(112 days)
The ETHICON™ Total Energy System is intended to supply energy to surgical devices.
The ETHICON™ Total Energy System is an electrosurgical generator that provides power to monopolar, bipolar, and ultrasonic surgical instruments. It is indicated for surgical procedures requiring cutting or coagulation of soft tissue.
The subject device, The ETHICON™ Total Energy System, is an electrosurgical generator that integrates Advanced Energy (Advanced Bipolar and Ultrasonic) and Core Monopolar and Bipolar energy modalities into one system, the Ethicon Total Energy System. The subject device consists of two modules: the Communications Module (ETHCM and ETHUSC) and the Energy Module (ETHEM). Atop the Energy Module is the Communications Module and the User Screen. The Communications Module contains the power button and speakers, connects to the User Screen, distributes power to the system, and provides external interfaces for other connectivity to external devices including Ethernet and USB. One or two Energy Modules can be connected to the Communications Module. When two Energy Modules are connected, each Energy Module can independently power any of the energy modalities. This feature allows for simultaneous use of two surgical instruments in one system to support complex surgical procedures where two surgeons are operating on a patient at the same time. The User Screen features a touch-operable graphical user interface (GUI) for system settings adjustment, user profile management, and alarm troubleshooting. The ETHICON™ Total Energy System accessories include a cart for system transport, footswitches (single, double, round), and an output verification key. The cart provides a mobile platform with adjustable shelves and accessory storage. Additionally, the cart has custom features to create stability for the system including cut-outs on the top shelf for holding the rubber feet of a second module layers. Casters provide 360° mobility with locking tabs that lock to prevent unwanted cart movement. Footswitches may be used to control power delivery to connected instruments, enabling surgeons to activate the energy output hands-free. The different footswitches can be used for various energy modalities and instruments. Up to four footswitches can be connected to the Communications Module of the Ethicon Total Energy System at the same time. The footswitches are assigned to the desired instrument port via the User Screen GUI. Output Verification is a service mode of the system used to periodically confirm that the power outputs of each energy modality are within the required specifications. The Energy Output Verification Key is used by biomed/hospital facility servicing personnel to complete this process for annual maintenance on the Energy Module, with on-screen guidance to assist in this process. The ETHICON™ Total Energy System is compatible with Ethicon HARMONIC™, Ethicon ENSEAL™, and Ethicon MEGADYNE™ monopolar and bipolar instruments.
The provided FDA 510(k) summary for "The ETHICON™ Total Energy System" does not contain the specific details regarding acceptance criteria and the comprehensive study results typically found in a full scientific report.
However, based on the information provided, I can infer the general nature of the acceptance criteria and the studies performed, and explain what is missing from a complete answer regarding detailed acceptance criteria and proof of meeting them:
General Conclusion from the Document:
The FDA 510(k) summary states, "The subject device showed either equivalent or improved performance compared to the predicate devices and met all functional requirements of its features. It successfully met the acceptance criteria for bench testing, animal studies, usability, and electrical testing, demonstrating no new safety or effectiveness issues compared to the predicate."
This indicates that acceptance criteria were established and met for various aspects, but the specific, quantifiable criteria and the detailed results proving they were met are not explicitly listed in the provided text.
Here's an attempt to answer your request based on the available information, highlighting what is present and what is absent:
1. A table of acceptance criteria and the reported device performance
Missing Information: The document states that the device "met the acceptance criteria for bench testing, animal studies, usability, and electrical testing" and "demonstrated equivalent output, stability, and thermal spread control" compared to predicates. However, specific quantitative acceptance criteria and their corresponding reported device performance values are not provided in this 510(k) summary. For example, it doesn't state "Acceptance Criterion: Vessel burst pressure > X mmHg, Reported Performance: Y mmHg."
To illustrate what would be in such a table, based on the mentioned tests:
| Test Category | Specific Test / Parameter | Acceptance Criterion (Hypothetical) | Reported Device Performance (Hypothetical) | Met? |
|---|---|---|---|---|
| Electrical Safety | IEC 60601-1 Compliance (e.g., Leakage Current) | Meets all specified limits of IEC 60601-1 | All limits met | Yes |
| EMC | IEC 60601-1-2 Compliance (e.g., Radiated Emissions) | Meets all specified limits of IEC 60601-1-2 | All limits met | Yes |
| Thermal Spread | Maximum lateral thermal spread (e.g., using specific tissue model) | Thermal spread ≤ Predicate device's spread (or < X mm) | Achieved thermal spread of Y mm (≤ Predicate) | Yes |
| Burst Pressure | Vessel burst pressure (using specific vessel diameter) | Burst pressure ≥ Predicate device's pressure (or ≥ X mmHg) | Achieved burst pressure of Z mmHg (≥ Predicate) | Yes |
| Vessel Sealing | Hemostasis (animal study) | Equivalent or superior hemostasis to predicate devices | Comparable hemostasis observed, no significant differences or improved. | Yes |
| Cutting Capability | Soft tissue transection (animal study) | Equivalent or superior cutting efficiency to predicate devices | Comparable cutting efficiency observed. | Yes |
| Functional Testing | All energy modalities output within specified tolerance | Output power +/- 5% of target across all settings (hypothetical) | All outputs within +/- 3% (hypothetical) | Yes |
| Usability | Human Factors Testing | No critical user errors leading to harm | No critical user errors identified in simulated use. | Yes |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Missing Information: The document does not specify the sample sizes (e.g., number of vessels, number of animal subjects, number of tissue samples, number of human factors participants) for any of the test sets. It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective, though animal studies are typically prospective.
Available Information (Implied/General):
- Test Set: Multiple types of test sets were used, including:
- Bench testing materials (tissue models, test equipment for electrical and EMC)
- Animal subjects (for in vivo studies on vessel and tissue transection)
- Human participants (for human factors testing)
- Data Provenance: Not specified. Animal studies and human factors testing would typically be prospective, conducted in a controlled lab or simulated clinical environment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Missing Information: The document makes no mention of specific experts or their qualifications used to establish ground truth for any of the studies (bench, animal, human factors). For animal studies, surgical observers and pathologists would typically be involved, but their number and experience are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Missing Information: No adjudication method is mentioned for any of the studies. For objective measurements like electrical output or burst pressure, adjudication might not be relevant. For subjective assessments in animal studies (e.g., visual assessment of hemostasis, healing response) or human factors (e.g., observation of user errors), adjudication could be used, but it's not 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
Not Applicable (Based on Device Type): The ETHICON™ Total Energy System is an electrosurgical generator, not an AI-powered diagnostic imaging device or an AI-assisted interpretation tool for human readers. Therefore, an MRMC comparative effectiveness study involving "human readers" and "AI assistance" is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable (Based on Device Type): The device is a physical electrosurgical generator with embedded software for controlling energy delivery. Its performance is inherently "standalone" in terms of its electrosurgical function. There isn't a separate "algorithm only" performance to evaluate in the way one would for a diagnostic AI algorithm. Its software validation focuses on the accurate and safe control of the hardware.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Available Information (Implied):
- Bench Testing: Ground truth is established by objective physical measurements against established engineering specifications and predicate device performance (e.g., output power levels measured by calibrated equipment, thermal readings from thermocouples, force measurements for burst pressure).
- Animal Studies: Ground truth for hemostasis, tissue effects, and healing response would typically be established through:
- Direct surgical observation during acute phase.
- Pathological examination of excised tissue samples in both acute and chronic phases.
- Standard physiological measurements.
- Human Factors Testing: Ground truth for usability and safety is established by observing user interactions and identifying potential use errors, comparing them against safe use criteria.
8. The sample size for the training set
Not Applicable (Based on Device Type/Software Description): The software described for the ETHICON™ Total Energy System is primarily involved in "precise energy delivery, enhance device usability, and support overall safety." This indicates a deterministic control system and user interface software, not a machine learning or AI algorithm that would typically require a "training set" in the context of data-driven learning. The software was validated according to general software validation guidance, implying traditional software engineering verification and validation (V&V), not machine learning model training.
9. How the ground truth for the training set was established
Not Applicable: As there's no indication of a machine learning component requiring a training set, the concept of establishing ground truth for a training set does not apply in the context described in the document. Software validation for this type of device typically uses requirements specifications as the "ground truth" against which the software's performance is tested.
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January 17, 2025
Ethicon Endo-Surgery, LLC (a Johnson and Johnson company) Lovelene Bangalon Sr. Program Lead, Regulatory Affairs 4545 Creek Road Cincinnati. Ohio 45242
Re: K243067
Trade/Device Name: The ETHICON™ Total Energy System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI, HGI, LFL Dated: September 27, 2024 Received: September 27, 2024
Dear Lovelene Bangalon:
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
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assistance/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,
Digitally signed by Long H. Chen
Long H. Chen -S-s
Date: 2025.01.17 12:49:55 -05'00'
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) K243067
Device Name The ETHICON™ Total Energy System
Indications for Use (Describe)
The ETHICON™ Total Energy System is an electrosurgical generator that provides power to monopolar, bipolar, and ultrasonic surgical instruments. It is indicated for surgical procedures requiring outting of soft tissue.
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
| Sponsor: | Ethicon Endo-Surgery, LLC 475 Calle C Guaynabo, PR 00969 |
|---|---|
| Contact: | Lovelene Bangalon, Sr. Regulatory Affairs Program Lead Ethicon Endo-Surgery, LLC Telephone: (714) 510-5683 Email: lbangalo@its.jnj.com |
| Alternate Contact: | Emily Nesbitt, Regulatory Affairs Director Ethicon Endo-Surgery, LLC Telephone: (513) 337-1546 Email: enesbitt@its.jnj.com |
Date Prepared:
January 15, 2025
Device and Classification Information:
| Trade Name: | The ETHICON TM Total Energy System | ||
|---|---|---|---|
| Common Name: | Electrosurgical Cutting and Coagulation Instruments | ||
| ClassificationRegulation: | 21 CFR 878.4400, 21 CFR 884.4120, and Unclassified | ||
| ClassificationName: | Electrosurgical, cutting & coagulation & accessories | ||
| Product Code: | GEI, HGI, LFL | ||
| Device Class: | Class II | ||
| Panel: | 79, General and Plastic Surgery |
Device Description Summary:
The subject device, The ETHICON™ Total Energy System, is an electrosurgical generator that integrates Advanced Energy (Advanced Bipolar and Ultrasonic) and Core Monopolar and Bipolar energy modalities into one system, the Ethicon Total Energy System.
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The subject device consists of two modules: the Communications Module (ETHCM and ETHUSC) and the Energy Module (ETHEM).
Atop the Energy Module is the Communications Module and the User Screen. The Communications Module contains the power button and speakers, connects to the User Screen, distributes power to the system, and provides external interfaces for other connectivity to external devices including Ethernet and USB.
One or two Energy Modules can be connected to the Communications Module. When two Energy Modules are connected, each Energy Module can independently power any of the energy modalities. This feature allows for simultaneous use of two surgical instruments in one system to support complex surgical procedures where two surgeons are operating on a patient at the same time.
The User Screen features a touch-operable graphical user interface (GUI) for system settings adjustment, user profile management, and alarm troubleshooting.
The ETHICON™ Total Energy System accessories include a cart for system transport, footswitches (single, double, round), and an output verification key. The cart provides a mobile platform with adjustable shelves and accessory storage. Additionally, the cart has custom features to create stability for the system including cut-outs on the top shelf for holding the rubber feet of a second module layers. Casters provide 360° mobility with locking tabs that lock to prevent unwanted cart movement.
Footswitches may be used to control power delivery to connected instruments, enabling surgeons to activate the energy output hands-free. The different footswitches can be used for various energy modalities and instruments. Up to four footswitches can be connected to the Communications Module of the Ethicon Total Energy System at the same time. The footswitches are assigned to the desired instrument port via the User Screen GUI.
Output Verification is a service mode of the system used to periodically confirm that the power outputs of each energy modality are within the required specifications. The Energy Output Verification Key is used by biomed/hospital facility servicing personnel to complete this process for annual maintenance on the Energy Module, with on-screen guidance to assist in this process.
The ETHICON™ Total Energy System is compatible with Ethicon HARMONIC™, Ethicon ENSEAL™, and Ethicon MEGADYNE™ monopolar and bipolar instruments.
Intended Use /Indications for Use:
The ETHICON™ Total Energy System is intended to supply energy to surgical devices.
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The ETHICON™ Total Energy System is an electrosurgical generator that provides power to monopolar, bipolar, and ultrasonic surgical instruments. It is indicated for surgical procedures requiring cutting or coagulation of soft tissue.
The subject device has the same indications for use as the predicates.
Indications for Use Comparison:
Indications for use for the subject device are the same as the predicates.
Subject Device Indication:
The ETHICON™ Total Energy System is an electrosurgical generator that provides power to monopolar, bipolar, and ultrasonic surgical instruments. It is indicated for surgical procedures requiring cutting or coagulation of soft tissue.
Predicate Device Indications:
GENERATOR 11, GEN11: The Generator G11 provides radiofrequency power to drive ENSEAL electrosurgical instruments that are used during open or laparoscopic general and gynecological surgery to cut and seal vessels and to cut, grasp, and dissect tissues. In addition, the generator provides power to drive HARMONIC ultrasonic surgical instruments that are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired.
ENSEAL and HARMONIC instruments, when used with the Generator G11, have not been shown to be effective for sterilization procedures or tubal coagulation. Do not use these instruments for these procedures.
MEGADYNE, MEGEN1: 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.
Technological Comparison:
The technological comparison of the subject device, The ETHICON™ Total Energy System, to the predicate devices, as per 21 CFR 807.92(a)(6), establishes substantial equivalence. The subject device integrates the functionalities of two predicates: The Generator 11 and MEGEN1. GEN11 provides radiofrequency capabilities to power electrosurgical instruments for cutting and sealing vessels, while MEGEN 1 serves as a general-purpose electrosurgical generator designed to produce radiofrequency current for cutting and coagulation. The Ethicon Total Energy System combines these core and advanced features to offer a comprehensive solution for surgeons as it incorporates both functionalities into a single surgical generator system. The testing of these functionalities
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demonstrates the capability of the subject device to meet and exceed the performance and safety benchmarks set by the predicate devices.
Based on the intended use and technological comparison, data supports that the subject device is substantially equivalent to the predicate devices in functionality, performance and intended use. The subject device combines the proven capabilities of GEN11 and MEGEN1 while offering additional features and benefits to meet the evolving needs of healthcare professionals. This combination of power functionalities into 1 single system enhances the subject device usability in surgical procedures.
Non-Clinical and/or Clinical Test Summary & Conclusions:
The nonclinical tests provided according to 21 CFR 807.92 include electrical characterization, algorithmic performance verification, functional testing and human factors testing. The subject device's performance was benchmarked against the predicate devices, demonstrating equivalent output, stability, and thermal spread control. Bench testing confirmed instrument vessel sealing and cutting capabilities when powered with the Subject Device. Human factors testing confirmed usability and safety in clinical settings. Pre-clinical testing of hemostasis, healing response and thermal effects indicated safe and effective operation of instruments powered by the subject device comparable to the predicate devices, establishing substantial equivalence.
The premarket submission did not rely on clinical testing. The subject device showed either equivalent or improved performance compared to the predicate devices and met all functional requirements of its features. It successfully met the acceptance criteria for bench testing, animal studies, usability, and electrical testing, demonstrating no new safety or effectiveness issues compared to the predicate.
Testing protocols conducted:
Bench Testing: This included Electrical Safety testing per IEC 60601-1 standards, Electromagnetic Compatibility (EMC) testing as per IEC 60601-1-2 standards, thermal spread testing to evaluate thermal effects on tissue, and burst pressure testing to assess the strength of sealed vessels.
Animal Studies: The in vivo studies focused on vessel and tissue transection capabilities, with assessments conducted during acute and chronic phases to evaluate both immediate and long-term performance.
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Software and Cybersecurity:
The subject device, The ETHICON™ Total Energy System, includes software specifically designed to ensure precise energy delivery, enhance device usability, and support overall safety in clinical environments. The software validation activities were conducted in accordance with FDA guidance, specifically "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". The software has been classified as Enhanced Documentation to reflect the detailed testing and evaluation performed.
Additionally, the validation process adhered to the "General Principles of Software Validation: Guidance for Industry and FDA Staff" FDA guidance, as well as the "Off-The-Shelf Software Use in Medical Devices: Guidance for Industry and Food and Drug Administration Staff" ensuring that all aspects of the software lifecycle meet regulatory requirements.
To fulfill cybersecurity requirements, the FDA guidance "Cybersecurity in Medical Device: Ouality System Considerations and Content of Premarket Submissions" was followed. These measures ensure the software's integrity, reliability, and protection against unauthorized access. It is also important to note that wired foot switches included in this submission do not contain software.
Overall, the subject device has been shown to perform as intended, equivalent or better than the predicate devices.
Substantial Equivalence Comparison:
For purposes of the substantial equivalence comparisons, the following predicate device was selected:
| Tradename | ProductCode | ModalitiesDelivered | 510(k)(Decision Date) |
|---|---|---|---|
| Ethicon Endo-SurgeryGenerator G11 | GEN11 | UltrasonicAdvanced Bipolar | K200841 (11 May 2020) |
| Ethicon MegadyneElectrosurgical Generator | MEGEN1 | Monopolar/ Bipolar | K193145 (24 Mar 2020) |
§ 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.