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. The NEW POTENZA consists of the following components: Electrosurgical Unit - Main body, handpieces (Predicate Device have Motor, AC handpieces), 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.

AI/ML Overview

This 510(k) summary describes a device (POTENZA) that is substantially equivalent to a previously cleared predicate device. The key changes are the addition of a new S handpiece and three new non-invasive electrode tips. The provided text primarily focuses on demonstrating the safety and effectiveness of these additions through non-clinical testing rather than complex AI performance studies. As such, many of the requested points regarding AI acceptance criteria, MRMC studies, and large-scale data sets are not directly applicable or available in this specific document.

However, based on the provided text, we can describe the acceptance criteria and study that proves the device meets them as they relate to the changes in the device.

1. Table of Acceptance Criteria and Reported Device Performance

For the specific changes (new S handpiece and non-invasive tips), the acceptance criteria are generally focused on safety and functionality demonstrating equivalence to the predicate device.

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred from text)	Reported Device Performance (as stated or inferred)
Biocompatibility	All four newly added electrode tips must pass biocompatibility tests (Cytotoxicity, Sensitization, Skin Irritation) as per ISO 10993 standards for devices with limited skin contact (<24 hours).	Pass: All specified tests (Cytotoxicity, Sensitization: Guinea Pig Maximization Test, Skin Irritation Test) were passed for the non-invasive electrode tips as per ISO 10993-05:2009 and ISO 10993-10:2010.
Electrical Safety & EMC	The POTENZA system (including new components) must conform to recognized consensus standards for electrical safety and electromagnetic compatibility (EMC), specifically IEC 60601-2-2:2017 and IEC 60601-1-2:2014.	Conformity: Electrical safety, EMC, device-related electrical safety for high frequency, and usability were conducted according to IEC 60601-2-2:2017 and IEC 60601-1-2:2014. Implies successful conformance.
Bench Testing / Performance	The device (with new handpiece and tips) must operate safely and within predefined design specifications, including accurate output power (monopolar/bipolar, 1MHz/2MHz), correct frequency, stable power fluctuation, negative output protection, accurate impedance measurement, HO count accuracy, motor speed, and safe failure mechanisms.	Conformity: Bench testing was conducted to assure safe operation and conformance to design specifications. Tested parameters included (and implicitly passed): Output accuracy (Monopolar/Bipolar at 1MHz and 2MHz), Frequency, Power fluctuation, Negative output protection, Impedance measurement accuracy/range, HO count accuracy, Safety test of various warnings/failsafe mechanisms, Motor speed level.
Ex Vivo Testing	Must demonstrate appropriate electrocoagulation and hemostasis characteristics on various tissue types (Liver, Kidney, Muscle) under GLP, and thermal testing in accordance with FDA guidance.	Conformity: Ex Vivo testing was conducted on three types of tissue (Liver, Kidney and Muscle) under GLP. Thermal testing was done 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. Implies successful outcomes for these tests.
Impact on Safety & Effectiveness	The addition of new S handpiece with three electrode tips must not introduce new or different questions of safety or effectiveness.	No New Questions: Verification and validation activities confirmed that the additions do not introduce new or different questions of safety or effectiveness. The new tip is explicitly stated as being "safer than the invasive type" due to being non-invasive.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify numerical sample sizes for most performance tests (e.g., number of units tested for electrical safety, number of times functions were tested). For biocompatibility, it refers to standard ISO test protocols, which imply specific sample sizes for each test type (e.g., Guinea Pig Maximization Test typically involves a certain number of animals). For Ex Vivo testing, it mentions "three types of tissue (Liver, Kidney and Muscle)," but not the quantity of each.
Data Provenance: The tests are described as non-clinical (bench and ex vivo) and conducted by Jeisys. There is no information regarding country of origin for data samples (as it's not a clinical study involving patients), or if the testing was retrospective or prospective. It is implied to be prospective testing specifically for this 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document as it pertains to AI/clinical ground truth establishment, which is not the focus of this 510(k) submission for an electrosurgical device modification. The "ground truth" here is based on engineering specifications and recognized consensus standards (e.g., ISO, IEC).

4. Adjudication Method for the Test Set

This information is not applicable/provided as it relates to expert review of data (e.g., medical images for AI), which is not detailed for this type of device submission. Performance is based on objective measurements against engineering specifications and standard test protocols.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical performance testing was performed." MRMC studies are typically for evaluating the impact of AI on human reader performance, which is not relevant here as there is no AI component or clinical reader assessment being evaluated.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable. This device is an electrosurgical unit, not an algorithm. There is no standalone algorithm performance described.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance validation is based on:

Engineering Specifications: Predefined design parameters for power output, frequency, impedance, motor speed, etc.
Recognized Consensus Standards: International standards like ISO 10993 (biocompatibility) and IEC 60601 series (electrical safety, EMC).
FDA Guidance Documents: Bench and thermal testing were conducted in accordance with FDA guidance for electrosurgical devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. As there is no training set, there is no ground truth establishment for it.

Summary

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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.

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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 (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

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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,

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

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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)

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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

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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.

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V.COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Predicate device of POTENZA	Subject device of POTENZA	Substantial Equivalence andDifferences
Jeisys Medical, Inc.	Jeisys Medical, Inc.	-
878.4400 / GEI	878.4400 / GEI	-
K201685	Pending	-
The POTENZA is intended for use indermatologic and general surgicalprocedures for electrocoagulation andhemostasis.	The POTENZA is intended for use indermatologic and general surgicalprocedures for electrocoagulation andhemostasis.	SE
Prescription use, only	Prescription use, only	SE
Monopolar or bipolar RF energy isdelivered through micro needleelectrode applying heat to targettissue to achieve coagulation andhemostasis	Monopolar or bipolar RF energy isdelivered through micro needleelectrode applying heat to target tissueto 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)(200 Ω)	up to 50 W (step: 1 watt)(200 Ω)	SE
200 Ω	200 Ω	SE
100 V - 240 V~, 50/60 Hz,500 VA	100 V - 240 V~, 50/60 Hz,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 andDifferences
• Ten different electrode tips for themotor handpiece: TIP S-49, TIP I-49, TIP S-25, TIP I-25, TIP S-16,TIP I-16, C21-2 TIP, C21-1 TIP,CP-21 TIP, and C9 TIP• Three electrode needle tips for theAC handpiece: P1-08, A1-12, andA1-15	• Three electrode tips for the Shandpiece: DDR TIP, SFA TIP, andDiamond TIP	Different #1The electrode of the newlyadded handpiece is a non-invasive type, which isdifferent from the previoushandpiece and tips.This difference does notaffect safety andeffectiveness.
Invasive	Non-Invasive	Different #2The new tip is a type thatonly contact the skin, and issafer than the invasive type.This difference does notaffect safety andeffectiveness.
1 use or 2 years, whichever occursfirst	1 use or 2 years, whichever occurs first	SE
Housing: PolycarbonateInsulation: ParacyclophaneNeedles: STS304	Gold potassium cyanide,SPI-707 Black Ink	#3 DifferentThe new tip is a type thatonly contact the skin, and issafer than the invasive type.This difference does notaffect safety andeffectiveness.
Single use	Single use	SE
Ethylene Oxide gas (EO)	Ethylene Oxide gas (EO)	SE
Neutral Electrode Pad for monopolaroperation, K201685	Neutral Electrode Pad for monopolaroperation, K201685	SE
		-
Transmit RF energy to electrode	Transmit RF energy to electrode	SE
Single pole, single throw Single pole,single throw	Single pole, single throw Single pole,single throw	Same, no differences
Steel and plastic	Steel and plastic	Same, no differences
Single pedal, IPX8	Single pedal, IPX8	Same, no differences

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The intended use, dermatologic and general surgical procedures for electrocoagulation and hemostasis, of the

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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 medicaldevices - Part 5: Tests for in vitro cytotoxicity	Pass
Sensitization: Guinea PigMaximization Test	ISO 10993-10:2010, Biological evaluation of medicaldevices - Part 10: Tests for irritation and skinsensitization	Pass
Skin Irritation Test	ISO 10993-10:2010, Biological evaluation of medicaldevices - Part 10: Tests for irritation and skinsensitization	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

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. 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.

Regulation Number and Section

§ 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.