(59 days)
No
The document describes a microprocessor-controlled electrosurgical generator and mentions image processing for thermal damage analysis, but there is no mention of AI, ML, or related concepts being used within the device's core functionality for cutting or coagulation.
Yes
The device is intended for cutting and coagulation of tissue during surgical procedures, which are therapeutic actions.
No
The device is an electrosurgical generator designed to produce radio frequency current for cutting and coagulation of tissue during surgical procedures, not for diagnosing conditions.
No
The device description clearly states it is a "microprocessor controlled, isolated output, high frequency generator" and mentions electrical safety and electromagnetic compatibility testing according to hardware standards (IEC 60601 series). While it includes software, it is an electrosurgical generator, which is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is 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." This describes a device used directly on tissue within the body during surgery.
- Device Description: The description reinforces its function in "cutting and coagulation of tissue" using RF current.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens (like blood, urine, tissue samples) outside the body to provide information about a patient's health. This device does not perform any such analysis of specimens.
- Bench Testing: While the bench testing mentions "thermal damage on tissue was measured through image analysis," this is a method used to evaluate the effect of the device on tissue, not a diagnostic test performed on a specimen.
Therefore, the Ethicon Megadyne Electrosurgical Generator is a surgical device used for cutting and coagulation, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
GEI
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
- 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: 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 Medical Devices". The recommended documentation for a software with a "Major" level of concern is provided in the software section of the submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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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 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