Mygen M-3004 RF Generator M-3004

{0}------------------------------------------------ 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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. September 2, 2022 RF Medical Co., Ltd % Dave Kim Regulatory Affairs Mtech Group 7505 Fannin St, Suite 610 Houston, Texas 77054 Re: K221277 Trade/Device Name: Mygen M-3004 RF Generator M-3004 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: April 22, 2022 Received: May 3, 2022 Dear Dave Kim: 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's {1}------------------------------------------------ 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 (OS) 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 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, for 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 {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. 510(k) Number (if known) K221277 Device Name Mygen™ M-3004 RF System ### Indications for Use (Describe) The Mygen M-3004 RF system is intended for use in percutaneous and intraoperative coagulation and ablation of tissue. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------| | <div> <span style="font-size: 10pt;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div> <span style="font-size: 10pt;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> | ### 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}------------------------------------------------ Page 1 of 7 # 510(k) Summary K221277 This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92. #### I. SUBMITTER | Submitter's Name : | RF Medical Co Ltd. | |------------------------------|-------------------------------------------------------------------| | Submitter's HQ Address: | #502~#507,#511, #601 254, Beotkkot-ro<br>Geumcheon-gu Seoul Korea | | Submitter's Telephone: | +82-2-2108-4200 | | Contact person: | Kwang S. Choi (ra@rfa.co.kr) / RD Manager | | Official Correspondent: | Dave Kim (davekim@mtech-inc.net) | | Address: | 7505 Fannin St. Suite 610, Houston, TX 77054 | | Telephone: | +713-467-2607 | | SUBJECT DEVICE | | | Trade/proprietary name: | Mygen™ M-3004 RF System | | Regulation Name: | Electrosurgical, cutting & coagulation device & accessories | | Regulation Number: | 21 CFR 878.4400 | | Product Code: | GEI | | Regulatory Class: | Class II | | Prescription Use. | | | PREDICATE DEVICE | | | Primary Device Manufacturer: | RF Medical Co., Ltd | | Device Name: | Mygen V-1000 RF System | | 510(k) Number: | K180999 | | Regulation Name: | Electrosurgical, cutting & coagulation device & accessories | | Regulation Number: | 21 CFR 878.4400 (Product Code: GEI) | | Regulatory Class: | Class II | | | | {4}------------------------------------------------ ### Page 2 of 7 | 1st REFERENCE DEVICE | | |------------------------------|-------------------------------------------------------------| | Primary Device Manufacturer: | STARmed Co., Ltd | | Device Name: | VIVA Combo RF System | | 510(k) Number: | K163450 | | Regulation Name: | Electrosurgical, cutting & coagulation device & accessories | | Regulation Number: | 21 CFR 878.4400 (Product Code: GEI) | | Regulatory Class: | Class II | | 2nd REFERENCE DEVICE | | | Primary Device Manufacturer: | Covidien LLC | | Device Name: | Cool-tip RF Ablation System | | 510(k) Number: | K203150 | | Regulation Name: | Electrosurgical, cutting & coagulation device & accessories | | Regulation Number: | 21 CFR 878.4400 (Product Code: GEI) | | Regulatory Class: | Class II | This predicate has not been subject to a design-related recall. #### II. DEVICE DESCRIPTION Mygen M-3004 RF System consists of a microprocessor based RF generator, a cooling pump and tubing, electrodes, and ground pads. The generator, pump and electrodes are designed to produce local tissue heating at the tip of the electrodes causing the coagulation (ablation) of the tissue. Mygen M-3004 RF System generator is capable of delivering up to 200 waits (into a 50 Ohm resistive load) while monitoring tissue impedance and electrode tip temperature during the RF energy. The generator includes manual and impedance control and displays/monitors impedance, current, power and temperature. The radiofrequency (RF) energy, which is delivered to an electrode, makes frictional heat for coagulation and ablation on diseased tissue by ionic agitation. The patient can receive safe therapy as leakage current is extremely low. Mygen M-3004 continually measures and displays RF output power, tissue impedance, and elapsed time of RF delivery. Tissue temperature is measured by the thermocouple embedded in the electrode tip and is displayed on the touch screen. This equipment automatically adjusts the output to maximize the delivery of high-frequency energy and displays the measured temperature from the treatment site during high-frequency emission. {5}------------------------------------------------ Mygen M-3004 automatically adjusts the output to optimize radiofrequency output and displays the measured temperature from the treatment area while delivering radiofrequency energy. #### INDICATIONS FOR USE: III. The Mygen M-3004 RF system is intended for use in percutaneous and intraoperative coagulation and ablation of tissue. | | Proposed device | Predicate device | Remark | |----------------------------------|-----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|--------| | Model name | M-3004 RF system | Mygen V-1000 RF system<br>(K180999) | | | Manufacturer | RF Medical Co., Ltd | RF Medical Co., Ltd | | | | The M-3004 RF system is<br>intended for use in<br>percutaneous and<br>intraoperative coagulation<br>and ablation of tissue. | The Mygen V-1000 RF system is<br>intended for use in percutaneous<br>and intraoperative coagulation<br>and ablation of tissue. | Same | | Type of Use | Prescription Use | Prescription Use | Same | | Components | Electrosurgical unit, active<br>electrode, grounding pad,<br>peristaltic pump and foot<br>pedal | Electrosurgical unit, active<br>electrode, grounding pad,<br>peristaltic pump and foot pedal | Same | | Electrosurgical RF<br>applicator | Monopolar<br>bipolar | Monopolar | SE | | Output energy<br>type | High frequency | High frequency | Same | | Operation mode | Manual mode / Auto mode | Manual mode / Auto mode | Same | | User interface | Color Touch Panel | Color Touch Panel | Same | | Electrical<br>Requirements | 110VC, 50/60Hz, 410VA | 110VAC, 50/60Hz, 300VA | SE | | Output Frequency | 480kHz ± 10% | 400kHz ± 10% | Same | | Max power | Max 200W @ 50Ω | Max 140W @ 50Ω | SE | | Power of per<br>electrode<br>pin | Max 200W | Max 140W | SE | | Power density | Max 200 W/cm² | Max 140 W/cm² | SE | | Treatment time | Up to 30min | 12 min , Up to 30 min | SE | | Electrode Length<br>(mm) | 60,70,100,150,200,250,300,<br>350 | 70, 100 | SE | | Exposure Tip Length<br>(mm) | 5, 10, 15, 20, 25, 30, 35, 40 | 5, 10,15. 20 | SE | ### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE IV. PREDICATE DEVICE {6}------------------------------------------------ | | Proposed device | Predicate device | Remark | |------------|------------------|------------------|--------| | Intensity | 0~240W (1W step) | 0~140W (1W step) | SE | | Sterile | EO Sterilization | EO Sterilization | Same | | Single Use | Single Use | Single Use | Same | # 1st Reference Device | | Proposed device | Reference device | Remark | |----------------------------------|-----------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|---------| | Model name | M-3004 RF system | VIVA COMBO RF SYSTEM<br>(K163450) | | | Manufacturer | RF MEDICAL CO.,LTD | STARmed Co., Ltd. | | | | The M-3004 RF system is<br>intended for use in<br>percutaneous and<br>intraoperative coagulation<br>and ablation of tissue. | The VIVA combo RF Ablation<br>System is intended for use in<br>percutaneous and intraoperative<br>coagulation and ablation of<br>tissue. | Same | | Electrosurgical RF<br>applicator | Monopolar / Bipolar<br>electrode | Monopolar Applicator | Similar | | Output energy<br>type | High frequency | High Frequency | Same | | Delivery system | Electrosurgical unit, active<br>electrode, grounding pad,<br>peristaltic pump and foot<br>pedal | Electrosurgical unit, active<br>electrode, grounding pad,<br>peristaltic pump and foot<br>pedal | Same | | Output Frequency | 480 kHz ± 10 % | 480 kHz ± 10 % | Same | | Electrode Length (mm) | 60,70,100,150,200,250,<br>300,350 | 70, 150, 200 | Similar | | Exposure Tip Length<br>(mm) | 5, 10, 15, 20, 25, 30, 35, 40 | 5, 10, 15, 20, 25, 30 | Similar | | RF Duration | Up to 30 minutes | Up to 30 minutes | Same | | Maximum Power Output | Up to 200 watts @ 50 Ω | Up to 200 watts @ 50 Ω | Same | # 2nd Reference Device | | Proposed device | Reference device | Remark | |--------------|-----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------| | Model name | M-3004 RF system | Cool-tip RF Ablation System<br>(K203150) | | | Manufacturer | RF MEDICAL CO.,LTD | Covidien LLC | | | Intended use | The M-3004 RF system is<br>intended for use in<br>percutaneous and<br>intraoperative coagulation<br>and ablation of tissue. | The Cool-tip RF Ablation<br>System E Series (generator,<br>pump, patient return electrodes,<br>water container, active<br>electrodes, footswitch, and<br>accessories) is intended for use<br>in percutaneous, laparoscopic,<br>and intraoperative coagulation | Same | {7}------------------------------------------------ | | Proposed device | Reference device | Remark | |-----------------------------|-------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|---------| | | | and ablation of tissue, including<br>partial or complete ablation of<br>non-resectable liver tumors. | | | Output energy<br>type | High frequency | High Frequency | Same | | Delivery system | Electrosurgical unit, active<br>electrode, grounding pad,<br>peristaltic pump and foot<br>pedal | Electrosurgical unit, active<br>electrode, grounding pad,<br>peristaltic pump and foot<br>pedal | Same | | Electrode Length (mm) | 60,70,100,150,200,250,300,350 | 100, 150, 200, 250 | Similar | | Exposure Tip Length<br>(mm) | 5, 10, 15, 20, 25, 30, 35, 40 | 7, 10, 20, 25, 30, 40 | Similar | | Maximum Power Output | Up to 200 watts @ 50 Ω | Up to 200 watts @ 50 Ω | Same | #### V. PERFORMANCE DATA The following performance data was provided in support of the substantial equivalence determination. In order to verify the device performance, the worst case was selected from each of the 4 types of electrodes included in the subject device. BIG-TIP(BTM3540QB) / JET-TIP®(JET3540XB) / VARY-TIP™(VCTU20XXB) / THYBLATE™(RFTP10XXHLN) Worst case was selected based on the high energy transfer rates: diameter thickness, long exposure, and longest needle length for each type. A total of 6 performance comparison tests were conducted with the selected 4 types of handpieces and the performance outcome was verified through CSA group's testing lab. - Test List - - (1) Accuracy of output - (2) Accuracy of energy transfer - (3) Active electrode resistor - (4) High frequency and mains frequency dielectric strength of active electrode - (5) Accuracy of tip temperature - (6) High frequency leakage of active electrode ## Biocompatibility testing: The patient contact components and materials are tested and validated according to ISO10993-1;2009 {8}------------------------------------------------ Biocompatibility Cytotoxicity study using MEM elution assay in L929 cells found that the extract from the test subject is non-cytotoxic Guinea Pig Maximization Test for Delayed Hypersensitivity result shows that the test subject is a nonsensitizer and non-allergenic material to the guinea pigs. Intracutaneous Reactivity Test result shows that the test subject is considered as a non-skin irritant. since the difference between the test extract and control score is less than 1 in both physiological saline and vegetable oil. Pyrogen Testing in New Zealand White Rabbits shows that the test subject is free of material mediated pyrogens and does not exhibit pyrogenicity potential in New Zealand White Rabbits Acute Systemic Toxicity test result shows that the test subject is not toxic to the ICR mice after single intravenous injection at a dose level of 20 mL/kg. LAL Validation and quantitative LAL test item showed endotoxin levels less than 0.0500 EU/device. Therefore, the requirement (endotoxin level < 20 EU/device) outlined as endotoxin tolerance limit K has been fulfilled for the tested device. ## Non Clinical testing: IEC 60601-1 Test for Medical Electrical Equipment was performed for General Requirements for basic safety and essential performance. The requirements of specified standards were fulfilled. IEC 60601-1-2 Test for Medical Electrical Equipment was performed for General Requirements for basic safety and essential performance (collateral standards: electromagnetic compatibility. IEC 60601-2-2: 2017 Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories ## Sterilization and Shelf Life The active electrode of Mygen M-3004 RF system is delivered in a sterile state and is intended for single use only. The sterilization method used is ethylene oxide and this device has a shelf life of 3 years. {9}------------------------------------------------ The requirements of sterilization testing standards including ISO 10993-7: 2008, ASTM F1929-15: 2015, and ASTM F88/F88M-15: 2015 were fulfilled. ## Animal testing : In vivo animal testing using micropig models was also conducted with Mygen M-3004 RF system to obtain histological data of values for depth and zone of ablation and thermal damage immediately post treatment; 7 days post treatment; and 14 days post treatment. The treatment was performed at the intensity(power) 10W, 60W, 120W, 200W and depth of needling 3mm, 5mm, 10mm, 15mm, 20mm, 25mm, 30mm, 35mm, 40mm. #### CONCLUSIONS VI. There are no significant differences between Mygen M-3004 RF system the subject device, and Mygen V-1000, the predicate device. The proposed device does not raise any questions regarding safety and effectiveness. Mygen M-3004 RF system has the same indication of use as the predicate device. All systems share the same technological characteristics. In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, it is the opinion of RF Medical Co, Ltd. that Mygen M-3004 RF system is substantially equivalent in comparison with the predicate device and the reference devices.