The MegaDyne uncoated electrosurgical electrode is very similar to other, commercially available, stainless steel electrodes. It is used in various electrosurgical procedures, in conjunction with a hand- or foot-activated "pencil", which is connected to a standard electrosurgical unit (ESU). The device consists of a formed stainless steel rod, insulated over most of its length by polyolefin insulation. The flat, or blade, end of the electrode conducts energy from a standard high-frequency electrosurgical generator to the target tissue. The round end fits into a standard electrosurgical handpiece. Various electrode configurations, such as blade, needle, and ball ends are available in assorted lengths from 2.5" to 8" overall. The blade, needle, and ball configurations are all identical to currently available uncoated stainless steel electrodes on the U.S. market.

AI/ML Overview

Please find the requested information regarding the acceptance criteria and study details below, based on the provided document.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Conformance with relevant clause of ANSI / AAMI HF18 - 1993: 4.3.5.4, Dielectric withstand of accessories.	The Electrosurgical Electrode conforms with the relevant clause of ANSI / AAMI HF18 -1993: 4.3.5.4, Dielectric withstand of accessories.

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

The document does not provide information regarding a specific "test set" in the context of clinical or performance data for software or diagnostic devices. The device is an electrosurgical electrode, and the performance data cited is related to an electrical safety standard. Therefore, there's no mention of sample size, country of origin, or retrospective/prospective nature as would be typical for clinical studies.

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

The document does not explicitly mention the use of experts to establish ground truth for a test set. The performance data refers to a technical standard (ANSI / AAMI HF18 - 1993), which likely involves engineering or electrical testing rather than expert-derived ground truth.

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method as it does not refer to a test set requiring such a process.

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

No. The document is for an electrosurgical electrode, a physical medical device, and does not involve AI or human-in-the-loop performance studies.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

No. This is not applicable to the device described, as it is a physical electrosurgical electrode and not an algorithm or software.

7. Type of Ground Truth Used:

The "ground truth" in this context is the adherence to the Dielectric withstand of accessories as defined by the ANSI / AAMI HF18 - 1993 standard. This is a measure of the insulation's ability to withstand voltage without breaking down.

8. Sample Size for the Training Set:

The document does not mention a training set as it is not for a machine learning or AI-based device.

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

This question is not applicable as there is no training set mentioned for this device.

Summary

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K973346

NOV - 7 1997

510(k) Summary

September 4, 1997

Submitter's Name/Address:

John W. Smith Director of Regulatory Affairs / Quality Assurance MegaDyne Medical Products, Inc. 11506 South State Street Draper, UT 84020 (801) 576-9669

(801) 576-9698 fax

Contact Person:

Same as above

Device Name:

Common Name: Trade Name: Classification (if known): Electrosurgical Electrode Not Yet Determined 21 CFR 878.4400, Electrosurgical cutting and coagulation device and accessories

Predicate Device:

Electrosurgical Blade, manufactured by National Wire and Stamping (K861495)

Applicant Device Description:

The device consists of a formed stainless steel rod, insulated over most of its length by polyolefin insulation. The flat, or blade, end of the electrode conducts energy from a standard high-frequency electrosurgical generator to the target tissue. The round end fits into a standard electrosurgical handpiece. Various electrode configurations, such as blade, needle, and ball ends are available in assorted lengths from 2.5" to 8" overall. The blade, needle, and ball configurations are all identical to currently available uncoated stainless steel electrodes on the U.S. market.

MegaDyne Uncoated Blade 510(k)

Page 18 of 29

MEGADYNE MEDICAL PRODUCTS, INC. 11506 South State Street Draper, Utah 84020 Phone (801) 576-9669 FAX (801) 576-9698 Toll Free (800) 747-6110

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Applicant Device Intended Use:

This device is intended to be used in any application which requires electrosurgical cutting or coagulation.

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Technological Characteristics:

Component/ Feature	MegaDyne'sElectrosurgicalElectrode	Predicate Device:Electrosurgical Blade(K861495)
Intended use	to be used in anyapplication whichrequires electrosurgicalcutting or coagulation	same
Electrode Material	300 series stainless steel	same
Insulation Material	Polyolefin	unknown
Configurations available	Blade, needle, and ballend electrode	same
Compatibility	Standard 3/32" shaft	same
Single use	yes	same
Conforms with ANSI / AAMI HF18 - 1993	yes	unknown

Performance Data:

The Electrosurgical Electrode conforms with the relevant clause of ANSI / AAMI HF18 -1993: 4.3.5.4, Dielectric withstand of accessories.

MEGADYNE MEDICAL PRODUCTS, INC. 11506 South State Street Draper, Utah 84020 Phone (801) 576-9669 FAX (801) 576-9698 Toll Free (800) 747-6110

MegaDyne Uncoated Blade 510(k)

Page 19 of 29

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the department's name around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, representing the department's mission to protect the health of all Americans. The text "AN SERVICES USA" is also included in the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. John W. Smith 'Director of Regulatory Affairs and Quality Assurance MegaDyne Medical Products, Inc. 11506 South State Street Draper, Utah 84020

NOV - 7 1997

Re: K973346 Trade Name: Electrosurgical Electrode Regulatory Class: II Product Code: GEI Dated: September 3, 1997 Received: September 5, 1997

Dear Mr. Smith:

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 (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. John W. Smith

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 vours.

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 Statement

510(k) Number (if known):

KaJ3342

Device Name:

Electrosurgical Electrode

Indications for use:

The MegaDyne uncoated electrode is indicated for use in any surgical procedure which requires electrosurgical cutting and/or coagulation.

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices

510(k) Number	K973346
---------------	---------

Prescription Use ✗(Per 21 CFR 801.109)	OR	Over-The-Counter Use ______
--------------------------------------------	----	-----------------------------

MegaDyne Uncoated Blade 510(k)

Page 8 of 29

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.