(59 days)
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.
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.
The Megadyne Electrosurgical Generator, a general-purpose electrosurgical generator designed to produce radio frequency (RF) current for cutting and coagulation of tissue during surgical procedures, underwent various performance tests to ensure its safety and effectiveness following design changes.
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to a predicate device (K193145) rather than explicitly stating acceptance criteria and reporting performance for each individual criterion in a pass/fail format. However, based on the provided "Performance Data" and the "Comparison of Technological Characteristics" tables, the acceptance criteria implicitly involve demonstrating that the device's technical specifications and performance are either identical to the predicate or that any differences do not adversely affect safety and effectiveness.
Here's a summary of the implied acceptance criteria and the device's reported performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: No direct or indirect patient contact. | Biocompatibility testing not applicable as the device does not have any direct or indirect patient-contacting components. |
| Electrical Safety: Compliance with IEC 60601-1 and 60601-2-2. | Testing was completed in compliance with IEC standard 60601-1 (electrical safety) and IEC 60601-2-2 (electrosurgical generators). |
| Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2 and 60601-2-18. | Testing was completed in compliance with IEC 60601-1-2 (EMC) and IEC 60601-2-18 (capacitive coupling for electrosurgical generators). |
| Sterilization/Shelf-Life: Device to be non-sterile. | The subject device is packaged and shipped non-sterile. |
| Bench Testing (Thermal Effects on Tissue): Thermal effect for subject device not significantly different from predicate. | Thermal effects on tissue were evaluated in comparison to the predicate. Testing was performed in triplicate at minimum, with default and maximum power settings for all Generator modes using corresponding devices. Image analysis with open-source software was used to measure thermal damage. Result: The thermal effect for the subject device is reported as "not significantly different" from that measured from the predicate device. |
| Software Verification and Validation (V&V): Compliance with FDA guidance for "Major" level of concern software. | Software validation and verification were completed following FDA's guidance: "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 Medical Devices." The recommended documentation for a "Major" level of concern software was provided. |
| Technological Characteristics: Maintain similar operating principles, design, and performance as predicate, with justified differences. | Most characteristics (Operating Voltage, Altitude/Pressure, Max Operating Duty Cycle, Current Rating, Power Consumption, Number of channels, Power Display Settings, Operating/Storage Conditions, Equilibration Time, Sterilization/Reprocessing, Cleaning, Operation and Service Manuals) are the same as the predicate. Differences: Maximum power output/setting of the monopolar mode decreased (except GEM mode), Auto-bipolar option removed, Single plate electrode accessories not compatible. These differences are implicitly accepted as the conclusion states substantial equivalence and no new questions of safety/effectiveness are raised. |
2. Sample size used for the test set and the data provenance:
- Sample Size: For "Bench Testing (Thermal Effects on Tissue)," testing was performed "in triplicate at minimum". This indicates at least three repetitions for each combination of Generator mode and power setting. The document does not specify a total number of tissue samples or test runs beyond this.
- Data Provenance: The data appears to be prospective bench testing conducted specifically for the purpose of this 510(k) submission to demonstrate the performance of the modified device. The document does not mention the country of origin of the data, but it is implied to be generated by the manufacturer or its contracted laboratories for the FDA submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not mention the use of experts to establish ground truth for the bench testing. The evaluation of thermal effects was done through "image analysis using open source image processing software." This suggests an objective, quantitative measurement rather than expert interpretation for the thermal effects study. For other tests like electrical safety and EMC, ground truth is established by adherence to specified standards.
4. Adjudication method for the test set:
- None specified. Given the nature of the tests (compliance with standards, objective thermal measurement via software), an adjudication method in the context of expert consensus or disagreement is not applicable or explicitly mentioned.
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:
- No MRMC study was done. This device is an electrosurgical generator, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study and analysis of AI-assisted human performance are not relevant to this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable directly as an "algorithm only" study. The device itself is electro-mechanical, with embedded software. Software verification and validation (V&V) was performed to ensure the software functions correctly independently, but this is not a "standalone algorithm" performance in the sense of a diagnostic or predictive AI. The entire device's performance, including its software, was assessed.
7. The type of ground truth used:
- Compliance with International Standards: For electrical safety and EMC, the ground truth is defined by the requirements and test methods specified in the relevant IEC 60601 series standards.
- Objective Measurement: For thermal effects on tissue, the ground truth was based on quantitative measurements of thermal damage obtained through image analysis software.
- Manufacturer's Specifications/Design Intent: For other characteristics like operating parameters and device features, the ground truth is established by the device's design specifications and comparison to the predicate device's known characteristics.
8. The sample size for the training set:
- Not applicable. This submission is for an electrosurgical generator, which is not an AI/ML-based device that would typically involve a "training set" for model development. The software V&V confirms the performance of the embedded software, but it's not a machine learning model that learns from a training dataset.
9. How the ground truth for the training set was established:
- Not applicable. As a training set is not relevant for this type of device, this question is not pertinent.
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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.
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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
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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) | ☐ |
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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.
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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:
-
- Maximum power output/setting of the monopolar mode has been decreased, except for the GEM mode.
-
- Auto-bipolar option has been removed.
-
- Single plate electrode accessories will not be compatible with this design of the subject device.
| Device Characteristic | Ethicon MegadyneElectrosurgical Generator(Subject Device) | Ethicon MegadyneElectrosurgical Generator(Predicate Device- K193145) |
|---|---|---|
| OperatingLow/High MainsVoltage | 90 to 132 VAC @ 50/60Hz | Same |
| OperatingLow/High MainsVoltage (international) | 216 to 264 VAC @ 50/60 Hz | Same |
| OperatingAltitude/Pressure | 700 hPa to 1060 hPa | Same |
| MaximumOperating DutyCycle | 25% at maximum power intorated load | Same |
| Current Rating | Maximum Current Rating 5.0Amps | Same |
| PowerConsumption | Maximum PowerConsumption <550 Watts | Same |
| Power Output | Maximum Power Output forall modes is 80W except GEMwhich is 150W | Maximum Power Output:Monopolar Cut mode is 300WMonopolar Coag mode is120WBipolar Mode is 80W |
| Device Characteristic | Ethicon MegadyneElectrosurgical Generator(Subject Device) | Ethicon MegadyneElectrosurgical Generator(Predicate Device- K193145) |
| Number of channelsand type | There are two channels,monopolar and bipolar | Same |
| Auto Bipolar Feature | Not available | Available |
| Power Display Settings | The power settings for Monopolarand Bipolar is displayed usingLCD segment white numericaldisplays indicating the desiredpower setting in watts. | Same |
| Operating Conditions | Temperature Range:+10°C (+50°F) to +40°C (+104°F)Humidity Range:15% to 75% Non-condensingAtmospheric 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%, CondensingAtmospheric Pressure:500 hPa (7.25 psi) to 1060 hPa (15.37psi) | Same |
| Equilibration Time | If the subject device has beenstored at a temperature outside ofits specified operating temperaturerange (10°C to 40°C) it should beallowed to reach room temperaturebefore being used. This time is aminimum of one hour. | Same |
| SterilizationandReprocessing | The device will be sold andused as non-sterile | Same |
| Cleaning | The subject device is designed tobe suitable for cleaning withdamp cloth and mild cleaningsolution or disinfectant. | Same |
| Device Characteristic | Ethicon MegadyneElectrosurgical Generator(Subject Device) | Ethicon MegadyneElectrosurgical Generator(Predicate Device- K193145) |
| Operation andService Manuals | An English language servicemanual will be provided witheach device. This service manualprovides information about theinstallation and periodic safetychecking required for the unit. | 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 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
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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.
§ 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.