The Mega 2000 Soft Dual Cord Patient Return Electrode Pad is to be used as a general purpose return electrode for one or two electrosurgical generators and/or a pressure reduction pad, in any surgical application. Electrosurgical use is restricted to use with isolated monopolar electrosurgical generators.

Device Description

The Mega 2000 Soft Dual Cord is constructed of a layer of conductive material strain-relieved with two sheets of urethane material, and sealed between two asymmetric layers of a viscoelastic polymer. (The top layer of polymer is thinner than the bottom layer.) The polymer is encapsulated by a layer of urethane film. Two cables connect the conductive layer of the device to two DetachaCables". The DetachaCable(s) are connected to a standard monopolar electrosurgical unit (ESU). The device cables are insulated and strain-relieved well inside the device to prevent patient or user burns. The device is large enough to extend at least the length and width of a typical patient torso. Pad size is approximately 20" x 46" x ½". In use, this device will lay on an operating room table with the patient lying on top, on the side labeled "patient side".

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Mega 2000 Soft Dual Cord Patient Return Electrode Pad." This document focuses on demonstrating substantial equivalence to a predicate device and safety and performance testing for a medical device that assists in electrosurgery. It is not an AI/ML device, so many of the requested categories (e.g., training set, MRMC study, ground truth for training set) are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Maximum Safe Temperature Rise (ANSI/AAMI HF-18, paragraph 4.2.3.1)	"The device is well within the requirements of the standard." (Tested with human volunteers and two electrosurgical generators, with and without a single linen layer between the pad and the patient). Infrared camera used to record temperature changes.
Electrode Contact Impedance (Minimum Capacitance Requirement)	"Conformance with the minimum capacitance requirement was demonstrated through bench testing. Device capacitance was evaluated under several different test setups intended to simulate clinical use."
Current Limiting (<100 mA/cm²)	"This device is designed to be current limiting (<100 mA/cm²) so as to prevent the patient from getting return electrode site burns. This current limiting attribute is achieved by selecting materials with high impedance per area." (This is a design characteristic, not explicitly a test result for the Dual Cord device, though implied by materials selection and overall safety claims).
Similar Technological Characteristics to Predicate Device	"The technological characteristics of the proposed device are similar to the predicate device. The only difference is the addition of a second cord... Other technological characteristics (capacitive coupling and pressure reduction) are identical to the predicate device."

2. Sample Size for Test Set and Data Provenance

Maximum Safe Temperature Rise: "human volunteers" were used. The exact number is not specified in the abstract, but the protocol document (X1150075-10 revision 3) would likely contain this detail.
Electrode Contact Impedance: Bench testing was performed; no human subjects or patient data.
Data Provenance: The testing was conducted by Megadyne Medical Products, Inc. in Draper, UT, USA. This suggests the data is from the USA. It is prospective testing designed to evaluate the manufactured device.

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

Not applicable. This device is a medical accessory, and the "ground truth" is based on objective measurements against engineering and safety standards, not expert interpretation of clinical data in the same way an AI diagnostic tool would be. The "ground truth" is defined by the ANSI/AAMI HF-18 standard.

4. Adjudication Method for the Test Set

Not applicable. Testing involves direct measurement and comparison to an established engineering standard, not subjective interpretations requiring adjudication.

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/ML device, nor is it a diagnostic device that involves human readers interpreting cases.

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

Not applicable. This is a physical electrosurgical accessory. Its performance is evaluated through physical and electrical testing.

7. The Type of Ground Truth Used

The "ground truth" is defined by the ANSI/AAMI HF 18-2001, Electrosurgical Devices standard. This standard sets objective performance criteria for maximum safe temperature rise and minimum capacitance.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device.

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

Not applicable. As this is not an AI/ML device, there is no "training set" or "ground truth for the training set" in the context of machine learning. The device's performance is tested directly against engineering standards.

Summary

{0}------------------------------------------------

尚 KO31285

MAY 1 9 2003

Section XIV 510(k) Summary

April 14, 2003

A. Submitter's Name / Address

Ronda K. Magneson Manager, Regulatory Affairs and Quality Assurance Megadyne Medical Products, Inc. 11506 South State Street Draper, UT 84020 (801) 576-9669 (801) 576-9698 fax

B. Contact Person

Primary: Ronda K. Magneson Manager of Regulatory Affairs / Quality Assurance Megadyne Medical Products, Inc. 11506 South State Street Draper, UT 84020 (801) 576-9669 (801) 576-9698 fax
Alternate: Ihsan Samara Compliance Engineer Megadyne Medical Products, Inc. 11506 South State Street Draper, UT 84020 (801) 576-9669 (801) 576-9698 fax

C. Device Name

Common Name:	Electrode, Electrosurgical, Patient Return
Trade Name:	Mega 2000 Soft Dual Cord Patient Return Electrode Pad
Classification (if known):	21 CFR 878.4400, Electrosurgical cutting and coagulation device and accessories

D. Predicate Device

Mega 2000® Soft Patient Return Electrode Pad manufactured by Megadyne (K021077).

Megadyne Medical Products, Inc. Page 30 of 35 510(k): Mega 2000® Soft Dual Cord Patient Return Electrode Pad

{1}------------------------------------------------

2 + 3 K031285

E. Applicant Device Description

The device is large enough to extend at least the length and width of a typical patient torso. Pad size is approximately 20" x 46" x ½".

In use, this device will lay on an operating room table with the patient lying on top, on the side labeled "patient side".

F. Applicant Device Intended Use

The Mega 2000 Soft Dual Cord Patient Return Electrode Pad is to be used as a general purpose return electrode for one or two electrosurgical generators and/or a pressure reduction pad in any surgical application. Electrosurgical use is restricted to use with isolated monopolar electrosurgical generators.

G. Technological Characteristics

The technological characteristics of the proposed device are similar to the predicate device. The only difference is the addition of a second cord for connection to two different electrosurgical units at the same time during a procedure. Other technological characteristics (capacitive coupling and pressure reduction) are identical to the predicate device.

H. Safety Information

The only current flow from the patient to the Mega2000 Soft Dual Cord Patient Return Electrode Pad is via capacitive coupling. This device is designed to be current limiting (<100 mA/cm²) so as to prevent the patient from getting return electrode site burns. This current limiting attribute is achieved by selecting materials with high impedance per area.

The large contact area between the electrode and the patient lowers the total impedance when there is substantial patient / pad contact area, and allows for enough current flow for electrosurgery to be performed at the surgical site(s).

Prior to release of the device for distribution, Megadyne conducted extensive testing of the device to assure its conformance to the voluntary standard ANSI /

Page 31 of 35 Megadyne Medical Products, Inc. 510(k): Mega 2000® Soft Dual Cord Patient Return Electrode Pad

{2}------------------------------------------------

3 of 3 KO31258

AAMI HF 18-2001, Electrosurgical Devices. The clauses of the standard which apply to capacitively-coupled return electrodes are:

Maximum Safe Temperature Rise:

Maximum Safe Temperature Rise was demonstrated, using the method specified by the standard, with human volunteers and two electrosurgical generators. The device is well within the requirements of the standard. (Ref. Appendix A.)

Electrode Contact Impedance:

Conformance with the minimum capacitance requirement was demonstrated through bench testing. Device capacitance was evaluated under several different test setups intended to simulate clinical use. (Ref. Appendix B.)

Both proposed and predicate device performed similarly during the above testing. This device conforms to the applicable sections of AAMI HF-18/2001, under test conditions. However, as with the predicate device, field conformance is affected by clinical set-up which is beyond Megadyne's control.

I. Megadyne's Manufacturing Facility

Megadyne Medical Products, Inc. 11506 South State Street Draper, UT 84020 (801) 576-9669 (801) 576-9698 fax

Section XV Appendix A: Mega2000 Soft Dual Cord Temperature Rise Test

Document Number: X1150075-03 Authored By: Doug Orr Eng. Approval: Doug Orr QA Approval: Ihsan Samara

ABSTRACT

Mega2000® Soft Dual Cord reusable return electrodes were tested per the requirements of protocol X1150075-10 revision 3. This testing was performed to ensure compliance with the requirements in ANSI/AAMI HF-18, paragraph 4.2.3.1. An infrared camera was used to record the temperature changes. The samples were tested in accordance with the IFU, specifically with no linen between the pad and the patient and with a single linen layer between the pad and the patient. The results show that the requirements of ANSI/AAMI HF-18,

Page 32 of 35 Megadyne Medical Products, Inc. 510(k): Mega 2000® Soft Dual Cord Patient Return Electrode Pad

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 9 2003

Ms. Ronda K. Magneson Manager, Regulatory Affairs and Quality Assurance Megadyne Medical Products, Inc. 11506 South State Street Draper, Utah 84020

Re: K031285

Trade/Device Name: Mega 2000 Soft Dual Cord Patient Return Electrode Pad Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: April 14, 2003 Received: April 23, 2003

Dear Ms. Magneson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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.

{4}------------------------------------------------

Page 2 - Ms. Ronda K. Magneson

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. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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.

Muriam C. Provost

for 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

{5}------------------------------------------------

Section IV Indications for Use Statement

510(k) Number (if known):

K031285

Device Name:

Mega 2000® Soft Dual Cord Patient Return Electrode Pad

Indications for use:

uriam C. Provost

Division of General, Restorative and Neurological Devices

510(k) Number K031285

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

Megadyne Medical Products, Inc. Page 11 of 35 510(k): Mega 2000® Soft Dual Cord Patient Return Electrode Pad

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.