The Ethicon Megadyne® Electrosurgical Generator is intended as a general-purpose electrosurgical generator designed to produce radio frequency (RF) current for cutting and coagulation to target tissue through an accessory electrode during open and laparoscopic surgical procedures.

Device Description

The Ethicon Megadyne Electrosurgical Generator is a microprocessor controlled, isolated output, high frequency generator designed for use in cutting and coagulation of tissue. The generator has the ability to perform both monopolar cutting and coagulation and bipolar coagulation of tissue in a wide range of surgical applications.

AI/ML Overview

This document is a 510(k) premarket notification for an electrosurgical generator. It does not pertain to an AI/ML powered device, therefore, the requested information regarding acceptance criteria, study design for AI/ML performance, sample sizes for training/test sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and ground truth type is not applicable.

The document discusses the substantial equivalence of the Ethicon Megadyne Electrosurgical Generator to a predicate device (Mega Power Electrosurgical Generator). The acceptance criteria and the study proving the device meets these criteria are described in terms of safety and performance bench testing, rather than AI/ML performance metrics.

Here's a breakdown of the relevant information provided, adapted to the context of this traditional medical device:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a formal table of "acceptance criteria" and "reported device performance" in the way one would for an AI/ML model with metrics like sensitivity/specificity. Instead, it describes compliance with recognized electrical safety and electromagnetic compatibility standards and comparative bench testing.

Acceptance Criteria (Bench Testing Focus)	Reported Device Performance (Summary)
Electrical Safety: Compliance with IEC 60601-1 and IEC 60601-2-2.	Testing was completed in compliance with IEC standard 60601-1 and IEC 60601-2-2.
Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2.	Testing was completed in compliance with IEC 60601-1-2.
Capacitive Coupling Safety: Compliance with IEC 60601-2-18.	IEC 60601-2-18 was also completed for capacitive coupling.
Thermal Effects on Tissue: No significant difference in thermal effect compared to the predicate device across all generator modes, power settings (minimum, default, maximum).	Ex-vivo harvested animal tissue (skeletal muscle, liver, and kidney) was used. Testing was performed in triplicate at minimum, default and maximum power settings. "Based on testing results, the thermal effect is not significantly different from what is measured from the predicate device."
Software Verification and Validation: Compliance with FDA guidance on software for medical devices (Major level of concern).	Software validation and verification was completed following FDA's "General Principles of Software Validation" and "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices." The recommended documentation for a software with a Major level of concern is provided.
Biocompatibility: No direct or indirect patient-contacting components.	The device does not have any direct or indirect patient contacting components, hence biocompatibility testing was not required.
Sterilization/Shelf-Life: Device shipped non-sterile.	The device is packaged and shipped non-sterile.
Design Validation: Overall acceptability of device setup and use for intended users.	The design validation testing demonstrated the overall acceptability of the subject device setup and use for its intended users.

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

Sample Size: For the thermal effects on tissue, testing was performed in triplicate at minimum, default and maximum power settings for each tissue type (skeletal muscle, liver, kidney) and each generator mode. The exact number of tissue samples is not explicitly stated beyond "triplicate" per condition.
Data Provenance: The thermal effects testing used ex-vivo harvested animal tissue (skeletal muscle, liver, and kidney). The country of origin is not specified, but it's presumed to be associated with the manufacturer's testing facilities. The nature of the study is bench testing rather than retrospective or prospective clinical data.

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

Not Applicable in the traditional AI/ML sense. For this device, "ground truth" for thermal effects would be the measurable thermal change on the tissue. The measurement was done through "image analysis using open source image processing software." It does not involve human expert consensus or labeling of images for diagnostic purposes. The expertise would lie in the design and execution of the bench tests and the interpretation of the physical measurements, not in expert clinical review for ground truth.

4. Adjudication Method for the Test Set:

Not Applicable. As this is not an AI/ML diagnostic device with expert annotation, there is no need for an adjudication method for labeling a test set. The data comes from physical measurements in a controlled bench setting.

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 diagnostic device that assists human readers. Therefore, an MRMC study is irrelevant to this submission.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not Applicable. This is an electrosurgical generator, a hardware device, not a standalone AI/ML algorithm. Its performance is evaluated through bench testing of its physical output and safety features.

7. The Type of Ground Truth Used:

For thermal effects on tissue, the "ground truth" was established by direct measurement of thermal damage through image analysis of ex-vivo animal tissue, compared to the performance of the predicate device.
For electrical safety, EMC, and software validation, the ground truth is compliance with relevant recognized consensus standards (IEC standards) and FDA guidance documents.

8. The Sample Size for the Training Set:

Not Applicable. This device does not use an AI/ML algorithm that requires a training set. The "training" in this context refers to engineering design and development, not machine learning.

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

Not Applicable. No training set or associated ground truth for machine learning was established for this device.

Summary

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March 24, 2020

Megadyne Medical Products, Inc. % Kweku Biney Senior Regulatory Affairs Program Lead Ethicon Endo-Surgery LLC 4545 Creek Road Cincinnati, Ohio 45242

Re: K193145

Trade/Device Name: Ethicon Megadyne Electrosurgical Generator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: February 26, 2020 Received: February 27, 2020

Dear Kweku Biney:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K193145

Device Name

Ethicon Megadyne® Electrosurgical Generator

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Company Megadyne Medical Products, Inc. 11506 South State St. Draper, UT 84020
Contact Kweku Biney Sr. Regulatory Affairs Program Lead Ethicon Endo-Surgery, Inc. Telephone: (513) 337-3135 Email: kbiney@its.jnj.com

Date Prepared

March 24, 2020

Device Name

Trade Name: Ethicon Megadyne Electrosurgical Generator Common Name: Electrosurgical Cutting and Coagulating Instruments

Classification Name

· Electrosurgical, Cutting & Coagulation & Accessories (21 CFR 878.4400, Product Code GEI)

Regulatory Class Class II

Predicate Device Mega Power Electrosurgical Generator initially cleared under K050579 on March 24, 2005.

Device Description

Indications for Use

The Ethicon Megadyne Electrosurgical Generator is intended as a general-purpose electrosurgical generator designed to produce radio frequency (RF) current for cutting and coagulation to be delivered to target tissue through an accessory electrode during open and laparoscopic surgical procedures.

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Comparison of Technological Characteristics with the predicate Device

The subject device is similar to the predicate device in design, intended use, energy delivery. materials, performance, safety, effectiveness, labeling and operating principle. Both the subject and predicate device use the same accessories except for the round bi-polar footswitch which is only compatible with the subject device.

Discussion of Differences

Both the subject and predicate share several features and characteristics. The major technological features that have been designed into the subject device are listed below. New Features:

a. Soft COAG: Pressing the SOFT button places the generator in the SOFT Coag mode. The SOFT mode desiccates tissue at a relatively slower rate with deeper thermal penetration. SOFT mode is typically used with an uncoated electrode. SOFT Coag power delivery takes place at much lower impedance than other Coag modes.

b. GEM LOW: This is a new mode on the subject device and has half the voltage of the GEM high mode. GEM high is equivalent to the ACE Cut mode in the predicate device.

c. Auto-Bipolar: The auto Bipolar is a new activation method which senses tissue impedance between the bipolar electrodes and uses this information to auto start or stop the delivery of bipolar energy. The user can select a long (1 second), short (0.5 second), or no delay prior to the onset of energy delivery.

New Accessory Footswitch:

a. A new bipolar footswitch is being introduced with introduction of the new device. The footswitch is the same as the square bipolar footswitch shown in figure 3 in section 11. This is just an ergonomic change from square to round.

Device Characteristic	Ethicon Megadyne ElectrosurgicalGenerator (Subject)	MEGA Power ElectrosurgicalGenerator (Predicate Device)
Operating Low/HighMains Voltage(Domestic)	90 to 132 VAC@ 50/60Hz	Same
	Operating Low/HighMainsVoltage (international)	216 to 264 VAC @ 50/60 Hz	240 to 264 VAC @ 50/60 Hz
		OperatingAltitude/PressureMaximum OperatingDutyCycle	700 hPa to 1060 hPa 25% at maximumpower into rated load
Device Characteristic			Ethicon Megadyne ElectrosurgicalGenerator (Subject)
Current Rating	Maximum Current Rating 5.0 Amps		Same
Power Consumption	Maximum Power Consumption <550Watts		Same
Number of channels andtype	There are two channels, one monopolarand the other is bipolar		Same
Power Display Settings	The power settings for Monopolar andBipolar is displayed using LCD segmentwhite numerical displays indicating thedesired power setting in watts.	The power settings for Monopolarand Bipolar is displayed usingindependent segment greennumerical displays indicating thedesired power setting in watts.
Operating Conditions	Ambient temperature:+10°C (+50°F) to +40°C (+104°F)Relative humidity: 15% to 75% Non-condensingAtm. pressure: 700 hPa (10.2 psi) to1060 hPa (15.37 psi)	Same
Storage Environment	Ambient temperature:-40°C (40°F) to +70°C (+158°F)Relative humidity:10% to 95%, CondensingAtmospheric Pressure:500 hPa (7.25 psi) to 1060 hPa (15.37 psi)	Ambient temperature:-40°C (40°F) to +70°C (+158°F)Relative humidity:10% to 95%, CondensingAtmospheric Pressure:500 hPa (7.25 psi) to 1060 hPa (15.37psi)
Equilibration Time	If the Ethicon Megadyne Generator hasbeen stored at a temperature outside of itsspecified operating temperature range(10°C to 40°C) it should be allowed toreach room temperature before beingused. This time is a minimum of one hour.	Same
Sterilization andReprocessing	This product is sold and used as non-sterile	Same
Cleaning	The Ethicon Megadyne Generator isdesigned to be suitable for cleaning withdamp cloth and mild cleaning solution ordisinfectant.	Same
Operation and ServiceManuals	An English language service manual isprovided with each Ethicon MegadyneGenerator. This service manual providesinformation about the installation andperiodic safety checking required for theunit.	Same

Summary Device Comparison Table

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Performance Data

The subject device has undergone testing to ensure that the design changes do not adversely affect the safety and performance of the device. A high-level summary of safety and performance testing that was completed for the device is documented below:

● Biocompatibility testing

The Ethicon Megadyne Electrosurgical Generator device does not have any direct or indirect patient contacting components.

● Electrical Safety and Electromagnetic Compatibility

To ensure electrical safety and electromagnetic compatibility of the subject device, testing was completed in compliance with IEC standard 60601-1 and IEC 60601-2-2 for electrical safety and IEC 60601-1-2 electromagnetic compatibility. IEC 60601-2-18 was also completed for capacitive coupling.

. Sterilization/Shelf-Life

The subject device is packaged and shipped non-sterile.

Bench Testing ●

Thermal effects on tissue was evaluated for the subject device in comparison to the predicate as recommended by the FDA guidance. All Generator modes were evaluated with the corresponding devices to test for thermal effects on tissue. Ex-vivo harvested animal tissue from skeletal muscle, liver and kidney were used. These tissue types are selected to support the general soft tissue indication for the subject device. Thermal damage on tissue was measured through image analysis using open source image processing software. Testing was performed in triplicate at minimum, default and maximum power settings. Based on testing results, the thermal effect is not significantly different from what is measured from the predicate device.

Software Verification and Validation Testing ●

Software validation and verification was completed for the subject device following FDA's issued guidance on software, "General Principles of Software Validation" and "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices". The recommended documentation for a software with a Major level of concerns is provided in the software section of the submission.

● Design Validation Testing

The design validation testing demonstrated the overall acceptability of the subject device setup and use for its intended users.

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Conclusion

Based on the testing completed for Ethicon Megadyne Electrosurgical generator from a safety and performance perspective, the subject device is substantially equivalent to the predicate device as defined by all applicable FDA regulatory requirements and issued guidance documents.

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.