The MegaDyne Mega 2000™ reusable patient return electrode is to be used as a general purpose return electrode in any electrosurgical application in which a standard monopolar electrosurgical generator is used.

Device Description

The MegaDyne Mega 2000™ reusable patient return electrode is constructed of a layer of conductive material, laminated between two sheets of dielectric plastic material. A two conductor cable to connect the device to a standard monopolar electrosurgical unit (ESU) is connected to the conductive layer of the electrode. This cable is insulated and strain-relieved well inside the device to prevent possible patient or user burns. The electrode is approximately 20'' x 36". This size is large enough to extend at least half the length and full width of the typical patient torso. The device is not intended to be attached to the patient. A clear plastic sheath is placed over the device. This sheath, which is replaced at a minimum each day, provides a second layer of dielectric protection.

AI/ML Overview

This document is a 510(k) summary for the MegaDyne Mega 2000™ reusable patient return electrode. It outlines the device's description, intended use, and substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Metric	Reported Device Performance
Safety: Prevention of Patient Burns (low current density)	The current density of capacitively-coupled current flow is designed to be less than 100 mA per square inch at an ESU output of 700 mA rms. This low current density prevents the patient from getting return electrode site burns.
Functionality: Sufficient Current Flow for Electrosurgery	The large capacitive contact area between the electrode and the patient allows for enough current flow for electrosurgery to be performed at the surgical site.
Conformance to Standards (ANSI/AAMI HF 18-1993): Minimum Capacitance Requirement	Conformance to the minimum capacitance requirement of the ANSI / AAMI HF 18 standard is no longer claimed for the Mega 2000™. (This is a change from the predicate device).
Conformance to Standards (ANSI/AAMI HF 18-1993): Other applicable sections	With the exception of the requirement for minimum capacitance, the device conforms with all applicable sections of ANSI / AAMI HF 18-1993.
Sheath Replacement Frequency	The electrode sheath is to be replaced on at least a daily basis (as a maximum interval between changes).

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

This document does not describe a clinical study with a test set in the conventional sense for a medical imaging or diagnostic device. The evaluation presented here is for an electrosurgical patient return electrode, focusing on electrical safety and functional characteristics, primarily through design specifications and conformance to standards. Therefore, information about a "test set" sample size or data provenance (country, retrospective/prospective) for a clinical performance study is not applicable to this submission. The "testing" appears to be engineering design and validation focused on achieving specific electrical and safety parameters.

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

Not applicable. As noted above, this submission does not describe a clinical study involving experts establishing ground truth for a test set. The safety and functional claims are based on engineering design, specified current densities, and expected adherence to industry standards.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of an adjudication method as no clinical test set requiring expert adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret results, and the document describes an electrosurgical patient return electrode.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

Not applicable. This device is an electrosurgical patient return electrode, not an algorithm or AI system. Its function is physical and electrical contact for current return during electrosurgery, not the standalone processing of data or images.

7. The Type of Ground Truth Used

The "ground truth" in this context is based on:

Engineering Design Specifications: Such as designing for a current density of less than 100 mA per square inch.
Conformance to Industry Standards: Specifically, ANSI / AAMI HF 18-1993 for electrosurgical devices, with the exception of the minimum capacitance requirement.
Predicate Device Equivalence: The primary assertion for clearance is that the device is substantially equivalent to a legally marketed predicate device (K972273), implying that the predicate device's established safety and effectiveness serve as the "ground truth" for the new device's performance.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

Summary

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q82826

510(k) Summary Section XIV

August 6, 1998

A. Sponsor's Name/Address

Matt Sansom Executive VP / COO MegaDyne Medical Products, Inc. 11506 South State Street Draper, UT 84020 (801) 276-9669 (801) 576-9698 fax

B. Contact Person

John W. Smith Regulatory Consultant 328 M Street Salt Lake City, UT 84103 (801) 532-3334

C. Device Name

Common Name:	Electrode, Electrosurgical, Patient Return
Trade Name:	Mega 2000™
Classification	21 CFR 878.4400, Electrosurgical cutting andcoagulation device and accessories

D. Predicate Device

Reusable Patient Return Electrode, manufactured by MegaDyne. (K972273)

E. Applicant Device Description

The electrode is approximately 20'' x 36". This size is large enough to extend at least half the length and full width of the typical patient torso. The device is not intended to be attached to the patient.

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A clear plastic sheath is placed over the device. This sheath, which is replaced at a minimum each day, provides a second layer of dielectric protection.

The proposed device consists of the same device cleared in K972273, with some minor changes:

The electrode sheath is no longer a single-use item. The sheath is to be . replaced on at least a daily basis (as a maximum interval between changes).
Conformance to the minimum capacitance requirement of the ANSI / AAMI ● HF 18 standard is no longer claimed.

F. Applicant Device Intended Use

This device is intended to be used as a general purpose reusable patient return electrode for any standard electrosurgical generator (ESU).

G. Technological Characteristics

The technological characteristics of the proposed device are identical to the predicate device.

H. Safety Information

The only current flow from the patient to the return electrode is via capacitive coupling, through the patient side of the electrode and the plastic sheath. The current density of this capacitively-coupled current flow is design to be less than 100 mA per square inch at an ESU output of 700 mA rms. This low current density prevents the patient from getting return electrode site burns.

The large capacitive contact area between the electrode and the patient allows for enough current flow for electrosurgery to be performed at the surgical site.

With the exception of the requirement for minimum capacitance, the device conforms with all applicable sections of ANSI / AAMI HF 18-1993.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

6 1998 NOV

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MegaDyne Medical Products, Inc. c/o Mr. John W. Smith Regulatory Consultant 328 M Street Salt Lake City, Utah 84103

K982826 Re: Mega 2000™ Trade Name: Requlatory Class: II Product Code: GEI Dated: August 06, 1998 Received: August 11, 1998

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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) 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 In addition, FDA may publish further announcements action. 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

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Page 2 - Mr. John W. Smith

Product Radiation Control provisions, or other Federal laws or regulations.

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,

fucell
coll

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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Section IV Indications for Use Statement

510(k) Number (if known):

Device Name:

Mega 2000™

Indications for use:

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K982826

Prescription Use	X
(Per 21 CFR 801.109)

Over-The-Counter Use
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MegaDyne Medical Products, Inc. 510(k): Mega 2000™ Reusable Patient Return Electrode

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.