This device is designed to be used whenever monopolar electrosurgery 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.

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

Device Description

The MegaSoft Universal Patient Return Electrode is constructed of a layer of conductive material strain-relieved with two sheets of urethane material, and sealed between two symmetric layers of a viscoelastic polymer called Akton® The Akton polymer is encapsulated by a layer of urethane film. One twoconductor cable 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 either side of the pad.

The pad size is approximately 36" x 20" x 0.135" and is intended for patients weighing ≥ 0.8 lb (350 grams).

AI/ML Overview

The provided text is related to a 510(k) submission for a medical device called the "MegaSoft Universal Patient Return Electrode." It describes the device, its intended use, and its technological characteristics, and references adherence to voluntary safety standards (IEC 60601-1:2005 and IEC 60601-2-2:2009).

However, the document does not contain information about:

Specific acceptance criteria with numerical targets.
A detailed study proving the device meets acceptance criteria, including sample sizes, data provenance, expert qualifications, or adjudication methods for a test set.
Standalone algorithm performance or comparative effectiveness studies (MRMC study) for an AI device. The described device is a physical electrode, not an AI/software device.
Training set details for an AI model.

Therefore, many of the requested fields cannot be populated from the provided text. The device is a physical electrosurgical accessory, and the regulatory submission heavily relies on demonstrating equivalence to a predicate device and adherence to industry safety standards through testing, rather than a clinical effectiveness study with AI-specific metrics.

Here is what can be extracted based on the provided text, and noted where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Safety Standards:
Conformance to IEC 60601-1:2005 (General requirements for safety and essential performance)	Megadyne has conducted extensive testing to ensure conformance to this standard.
Conformance to IEC 60601-2-2:2009 (Particular requirements for the safety of high frequency surgical equipment)	Megadyne has conducted extensive testing to ensure conformance to this standard.
Current Limiting:
Current limiting to prevent patient return electrode site burns.	Device is designed to be current limiting (<100 mA/cm²).
Predicate Device Equivalence:
Substantial equivalence to Megadyne's Mega Soft Return Electrode Pad (K080741).	FDA determined the device is substantially equivalent to the predicate device.

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

Sample Size: Not specified. The document states "Megadyne has conducted extensive testing" but does not detail the size or nature of what would constitute a "test set" in the context of device performance studies.
Data Provenance: Not applicable in the context of clinical data provenance for an AI device. For hardware testing, typically in-house lab testing data would be generated.

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

Not applicable. The device is a physical electrosurgical accessory. The "ground truth" for its safety and performance would be established through compliance with engineering standards and specific electrical/thermal measurements, not expert review of clinical data.

4. Adjudication Method for the Test Set

Not applicable. See point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No. This is a physical electrosurgical return electrode, not an AI-assisted diagnostic or therapeutic device. Therefore, no MRMC study comparing human readers with and without AI assistance was performed.

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

No. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance relies on engineering and safety standards compliance (e.g., current limiting thresholds, electrical safety requirements, thermal limits) as defined by IEC 60601-1 and IEC 60601-2-2, and demonstration of substantial equivalence to a previously cleared predicate device.

8. The Sample Size for the Training Set

Not applicable. As a physical device, there is no "training set" in the context of machine learning or AI.

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

Not applicable. See point 8.

Summary

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K133726 Paqe 1 of 3

JAN 2 4 2014

Section 4 510(k) Summary

December 4, 2013

A. Submitter's Name / Address

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

Alternate:

Katie Hoff Regulatory Affairs Specialist II Megadyne Medical Products, Inc. 11506 South State Street Draper, UT 84020 khoff(@megadyne.com (801) 576-9669 (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:	MegaSoft Universal Patient Return Electrode
Classification (if known):	21 CFR 878.4400, Electrosurgical cutting andcoagulation device and accessories

Megadyne Medical Products, Inc. 510(k): Mega Soft Universal Reusable Patient Return Electrode Page 12 of 64

ﺗﮭ

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E. Predicate Devices

ﺗﮭ

The predicate device is Megadyne's Mega Soft Return Electrode Pad which was cleared for marketing via 510(k) # K080741 by FDA's Office of Device Evaluation on December 12, 2008

F. Applicant Device Description

The pad size is approximately 36" x 20" x 0.135" and is intended for patients weighing ≥ 0.8 lb (350 grams).

G. Applicant Device Intended Use

The intended use of the MegaSoft Universal Patient Return Electrode is to conduct monopolar electrosurgical energy from target tissue of a patient back to an electrosurgical unit (ESU), or generator.

This device is intended to be used whenever monopolar electrosurgy is indicated. Electrosurgical use is restricted to use with isolated monopolar electrosurgical generators.

H. Technological Characteristics

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

I. Safety information

ﮟ

The only current flow from the patient to the MegaSoft Universal Patient Return Electrode Pad is via capacitive coupling. This device is designed to be current limiting (<100 mA/cm2) to prevent the patient from getting return electrode site burns.

Megadyne Medical Products, Inc. 510(k): Mega Soft Universal Reusable Patient Return Electrode Page 13 of 64

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The Akton is used as a dielectric layer. The desirable attribute of this polymer is that it compresses but does not laterally move under pressure, thus maintaining dielectric protection.

ー

Questions of safety and effectiveness are the same for this device as they are for the predicate device 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 following voluntary standards:

IEC 60601-1:2005, Medical electrical equipment, Part 1: General requirements for safety and essential performance

IEC 60601-2-2:2009, Medical electrical equipment, Part 2: Particular requirements for the safety of high frequency surgical equipment

Megadyne Medical Products, Inc. 510(k): Mega Soft Universal Reusable Patient Return Electrode Page 14 of 64

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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 eagle or bird-like symbol 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 symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

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

January 24, 2014

Re: K133726

Trade/Device Name: MegaSoft Universal® Patient Return Electrode Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: December 26, 2013 Received: December 27, 2013

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical

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Page 2 - Ms. Ronda K. Magneson

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Radiological Health

Joshua C. Nipper -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and

For

Enclosure

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്കുന്നു. അവലംബം

Indications for Use Statement Section 3

510(k) Number (if known):

K133726

Device Name:

MegaSoft Universal® 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)

DSD-DIVISION SIGN-OFF
Division of Surgical Devices
510(k) Number:	K133726
	Long H. Chen -A
	Digitally signed by Long H. Chen-A : DN: c=US, o=US. Government, ou=HHS, ou=FDA, ou=People, cn=Long H. Chen-A, 0.9.2342.19200300.100.1.1=130036 9056 Date: 2014.01.23 08:43:53 -05'00'
	for BSA

Prescription Use__X (Per 21 CFR 801.109) OR

Over-The-Counter Use_

Megadyne Medical Products, Inc. Megadyne Medical Products, 210.
5 10(k): Mega Soft Universal Reusable Patient Return Electrode Page 11 of 64

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.