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 IMHz 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.

AI/ML Overview

The provided text is a 510(k) Summary for the POTENZA device, which is an electrosurgical cutting and coagulation device. The document primarily focuses on demonstrating substantial equivalence to a predicate device (also named POTENZA, K201685) rather than presenting a study to prove acceptance criteria for a new device.

The "acceptance criteria and reported device performance" in this context refer to the performance standards and test results that show the modified device is substantially equivalent to the previously cleared predicate device.

Here's an analysis of the provided information, framed to address your request as best as the document allows:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a performance study. Instead, it details various tests performed to demonstrate that the changes made to the device (new electrode tips) do not raise new questions of safety or effectiveness and that the device continues to conform to applicable standards. The "reported device performance" are the results of these tests, which consistently show "Pass."

Test Type	Standard / Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility Testing (for new electrode tips)
Cytotoxicity	ISO 10993-05:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (Implied acceptance: pass cytotoxicity assessment)	Pass
Sensitization: Guinea Pig Maximization Test	ISO 10993-10:2021 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (Implied acceptance: no sensitization)	Pass
Irritation or Intracutaneous Reactivity	ISO 10993-23: Biological Evaluation of Medical Devices: Test for irritation, 2021 (Implied acceptance: no irritation/reactivity)	Pass
Acute Systemic Toxicity	ISO 10993- 11: Biological Evaluation of Medical Devices- Part 11: Tests for Systemic Toxicity, 2017 (Implied acceptance: no acute systemic toxicity)	Pass
Material Mediated Pyrogen Test	ISO 10993- 11: Biological Evaluation of Medical Devices- Part 11: Tests for Systemic Toxicity, 2017 (Implied acceptance: no pyrogenic response)	Pass
In-vitro Hemolysis Test direct contact method	ISO 10993-04: Biological Evaluation of Medical Devices - Part 04, Selection of Tests for Interactions with Blood, 2017/ ASTM F 756-17 (Standard Practice for the Assessment of Hemolytic Properties of Materials) (Implied acceptance: no hemolysis)	Pass
In-vitro Hemolysis Test Indirect Method	ISO 10993-04: Biological Evaluation of Medical Devices - Part 04, Selection of Tests for Interactions with Blood, 2017/ ASTM F 756-17 (Implied acceptance: no hemolysis)	Pass
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical Safety	IEC 60601-2-2:2017 (Implied acceptance: conformance to standard)	Conforms
EMC	IEC 60601-1-2:2014 (Implied acceptance: conformance to standard)	Conforms
Bench Testing
Output accuracy (Monopolar at 1MHz and 2 MHz)	Predefined design specifications (Implied acceptance: within specified accuracy range)	Conforms
Output accuracy (Bipolar at 1MHz and 2MHz)	Predefined design specifications (Implied acceptance: within specified accuracy range)	Conforms
Frequency: manual and standard	Predefined design specifications (Implied acceptance: correct frequency output)	Conforms
Power fluctuation characteristics	Predefined design specifications (Implied acceptance: stable power output)	Conforms
Negative output protection	Predefined design specifications (Implied acceptance: protection functions correctly)	Conforms
Impedance measurement accuracy and range	Predefined design specifications (Implied acceptance: accurate measurement within range)	Conforms
HO count accuracy	Predefined design specifications (Implied acceptance: accurate count)	Conforms
Safety test of various warnings / failsafe mechanisms	Predefined design specifications (Implied acceptance: warnings/failsafes function correctly)	Conforms
Needle depth	Predefined design specifications (Implied acceptance: accurate needle depth)	Conforms
Motor speed level	Predefined design specifications (Implied acceptance: correct motor speed)	Conforms
Ex Vivo testing (Thermal testing)	Guidance for Industry and FDA Staff: Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery, August 15, 2014 (Implied acceptance: consistent thermal effects for electrocoagulation/hemostasis)	Conforms

2. Sample size used for the test set and the data provenance

Sample Size: The document does not specify exact sample sizes for each test (e.g., number of devices tested for electrical safety, number of tissue samples for ex vivo testing). For biocompatibility, it states "four newly added electrode tips" were tested, but not the number of samples for each biological test. For ex-vivo testing, it mentions "three types of tissue Liver, Kidney and Muscle," but not the quantity of each.
Data Provenance: The tests were conducted by Jeisys Medical Inc., the manufacturer. The data is retrospective in the sense that it was generated for this regulatory submission. Country of origin for the data is implied to be South Korea, where Jeisys Medical Inc. is based. The tests were laboratory (bench) and ex-vivo animal tissue tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This submission relies on performance against recognized standards and technical specifications for electrosurgical devices, rather than human expert-established ground truth for a diagnostic AI algorithm. The device is a physical instrument, not an AI or diagnostic software.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are typically used in studies involving human interpretation or subjective assessments, often in diagnostic contexts. The tests described are objective, physical, electrical, and biological performance tests against defined standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an electrosurgical tool, not an AI-assisted diagnostic or interpretation system. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI algorithm. Its performance is evaluated through bench testing and ex-vivo studies.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the tests performed consists of:

Specified limits/ranges within recognized consensus standards (e.g., ISO 10993 series, IEC 60601 series).
The device's own predefined design specifications for parameters like output accuracy, frequency, power, impedance, needle depth, motor speed, etc.
The expected biological responses for biocompatibility (e.g., no cytotoxicity, no sensitization).
Expected thermal effects consistent with electrocoagulation and hemostasis in ex-vivo tissue.

8. The sample size for the training set

Not applicable. No AI/machine learning model is described, so there is no training set.

9. How the ground truth for the training set was established

Not applicable. As there is no training set mentioned, the establishment of its ground truth is not relevant.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which 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.

December 10, 2024

Jeisys Medical Inc. % Sanghwa Myung Regulatory Affair Consultant E&M D-1474, 230, Simin-daero, Dongan-gu Anyang-si. Gyeonggi-do 14067 South Korea

Re: K231216

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, OUH Dated: December 3, 2024 Received: December 4, 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.

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"

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(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 OS 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 Rue"). 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-devices/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 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).

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Sincerely,

Digitally signed by Long H. Chen Long H. Chen-S Date: 2024.12.10 16:07:57 -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) K231216

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

K231216

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 Incorporated307 Daeryung Techno Town 8thGamasan-ro 96, Geumcheon-Gu, Seoul, 08501, South KoreaTelephone: +82-70-7435-4930 Fax: 82-10-2843-3547E-mail: jhpark@jeisys.com
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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: December 10, 2024

1. 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, OUH

2. PREDICATE DEVICE

Jeisys Medical, Inc.
878.4400 / GEI
K201685, POTENZA

Note: the POTENZA has not been subject to a design-related recall, removal or correction.

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3. 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 IMHz 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.

4. INDICATIONS FOR USE

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

5. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The subject device, POTENZA, is identical to the predicate device, POTENZA, cleared under K201685 except for the following changes described in below.

Addition of Three electrode tips for the motor handpiece: CP-16 TIP and CP-25 . TIP, CP-49 for monopolar and bipolar operating modes
Labeling changes to add the new tips; refer to Section 14. Proposed Labeling .

The NEW POTENZA consists of the following components:

. Electrosurgical Unit - Main body
. handpieces

-> electrode tips for the handpiece - Add three invasive tips

Neutral electrode pad and neutral electrode pad cable, cleared under . K201685

. Handpiece stand
Foot switch ●

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Power cord

	Subject	Predicate	SubstantialEquivalence
Manufacturer	Jeisys Medical, Inc.	Jeisys Medical, Inc.	-
Regulation Number /Product Code	878.4400 / GEI	878.4400 / GEI	-
510(k) Number(s)	Pending	K201685	-
Intended Use/Indications	The POTENZA is intendedfor use in dermatologic andgeneral surgical proceduresfor electrocoagulation andhemostasis.	The POTENZA is intendedfor use in dermatologic andgeneral surgical proceduresfor electrocoagulation andhemostasis.	SE
Prescription / OTC	Prescription use, only	Prescription use, only	SE
Principal of Operation	Monopolar or bipolar RFenergy is delivered throughmicro needle electrodeapplying heat to target tissueto achieve coagulation andhemostasis	Monopolar or bipolar RFenergy is delivered throughmicro needle electrodeapplying heat to target tissueto achieve coagulation andhemostasis	SE
Electrosurgical Unit	-	-	-
Operating Mode	Monopolar and Bipolar	Monopolar and Bipolar	SE
Output Frequency	1 MHz / 2 MHz	1 MHz / 2 MHz	SE
Nominal OperatingPower	0 ~ 50 watt (step: 1 watt)	0 ~ 50 watt (step: 1 watt)	SE
Maximum PowerDelivered to Patient	up to 50 W (step: 1 watt)(200 Ω)	up to 50 W (step: 1 watt)(200 Ω)	SE
Impedance	200 Ω	200 Ω	SE
Power Source	100 V - 240 V~, 50/60 Hz,500 VA	100 V - 240 V~, 50/60 Hz,500 VA	SE
Dimensions (mm)	503.2 (W) x 365.6 (L) x 316(H)	503.2 (W) x 365.6 (L) x 316(H)	SE
Weight	12.5 kg	12.5 kg	SE
Active Accessory(Electrode)	-	-	-
Operating Mode	Monopolar / Bipolar	Monopolar / Bipolar	SE
	Subject	Predicate	SubstantialEquivalence
Electrode Tips	Ten different electrodetips for the motorhandpiece: S-49 TIP, I-49 TIP S-25 TIP, I-25TIP, S-16 TIP, and I-16TIP, C21-2 TIP, C21-1TIP, CP-21 TIP, and C9TIPThree electrode needletips for the AChandpiece: P1-08, A1-12,and A1-15Three electrode tips forthe motor handpiece:CP-16 TIP, CP-25 TIPand CP-49 TIP.	Ten different electrodetips for the motorhandpiece: TIP S-49, TIPI-49, TIP S-25, TIP I-25,TIP S-16, TIP I-16, C21-2 TIP, C21-1 TIP, CP-21TIP, and C9 TIPThree electrode needletips for the AChandpiece: P1-08, A1-12, and A1-15	Difference#1Differentin theaddition ofthreeelectrodetips for themotorhandpiece
Electrode Type	Micro needle type	Micro needle type	SE
Electrode Tip Shelf-life	3 Years	2 Years	Difference #2
RF Treatment Area	Spot Size (Treated area):1 cm x 1cm	Spot Size (Treated area):1 cm x 1cm	SE
Enhanced engagementwith tissue	Piston Mechanism	Piston Mechanism	SE
Material	Housing: PolycarbonateInsulation: ParacyclophaneNeedles: STS304	Housing: PolycarbonateInsulation: ParacyclophaneNeedles: STS304	SE
Single Use / Reusable	Single use	Single use	SE
Method of Sterilization	Ethylene Oxide gas (EO)	Ethylene Oxide gas (EO)	SE
Depth of SkinAblation / Thickness	Depth of skin ablation: 0.5 ~2.5 mm (step: 0.25 mm)Thickness: 0.2 mm	Depth of skin ablation: 0.5 ~4.0 mm (step: 0.25 mm)Thickness: 0.2 mm	Difference #3
Neutral Electrode Pad	Neutral Electrode Pad formonopolar operation,K201685	Neutral Electrode Pad formonopolar operation,K201685	SE
Footswitch			SE
Function	Transmit RF energy toelectrode	Transmit RF energy toelectrode	SE
Performance	Single pole, single throw	Single pole, single throw	SE
Materials	Steel and plastic	Steel and plastic	SE
	Subject	Predicate	SubstantialEquivalence
Other Characteristics	Single pedal, IPX8	Single pedal, IPX8	SE
Energy parameter	-	-
Treatment Area(Dimension of theactive part of theneedles)	CP-497.8 mm X 7.8 mmCP-258.0 mm X 8.0 mmCP-163.9mm X 3.9 mm	I-497.8 mm X 7.8mmI-258.0 mm X 8.0 mmI-167.8 mm X 7.8 mm	Difference #4
Inter-needle spacing	CP-491.3 mmCP-252.0 mmCP-161.3 mm	I-491.3 mmI-252.0 mmI-162.6 mm	Difference #5
Max insertion depth	2.5 mm	4.0 mm	Difference #6
Min insertion depth	0.5mm	0.5mm	SE
Thickness of theneedle	0.35mm	0.25mm	Difference #7
Max Power	50W	50W	SE

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The intended use, dermatologic and general surgical procedures for electrocoagulation and hemostasis, of the 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 (CP-16, CP-25, and CP-49) for 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. The technical characteristics of the CP-series tips are similar to the I-series tips. Performance testing of the added tips, CP-16, CP-25, CP-49, demonstrated substantial equivalence to the subject device, specifically the I-16, I-25, and I-49 tips.

6. Performance Characteristics

Verification and validation activities confirmed that the addition of four new electrode tips for the motor handpiece do not raise 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.

Biocompatibility Testing

Jeisys performed biocompatibility testing for the four newly added electrode tips according to FDA's "Use of International Standard ISO-10993, "Biological

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Evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process", June 6, 2016. 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 electrode tips were tested as shown in Table 1 below.

Test Type	Standard	Results
Cytotoxicity	ISO 10993-05:2009, Biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity	Pass
Sensitization:Guinea PigMaximizationTest	ISO 10993-10:2021 Biological evaluation of medical devices- Part 10: Tests for irritation and skin sensitization	Pass
Irritation orIntracutaneousReactivity	ISO 10993-23: Biological Evaluation of Medical Devices:Test for irritation, 2021	Pass
AcuteSystemicToxicity	ISO 10993- 11: Biological Evaluation of Medical Devices-Part 11: Tests for Systemic Toxicity, 2017	Pass
MaterialMediatedPyrogen Test	ISO 10993- 11: Biological Evaluation of Medical Devices-Part 11: Tests for Systemic Toxicity, 2017	Pass
In-vitroHemolysisTest directcontactmethod	ISO 10993-04: Biological Evaluation of MedicalDevices - Part 04, Selection of Tests for Interactionswith Blood, 2017/ ASTM F 756-17 (Standard Practice for the Assessment of HemolyticProperties of Materials)	Pass
In-vitroHemolysisTest IndirectMethod	ISO 10993-04: Biological Evaluation of MedicalDevices - Part 04, Selection of Tests for Interactionswith Blood, 2017/ ASTM F 756-17 (Standard Practice for the Assessment of HemolyticProperties of Materials)	Pass

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety, EMC, device-related electrical safety for high frequency and usability were conducted on the subject device 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
. 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

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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
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

Clinical Studies

No clinical performance testing was performed.

CONCLUSIONS

The subject device (POTENZA) is the same as the predicate device (K201685) 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.