(132 days)
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No
The document describes a microprocessor-controlled electrosurgical generator and mentions using open-source image processing software for thermal damage analysis during testing. There is no mention of AI, ML, or any related technologies being incorporated into the device's functionality or control.
Yes
The device is described as an electrosurgical generator designed for "cutting and coagulation to target tissue" during surgical procedures, which are therapeutic interventions.
No
The device is described as an electrosurgical generator designed to produce RF current for cutting and coagulation of tissue, which are therapeutic actions, not diagnostic ones.
No
The device description explicitly states it is a "microprocessor controlled, isolated output, high frequency generator" and is intended to "produce radio frequency (RF) current for cutting and coagulation to target tissue through an accessory electrode." This indicates a hardware component (the generator) that produces energy and interacts directly with tissue, which is not characteristic of a software-only medical device. While software is involved in controlling the device, it is not the primary functional component.
Based on the provided information, the Ethicon Megadyne® Electrosurgical Generator is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to produce RF current for cutting and coagulation of tissue during surgical procedures on a patient. This is an in-vivo application, directly on living tissue within the body.
- Device Description: The device is designed for use in surgical applications, performing monopolar and bipolar procedures on tissue.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue samples) outside the body to provide information for diagnosis, monitoring, or treatment. This device does not perform any analysis of specimens.
- Mentions of Tissue: While the document mentions testing on ex-vivo tissue, this is for performance evaluation of the device's effect on tissue, not for diagnostic purposes based on analyzing the tissue itself. The image processing is used to measure the thermal damage caused by the device, not to diagnose a condition from the tissue.
In summary, the Ethicon Megadyne® Electrosurgical Generator is a surgical device used directly on a patient's tissue during a procedure, which is the opposite of an in-vitro diagnostic device.
N/A
Intended Use / 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 target tissue through an accessory electrode during open and laparoscopic surgical procedures.
Product codes
GEI
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.
Mentions image processing
Thermal damage on tissue was measured through image analysis using open source image processing software.
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Studies:
- Biocompatibility testing
- Electrical Safety and Electromagnetic Compatibility (IEC standard 60601-1 and IEC 60601-2-2, IEC 60601-1-2)
- Sterilization/Shelf-Life
- Bench Testing on thermal effects on tissue (Ex-vivo harvested animal tissue from skeletal muscle, liver and kidney)
- Software Verification and Validation Testing (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")
- Design Validation Testing
Key Results: Thermal effects on tissue are not significantly different from the predicate device.
Key Metrics
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Predicate Device(s)
Mega Power Electrosurgical Generator initially cleared under K050579 on March 24, 2005.
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around it. On the right, there is the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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)
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.
| 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
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.
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 Electrosurgical
Generator (Subject) | MEGA Power Electrosurgical
Generator (Predicate Device) | |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| Operating Low/High
Mains Voltage
(Domestic) | 90 to 132 VAC@ 50/60Hz | Same | |
| | Operating Low/High
Mains
Voltage (international) | 216 to 264 VAC @ 50/60 Hz | 240 to 264 VAC @ 50/60 Hz |
| | | Operating
Altitude/Pressure
Maximum Operating
Duty
Cycle | 700 hPa to 1060 hPa 25% at maximum
power into rated load |
| Device Characteristic | | | Ethicon Megadyne Electrosurgical
Generator (Subject) |
| Current Rating | Maximum Current Rating 5.0 Amps | | Same |
| Power Consumption | Maximum Power Consumption