The VYBE RF Electrosurgical System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis and the percutaneous treatment of facial wrinkles for use with Fitzpatrick Skin Type I to Skin Type V when using the 1MHz setting. The 2MHz setting has not been evaluated for use in the percutaneous treatment of facial wrinkles and is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

Device Description

The VYBE RF Electrosurgical System is comprised of the following components:

. The system main body, consisting of:
- o LCD touch screen control panel
- High-frequency generating output section (main P.C.B board or RF Generator) O
- Power supply component Switch Mode Power Supply (SMPS) O
The accessories to the device include:
- Handpiece with Handpiece Connector O
- Disposable micro-needle cartridge (electrode) for insertion into Handpiece o
- Foot switch O
  Radio frequency current (RF energy) is delivered from the RF Generator, through the handpiece and electrode tip into the target tissue. As RF energy passes through the skin, it generates an electro thermal reaction, which is capable of coagulating (causing minor dermal damage) the tissue. The bi-polar RF energy is delivered between independent adjacent electrode pairs (total 36 needle electrode, 6 x 6 array insertion). The RF generator and hand piece are not disposable. Each disposable micro-needle cartridge (electrode) is supplied sterile and is for single patient use only and cannot be re-sterilized.

AI/ML Overview

The document provided describes the VYBE RF Electrosurgical System and its substantial equivalence to a predicate device, the VIVACE Electrosurgical System. It includes performance data, but does not describe an acceptance criteria and study proving the device meets the acceptance criteria in the manner requested by the prompt for a typical AI/ML medical device submission.

Specifically, the document focuses on regulatory compliance through electrical, biocompatibility, sterility, software verification and validation, and thermal testing. These are standard tests for medical devices to ensure safety and fundamental functionality, not necessarily performance benchmarks against clinical criteria in the same way an AI/ML diagnostic or prognostic tool would be evaluated.

Therefore, many of the requested categories in the prompt regarding acceptance criteria, human reader studies, and ground truth establishment are not applicable or not explicitly detailed in the provided text.

Here's a breakdown of what can and cannot be extracted from the document:

1. A table of acceptance criteria and the reported device performance

The document lists various tests and states that "All acceptance criteria were met." However, it does not provide a table with specific acceptance criteria values (e.g., a specific thermal threshold) or the quantitative reported performance for each of these tests. It only lists the standards followed.

Acceptance Criteria Category	Reported Device Performance
Electrical Testing	Met IEC 60601-1, IEC 60601-1-2, IEC 60101-2-2, IEC 60601-1-6, IEC 62366 standards.
Biocompatibility Testing	Met ISO 10993-1, ISO 10993-5, ISO 10993-10 standards.
Sterility Testing (micro-needle cartridge)	Conforms to a Sterility Assurance Level (SAL) of 10^-6, meeting ISO 11135, ISO 11138-1, ISO 11138-2, ISO 11737-1, ISO 11737-2, ISO 10993-7 standards.
Software Verification and Validation Testing	Conducted as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", issued May 11, 2005.
Thermal Testing	Completed in accordance with FDA's Guidance for Industry and FDA Staff "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery", issued March 9, 2020.

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

Not applicable for the types of tests conducted. These are primarily engineering, laboratory, and compliance tests, not clinical studies with patient data.

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

Not applicable. Ground truth as typically understood in AI/ML clinical studies (e.g., expert consensus on image interpretation) is not relevant to these engineering and compliance tests.

4. Adjudication method for the test set

Not applicable for the types of tests conducted.

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

Not applicable. This device is an electrosurgical system, not an AI-assisted diagnostic tool.

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

Not applicable. This device is an electrosurgical system.

7. The type of ground truth used

For the sterility testing, the ground truth is the established Sterility Assurance Level (SAL) of 10^-6 and adherence to the listed ISO standards.
For other tests, the "ground truth" is adherence to the specified engineering and biocompatibility standards.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set in the conventional sense.

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

Not applicable.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

July 6, 2023

ShenB Co Ltd % Connie Hoy Consultant Hoy and Associates 1830 Bonnie Way Sacramento, California 95825

Re: K230968

Trade/Device Name: VYBE RF Electrosurgical System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: June 12, 2023 Received: June 12, 2023

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/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.

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

{1}------------------------------------------------

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 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).

Sincerely,

MarkTrumbore -S	Digitally signed byMark Trumbore -SDate: 2023.07.0614:32:19 -04'00'
---------------------	---------------------------------------------------------------------------------

Mark Trumbore, 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K230968

Device Name VYBE RF Electrosurgical System

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

K230968

510(k) Summary VYBE RF

This 510(k) Summary is in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content of this 510(k) summary is provided in conformance with 21 CFR Part 807.92.

A. SPONSOR INFORMATION

Name:	ShenB Co., Ltd.
Address:	Shenb Bldg 148, Seongsui-roSeongdong-Gu, Seoul, 04796Republic of Korea
Phone:	82-2-466-0010
Fax:	82-2-466-5473

Official Correspondent:

Name:	Connie Hoy
Address:	Hoy & Associates Regulatory Consulting, LLC1830 Bonnie WaySacramento, CA 95825
Phone:	530-908-4903
Email:	conniehoy@hoyregulatory.com

Establishment Reg. No.: 3010226575

Date Prepared: June 12, 2023

{4}------------------------------------------------

B. DEVICE NAME

Trade Name:	VYBE RF Electrosurgical System
Common Name:	Electrosurgical System and Accessories
Classification Name:	Electrosurgical cutting and coagulation device and accessories
Classification Number:	21 CFR 878.4400 (Class II)
Product Code:	OUH
Classification Panel:	General and Plastic Surgery

C. PREDICATE DEVICE

The VYBE RF Electrosurgical System is substantially equivalent to the VIVACE Electrosurgical System (K193070). Both the subject device (VYBE RF) and the predicate device (VIVACE) are manufactured by ShenB Co., Ltd.

D. INDICATIONS FOR USE

E. DEVICE DESCRIPTION

The VYBE RF Electrosurgical System is comprised of the following components:

. The system main body, consisting of:
- o LCD touch screen control panel
- High-frequency generating output section (main P.C.B board or RF Generator) O
- Power supply component Switch Mode Power Supply (SMPS) O
The accessories to the device include:
- Handpiece with Handpiece Connector O
- Disposable micro-needle cartridge (electrode) for insertion into Handpiece o
- Foot switch O

{5}------------------------------------------------

Radio frequency current (RF energy) is delivered from the RF Generator, through the handpiece and electrode tip into the target tissue. As RF energy passes through the skin, it generates an electro thermal reaction, which is capable of coagulating (causing minor dermal damage) the tissue. The bi-polar RF energy is delivered between independent adjacent electrode pairs (total 36 needle electrode, 6 x 6 array insertion). The RF generator and hand piece are not disposable. Each disposable micro-needle cartridge (electrode) is supplied sterile and is for single patient use only and cannot be re-sterilized.

F. TECHNOLOGICAL SPECIFICATIONS

The VYBE RF Electrosurgical System is substantially equivalent to the noted predicate devices, with respect to technological characteristics, such as intended use, principles of operation, target population, and energy source.

Electrical voltage and frequency	AC 120V 50/60 Hz
Power conception	180 VA
Maximum Power	59W 10% (load resistance 500Ω)
Frequency	1 MHz, 2 MHz
MicroneedleCartridge	Electrode	36 each, 6 x 6 array
	Exposed length	0.5 ~ 3.5mm (0.1mm increments)
	Outer diameter	Ø 0.3mm
Dimensions	(W)380mm x (L)340mm x (H)1200mm

G. PERFORMANCE DATA

To establish safety and efficacy of the VYBE RF Electrosurgical System, the following evaluations were completed following standards and FDA guidance documents. All acceptance criteria were met:

. Electrical Testing per:
- o IEC 60601-1:2005/(R)2012, A1:2012
- o IEC 60601-1-2:2014, Ed. 4.0
- o IEC 60101-2-2:2017, Ed. 6.0
- o IEC 60601-1-6:2010 +A1 2013
- o IEC 62366:2007/AMD 1:2014
0 Biocompatibility Testing per:
- o ISO 10993-1:2009
- o ISO 10993-5:2009
- o ISO 10993-10:2010

{6}------------------------------------------------

Sterility Testing:
- o The micro-needle cartridge is supplied sterility conforms to a Sterility Assurance Level (SAL) of 10-6:
  - ISO 11135:2014
  - ISO 11138-1:2017
  - ISO 11138-2:2017
  - ISO 11737-1:2018
  - ISO 11737-2:2019
  - ISO 10993-7:2008
Software Verification and Validation Testing:
- o Software verification and validation testing were conducted as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", issued May 11, 2005.
Thermal Testing: .
- o Testing of the thermal effects on tissue was completed in accordance with FDA's Guidance for Industry and FDA Staff "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery", issued March 9, 2020.

Device name	VYBE RF (Subject Device)	PREDICATE VIVACE (K193070)	Comparison
Manufacturer	ShenB Co., Ltd.	ShenB Co., Ltd.	SAME
Classification #& ProductCode	878.4400OUH, GEI	878.4400OUH	SAME
Indication forUse	The VYBE RF Electrosurgical System isintended for use in dermatologic andgeneral surgical procedures forelectrocoagulation and hemostasis andthe percutaneous treatment facialwrinkles for use with Fitzpatrick SkinType I to Skin Type V when using the1MHz setting. The 2MHz setting hasnot been evaluated for use in thepercutaneous treatment of facialwrinkles and is intended for use indermatologic and general surgicalprocedures for electrocoagulation andhemostasis.	The VIVACE Electrosurgical System isintended for use in dermatologic andgeneral surgical procedures forelectrocoagulation and hemostasis andthe percutaneous treatment facialwrinkles for use with Fitzpatrick SkinType I to Skin Type V when using the1MHz setting. The 2MHz setting hasnot been evaluated for use in thepercutaneous treatment of facialwrinkles and is intended for use indermatologic and general surgicalprocedures for electrocoagulation andhemostasis.	SAME

H. Comparison to the Predicate Device

{7}------------------------------------------------

510(k) Summary

VYBE RF

Device name	VYBE RF (Subject Device)	PREDICATE VIVACE (K193070)	Comparison
Source ofEnergy	Bipolar Fractional RF	Bipolar Fractional RF	SAME
Delivery system	Bipolar Handpiece + Micro needleelectrodes	Bipolar Handpiece + Micro needleelectrodes	SAME
RF Frequency	1MHz (±10%)	1MHz (±10%)	SAME
	2MHz (±10%)	2MHz (±10%)	SAME
Max power	1MHz: 36 W (Load resistance 500Ω)	1MHz: 36 W (Load resistance 500Ω)	SAME

I. CONCLUSION

The subject VYBE RF Electrosurgical System is identical to the Vivace Electrosurgical device. The only difference is the packaging for the sterile disposable tip has been changed to a blister pak with Tyvek. This change does not raise any new concerns for the safety or effectiveness of the device.

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.