This device is designed to be used whenever monopolar electrosurgy is indicated. The intended use of this device is to conduct monopolar electrosurgical energy from target tissue of a patient back to one or two electrosurgical units (ESU), or generators. At the same time the product reduces the risk of pressure related injury due to immobility during surgery.

Electrosurgical use is restricted to use with isolated monopolar electrosurgical generators. The device is not intended for RF ablation.

Device Description

The Mega Soft Patient Return Electrode is constructed of a layer of conductive material strain-relieved with two sheets of urethane material, and sealed between two asymmetric lavers of a viscoelastic polymer called Akton . (The top layer of polymer is thinner than the bottom layer.) The Akton polymer is encapsulated by a layer of urethane film. One or two two-conductor cables connects the conductive layer of the device to a two conductor DetachaCable". The DetachaCable is connected to a standard monopolar electrosurgical unit (ESU). The device cable is insulated, strain-relieved, and connected well inside the device to prevent patient or user burns. In use, this device will lay on the operating surface with the patient lying on top, on the side labeled "patient side".

The adult-size 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 1/2". The pediatricsize device is approximately 12" x 26" x 1/2" and is intended for pediatric patients weighing between 0.8 and 50 lbs.

AI/ML Overview

This is a 510(k) summary for a medical device that received clearance, not a study report. Therefore, it primarily focuses on establishing substantial equivalence to existing devices rather than presenting the results of a detailed clinical efficacy or performance study with specific acceptance criteria and ground truth validation.

Based on the provided information, I can answer some of your questions but others are not applicable as this document is not a study report.

1. Table of Acceptance Criteria and Reported Device Performance
This document, a 510(k) summary, does not specify quantitative acceptance criteria for device performance in the way a clinical study would. It focuses on demonstrating substantial equivalence to predicate devices, primarily through adherence to recognized safety standards. The performance is implied to be equivalent to the predicate devices.

Acceptance Criteria	Reported Device Performance
Not explicitly stated in terms of measurable performance metrics for a novel study.	Implied to be equivalent to predicate devices based on technological characteristics and safety testing to standards.
Conformance to ISO 60601-2-2:2006 (Medical electrical equipment, Part 2: Particular requirements for the safety of high frequency surgical equipment)	Successful conformance testing (implied by statement: "Megadyne has conducted extensive testing to ensure conformance...")
Conformance to ANSI / AAMI HF 18-2001 (Electrosurgical Devices)	Successful conformance testing (implied by statement: "Megadyne has conducted extensive testing to ensure conformance...")

2. Sample size used for the test set and the data provenance
The document does not describe a "test set" in the context of a clinical study assessing a new algorithm or diagnostic performance. The testing mentioned is safety and performance compliance to standards for the electrosurgical device itself. Therefore, sample size and data provenance in this context are not applicable in the way you might expect for an AI/algorithm study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable. Ground truth, in the sense of expert consensus for diagnostic accuracy, is not relevant for this type of device submission. The device is an electrosurgical patient return electrode, and its evaluation focuses on electrical safety and performance, not diagnostic accuracy.

4. Adjudication method for the test set
This is not applicable for the reasons stated above.

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
This is not applicable. The device is an electrosurgical patient return electrode, not an AI or imaging diagnostic tool that would involve human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This is not applicable. The "ground truth" for an electrosurgical return electrode is its ability to safely and effectively conduct electrosurgical energy and reduce the risk of pressure-related injury. This is assessed through engineering testing and adherence to recognized standards, not by expert consensus on clinical findings or pathological diagnoses.

8. The sample size for the training set
This is not applicable. There is no AI algorithm being developed or trained for this device.

9. How the ground truth for the training set was established
This is not applicable. There is no AI algorithm being developed or trained for this device.

Study Description (based on the provided 510(k) Summary):

The document describes a device safety and performance validation rather than a typical clinical study. The "study" (or validation process) performed by Megadyne Medical Products, Inc. for the Mega Soft Patient Return Electrode primarily focused on demonstrating:

Technological Equivalence: The device shares the same technological characteristics as predicate devices.
Safety and Effectiveness Equivalence: The safety and effectiveness questions are considered the same as for predicate devices, with no new technologies incorporated.
Conformance to Standards: "Megadyne has conducted extensive testing to ensure conformance to the voluntary standard ISO 60601-2-2:2006, Medical electrical equipment, Part 2: Particular requirements for the safety of high frequency surgical equipment, and ANSI / AAMI HF 18-2001, Electrosurgical Devices."

This type of submission relies on demonstrating that the new device meets established industry safety and performance standards equivalent to legally marketed predicate devices, rather than performing a de novo clinical trial with specific diagnostic accuracy metrics.

Summary

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K050741

DEC 1 6 2008

510(k) Summary Section 5

December 15, 2008

A. Submitter's Name / Address

Ronda K. Magneson Director, Regulatory Affairs Megadyne Medical Products, Inc. 11506 South State Street Draper, UT 84020 (801) 276-9669 (801) 576-9698 fax

B. Contact Person

Primary:

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

Alternate:

Ihsan Samara Quality Manager Megadyne Medical Products, Inc. 11506 South State Street Draper, UT 84020 (801) 276-9669 (801) 576-9698 fax

C. Megadyne's Manufacturing Facility

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

D. Device Name

Common Name:

Device, electrosurgical, cutting & coagulation & accessories

Trade Name:

Classification (if known):

21 CFR 878.4400, Electrosurgical cutting and coagulation device and accessories

Mega Soft Patient Return Electrode

Megadyne Medical Products, Inc. 510(k): Mega Soft Reusable Patient Return Electrode Page 11 of 54

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E. Predicate Devices

The predicate devices include:

Megadyne's Mega 2000™ Soft Patient Return Electrode Pad which was cleared for marketing via 510(k) # K021077 by FDA's Office of Device Evaluation on April 17, 2002;

Megadyne's Mega 2000™ Soft Dual Cord Patient Return Electrode Pad which was cleared for marketing via 510(k) # K031285 by FDA's Office of Device Evaluation on May 19, 2003;

Valleylabs E7512 Neonatal REM Polyhesive II Patient Return which was cleared for marketing via 510(k) #K994428 by FDA's Office of Device Evaluation on March 7, 2000; and

Leonard Lang's Skintact® Cool Contact Electrosurgical Grounding Plates with NH 04 gel which was cleared for marketing via 510(k) # K063161 by FDA's Office of Device Evaluation on November 26, 2006.

F. Applicant Device Description

G. Applicant Device Intended Use

The intended use of the Mega Soft Patient Return Electrode is to conduct monopolar electrosurgical energy from target tissue of a patient back to an electrosurgical unit (ESU), or generator. At the same time, the product reduces the risk of pressure related injury due to immobility during surgery.

This device is intended to be used whenever monopolar electrosurgy is indicated. Electrosurgical use is restricted to use with isolated monopolar electrosurgical generators. The device is not indicated for RF ablation.

Megadyne Medical Products, Inc.

510(k): Mega Soft Reusable Patient Return Electrode

Page 12 of 54

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H. Technological Characteristics

The proposed device shares the same technological characteristics found in the Megadyne predicate devices.

I. Safety information

Questions of safety and effectiveness are the same for this device as they are for the predicate devices and other patient return electrodes on the market. There are no new technologies incorporated into the device.

Megadyne has conducted extensive testing to ensure conformance to the voluntary standard ISO 60601-2-2:2006, Medical electrical equipment, Part 2: Particular requirements for the safety of high frequency surgical equipment, and ANSI / AAMI HF 18-2001, Electrosurgical Devices.

Megadyne Medical Products, Inc. 510(k): Mega Soft Reusable Patient Return Electrode Page 13 of 54

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a bird in flight, rendered in a stylized manner.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DFC 1 6 2008

Megadyne Medical Products, Inc. % Ms. Ronda K. Magneson Director. Regulatory Affairs 11506 South State Street Draper, Utah 84020

Re: K080741

Trade/Device Name: Mega Soft® Reusable Patient Return Electrode Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: December 10, 2008 Received: December 12, 2008

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.

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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliation at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Prosmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark M. Milliman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 4 Indications for Use Statement

K080741 510(k) Number (if known):

Device Name:

Mega Soft® Reusable Patient Return Electrode

Indications for use:

Electrosurgical use is restricted to use with isolated monopolar electrosurgical generators. The device is not intended for RF ablation.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nil R. Gode for mxm

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K080741

Prescription Use V

(Per 21 CFR 801.109)

Over-The-Counter Use

Megadyne Medical Products, Inc. 510(k): Mega Soft Reusable Patient Return Electrode

Page 10 of 54

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.