Potenza

K192545 · Jeisys Medical Incorporated · GEI · Feb 20, 2020 · General, Plastic Surgery

Device Facts

• Record ID: K192545
• Device Name: Potenza
• Applicant: Jeisys Medical Incorporated
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Feb 20, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The POTENZA is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

Device Story

Potenza is a software-controlled electrosurgical device for soft tissue electrocoagulation and hemostasis. It utilizes high-frequency radiofrequency (RF) energy at 1MHz or 2MHz. The system comprises a main electrosurgical unit, two handpieces (motor and AC), single-use sterile electrode/needle tips, a neutral electrode pad, and a footswitch. In monopolar mode, RF energy flows between an active electrode tip and a neutral pad; in bipolar mode, energy flows between adjacent needles in the tip. The user selects modes and adjusts parameters via a touchscreen interface. Used in clinical settings by healthcare professionals, the device generates electrothermal reactions in target tissue to achieve coagulation. It provides clinicians with adjustable power and frequency settings to manage tissue effects during dermatologic and surgical procedures, potentially benefiting patients through controlled, localized tissue treatment.

Clinical Evidence

No clinical or animal studies were performed. Substantial equivalence was demonstrated through bench testing, including biocompatibility (ISO 10993), electrical safety (IEC 60601-1, IEC 60601-2-2), EMC (IEC 60601-1-2), and software verification/validation. Bench testing confirmed output accuracy, impedance measurement, and failsafe mechanism functionality.

Technological Characteristics

RF electrosurgical device; 1MHz/2MHz output frequency; monopolar and bipolar modes. Components: main unit, motor/AC handpieces, single-use sterile electrode/needle tips, neutral electrode pad. Materials: biocompatible electrode tips (ISO 10993). Connectivity: touchscreen UI for parameter adjustment. Standards: IEC 60601-1, IEC 60601-2-2, IEC 60601-1-2, IEC 60601-1-6. Software: moderate level of concern.

Indications for Use

Indicated for dermatologic and general surgical procedures requiring electrocoagulation and hemostasis.

Regulatory Classification

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.

Predicate Devices

• INTRAcel Premium Fractional RF Micro Needle (FRM) System (K153727)
• InMode System with Fractora3D/3D-90 Applicators (K180189)

Reference Devices

• AGNES (K160469)
• Secret RF (K170325)

Submission Summary (Full Text)

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February 20, 2020

Jeisys Medical Incorporated % Pamela Weagraff Director, MedTech Regulatory IOVIA 18 Bridie Lane Norfolk, Massachusetts 02056

Re: K192545

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: January 20, 2020 Received: January 21, 2020

Dear Pamela Weagraff:

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.

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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 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 ([e-mail]) or phone [phone] 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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Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known) K192545

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)

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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# 510(k) Summary 1

#### 510(K) SUBMITTER I.

## a) Company Name and Address

Jeisys Medical Incorporated 307 Daeryung Techno Town 8th Gamasan-ro 96, Geumcheon-Gu Seoul 08501 KOREA

## b) Company Contact:

Wonchel Choi, Deputy Manager, Regulatory Affairs Jeisys Medical, Inc. 811, Daeryung Techno Town 8th, 96, Gamasan-ro, Geumcheon-gu Seoul, 08501, Korea

Phone: [phone]

- c) Date Prepared: February 19, 2020
#### II. DEVICE

Name of Device: POTENZA

Common or Usual Name: Electrosurgical coagulation device and accessories

Classification Name: Electrosurgical cutting and coagulation device and accessories (21 CFR Part 878.4400)

Regulatory Class: II

Product Code: GEI

#### PREDICATE DEVICE III.

## a) Predicate Devices

- Predicate Device 1: INTRAcel Premium Fractional RF Micro Needle (FRM) System, K153727
- Predicate Device 2: InMode System with Fractora3D/3D-90 Applicators, K180189 ●

## b) Reference Devices

- Reference Device 1: AGNES, K160469
- Reference Device 2: Secret RE , K170325 ●

¹ Prepared according to FDA's "Guidance for Industry and FDA Staff: The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" July 24, 2014

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Note: none of the above mentioned devices have been subject to a design-related recall, removal or correction.

#### IV. DEVICE DESCRIPTION

The POTENZA is an RF (radiofrequency), software-controlled electrosurgical device used for electrocoagulation of soft tissue and hemostasis.

The POTENZA consists of the following components:

- o Electrosurgical Unit - Main body
- o Two different handpieces ( motor and AC)
- Six different electrode tips for the motor handpiece and three needle tips for the AC handpiece; provided as single use, sterile products
- Neutral electrode pad and neutral electrode pad cable, cleared under K092761
- Handpiece stand ●
- o Foot switch
- Power cord

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 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.

#### V. INDICATIONS FOR USE

The POTENZA is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

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#### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The POTENZA compares to the predicate devices and reference devices as follows:

- . The principle of operation of the POTENZA is the same as the predicate devices with respect delivery of bipolar RF energy through micro needle electrode to achieve coagulation and hemostasis. It differs from the predicate devices, in that the POTENZA also supports monopolar mode of energy delivery. Reference device 1, however also supports monopolar RF energy delivery.
- Electrosurgical Unit:
- > The POTENZA bipolar operating mode is the same as the predicate devices. It differs from the predicate devices in that it also supports a monopolar operating mode. Reference device 1. however, also supports monopolar RF energy delivery.
- Λ The POTENZA is the same as the predicate devices with respect to output frequency of 1MHz. It differs from the predicate devices in that it also operates at 2 MHz. however. reference device 2 also supports an output frequency of 2MHz.
- Λ The POTENZA is the same as predicate device 1 with respect to flexibility to operate up to 50 W. The sole difference is the number of levels up to 50 W, 10 versus 7 levels. However, reference device 2 also offers normal operating power over 10 levels.
- > The maximum power available with the POTENZA is the same as predicate device 1. There are no differences.
- > The impedance available with the POTENZA is the same as predicate device 1. There are no differences.
- > The POTENZA power source is the same as predicate device 1. There are no differences.
- Active Accessory (Electrode): ●
- > The POTENZA bipolar operating mode is the same as the predicate devices. It differs from the predicate devices in that it also supports a monopolar operating mode. Reference device 1, however, also supports monopolar RF energy delivery.
- > The POTENZA is the same as the predicate devices with respect to the electrode type. There are no differences.
- > The POTENZA is the same as predicate device 1 with respect to the RF treatment area. There are no differences.
- > The material of the POTENZA active electrode is the same as predicate device 1 with respect to the electrode type. There are no differences.
- > The POTENZA is the same as the predicate devices with respect to the active electrode being intended for single use. There are no differences.
- > The POTENZA is the same as predicate device 2 with respect to depth of Skin ablation: up to 4.0 mm. There are no differences.
- Neutral Electrode Pad: the POTENZA includes a 510(k)-cleared neutral electrode pad ● for monopolar operation which is similar to the reference device 1.

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#### VII. PERFORMANCE DATA

### a) Biocompatibility Testing

Jeisys performed biocompatibility testing for the 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. Of the POTENZA components, only the electrode tips and neutral electrode pad come into direct contact with the patient. The electrode tips are external communicating devices which come into contact with tissue / bone / dentin, for a limited period of time, i.e., less than 24 hours. The neutral electrode pad is a surface device which comes into contact with intact skin, also for a limited period of time.

Since the neutral electrode pad is a purchased component and has received a 510(k) clearance decision, K092761, biocompatibility testing was not performed. The electrode tips were tested as shown in Table 1 below.

| Test Type | Standard | Results |
|-------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Cytotoxicity | ISO 10993-05:2009, Biological evaluation of medical<br>devices - Part 5: Tests for in vitro cytotoxicity<br>USP 41:2018 <87> Biological Reactivity Tests, in vitro<br>elution test | Pass |
| Sensitization: Guinea Pig<br>Maximization Test (GPMT) | ISO 10993-10:2010, Biological evaluation of medical<br>devices - Part 10: Tests for irritation and skin<br>sensitization | Pass |
| Irritation or Intracutaneous<br>Reactivity [Animal<br>Intracutaneous (Intradermal)<br>Reactivity Test | ISO 10993-10:2010, Biological evaluation of medical<br>devices - Part 10: Tests for irritation and skin<br>sensitization | Pass |
| Acute Systemic Toxicity | ISO 10993:2017, Biological evaluation of medical<br>devices - Part 11: Tests for systemic toxicity | Pass |
| Hemolysis | ISO 10993-4, Biological evaluation of medical devices -<br>Part 4: Selection of tests for interactions with blood | Pass |
| | ASTM F756, Standard Practice for Assessment of<br>Hemolytic Properties of Materials | |
| USP Rabbit Pyrogen | ISO 10993-11, Biological evaluation of medical devices<br>- Part 11: Tests for systemic toxicity | Pass |
| | USP, General Chapter < 151 >, Pyrogen Test | |

Table 1: Electrode Tips – Biocompatibility Testing

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## b) Electrical safety and electromagnetic compatibility (EMC)

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 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2-12, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance
- IEC 60101-2-2:2017. 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
- 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
- IEC 60601-1-6:2010, AMDI:2013, Medical electrical equipment Part 1-6, General . requirements for Safety – Collateral Standard: Usability

## c) Software Verification and Validation Testing

Software verification and validation testing was conducted for the subject device, and documentation was provided in accordance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", May 11, 2005, commensurate with a moderate level of concern.

## d) 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 ●
- Needle depth
- Motor speed level
- . 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

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### e) Animal Studies / Clinical Studies

The differences between the POTENZA and the predicate and reference devices did not require animal testing or clinical testing in humans.

#### VIII. CONCLUSIONS

The subject POTENZA device is similar to the predicate and reference devices with respect to the principles of operation, technological characteristics, as well as performance characteristics. Non-clinical testing was conducted to evaluate the performance of 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.