Who is the manufacturer of ETHICON Megadyne Electrosurgical Generator?

Megadyne Medical Products, Inc. filed the 510(k) submission for ETHICON Megadyne Electrosurgical Generator (K213696).

What is the FDA product code for ETHICON Megadyne Electrosurgical Generator?

GEI. It is classified under 21 CFR 878.4400 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for ETHICON Megadyne Electrosurgical Generator?

510(k) clearance (submission type: Traditional).

What are the predicate devices for ETHICON Megadyne Electrosurgical Generator?

Ethicon Megadyne Electrosurgical Generator (K193145).

Who can help prepare an FDA 510(k) submission like ETHICON Megadyne Electrosurgical Generator?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ETHICON Megadyne Electrosurgical Generator

K213696 · Megadyne Medical Products, Inc. · GEI · Jan 21, 2022 · General, Plastic Surgery

Device Facts

Record ID	K213696
Device Name	ETHICON Megadyne Electrosurgical Generator
Applicant	Megadyne Medical Products, Inc.
Product Code	GEI · General, Plastic Surgery
Decision Date	Jan 21, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Ethicon Megadyne Electrosurgical Generator (ESU) 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.

Device Story

Microprocessor-controlled, isolated output, high-frequency electrosurgical generator; produces RF current for cutting and coagulation. Used in open and laparoscopic surgery; operated by surgical staff. Inputs include user-selected power settings via interface; outputs RF energy delivered to target tissue via accessory electrodes. Device features two channels (monopolar and bipolar). Output power is displayed on an LCD segment numerical display. Clinical benefit includes precise tissue management during surgical procedures. Subject device represents a modification of the predicate (K193145) involving reduced maximum power output in monopolar modes, removal of auto-bipolar functionality, and incompatibility with single-plate electrode accessories.

Clinical Evidence

No clinical data. Bench testing only. Thermal effects on tissue were evaluated in triplicate at default and maximum power settings using image analysis software; results showed no significant difference in thermal damage compared to the predicate device. Electrical safety and electromagnetic compatibility were verified per IEC standards.

Technological Characteristics

Microprocessor-controlled, isolated output, high-frequency generator. Power output: 80W (all modes except GEM at 150W). Two channels: monopolar and bipolar. Connectivity: standalone. Power: 90-132 VAC or 216-264 VAC. Compliance: IEC 60601-1, IEC 60601-2-2, IEC 60601-1-2, IEC 60601-2-18. Non-sterile, reusable device. Software: Major level of concern.

Indications for Use

Indicated for use in open and laparoscopic surgical procedures requiring radio frequency (RF) current for tissue cutting and coagulation.

Regulatory Classification

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.

Predicate Devices

Ethicon Megadyne Electrosurgical Generator (K193145)

Related Devices

K193145 — Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch · Megadyne Medical Products, Inc. · Mar 24, 2020
K162656 — ESU-1 Electrosurgical Generator · Tva Medical, Inc. · Nov 10, 2016
K050579 — MEGA POWER ELECTROSURGICAL GENERATOR · Megadyne Medical Products, Inc. · Mar 24, 2005
K171869 — Sutter CURIS RF Generator · Sutter Medizintechnik GmbH · Feb 23, 2018
K160639 — Electrosurgical Generator ESG-200 · Olympus Winter & Ibe GmbH · May 4, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the word "ADMINISTRATION". January 21, 2022 Megadyne Medical Products, Inc. % Rubina Dosani Manager, Regulatory Affairs Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242 Re: K213696 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: November 22, 2021 Received: November 23, 2021 Dear Rubina Dosani: 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/cfpm/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. {1}------------------------------------------------ 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 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 mediation-emitting products, including information about labeling regulations, please see Device (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, PhD 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K213696 Device Name ETHICON Megadyne Electrosurgical Generator Indications for Use (Describe) The Ethicon Megadyne Electrosurgical Generator (ESU) 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. 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) | ☐ | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ### 510(k) Summary Company Megadyne Medical Products, Inc. 11506 South State St. Draper, UT 84020 Contact Rubina Dosani Manager, Regulatory Affairs Ethicon Endo-Surgery, Inc. Telephone: (513) 337-3566 Email: rdosani(@its.jnj.com Date Prepared November 22, 2021 ### Subject Device Name | Common Name: | Electrosurgical Cutting and Coagulating Instruments | | |----------------------------|------------------------------------------------------|--| | Trade Name: | Ethicon Megadyne™ Electrosurgical Generator | | | Model: | OTTMEGEN | | | Classification Name: | Electrosurgical, Cutting & Coagulation & Accessories | | | Classification Regulation: | 21 CFR 878.4400 | | | Regulatory Class: | Class II | | | Panel: | 79, General and Plastic Surgery | | | Product Code: | GEI | | | Common Name: | Electrosurgical Cutting and Coagulating Instruments | | | Trade Name: | Ethicon Megadyne™ Electrosurgical Generator | | | 510(k) Number: | Initially cleared under K193145 | | | Date of Clearance: | March 24, 2020 | | | Model: | MEGEN1 | | ### Device Description The Ethicon Megadyne TM 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. ### Indications for Use The Ethicon Megadyne "" Electrosurgical Generator (ESU) 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. {4}------------------------------------------------ # Comparison of Technological Characteristics with the Predicate Device The subject device has the same intended use and indications of use as the predicate device. The basic design, function, materials, performance, safety, effectiveness, and operating principle remain the same. # Differences Both the subject and predicate devices share several features and characteristics. The major changes to the technological feature of the subject device compared to the predicate are as follows: - 1. Maximum power output/setting of the monopolar mode has been decreased, except for the GEM mode. - 2. Auto-bipolar option has been removed. - 3. Single plate electrode accessories will not be compatible with this design of the subject device. | Device Characteristic | Ethicon Megadyne Electrosurgical Generator (Subject Device) | Ethicon Megadyne Electrosurgical Generator (Predicate Device- K193145) | |--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------| | Operating Low/High Mains Voltage | 90 to 132 VAC @ 50/60Hz | Same | | Operating Low/High Mains Voltage (international) | 216 to 264 VAC @ 50/60 Hz | Same | | Operating Altitude/Pressure | 700 hPa to 1060 hPa | Same | | Maximum Operating Duty Cycle | 25% at maximum power into rated load | Same | | Current Rating | Maximum Current Rating 5.0 Amps | Same | | Power Consumption | Maximum Power Consumption <550 Watts | Same | | Power Output | Maximum Power Output for all modes is 80W except GEM which is 150W | Maximum Power Output: Monopolar Cut mode is 300W Monopolar Coag mode is 120W Bipolar Mode is 80W | | Device Characteristic | Ethicon Megadyne Electrosurgical Generator (Subject Device) | Ethicon Megadyne Electrosurgical Generator (Predicate Device- K193145) | | Number of channels and type | There are two channels, monopolar and bipolar | Same | | Auto Bipolar Feature | Not available | Available | | Power Display Settings | The power settings for Monopolar and Bipolar is displayed using LCD segment white numerical displays indicating the desired power setting in watts. | Same | | Operating Conditions | Temperature Range: +10°C (+50°F) to +40°C (+104°F) Humidity Range: 15% to 75% Non-condensing Atmospheric Pressure: 700 hPa (10.2 psi) to 1060 | Same | | Storage Environment | Temperature Range: -40°C (40°F) to +70°C (+158°F) Humidity Range: 10% to 95%, Condensing Atmospheric Pressure: 500 hPa (7.25 psi) to 1060 hPa (15.37 psi) | Same | | Equilibration Time | If the subject device has been stored at a temperature outside of its specified operating temperature range (10°C to 40°C) it should be allowed to reach room temperature before being used. This time is a minimum of one hour. | Same | | Sterilization and Reprocessing | The device will be sold and used as non-sterile | Same | | Cleaning | The subject device is designed to be suitable for cleaning with damp cloth and mild cleaning solution or disinfectant. | Same | | Device Characteristic | Ethicon Megadyne Electrosurgical Generator (Subject Device) | Ethicon Megadyne Electrosurgical Generator (Predicate Device- K193145) | | Operation and Service Manuals | An English language service manual will be provided with each device. This service manual provides information about the installation and periodic safety checking required for the unit. | Same | ## Summary Device Comparison Table {5}------------------------------------------------ {6}------------------------------------------------ ## 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 summary of safety and performance testing that was completed for the device is provided below: #### 0 Biocompatibility testing The Ethicon Megadyne Electrosurgical Generator device does not have any direct or indirect patient contacting components and therefore biocompatibility testing is not applicable. #### ● 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, IEC 60601-1-2 electromagnetic compatibility and IEC 60601-2-18 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. Thermal damage on tissue was measured through image analysis using open source image processing software. Testing was performed in triplicate at minimum, with default and maximum power settings. Based on testing results, the thermal effect for subject device is not significantly different from what is measured from the predicate device. #### Software Verification and Validation Testing 0 Software validation and verification was completed for the subject device following FDA's issued guidance on software, "General Principles of Software Validation" "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices" and "Content of Premarket Submissions for Management of Cybersecurity in {7}------------------------------------------------ Medical Devices". The recommended documentation for a software with a "Major" level of concern is provided in the software section of the submission. ## Conclusion In conclusion, the performance testing demonstrates that the subject device performs substantially equivalent to the predicate device and does not raise new questions of safety and effectiveness. This submission does not include data from Clinical Studies.