POTENZA

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. November 5, 2024 Jeisys Medical Inc. % Sanghwa Myung Regulatory Affairs Consultant E&m D-1474. 230. Simin-daero, Dongan-gu Anyang-si, Gyeonggi-do 14067 Korea. South Re: K231287 Trade/Device Name: Potenza Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: November 1, 2024 Received: November 1, 2024 Dear Sanghwa Myung: 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. {1}------------------------------------------------ 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 (QS) 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 {2}------------------------------------------------ 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, Image /page/2/Picture/3 description: The image shows a digital signature. The signature is for James H. Jang -S. The date of the signature is 2024.11.05, and the time is 17:48:59 -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 {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K231287 Device Name POTENZA Indications for Use (Describe) The POTENZA is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### 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." {4}------------------------------------------------ # 510(k) Summary This summary of 510(k) Safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92. Submitter: Jeisys Medical Incorporated 307 Daeryung Techno Town 8th Gamasan-ro 96, Geumcheon-Gu, Seoul, 08501, South Korea Telephone: +82-70-7435-4930 Fax: 82-10-2843-3547 E-mail: jhpark@jeisys.com #### Contact Person: E&M Regulatory Affair/Sang Hwa Myung Telephone: +80-70-7807-0550 FAX: +82-31-388-9263 Cellphone: +82-10-4952-6638 E-mail: mshenmc@gmail.com Primary Contact: Sanghwa Myung Date 510(k) summary prepared: September 19th, 2023 #### I.DEVICE Name of Device: POTENZA Trade name : Fractional RF Microneedle Electrosurgical Unit Classification Name: Electrosurgical cutting and coagulation device and accessories (21 CFR Part 878.4400) Regulatory Class: II Product Code: GEI. #### II.PREDICATE DEVICE Jeisys Medical, Inc. 878.4400 / GEI K201685, POTENZA {5}------------------------------------------------ Note: the POTENZA has not been subject to a design-related recall, removal or correction. #### III.DEVICE DESCRIPTION The POTENZA is an RF (radiofrequency), software-controlled electrosurgical device used for electrocoagulation of soft tissue and hemostasis. The POTENZA generates radiofrequency (RF) energy by means of high RF at 1MHz or 2MHz. The RF energy is delivered through the skin into the target tissue via a handpiece equipped with an electrode tip. As the RF energy passes through the tissue, it generates an electrothermal reaction which is capable of coagulating the tissue. The POTENZA has two operating modes: monopolar mode and bipolar mode. In the monopolar mode, RF energy flows from the main unit and a patient loop is formed by pairing the active electrode tip with the neutral electrode pad. Heat is not generated in the neutral electrode pad due to its low contact resistance, but heat is generated in the active electrode tip which has higher contact resistance. The higher contact resistance heats up the tissue resulting in coagulation. In the bipolar mode, RF energy is delivered between adjacent needles in the electrode tip without use of the neutral electrode pad. The user can select the mode and adjust parameters through the touch screen user interface of the electrosurgical device. The S. handpiece supports monopolar and bipolar operation modes. S. handpiece support bipolar mode by inserting non-invasive tips which is DDR, SFA). Also it support bipolar and monopolar mode by inserting non-invasive tips of Diamond. The clinical use model for the POTENZA is identical to that of comparable electrosurgical devices, intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The NEW POTENZA consists of the following components: - . Electrosurgical Unit - Main body - . handpieces (Predicate Device have Motor, AC handpieces) - . For subject device that add the S handpiece. -> electrode tips for the handpiece – Add three non-invasive tips connect to S handpiece - . Neutral electrode pad and neutral electrode pad cable, cleared under K201685 - . Handpiece stand - . Foot switch - Power cord ## IV.INDICATIONS FOR USE The POTENZA is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. {6}------------------------------------------------ ## V.COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE | Predicate device of POTENZA | Subject device of POTENZA | Substantial Equivalence and<br>Differences | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Jeisys Medical, Inc. | Jeisys Medical, Inc. | - | | 878.4400 / GEI | 878.4400 / GEI | - | | K201685 | Pending | - | | The POTENZA is intended for use in<br>dermatologic and general surgical<br>procedures for electrocoagulation and<br>hemostasis. | The POTENZA is intended for use in<br>dermatologic and general surgical<br>procedures for electrocoagulation and<br>hemostasis. | SE | | Prescription use, only | Prescription use, only | SE | | Monopolar or bipolar RF energy is<br>delivered through micro needle<br>electrode applying heat to target<br>tissue to achieve coagulation and<br>hemostasis | Monopolar or bipolar RF energy is<br>delivered through micro needle<br>electrode applying heat to target tissue<br>to achieve coagulation and hemostasis | SE | | - | - | - | | Monopolar and Bipolar | Monopolar and Bipolar | SE | | 1 MHz / 2 MHz | 1 MHz / 2 MHz | SE | | 0~ 50 watt (step: 1 watt) | 0 ~ 50 watt (step: 1 watt) | SE | | up to 50 W (step: 1 watt)<br>(200 Ω) | up to 50 W (step: 1 watt)<br>(200 Ω) | SE | | 200 Ω | 200 Ω | SE | | 100 V - 240 V~, 50/60 Hz,<br>500 VA | 100 V - 240 V~, 50/60 Hz,<br>500 VA | SE | | 503.2 (W) x 365.6 (L) x 316 (H) | 503.2 (W) x 365.6 (L) x 316 (H) | SE | | 12.5 kg | 12.5 kg | SE | | - | - | - | | Monopolar / Bipolar | Monopolar / Bipolar | SE | | Predicate device of POTENZA | Subject device of POTENZA | Substantial Equivalence and<br>Differences | | • Ten different electrode tips for the<br>motor handpiece: TIP S-49, TIP I-<br>49, TIP S-25, TIP I-25, TIP S-16,<br>TIP I-16, C21-2 TIP, C21-1 TIP,<br>CP-21 TIP, and C9 TIP<br>• Three electrode needle tips for the<br>AC handpiece: P1-08, A1-12, and<br>A1-15 | • Three electrode tips for the S<br>handpiece: DDR TIP, SFA TIP, and<br>Diamond TIP | Different #1<br>The electrode of the newly<br>added handpiece is a non-<br>invasive type, which is<br>different from the previous<br>handpiece and tips.<br>This difference does not<br>affect safety and<br>effectiveness. | | Invasive | Non-Invasive | Different #2<br>The new tip is a type that<br>only contact the skin, and is<br>safer than the invasive type.<br>This difference does not<br>affect safety and<br>effectiveness. | | 1 use or 2 years, whichever occurs<br>first | 1 use or 2 years, whichever occurs first | SE | | Housing: Polycarbonate<br>Insulation: Paracyclophane<br>Needles: STS304 | Gold potassium cyanide,<br>SPI-707 Black Ink | #3 Different<br>The new tip is a type that<br>only contact the skin, and is<br>safer than the invasive type.<br>This difference does not<br>affect safety and<br>effectiveness. | | Single use | Single use | SE | | Ethylene Oxide gas (EO) | Ethylene Oxide gas (EO) | SE | | Neutral Electrode Pad for monopolar<br>operation, K201685 | Neutral Electrode Pad for monopolar<br>operation, K201685 | SE | | | | - | | Transmit RF energy to electrode | Transmit RF energy to electrode | SE | | Single pole, single throw Single pole,<br>single throw | Single pole, single throw Single pole,<br>single throw | Same, no differences | | Steel and plastic | Steel and plastic | Same, no differences | | Single pedal, IPX8 | Single pedal, IPX8 | Same, no differences | {7}------------------------------------------------ The intended use, dermatologic and general surgical procedures for electrocoagulation and hemostasis, of the {8}------------------------------------------------ ## K231287 Subject device of POTENZA is identical to the intended use of the predicate device of POTENZA, cleared under K201685. The technological characteristics of the Subject device of POTENZA are identical to the technological characteristics of the predicate device of POTENZA(K201685) with the sole exception of three invasive electrode tips for the S handpiece and changes to the labelling new electrode tips. For this difference in technological characteristics, reasonable safety and effectiveness can be assured by the completed Design Control and Risk Management activities. ## VI. PERFORMANCE CHARACTERISTICS Verification and validation activities confirmed that the addition of new S handpiece with three electrode tips do not new or different questions of safety or effectiveness. Testing confirmed the continued conformance to applicable technical design specifications and performance requirements including conformance to requirements of recognized consensus standards. ## a) Biocompatibility Testing Jeisys performed biocompatibility testing for the four newly added electrode tips according to FDA's "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process"', June 6, 2016. The new electrode tips are noninvasive devices which come into contact with skin, for a limited period of time, i.e., less than 24 hours. The electrode tips were tested as shown in Table 1 below. Table 1: Non-Invasive Electrode Tips – Biocompatibility Testing | Test Type | Standard | Results | |------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|---------| | Cytotoxicity | ISO 10993-05:2009, Biological evaluation of medical<br>devices - Part 5: Tests for in vitro cytotoxicity | Pass | | Sensitization: Guinea Pig<br>Maximization Test | ISO 10993-10:2010, Biological evaluation of medical<br>devices - Part 10: Tests for irritation and skin<br>sensitization | Pass | | Skin Irritation Test | ISO 10993-10:2010, Biological evaluation of medical<br>devices - Part 10: Tests for irritation and skin<br>sensitization | Pass | #### Electrical safety and electromagnetic compatibility (EMC) a) Electrical safety, EMC, device-related electrical safety for high frequency and usability were conducted on the POTENZA system according to the following consensus standards: - IEC 60601-2-2:2017. Medical electrical equipment Part 2-2: Particular requirements . for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories {9}------------------------------------------------ - . IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and Tests #### b) Bench Testing Jeisys conducted bench testing to assure that the POTENZA operates safely and within the predefined design specifications. Tested parameters included: - Output accuracy (Monopolar at 1MHz and 2 MHz) - Output accuracy (Bipolar at 1MHz and 2MHz) ● - Frequency: manual and standard - . Power fluctuation characteristics - Negative output protection - Impedance measurement accuracy and range - HO count accuracy - Safety test of various warnings / failsafe mechanisms - . Motor speed level - Ex Vivo testing conducted on three types of tissue Liver, Kidney and Muscle under ● GLP Thermal testing in accordance with FDA's "Guidance for Industry and FDA Staff: Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery", August 15, 2014 #### c) Clinical Studies No clinical performance testing was performed. ## VII.CONCLUSIONS The POTENZA device is the same as the predicate device with respect to the principles of operation, technological characteristics, as well as performance characteristics. Non-clinical testing was conducted to evaluate the performance of the subject device in comparison to the predicate device. Results of design validation and verification activities, i.e., testing to designated standards and performance testing of the devices. have demonstrated substantial equivalence of the subject device to the predicate in terms of safety and effectiveness for requested intended use.