(592 days)
Not Found
No
The description focuses on RF energy delivery and control, with no mention of AI/ML terms or functionalities. The performance studies also do not indicate any AI/ML components.
Yes
The device is described as an electrosurgical device intended for electrocoagulation and hemostasis in dermatologic and general surgical procedures, which are therapeutic interventions.
No
The device is described as an electrosurgical device used for electrocoagulation of soft tissue and hemostasis, which are therapeutic procedures, not diagnostic ones.
No
The device description explicitly states it is an RF (radiofrequency), software-controlled electrosurgical device that generates and delivers RF energy through a handpiece and electrode tip, indicating the presence of hardware components beyond just software. The performance studies also detail testing on hardware components like electrode tips and the device system itself.
Based on the provided information, the POTENZA device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis." This describes a device used directly on a patient's tissue during a surgical procedure.
- Device Description: The description details how the device generates and delivers RF energy to tissue for coagulation. This is a therapeutic or surgical function, not a diagnostic one performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, tissue biopsies) or providing diagnostic information based on such analysis. IVDs are designed to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
The POTENZA is an electrosurgical device used for therapeutic purposes (coagulation and hemostasis) during surgical procedures.
N/A
Intended Use / Indications for Use
The POTENZA is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
Product codes
GEI, OUH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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 (table present in source document showing various ISO 10993 standards tests with "Pass" results).
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 IEC 60601-2-2:2017 and IEC 60601-1-2:2014.
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
No clinical performance testing was performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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"
1
(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).
2
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
3
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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4
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 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: 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.
5
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 ●
6
Power cord
.
| | Subject | Predicate | Substantial
Equivalence |
|-----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| 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 intended
for use in dermatologic and
general surgical procedures
for electrocoagulation and
hemostasis. | The POTENZA is intended
for use in dermatologic and
general surgical procedures
for electrocoagulation and
hemostasis. | SE |
| Prescription / OTC | Prescription use, only | Prescription use, only | SE |
| Principal of Operation | Monopolar or bipolar RF
energy is delivered through
micro needle electrode
applying heat to target tissue
to achieve coagulation and
hemostasis | Monopolar or bipolar RF
energy is delivered through
micro needle electrode
applying heat to target tissue
to achieve coagulation and
hemostasis | SE |
| Electrosurgical Unit | - | - | - |
| Operating Mode | Monopolar and Bipolar | Monopolar and Bipolar | SE |
| Output Frequency | 1 MHz / 2 MHz | 1 MHz / 2 MHz | SE |
| Nominal Operating
Power | 0 ~ 50 watt (step: 1 watt) | 0 ~ 50 watt (step: 1 watt) | SE |
| Maximum Power
Delivered 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 | Substantial
Equivalence |
| Electrode Tips | Ten different electrode
tips for the motor
handpiece: S-49 TIP, I-
49 TIP S-25 TIP, I-25
TIP, S-16 TIP, and I-16
TIP, C21-2 TIP, C21-1
TIP, CP-21 TIP, and C9
TIPThree electrode needle
tips for the AC
handpiece: P1-08, A1-12,
and A1-15Three electrode tips for
the motor handpiece:
CP-16 TIP, CP-25 TIP
and CP-49 TIP. | Ten different electrode
tips for the motor
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 TIPThree electrode needle
tips for the AC
handpiece: P1-08, A1-
12, and A1-15 | Difference
#1
Different
in the
addition of
three
electrode
tips for the
motor
handpiece |
| 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 engagement
with tissue | Piston Mechanism | Piston Mechanism | SE |
| Material | Housing: Polycarbonate
Insulation: Paracyclophane
Needles: STS304 | Housing: Polycarbonate
Insulation: Paracyclophane
Needles: STS304 | SE |
| Single Use / Reusable | Single use | Single use | SE |
| Method of Sterilization | Ethylene Oxide gas (EO) | Ethylene Oxide gas (EO) | SE |
| Depth of Skin
Ablation / 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 for
monopolar operation,
K201685 | Neutral Electrode Pad for
monopolar operation,
K201685 | SE |
| Footswitch | | | SE |
| Function | Transmit RF energy to
electrode | Transmit RF energy to
electrode | SE |
| Performance | Single pole, single throw | Single pole, single throw | SE |
| Materials | Steel and plastic | Steel and plastic | SE |
| | Subject | Predicate | Substantial
Equivalence |
| Other Characteristics | Single pedal, IPX8 | Single pedal, IPX8 | SE |
| Energy parameter | - | - | |
| Treatment Area
(Dimension of the
active part of the
needles) | CP-49
7.8 mm X 7.8 mm
CP-25
8.0 mm X 8.0 mm
CP-16
3.9mm X 3.9 mm | I-49
7.8 mm X 7.8mm
I-25
8.0 mm X 8.0 mm
I-16
7.8 mm X 7.8 mm | Difference #4 |
| Inter-needle spacing | CP-49
1.3 mm
CP-25
2.0 mm
CP-16
1.3 mm | I-49
1.3 mm
I-25
2.0 mm
I-16
2.6 mm | Difference #5 |
| Max insertion depth | 2.5 mm | 4.0 mm | Difference #6 |
| Min insertion depth | 0.5mm | 0.5mm | SE |
| Thickness of the
needle | 0.35mm | 0.25mm | Difference #7 |
| Max Power | 50W | 50W | SE |
7
8
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
9
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 Pig
Maximization
Test | ISO 10993-10:2021 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Pass |
| Irritation or
Intracutaneous
Reactivity | ISO 10993-23: Biological Evaluation of Medical Devices:
Test for irritation, 2021 | Pass |
| Acute
Systemic
Toxicity | ISO 10993- 11: Biological Evaluation of Medical Devices-
Part 11: Tests for Systemic Toxicity, 2017 | Pass |
| Material
Mediated
Pyrogen Test | ISO 10993- 11: Biological Evaluation of Medical Devices-
Part 11: Tests for Systemic Toxicity, 2017 | 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) | 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 (Standard Practice for the Assessment of Hemolytic
Properties 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
10
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.