(211 days)
No
The document describes a standard RF electrosurgical device and does not mention any AI or ML capabilities in its description, intended use, or performance studies.
Yes
Explanation: The device is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis, which are therapeutic interventions.
No
This device is an electrosurgical device intended for electrocoagulation and hemostasis, which are treatment procedures rather than diagnostic ones. It generates RF energy to coagulate tissue.
No
The device description clearly lists multiple hardware components including an Electrosurgical Unit, handpieces, electrode tips, a neutral electrode pad and cable, a handpiece stand, a foot switch, and a power cord. The device generates and delivers RF energy through these hardware components.
Based on the provided information, the POTENZA device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "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, not a device used to examine specimens (like blood, urine, or tissue samples) outside of the body to diagnose a condition.
- Device Description: The description details an electrosurgical unit that delivers RF energy through the skin into target tissue to coagulate it. This is a therapeutic and surgical function, not a diagnostic one performed on in vitro samples.
- Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVDs, such as reagents, assays, sample handling, or analysis of biological specimens.
Therefore, the POTENZA is a surgical device, not an in vitro diagnostic device.
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
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:
- Electrosurgical Unit - Main body
- 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
- 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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
- 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. All tests (Extractables, Cytotoxicity, Sensitization, Irritation or Intracutaneous Reactivity, Acute Systemic Toxicity, Hemolysis, USP Rabbit Pyrogen) passed.
- Electrical Safety and Electromagnetic Compatibility (EMC): Conducted on the POTENZA system according to IEC 60601-1:2005+A1:2-12, IEC 60101-2-2:2017, IEC 60601-1-2:2014, and IEC 60601-1-6:2010, AMDI:2013.
- Software Verification and Validation Testing: Conducted 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.
- Bench Testing: Conducted to assure that the four new electrode pins operate safely and within predefined design specifications. Tested parameters included output accuracy (monopolar and bipolar at 1MHz and 2MHz), frequency, power fluctuation, negative output protection, impedance measurement accuracy and range, HP count accuracy, safety test of warnings/failsafe mechanisms, needle depth, motor speed level, and thermal testing according to FDA's "Guidance for Industry and FDA Staff: Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery", August 15, 2014.
- Sterilization: Four new electrode tips are subject to Ethylene Oxide (EO) sterilization. EO sterilization residual testing according to ISO 10993-7:2008 passed. Sterility assurance level (SAL) is 10-6 according to ISO 11135:2014.
- Shelf-life (Accelerated Aging) / Sterility: Shelf-life testing established a two-year shelf-life based on 65-days accelerated aging in accordance with ASTM F1980-16, USP , and ASTM F1929-15.
- Animal Studies / Clinical Studies: The addition of the four new electrode pins did not require animal testing or clinical testing in humans.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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 shows 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.
January 19, 2021
Jeisys Medical, Inc. % Ms. Pamela Weagraff. MBA Senior Principal MedTech Regulatory Solutions - North America IOVIA MedTech 18 Bridie Lane Norfolk, Massachusetts 02056
Re: K201685
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: October 30,2020 Received: November 2, 2020
Dear Ms. 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, against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
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-devices/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 (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Addtionally, 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).
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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Indications for Use
510(k) Number (if known) K201685
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)
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3
510(k) Summary1
I. TRADITIONAL 510(K) SUBMITTER
a) Company Name and Address
Jeisys Medical Incorporated 307 Daeryung Techno Town 8th Gamasan-ro 96, Geumcheon-Gu Seoul 08501
KOREA
b) Official Correspondent
Do Hyun Kim / Regulatory Affairs Team Staff Jeisys Medical, Inc. 307, Daeryung Techno Town 8th, 96, Gamasan-ro, Geumcheon-gu Seoul, 08501, Korea
c) Alternate Correspondent
Pamela J. Weagraff, MBA Senior Principal, MedTech Regulatory Solutions - North America IQVIA MedTech 18 Bridie Lane Norfolk, MA 02056
E-mail: pamela.weagraff@quintiles.com Phone: +1(978)317-3975
d) Date Prepared: January 11, 2021
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
III. PREDICATE DEVICE
POTENZA, cleared under Traditional 510(k) K192545.
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
4
Note: the POTENZA has not 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:
- Electrosurgical Unit - Main body
- 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
- . 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.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE
a) PREDICATE DEVICE
The predicate device, POTENZA, cleared under K192545, is an RF (radiofrequency), software-controlled electrosurgical devices used for electrocoagulation of soft tissue and hemostasis. The device consists of the following components:
5
- . Electrosurgical Unit - Main body
- Two different handpieces ( motor and AC)
- . Neutral electrode pad and neutral electrode pad cable, cleared under K092761
- Handpiece stand
- Foot switch ●
- . Power cord
In this Traditional 510(k), four additional electrode tips are being added to the six different electrode tips for the motor handpiece. All electrode tips are provided as single use, sterile products. The four newly added electrode tips for the motor handpiece are: C21-2 TIP. C21-1 TIP, CP-21 TIP, and C9 TIP, for monopolar and bipolar operating modes. Changes have been made to the instructions for use and to the packaging labels to include the four new tips.
The fundamental technological features of the POTENZA and its intended use are the same as the predicate device.
- Principle of operation of the POTENZA with the four additional electrode tips: 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 device, in that the four newly added electrode tips were not available for the predicate device.
- Electrosurgical Unit: .
- Bipolar and monopolar operating mode: same as for the predicate device. >
- Output frequency of 1MHz and 2 MHz: same as for the predicate device. >
- Operating levels up to 50 W, at 10 different levels: same as for the predicate device. >
- Maximum power available: same as predicate device. >
- Impedance available: same as predicate device. >
-
Power source: same as predicate device.
- Active Accessory (Electrode): ●
- Bipolar and monopolar operating mode: same as the predicate device. >
- Electrode types: four new electrode tips are being added to the six different > electrode tips for the motor handpiece. All electrode tips are provided as single use, sterile products. The four newly added electrode tips for the motor handpiece are: C21-2 TIP, C21-1 TIP, CP-21 TIP, and C9 TIP, for bi-polar and monopolar operation.
- RF treatment area: same as the predicate device. >
- Material of four new electrode tips: similar to predicate device: performance testing > and biocompatibility testing has been completed.
- Four new electrode tips are intended for single use: same as the predicate device. >
- Depth of skin ablation, 0.5~2.5 mm: same as predicate device; within range of > ablation depth of predicate device..
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VII. PERFORMANCE DATA
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.
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 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.
Table 1: Biocompatibility Testing Requirements and Results
| Test Type / Method | Acceptance Criteria | Results |
|---|---|---|
| Extractables: ISO 10993-12:2012, | ||
| Biological evaluation of medical devices |
- Part 12, Sample preparation and
reference materials | Property - per standard | Pass |
| pH $\leq$ 1.5 | Pass | |
| Potassium permanganate
reducing substances $\leq$
2.0 mL | Pass | |
| Residue after
evaporation
$\leq$ 1.0 mg | Pass | |
| UV spectrum (250 nm -
350 nm) $\leq$ 0.1 | Pass | |
| Heavy Metals per
standard | Pass | |
| Cytoxicity:
• ISO 10993-05:2009, Biological
evaluation of medical devices - Part 5:
Tests for in vitro cytotoxicity
• USP 41:2018 Biological
Reactivity Tests, in vitro elution test | Meet requirements of
standard | Pass |
| Sensitization: Guinea Pig Maximization
Test (GPMT): ISO 10993-10:2010,
Biological evaluation of medical devices - Part 10: Tests for irritation and skin
sensitization | Meet requirements of
standard | Pass |
7
| Test Type / Method | Acceptance Criteria | Results |
|---|---|---|
| Irritation or Intracutaneous Reactivity | ||
| [Animal Intracutaneous (Intradermal) | ||
| Reactivity Test: ISO 10993-10:2010, | ||
| Biological evaluation of medical devices |
- Part 10: Tests for irritation and skin
sensitization | Meet requirements of
standard | Pass |
| Acute Systemic Toxicity: ISO10993-
11:2017, Biological evaluation of
medical devices - Part 11: Tests for
systemic toxicity | Meet requirements of
standard | Pass |
| Hemolysis:
• ISO 10993-4, Biological evaluation of
medical devices - Part 4: Selection of
tests for interactions with blood
• ASTM F756, Standard Practice for
Assessment of Hemolytic Properties of
Materials | Meet requirements of
standard | Pass |
| USP Rabbit Pyrogen:
• ISO 10993-11, Biological evaluation
of medical devices - Part 11: Tests for
systemic toxicity
• USP, General Chapter ,
Pyrogen Test | Meet requirements of
standard / USP | Pass |
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
8
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 four new electrode pins operate safely and within the predefined design specifications when used with the POTENZA.
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
- HP 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
e) Sterilization
The four new electrode tips are subject to Ethylene Oxide (EO) sterilization. EO sterilization residual testing for the four new electrode tips according to ISO 10993-7:2008, Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals to acceptance criteria as specified in the standard.
According to ISO 11135:2014, Sterilization of health-care products - Ethylene oxide -Requirements for the development, validation and routine control of a sterilization process for medical devices, the sterility assurance level (SAL) is 10-6.
f) Shelf-life (Accelerated Aging) / Sterility
Jeisys performed shelf-life testing to establish a two year shelf-life based on 65-days accelerated aging in accordance with the following standards to the acceptance criteria as specified in the standard:
- . ASTM F1980-16, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices - Accelerated Aging
- USP , Sterility Tests 42-NF37 - Sterility
9
- . ASTM F1929-15: Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration - Packaging Test
g) Animal Studies / Clinical Studies
The addition of the four new electrode pins did not require animal testing or clinical testing in humans.
CONCLUSIONS VIII.
The POTENZA device with the addition of the four new electrodes is similar to 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 four newly added electrode pins 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.