1MHz Indications for use: Intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles. The VirtueRF Electrosurgical System is intended for use with Skin Types I-V.

2MHz Indications for use: Intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The 2mHz frequency is not intended to treat wrinkles.

Device Description

The VirtueRF device is a radio frequency output device using 1MHz & 2Mhz to deliver radio frequency energy to the human body with an applicator attached to the connecting cable. The energy is applied to the human body using a sterile disposable needle array consisting of 36 needles. This product consists of main body, Needle Bipolar RF (Smart RF) handpiece cable, foot switch and power cord.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the VirtueRF device:

Based on the provided K202415 510(k) Summary for the VirtueRF device, the submission primarily focuses on establishing substantial equivalence to predicate devices through technical comparisons and standard performance testing. This type of submission generally does not include extensive clinical studies with specified acceptance criteria regarding diagnostic performance or human-AI comparative effectiveness, as it's not a diagnostic AI device.

Therefore, many of your requested points regarding acceptance criteria for diagnostic performance, sample sizes for test sets, expert ground truth, MRMC studies, or standalone algorithm performance are not applicable in this context. The acceptance criteria here are related to meeting safety, electrical, biological, and thermal performance standards to demonstrate equivalence to existing devices.

Nonetheless, I will extract what information is present or clearly implied.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implied/Direct)	Reported Device Performance
Electrical Safety & Performance	Compliance with IEC 60601-1 (General Requirements for basic safety and essential performance).	Testing was performed per IEC 60601-1.
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2 (General Requirements for basic safety and essential performance: electromagnetic compatibility).	Testing was performed per IEC 60601-1-2.
High Frequency Surgical Equipment	Compliance with IEC 60601-2-2 (Particular requirements for the basic safety and essential performance of high frequency surgical equipment).	Testing was performed per IEC 60601-2-2.
Biocompatibility	Compliance with ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process).	Testing was performed per ISO 10993-1.
Thermal Effects	Thermal effects comparable to predicate devices, demonstrating safe and effective energy delivery to tissues.	"Thermal Effect Tests on 4 types of tissues (liver, kidney, muscle and skin) per FDA guidance... Test shows that the VirtueRF is substantially equivalent to the predicate device."
Technical Equivalence (1MHz)	Same source of energy/modality, radiofrequency, output energy type, electrode type, max power, and RF duration as Vivace Electrosurgical System (K150409).	All characteristics (except MAX Power is 35.9W for VirtueRF vs 61W for Vivace) are "Same" or acceptable for equivalence, as stated.
Technical Equivalence (2MHz)	Same source of energy/modality, radiofrequency, output energy type, electrode type, max power, and similar RF duration as Secret RF (K182355).	All characteristics are "Same" except RF Duration, which is "Similar" (100ms-800ms subset of 50ms-950ms).

2. Sample Size Used for the Test Set and Data Provenance

This information is not present for the efficacy or diagnostic performance as those types of studies were not conducted or described. The "test set" in this context refers to the samples used for the engineering and bench testing (e.g., tissue samples for thermal effect tests, electrical testing setup), not a clinical trial test set for diagnostic performance. The document does not specify the number of tissue samples or the specifics of the electrical test configurations used.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as the submission is not for a diagnostic device or an AI algorithm requiring expert-established ground truth for performance evaluation.

4. Adjudication Method for the Test Set

This information is not applicable for the reasons stated above.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices or AI-assisted diagnostic tools, which the VirtueRF electrosurgical system is not.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

No, a standalone algorithm performance study was not done. The VirtueRF is a medical device, not a standalone AI algorithm for diagnostic purposes. Its performance is evaluated through engineering, electrical, biocompatibility, and thermal tests, and comparison to predicates, not through AI-specific performance metrics.

7. The Type of Ground Truth Used

For the thermal effect tests, the "ground truth" would be established by direct physical measurements of temperature changes and tissue effects, validated against established scientific principles and comparison to the predicate device's known effects. This is a scientific and engineering ground truth rather than a clinical ground truth like pathology or expert consensus.

8. The Sample Size for the Training Set

This information is not applicable. The VirtueRF is a hardware device, not an AI model that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the reasons stated above.

Summary

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January 22, 2021

ShenB Co Ltd % Connie Hoy Consultant Hoy and Associates 3916 N. Potsdam Ave #4676 Sioux Falls, South Dakota 57104

Re: K202415

Trade/Device Name: VirtueRF Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: November 29, 2020 Received: December 1, 2020

Dear Connie Hoy:

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/cdrl/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about 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). 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).

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) K202415

Device Name

VirtueRF

Indications for Use (Describe)

The VirtueRF Electrosurgical System has separate indications for use for each of its functionalities: 1MHz and 2MHz.

1MHz Indications for use

Intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles. The VirtueRF Electrosurgical System is intended for use with Skin Types I-V.

2MHz Indications for use

Intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The 2mHz frequency is not intended to treat wrinkles.

Type of Use (Select one or both, as applicable)
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{ Prescription Use (Part 21 CFR 801 Subpart D)

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

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510K Summary K202415

This 510(K) Summary of safety and effectiveness for the VirtueRF is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.

Applicant:	ShenB Co Ltd.
Address:	Shenb Bldg 148Seongsui-roSeongdong-Gu, Seoul , KR 04796
Contact Person:	Mr. Oskar Lee
Telephone:	82 70.4912.2702 - phoneoskar@shenb.com
Preparation Date:	January 22, 2021
Device Trade Name:	VirtueRF
Common Name:	Electrosurgical, cutting & coagulation & accessories
Regulation Name:	Electrosurgical cutting and coagulation device andaccessories
Regulation Number:	21 CFR 878.4400 (Product Code: GEI)
Legally Marketed Predicate Device:	Vivace Electrosurgical SystemK150409
Legally Marketed Reference Device:	Secret RFK182355
Regulatory Class:	Class II Prescription Use
Description of the VirtueRF :	The VirtueRF device is a radio frequency output deviceusing 1MHz & 2Mhz to deliver radio frequency energy to thehuman body with an applicator attached to the connectingcable. The energy is applied to the human body using asterile disposable needle array consisting of 36 needles.
	This product consists of main body, Needle Bipolar RF(Smart RF) handpiece cable, foot switch and power cord.
Intended use of VirtueRF :	The VirtueRF Electrosurgical System has separateindications for use for each of its functionalities:1MHz and 2MHz.
	1MHz Indications for use: Intended for use indermatologic and general surgical procedures forelectrocoagulation and hemostasis, and thepercutaneous treatment of facial wrinkles. TheVirtueRF Electrosurgical System is intended for usewith Skin Types I-V.

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510K Summary K202415

2MHz Indications for use: Intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The 2mHz frequency is not intended to treat wrinkles.

Performance Testing: The following performance data was provided in support of the substantial equivalence determination:

IEC 60601-1 Test for Medical Electrical equipment was performed for General Requirements for basic safety and essential performance;

IEC 60601-1-2 Test for Medical Equipment for General Requirements for basic safety and essential performance: electromagnetic compatibility

IEC 60601-2-2 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 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

Thermal Effect Tests on 4 types of tissues (liver, kidney, muscle and skin) per FDA guidance Premarket Notification (510(K)) Submissions for Electrosurgical Devices for General Surgery. Test shows that the VirtueRF is substantially equivalent to the predicate device.

Technical Specifications / Indications for Use Comparison:

Comparison for 1MHz Functionality
	Proposed DeviceShenB VirtueRF	Predicate devicefor 1MHzVivaceElectrosurgicalSystem	Comparison
Source ofenergy/Modality	Bipolar Fractional RF	Bipolar Fractional RF	Same
Radiofrequency	1MHz	1MHz	Same
Output energy type	High Frequency	High Frequency	Same
Electrode type	Bipolar microneedle	Bipolar microneedle	Same
Max Power	35.9W	61 w	Same
RF Duration	100ms-800ms, with100ms increments	100ms-800ms, with100ms increments	Same

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510K Summary K202415

	Comparison for 2MHz Functionality
	Proposed DeviceShenB VirtueRF	Reference devicefor 2MHzSecret RF	Comparison
Source ofEnergy/Modality	Bipolar Fractional RF	Bipolar Fractional RF	Same
Radiofrequency	2MHz	2MHz	Same
Output energy type	High Frequency	High Frequency	Same
Electrode type	Bipolar microneedle	Bipolar microneedle	Same
Max Power	25 W	25W	Same
RF Duration	100ms-800ms, with100ms increments	50ms - 950ms	Similar

Conclusion: The VirtueRF and the predicate device relevant to 1MHz functionality, the Vivace Electrosurgical System, have the same indications for use and the same technological characteristics. The VirtueRF and the reference device relevant to 2MHz functionality, the Secret RF, have the same indications for use and nearly identical technological characteristics. The RF duration for the proposed VirtueRF (100ms-800ms) varies from the Secret RF only in that it is a subset of the Secret RF Duration. Therefore, VirtueRF substantially equivalent to both the predicate device and the reference device and there are no new questions of safety or effectiveness.

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.