(464 days)
The radiofrequency energy delivery components of the DUET-V(ESK-3261DV) and Accessories are indicated for use in: - Fractional Tips (FRF Tips): Fractional Tip is intended for use in dermatological procedures requiring ablation and resurfacing of the skin. - Thermal Tips (TRF Tips): Dermatologic and general surgical procedures for electrocoagulation
DUET-V (Model: ESK-3261DV) is a High Frequency Therapy Device system using 4 MHz high frequency electrical current. Single-use, disposable Treatment Tips attach to the handpiece that comes into contact with the patient during treatment procedures. Treatment tips are classified as direct skin contact devices of limited duration (<24 hours). The RF handpiece has 2 types of fractional tips and 3 types of thermal tips. The tips are disposable and are provided in a non-sterile state. Mono-polar electrodes TRF TIP-S, TRF TIP-R, and TRF TIP-E are used with a grounding pad. Bipolar electrodes FRF TIP-64 and FRF TIP-100, unlike mono-polar electrodes, do not have a ground pad and current flows between electrodes on the contact surface. The tip has three modes: Shot mode, Auto Shot mode, and Continuous mode - Shot Mode this mode delivers the output value set by the user once - Auto Shot Mode In this mode, the set output value delivered continuously according . to the interval time set by the user. (only TRF-TIP-S) - Continuous Mode - this mode continuously delivers RF current until stopped by the user.
The provided text describes the regulatory clearance for the DUET-V (Model: ESK-3261DV) electrosurgical device and its accessories. It outlines performance testing, but does not contain information about a study comparing the device's performance against human readers (MRMC study) or a standalone (algorithm only) performance study, nor does it detail the ground truth establishment for a test set in a clinical evaluation context.
Based on the provided information, here's a summary of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily focused on the device's technical specifications, safety, and functional performance.
| Item | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | No risks from biological hazards associated with materials of manufacture and final device. | Tests conducted according to ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-10:2020, ISO 10993-23:2021, and ISO 10993-11:2017 to ensure compliance. |
| Software | Verification and validation according to FDA Guidance "Content of Premarket Submission for Software Contained in Medical Devices" and IEC 62304: 2006 + A1:2015. Cybersecurity compliance to FDA guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions". | Firmware was verified and validated according to the specified FDA guidance and IEC 62304. Cybersecurity complied with FDA guidance. |
| Electrical Safety and Electromagnetic Compatibility | Control electrical and high temperature hazards; compliance with AAMI/ANSI ES 60601-1: 2005+A1: 2012 and IEC 60601-1-2:2020. | Risks controlled by design, protection method, and information according to AAMI/ANSI ES 60601-1. Electromagnetic compatibility verified according to IEC 60601-1-2. |
| Reprocessing | Cleaning and disinfection established and validated according to FDA 'Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling'. | Cleaning and disinfection for re-usable parts are established and validated in accordance with FDA guidance. |
| Bench Performance - Frequency Test | Not exceed the standard value of 4MHz. | Not explicitly stated as "met," but implied by "Performance Testing - Bench." |
| Bench Performance - Output Waveform | Confirm the waveform shape as sine wave. | Not explicitly stated as "met," but implied by "Performance Testing - Bench." |
| Bench Performance - Power Variation | 1) Input voltage fluctuates within the range of ±10% of 220V, 2) No abnormalities in each part. | Not explicitly stated as "met," but implied by "Performance Testing - Bench." |
| Bench Performance - Output Voltage and Current | Be within ±20% of standard value. | Not explicitly stated as "met," but implied by "Performance Testing - Bench." |
| Bench Performance - Output ON/OFF Time | Be within ±10% of standard value. | Not explicitly stated as "met," but implied by "Performance Testing - Bench." |
| Bench Performance - Max. Output Voltage and Current | Be within ±20% of standard value when voltage connect a 500 Ω load to the output terminal, set the maximum output. | Not explicitly stated as "met," but implied by "Performance Testing - Bench." |
| Bench Performance - Accuracy of Temperature Control | Be within ±1°C of set value. | Not explicitly stated as "met," but implied by "Performance Testing - Bench." |
| Bench Performance - Automatic Stop function when temperature rise | Automatically stop at the set temperature. | Not explicitly stated as "met," but implied by "Performance Testing - Bench." |
| Bench Performance - Switch Interlock | Be normally operated of switch interlock when control the foot or hand-piece switch select. | Not explicitly stated as "met," but implied by "Performance Testing - Bench." |
| Bench Performance - Output function upon skin contact | Output comes out when two or more of the four skin contact of FRF tip. | Not explicitly stated as "met," but implied by "Performance Testing - Bench." |
| System Testing - Thermal Effects on Tissue | Compliance with FDA guidance 'Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery' requirements. | Test performed according to FDA guidance; results not detailed but described as demonstrating "substantially equivalent performance." |
| System Testing - Temperature Monitoring | Compliance with FDA guidance 'Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery' requirements. | Test performed according to FDA guidance; results not detailed but described as demonstrating "substantially equivalent performance." |
| System Testing - Accuracy of Output control setting (monopolar) | Acceptance criteria ±20%. | Conducted according to IEC 60601-2-2 201.12.1.101; results not detailed but described as demonstrating "substantially equivalent performance." |
| System Testing - Accuracy of Output control setting (bipolar) | Acceptance criteria ±20%. | Conducted according to IEC 60601-2-2 201.12.1.101; results not detailed but described as demonstrating "substantially equivalent performance." |
| System Testing - Monotonicity of Output control setting (monopolar) | Acceptance criteria ±20%. | Conducted according to IEC 60601-2-2 201.12.1.102; results not detailed but described as demonstrating "substantially equivalent performance." |
| System Testing - Monotonicity of Output control setting (bipolar) | Acceptance criteria ±20%. | Conducted according to IEC 60601-2-2 201.12.1.102; results not detailed but described as demonstrating "substantially equivalent performance." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of a clinical performance evaluation (e.g., patient images or data). The performance testing described is focused on bench testing, electrical safety, biocompatibility, and software validation. Therefore, there is no information provided on sample size or data provenance for a clinical test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
As there is no clinical test set described, there is no information on the number or qualifications of experts for establishing ground truth. The evaluations are technical and regulatory compliance tests.
4. Adjudication Method for the Test Set
Again, given the nature of the evaluation (technical and regulatory compliance), there is no mention of an adjudication method for a clinical test set.
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
There is no mention of an MRMC comparative effectiveness study, nor is there any AI component described that would require such a study. The device is an electrosurgical unit, not an AI-powered diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
There is no mention of a standalone algorithm performance study, as the device described is an electrosurgical unit and not an AI algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the described technical and safety performance tests, the "ground truth" is established by engineering standards, regulatory guidelines (e.g., ISO, IEC, FDA guidances), and pre-defined acceptable ranges for physical and electrical parameters. For example, for "Accuracy of Output control setting," the ground truth is the ±20% acceptance criteria of the standard value. The "Thermal Effects on Tissue" and "Temperature Monitoring" tests are performed against the requirements of specific FDA guidances.
8. The Sample Size for the Training Set
The concept of a "training set" is relevant for machine learning algorithms. Since this device is an electrosurgical unit and not an AI-driven system, there is no training set described.
9. How the Ground Truth for the Training Set Was Established
As there is no training set, there is no information on how its "ground truth" was established.
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January 03, 2025
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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.
Eunsung Global Corp. % Milly RA Consultant Kmc, Inc. (G-Plus Tower, #1709) 123, Digital-ro 26-gil, Guro-gu Seoul, 08390 Korea. South
Re: K233118
Trade/Device Name: DUET-V (Model: ESK-3261DV) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: November 28, 2024 Received: December 3, 2024
Dear Milly:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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-regulatory
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/2/Picture/3 description: The image shows a digital signature. The signature is for James H. Jang -S. The date of the signature is 2025.01.03, and the time is 12:29:16 -05'00'.
For 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) K233118
Device Name DUET-V (Model: ESK-3261DV)
Indications for Use (Describe)
The radiofrequency energy delivery components of the DUET-V(ESK-3261DV) and Accessories are indicated for use in: - Fractional Tips (FRF Tips): Fractional Tip is intended for use in dermatological procedures requiring ablation and resurfacing of the skin.
- Thermal Tips (TRF Tips): Dermatologic and general surgical procedures for electrocoagulation
| 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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510(k) Summary (K233118)
This summary of 510(K) - safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: January 2, 2025
1. Applicant / Submitter
EUNSUNG GLOBAL CORP
120, Gieopdosi-Ro, Jijeong-Myeon, Wonju-Si, Gangwon-do, 26354, Republic of Korea
Tel : +82-33-760-1771 Email : juanms(@esglobal.co.kr
2. Official Correspondent (RA Consultant)
Milly (RA Consultant / KMC, Inc.)
Address: (G-Plus Tower, # 1709) 123, Digital-ro 26-gil, Guro-gu, Seoul, 08390, South Korea
Tel: +82-70-8965-5554 Email: milly(@)kmcerti.com
3. Device Information
- 3.1. Trade Name: DUET-V (Model: ESK-3261DV)
- 3.2. Model Name: ESK-3261DV
- 3.3. Classification Name:
21 CFR 878.4400 Electrosurgical cutting and coagulation device and accessories
- 3.4. Product Code: GEI
- 3.5. Device Class: 2
4. Predicate Device
Predicate Device 1 for Thermal RF Tip
- 4.1. K-Number: K173759
- 4.2. Manufacturer: Solta Medical Inc.
- Model Name: Thermage CPT System and Accessories 4.3.
Predicate Device 2 for Fractional RF Tip
- K-Number: K201164 4.4.
- Manufacturer: Venus Concept USA Inc. 4.5.
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4.6. Model Name: Venus Viva MD Device
5. General Description
DUET-V (Model: ESK-3261DV) is a High Frequency Therapy Device system using 4 MHz high frequency electrical current.
Single-use, disposable Treatment Tips attach to the handpiece that comes into contact with the patient during treatment procedures. Treatment tips are classified as direct skin contact devices of limited duration (<24 hours). The RF handpiece has 2 types of fractional tips and 3 types of thermal tips. The tips are disposable and are provided in a non-sterile state.
Mono-polar electrodes TRF TIP-S, TRF TIP-R, and TRF TIP-E are used with a grounding pad. Bipolar electrodes FRF TIP-64 and FRF TIP-100, unlike mono-polar electrodes, do not have a ground pad and current flows between electrodes on the contact surface.
The tip has three modes: Shot mode, Auto Shot mode, and Continuous mode
- Shot Mode this mode delivers the output value set by the user once
- Auto Shot Mode In this mode, the set output value delivered continuously according . to the interval time set by the user. (only TRF-TIP-S)
- Continuous Mode - this mode continuously delivers RF current until stopped by the user.
6. Indication for use
The radiofrequency energy delivery components of the DUET-V(Model: ESK-3261DV) and Accessories are indicated for use in:
- Fractional Tips (FRF Tips): Fractional Tip is intended for use in dermatological • procedures requiring ablation and resurfacing of the skin.
- Thermal Tips (TRF Tips): Dermatologic and general surgical procedures for electrocoagulation
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7. Comparison of the subject device to the predicate device
The following comparison table is presented to demonstrate substantial equivalence.
7.1 RF Device Including Non-fractional RF Tip (TRF Tip)
| Descriptive Information | Subject Device | Predicate Device 1 | |
|---|---|---|---|
| Manufacturer | EUNSUNG GLOBAL CORP | Solta Medical Inc. | |
| Regulation number | 21 CFR 878.4400 | 21 CFR 878.4400 | |
| Regulation Name | Electrosurgical Cutting and Coagulation Device and Accessories | Electrosurgical Cutting and Coagulation Device and Accessories | |
| Trade Name | DUET-V (Model: ESK-3261DV) | Thermage CPT System and Accessories | |
| 510(k) number | - | K132431K173759 | |
| Regulatory Number and Classification Product Code | GEI | GEI, ISA | |
| Indications for Use | The radiofrequency energy delivery components of the DUET-V(ESK-3261DV) and Accessories are indicated for use in:• Thermal Tips (TRF Tips): Dermatologic and general surgical procedures for electrocoagulation | The radiofrequency energy delivery components of the Thermage CPT System and Accessories are indicated for use in:• Dermatologic and general surgical procedures for electrocoagulation and hemostasis;• Non-invasive treatment of periorbital wrinkles and rhytids including upper and lower eyelids;• Non-invasive treatment of wrinkles and rhytids. | |
| Prescription or OTC | Prescription use | Prescription use | |
| ESU | Energy | RF | RF |
| Treatment type | Non-Ablative | Non-Ablative | |
| Input power | 110-240VAC, 50/60Hz | Unknown | |
| Maximum power | 250VA | 500W | |
| Operating frequency | 4MHz | 6.78MHz | |
| Treatment level | Multiple treatment level | Multiple treatment level | |
| Mode of Operation | Manual or Footswitch | Manual or Footswitch | |
| Characteristic | Hand-held | Hand-held | |
| Electrode | Removable exchangeable to different | Removable exchangeable to different | |
| Descriptive Information | Subject Device | Predicate Device 1 | |
| Hand-piece | size | size | |
| Condition ofuse | Disposable Singlepatient use only | Disposable Singlepatient use only | |
| Electrode type | Mono-polar | Mono-polar | |
| Electrode type | Mono-polar | Mono-polar | |
| Dimension | TRF TIP-S: 37(L) x 36.1(D) x27.7 (H)mm / 13 gTRF TIP-E: 37.5(L) x 36.1(D) x37.1(H) mm/ 10 gTRF TIP-R: 37.5(L) x 36.1(D) x28.4 (H)mm, 12 g | Unknown | |
| Activeaccessory | Treatment area | TRF TIP-S / 20.8 x20.8 mm TRF TIP-E /9.80mmȳ TRF TIP-R /18.60mmȳ | 0.25cm² ~ 16cm² |
| Rated voltage | TRF TIP-S / 317 Vp TRF TIP-E /238 VpTRF TIP-R / 290 Vp | Unknown | |
| Neutralelectrode | Neutral pad was registered with K073360 and attached the certification of the productin Appendix 16. |
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| Descriptive Information | Subject Device | Predicate Device 2 | |
|---|---|---|---|
| Manufacturer | EUNSUNG GLOBAL CORP | Venus Concept USA Inc | |
| Regulation number | 21 CFR 878.4400 | 21 CFR 878.4400 | |
| Regulation Name | Electrosurgical Cutting andCoagulation Device andAccessories | Electrosurgical Cutting andCoagulation Device andAccessories | |
| Trade Name | DUET-V(Model: ESK-3261DV) | Venus Viva MD™ | |
| 510(k) number | - | K201164 | |
| Regulatory Number andClassification Product Code | GEI | GEI | |
| Indications for Use | The radiofrequency energydelivery components of theDUET-V(ESK-3261DV)and Accessories are indicated for usein:• Fractional Tips (FRF Tips):Fractional Tip is intended for usein dermatological proceduresrequiring ablation and resurfacingof the skin. | The Venus Viva MD™ is a non-invasive device intended to be usedby aesthetic-related physicians ordermatologists.• When used with the Viva MDapplicator, the Venus Viva MD™ device is intended for use indermatological proceduresrequiring ablation and resurfacingof the skin.• When used with theDiamondpolar applicator, theVenus Viva MD™ device isintended for use in dermatologicaland surgical procedures for femalesfor the non- invasive treatment ofmoderate to severe facial wrinklesand rhytidesin Fitzpatrick skin type I-IV. | |
| Prescription or OTC | Prescription use | Prescription use | |
| Energy | RF | RF | |
| Treatmenttype | Ablative | Ablative | |
| Input power | 110-240VAC, 50/60Hz | 110-240VAC, 50/60Hz | |
| ESU | Maximumpower | 250VA | 120W |
| Operatingfrequency | 4MHz | 1MHz, 0.46MHz | |
| Treatmentlevel | Multiple treatment level | Multiple treatment level | |
| Mode ofOperation | Manual or Footswitch | Manual or Footswitch | |
| Characteristic | Hand-held | Hand-held | |
| Electrode | Removable exchangeableto different size | Removable exchangeableto different size | |
| Hand-piece | Treatment tip | Sterile | Sterile |
| Condition of | Disposable Single patient use only | Disposable Single patient use only | |
| Descriptive Information | Subject Device | Predicate Device 2 | |
| Activeaccessory | use | ||
| Electrode type | Bi-polar | Bi-polar | |
| Electrode type | Bi-polar | Bi-polar | |
| Dimension | FRF TIP-64: 37(L) x 36.1(D) x 27.7 (H) mm / 13 g | 80 pin tip: 1.33cm² 160 Pin tip:1.33cm² | |
| Dimension | FRF TIP-100: 37(L) x 36.1(D) x 27.7 (H) mm / 13 g | ||
| Treatment area | FRF TIP-64 / 20.8 x 20.8 mmFRF TIP-100 / 20.8 x20.8 mm | Unknown | |
| Max OutputPower | FRF Tip-64: 0.12JFRF TIP-100: 0.19J | 2mJ/pin |
7.2 RF Device Including Fractional RF Tip (FRF Tip)
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8. Description of Performance Testing
8.1. Biocompatibility
Biocompatibility tests were conducted to ensure that no risks arise from biological hazards associated with materials of manufacture and the final device.
-
- ISO 10993-5:2009, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
-
- ISO 10993-10:2010, Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization.
-
- ISO 10993-10:2020, Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization.
-
- ISO 10993-23:2021, Biological evaluation of medical devices Part 23: Tests for irritation
-
- ISO 10993-11:2017, Biological evaluation of medical devices Part 11: Tests for systemic toxicity
8.2. Software
The firmware is intended to control the device. It is installed in a microprocessor of the device. The firmware was verified and validated according to FDA Guidance "Content of Premarket Submission for Software Contained in Medical Devices" and IEC 62304: 2006 + A1:2015, Medical device software - Software life cycle processes.
Cybersecurity of the subject device is compliance to FDA guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions"
8.3. Electrical Safety and Electromagnetic compatibility
Electrical hazard and high temperature hazard are included within the device. The risks are controlled by design, protection method and information according to the FDA recognized standard, AAMI/ANSI ES 60601-1: 2005+A1: 2012.
Electromagnetic compatibility was tested and verified according to the FDA recognized
{10}------------------------------------------------
standard, IEC 60601-1-2:2020
8.4. Reprocessing
Re-usable part of the subject device is intended to be cleaned and disinfected by user after use. Therefore, the cleaning and disinfection is established and validated in accordance with FDA 'Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling'
8.5. Performance Testing - Bench
8.5.1.General
| Item | Criteria |
|---|---|
| Frequency Test | Not exceed the standard value of 4MHz |
| Output waveform | Confirm the waveform shape as sine wave |
| Power variation characteristic | 1) Input voltage fluctuates within the range ofwithin the range of $\pm$ 10% of 220V,2) No abnormalities in each part |
| Output voltage and current | Be within must be within $\pm$ 20% of standard value |
| Output ON/OFF time | Be within must be within $\pm$ 10% of standard value |
| Max. output voltage and current | Be within must be within $\pm$ 20% of standard value when voltageconnect a 500 $\Omega$ load to the output terminal, set the maximum output |
| Accuracy of temperature control | Be within $\pm$ 1°C of set value |
| Automatic Stop function whentemperature rise | Automatically stop at the set temperature |
| Switch interlock | Be normally operated of switch interlock when control the foot orhand-piece switch select. |
| Output function upon skincontact | Output comes out when two or more of the four skin contact of FRF tip |
8.5.2.Neutral electrode
The neutral electrode was supplied by sub-contracted company as finished product and already clearance (K073360, Trade Name: Proplate) product of neutral electrode.
8.5.3.System testing
1) Thermal Effects on Tissue
The subject device's function and electrical specifications are the predicate device. Thermal Effects on Tissue test was performed by FDA guidance 'Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery' requirements.
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2) Temperature Monitoring
The subject device was performed about temperature during operation. The temperature monitoring was performed by FDA guidance 'Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery' requirements
3) Accuracy of output
ESU power output accuracy Performance test (according to test as IEC 60601-2-2 201.12.1.101) has been conducted
| Applied Clause | Criteria |
|---|---|
| 201.12.1.101a | Accuracy of Output control setting_monopolarAcceptance criteria ±20% |
| 201.12.1.101b | Accuracy of Output control setting_bipolarAcceptance criteria ±20% |
| 201.12.1.102a | Monotonicity of Output control setting_monopolarAcceptance criteria ±20% |
| 201.12.1.102b | Monotonicity of Output control setting_bipolarAcceptance criteria ±20% |
9. Conclusion
The subject device has similar design (functions, components, accessories, and shape) to the predicate device 1 (K173759) and predicate device 2 (K201164). The performance testing has been conducted according to the FDA recognized standards and the results demonstrate substantially equivalent performance to compare to the predicate devices.
Therefore, subject device is substantially equivalent to the predicate devices for requested indications for use.
§ 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.