The Mega 2000 Soft Patient Return Electrode Pad is to be used as a general purpose return electrode 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 Patient Return Electrode Pad is constructed of a layer of viscoelastic polymer called Akton®, sealed between two asymmetric layers of urethane material, and a conductive material strain-relieved inside the device. (The top layer of polymer is thinner than the bottom layer, approximately 1.0000m layer.) The Akton polymer is encapsulated by a layer of urethane. A two conductor DetachaCable™ connects the conductive layer of the device to a standard electrosurgical generator. The DetachaCable is connected to a 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 operating room table, 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

Here's an analysis of the provided text regarding the acceptance criteria and study for the Mega 2000 Soft Patient Return Electrode Pad (K021077).

Important Note: The provided 510(k) summary (K021077) for the Mega 2000 Soft Patient Return Electrode Pad heavily relies on demonstrating equivalence to predicate devices rather than independent performance testing against strict acceptance criteria. This is typical for Class II devices seeking 510(k) clearance where substantial equivalence is the primary pathway. Therefore, the information you're looking for regarding explicit acceptance criteria and a detailed study proving performance against them is largely absent in this specific document. The "study" mentioned is primarily a series of safety and performance tests to ensure the device performs as intended and is equivalent to the predicate, rather than a clinical trial with statistical endpoints.

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned above, explicit numerical acceptance criteria, as might be found in a clinical trial to prove a specific efficacy, are not detailed in this 510(k) summary. The "acceptance criteria" here are largely implied by compliance with standards and demonstration of equivalent functional performance and safety to predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance
Electrosurgical Safety: - Prevent patient/user burns - Return electrode monitoring (<100 nW/cm²) - High impedance per area	- Conductive layer connected to a "strain-relieved well" inside the device to prevent patient or user burns. - Designed for current monitoring (<100 nW/cm²) to prevent patient burns. - Achieved by selecting materials with high impedance per area.
Contact Area/Current Dispersion: - Large enough contact area to lower total current density	- Large contact area between electrode and patient lowers total current density. - Device dimensions: approximately 20" x 46" x ½". - Large enough to extend at least the length and width of a typical patient.
Pressure Reduction & Skin Protection: - Provides load distribution - Reduces pressure - Decreases shear and friction - Maintains dielectric protection	- Use of Akton® as a dielectric layer and cushioning agent provides load distribution and reduces pressure. - Softness of material decreases shear and friction, which are chief causes of pressure sores. - Akton® polymer compresses but does not laterally move under pressure, thus maintaining dielectric protection.
Compliance with Standards: - AAMI HF-18/2001 (Electrosurgical Devices - Safety Guidelines)	- "This device conforms to the applicable sections of AAMI HF-18/2001."
Technological Equivalence to Predicate: - Identity of technological characteristics to predicate devices (Mega2000® Reusable Patient Return Electrode (K982826) and Action® Operating Table Pad (K801694))	- "The technological characteristics of the proposed device are identical to the predicate devices." (This is a key claim for 510(k) clearance and implies that if the predicate devices meet safety and performance, so does the new device). The predicate Mega2000 used a viscoelastic polymer (Akton), as does the new device. The predicate Action® Operating Table Pad is also made of Akton® and offers similar pressure reduction properties. The key distinction acknowledged is the added electrosurgical function to the pressure reduction pad concept.

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

The document does not describe a "test set" in the sense of a clinical trial patient cohort. The "testing" appears to be largely bench testing and verification against engineering specifications and standards.

Sample Size: Not applicable in the context of a patient-based test set described. Any material or device-level functional tests would have their own sample sizes (e.g., number of pads tested for impedance), but these are not specified in the summary.
Data Provenance: Not applicable for a clinical test set. The data presented is from the manufacturer's internal testing and analysis for regulatory submission.

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

Relevant to clinical trials or performance studies involving human assessment, this information is not applicable here as no such "test set" or human assessment of results to establish ground truth is described.

4. Adjudication Method for the Test Set

Not applicable, as no external adjudication of a clinical test set is described.

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 pad, not an AI-powered diagnostic or interpretive 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.)

For this type of device, "ground truth" relates to fundamental physical principles, material science, and engineering standards.

Electrosurgical Safety: Ground truth is established by electrical engineering principles, heat transfer physics, and compliance with recognized safety standards (like AAMI HF-18/2001) that define safe current densities and impedance pathways to prevent burns.
Pressure Reduction: Ground truth is established by biomechanical principles, material properties of the Akton® polymer, and clinical understanding of pressure sore prevention.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or a "training set."

9. How the ground truth for the training set was established

Not applicable. This device does not involve machine learning or a "training set."

Summary

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K 021077

510(k) Summary Section XIV

February 28, 2002

A. Submitter's Name / Address

Ronda K. Magneson Ronda II. 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: Trade Name: Classification (if known):

Electrode, Electrosurgical, Patient Return Mega 2000 Soft Patient Return Electrode Pad 21 CFR 878.4400, Electrosurgical cutting and coagulation device and accessories

D. Predicate Devices

Mega2000® Reusable Patient Return Electrode manufactured by Megadyne (K982826) and the Action® Operating Table Pad (K801694).

Page 28 of 33 Megadyne Medical Products, Inc. 510(k): Mega 2000® Soft Patient Return Electrode Pad

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E. Applicant Device Description

Applicant Device Deserprises
The Mega 2000 Soft Patient Return Electrode Pad is constructed of a layer of
the Mega 2000 Soft Patient Return Electrode Pad is constructed on a The Mega 2000 Soft Faticil Recurn Libers of urethane material, and conductive material strain-reneved must a viscoelastic polymer called Akton®. sealed between two asymilieure layers of a +1.0000m layer.) The Akton polymer is
(The top layer of polymer is thinner than the bottom layer, it as the company the (The top layer of polymer is thinner than the so conductor cable connects the least the learned encapsulated by a layer of are to a two conductor DetachaCable"". The conductive layer of the device to a the over on and institution the device to preven DetachaCable is comfected to a starratered 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 The device is harge enos 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 Patient Return Electrode Pad is to be used as a general The Mega 2000 Soft I atient Ar a pressure reduction pad in any surgical purpose return clectrosurgical use is restricted to use with isolated monopolar electrosurgical generators.

G. Technological Characteristics

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

H. Safety information

Burent working of the patient to the Mega2000 Soft Patient Return a The only current now from the poupling. This device is designed to be current Electrode I ad 13 Via capacitire oo aprevent the patient from getting return electrode minting ( <100 nirvom ) 30 as w prribute is achieved by selecting materials with high impedance per area.

The large contact area between the electrode and the patient lowers the total I hic farge comaol urea sevel stantial patient / pad contact area, and allows for mipedated when there is buttomating ry to be performed at the surgical site.

The use of Akton as a dielectric layer and a cushioning agent provides load The use of Anton as a crelections use pressure. The softness of the material also dences shear and friction, some of the chief causes of pressure sores. The

Page 29 of 33 Megadyne Medical Products, Inc. 510(k): Mega 2000® Soft Patient Return Electrode Pad

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desirable attribute of this polymer is that it compresses but does not laterally move under pressure, thus maintaining dielectric protection.

This device conforms to the applicable sections of AAMI HF-18/2001.

Page 30 of 33 Megadyne Medical Products, Inc. 510(k): Mega 2000® Soft Patient Return Electrode Pad

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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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 7 2002

Megadyne Medical Products, Inc. c/o Mr. Robert Mosenkis President Citech 5200 Butler Pike Plymouth Meeting, PA 19462-1298

Re: K021077

Roz1077
Trade/Device Name: Mega 2000 Soft Patient Return Electrode Pad Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: April 1, 2002 Received: April 3, 2002

Dear Mr. Mosenkis:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 910(x) premisor is substantially equivalent (for the indications felerenced above and nave decembers and and marketed predicate devices marketed in interstate for use stated in the enclosure) to regars and the Medical Device Americal Device American be on to commerce prior to May 20, 1976, the excordance with the provisions of the Federal Food, Drug, devices that have occh recatistical in assess approval of a premarket approval application (PMA). and Cosment Act (Act) that to not require subject to the general controls provisions of the Act. The You may, uccerore, market the act include requirements for annual registration, listing of general controls provisions of are tice, 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 If your device is classified (see above) and existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations of t may be subject to such additional controller Entrologiations, Title 21, Parts 800 to 898. In addition, FDA may be found in ther announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease be advised that I DTT blossantes or our device complies with other requirements of the Act that I Dri has made a collations administered by other Federal agencies. You must or any I collar statutes and registerients, including, but not limited to: registration and listing (21 compry will an the Hot C21 CFR Part 801); good manufacturing practice requirements as set CITY art 607), adoning (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 -- Mr. Robert Mosenkis

This letter will allow you to begin marketing your device as described in your Section 510(k)
The status and the security of allers of solucterial scuivelence of your device This letter will allow you to begin marketing your device of your device of your device to a legally
premarket notification. The FDA finding of substantial equire and this, premarket notification. The FDA finding of substantal equirations on 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 If you desire specific advice for your devices directions on the except and the Office of
additionally 21 CFR Part 809.10 for in the consections on the promotion and advertis additionally 21 CFR Part 809.10 to million and the promotion and advertising of
Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of Compliance at (301) 594-4659. Additionally, tor questions of additions. Also, please note the your device, please contact the Office of Collipination'' (21CFR Patt 807.97).
regulation entitled, "Misbranding by reference to premarket not may be obtained from the regulation entitled, "Misbranding by relecited in promatible Act may be obtained from the from the Other general information on your responsional and Consumer Assistance at its toll-free number
Division of Small Manufacturers, International and Consumer Assistance at its t Division of Sman Manaratas, or at its Internet address (600) 030 250 2017 11:11 11 11 11 11 11 11 11

Sincerely yours,

Mark n millican

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

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Section IV Indications for Use Statement

510(k) Number (if known):

(021077

Device Name:

Mega 2000® Soft Patient Return Electrode Pad

Indications for use:

The Mega 2000 Soft Patient Return Electrode Pad is to be used as a general purpose
rs and in and the courselves and in any currence lapplication. The Mega 2000 Soft Patient Return Licitorion pad in any surgical application.
return electrode and/or a pressure reduction pad in any surgical application. return electrode and/or a pressure reduction pad in any surgicul specifical generators.
Electrosurgical use is restricted to use with isolated monopolar electrosurgical gener

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Millner
for (Division Sign-Off)
Division of General, Restorative

and Neurological Devices

510(k) Number K021077

Prescription Use_ (Per 21 CFR 801.109)

Over-The-Counter Use_

Page 11 of 33 Megadyne Medical Products, Inc. Mcgadyne Modioal® Soft 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.