf Bipolar Button Electrode with Suction Applicator consists of the suction applicator with a suction channel, a button electrode, and the bipolar connector.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device, the "Bipolar Button Electrode with Suction Applicator." It describes the device, its intended use, and a comparison to a predicate device to establish substantial equivalence.

However, the document does NOT contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way envisioned by the request. This document is a regulatory submission for premarket clearance and focuses on establishing substantial equivalence to a legally marketed predicate device rather than presenting detailed performance studies with acceptance criteria and statistical analysis typical of clinical trials or AI/software validation studies.

Specifically, the document lacks the following key information requested:

A table of acceptance criteria and the reported device performance: No specific performance metrics or thresholds are mentioned.
Sample sized used for the test set and the data provenance: No test set is described, beyond a general "Abrasion/Flaking testing."
Number of experts used to establish the ground truth... and the qualifications: Not applicable as there's no clinical study with ground truth establishment.
Adjudication method: Not applicable.
MRMC comparative effectiveness study: No such study is mentioned or implied.
Standalone (algorithm only) performance: Not applicable, as this is a physical medical instrument, not an AI or software algorithm.
Type of ground truth used: Not applicable.
Sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

The only "performance data" mentioned is:

"Abrasion/Flaking testing was performed to assure the integrity and bonding of the insulation material to the instruments."

And the "Conclusions Drawn" state:

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

This indicates that some internal testing related to material integrity occurred, but no details on acceptance criteria, specific results, sample sizes, or a formal study are provided in this regulatory submission. The FDA clearance is based on substantial equivalence to a predicate device, not on extensive de novo performance data.

Therefore, I cannot populate the table and answer the questions as requested, as the necessary information is not present in the provided text.

Summary

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1 F47 913 0924 Vernon I tills, Illinois 80084 Phone: 847,943,4445 Fax: 847.913.1488

973295

MEDICAL INSTRUMENTS CORPORATION

Submitter:	Date of Preparation: August 27, 1997
Company / Institution Name:	Richard Wolf Medical Instruments Corp.
FDA establishment registration number:	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:	Vernon Hills
State / Province:	Illinois
Country:	USA
ZIP / Postal Code:	60061
Contact Name:	Mr. Robert L. Casarsa
Contact Title:	Quality Assurance Manager

Product Information:

Trade name:	Bipolar Button Electrode w/ Suction Applicator
Model number:	8801.551. 8801,451
Common name:	Bipolar Electrode
Classification name:	General and Plastic Surgery

Information on devices to which substantial equivalence is claimed:

510(k) Number	Trade or proprietary or model name	Manufacturer
1 K945805	1 Monopolar/Frazier Suction Probe	1 Wells Endoscopic
2	2	2
3	3	3
4	4	4

1.0 Description

The Richard Wolf Bipolar Button Electrode with Suction Applicator consists of the suction applicator with a suction channel, a button electrode, and the bipolar connector.

2.0 Intended Use

Richard Wolf Bipolar Button Electrode with Suction Applicator is designed for use in plastic and reconstructive surgery. The device provides a method of coagulating small blood vessels that bleed as a result of blunt dissue subcutaneously. When used in conjunction with the suction applicator, smoke caused by the cauterization of issue is evacuated from the operative site,

Rrvised 11/12/97 3. 3. 4

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evacuated from the operative site.

3.0 Technological Characteristics

· Electrical current is confined to between the two prongs at the distal tip of the instrument which prevents the electrical current to migrate to critical anatomy in the facial area.
· Working length of 150 mm and 280 mm
. Suction applicator diameter is 3 mm

4.0 Substantial Equivalence

The Richard Wolf Bipolar Cautery and Suction Tube has the same intended use as the Wells Endoscopic Company's Monopolar/Frazier Suction Probe.

5.0 Performance Data

Abrasion/Flaking testing was performed to assure the integrity and bonding of the insulation material to the instruments.

6.0 Clinical Tests

None

}

ﻤﺴﺎ

7.0 Conclusions Drawn

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

By: Robert L. Larson

Robert L. Casarsa Quality Assurance Manager

Date: Aug 22, 92

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 26 1997

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

Re: K973295

Trade Name: Bipolar Button Electrode w/Suction Applicator Regulatory Class: II Product Code: GEI Dated: August 27, 1997 Received: September 2, 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. 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,

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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5 10(k) Number (if known): ___K973295

Device Name:__________________________________________________________________________________________________________________________________________________________________ Bipolar Button Electrode with Suction Applicator

comments marked the first and in which the such and the more the more has

Indications for Use:

of National Comments of the more of the country of the

Indications for Use:

Cla Watts

Prescription Use (Per 21 CFR 801.109)

Revised 11/12/97

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.