Microneedle Array Handpiece (1MHz): The Microneedle Array Handpiece with 1 MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. At power less than 36W, the Microneedle Array Handpiece with 1 MHz functionality is intended for the percutaneous treatment of facial winkles in Skin Types I-V.

Microneedle Array Handpiece (2MHz): The Microneedle Array Handpiece with 2 MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The Microneedle Array handpiece with 2MHz functionality is not intended to treat wrinkles.

One Pin Exact Handpiece: The One Pin Exact handpiece with 1MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The One Pin Exact Handpiece is not intended to treat wrinkles.

Device Description

VYBE RF II is a High Frequency Electrosurgical Unit that uses electrical currents to coagulate tissue. The device consists of the device console, Microneedle Array Handpiece, One Pin Exact Handpiece, RF plate, Foot Switch, and Power Cord. VYBE RF II is operated through an intuitive user interface (UI) on a 10.4- inch wide touch LCD screen. This product delivers high-frequency energy to the human body through the needle tip cartridge connected to the Microneedle Array Handpiece (1MHz, 2MHz) and One Pin Exact Handpiece (1MHz).

AI/ML Overview

The provided text is a 510(k) Summary for the Vybe RF II electrocoagulation and hemostasis device. It details the device's intended use, comparison with predicate devices, and performance testing, but it does NOT contain an acceptance criteria table or information related to AI or clinical studies for facial wrinkles. The information provided heavily focuses on electrical safety, EMC, software lifecycle, risk management, and the device's ability to achieve consistent thermal damage profiles in ex vivo tissue, which are not directly about the performance against acceptance criteria for clinical efficacy for wrinkle treatment.

Therefore, many of the requested sections about acceptance criteria, clinical studies, sample sizes, expert ground truth, adjudication methods, and AI performance cannot be extracted from this document in the context of clinical efficacy for facial wrinkles as it states "No clinical studies were conducted as part of this submission."

However, I can extract information related to the technical performance testing conducted to support substantial equivalence.

Here's a breakdown of the available information based on your request:

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

The document does not explicitly provide a table of acceptance criteria with corresponding performance for clinical use, especially for wrinkle treatment. It describes technical performance testing conducted for safety and verification of RF energy output.

Acceptance Criteria (Implied from testing)	Reported Device Performance (Summary from testing)
Basic Safety and Essential Performance	Compliance with IEC 60601-1:2005 + A1:2012, IEC 60601-1-2:2014, IEC 60601-2-2:2017.
Software Life Cycle Processes	Compliance with IEC 62304:2006+A1:2015.
Risk Management	Compliance with EN ISO 14971:2012.
Usability	Compliance with IEC 60601-1-6:2010, AMD1:2013, AMD2:2020.
Accuracy of RF Energy Output	Bench testing performed to verify accuracy of output. (Specific metrics not provided in summary)
Thermal Effect (Electrocoagulation/Hemostasis)	Histopathology testing demonstrated the ability of the device to achieve consistent thermal damage profiles in line with the target treatment in ex vivo bovine kidney and Yucatan mini-pig skin. Testing was performed at minimum, medium (default), and maximum power settings (levels 1, 5, and 10) for both 1 MHz and 2 MHz frequencies with the longest pulse width.
Biocompatibility	Patient contacting materials determined to be biocompatible.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Histopathology (Test Set):
- Ex vivo bovine kidney (unspecified number of samples/sections).
- Ex vivo Yucatan mini-pig skin (abdomen site) (unspecified number of samples/sections).
Data Provenance: In vitro/ex vivo lab testing. The country of origin is not specified but the applicant is from Republic of Korea. The testing itself is not clinical trial data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The histopathology testing involves objective measurements of thermal damage profiles, which are typically assessed by pathologists or histologists. However, the document does not specify the number or qualifications of any experts involved in reviewing the histopathology slides.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This type of adjudication method is used in clinical studies for diagnostic accuracy, where multiple readers evaluate medical images. The testing described is bench and histopathology.

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. There is no mention of an MRMC study, human readers, or AI assistance in this submission.

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

Not applicable. This device is an electrosurgical unit, not an AI software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the histopathology testing, the "ground truth" was established by histological analysis of the thermal damage profiles observed in the ex vivo tissues after treatment with the device. This is a form of pathology assessment.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device. The testing described does not involve a training set for an algorithm.

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

Not applicable. There is no training set for an algorithm.

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 & 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.

September 25, 2024

ShenB Co. Ltd. % Aubrey Thompson Regulatory Consultant Hoy & Associates Regulatory Consultants 1830 Bonnie Way Sacramento, California 95825

Re: K241535

Trade/Device Name: Vybe RF II Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: August 27, 2024 Received: August 27, 2024

Dear Aubrey Thompson:

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/cdrb/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 Rule"). The UDI Rule requires, among other things, that a 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-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 3 Date: 2024.09.25 07:42:48 -04'00'

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) K241535

Device Name VYBE RF II

Indications for Use (Describe)

The VYBE RF II 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)
---------------------------------------------------------------------------------------------------------------	--------------------------------------------------------------------------------------------------------------

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."

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

510(K) Summary Vybe RF II System K241535

ApplicantAddress	ShenB Co., Ltd.Shenb Bldg 148, Seongsui-roSeongdong-Gu, Seoul, 04796Republic of Korea
Contact Person	Aubrey Thompson, Regulatory Consultant
Contact InformationPreparation Date	aubreythompson@hoyregulatory.comSeptember 24, 2024
Device Trade Name	Vybe RF II
Classification Name	Electrosurgical Cutting and Coagulation Device andAccessories
Regulation Number	878.4400
Product Code	GEI
Regulatory Class	II
Legally Marketed Predicate Devices	Virtue RF (K211562)Vybe RF (K230986)

Device Description:

Indications for use:

The VYBE RF II is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

Microneedle Array Handpiece:

Microneedle Array (2MHz): The Microneedle Array Handpiece with 2 MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The Microneedle Array handpiece with 2MHz functionality is not intended to treat wrinkles.

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

K241535

510(K) Summary

Vybe RF II System

Substantial Equivalence—Indications for use and Technical Compariso

Specification	Vybe RF II (Subject Device)	Virtue RF (K211562)	Vybe RF (K230986)	Comparison
Product Code Operation	GEIRadiofrequency Microneedling	GEIRadiofrequency Microneedling	GEIRadiofrequency Microneedling	Same
# of needles	36 needle tip, 1 needle tip	36, 12, and 1 needle tips	36 needle tip	The 36 and 1 needle tips are identical to those used in the Virtue RF. The 12 needle tip in the Virtue RF is not included in Vybe RF II. The reference device, K230986, includes only a 36 needle tip.
Frequency	2MHz, 1MHz	2MHz, 1MHz, 0.5Mhz	2MHz, 1MHz	The 0.5 MHz frequency of the Virtue RF corresponds to the 12 needle tip and is not included in Vybe RF II.
Modality	Monopolar and Bipolar	Monopolar and Bipolar	Bipolar	Same as predicate. Reference device contains only bipolar.
Indications	The VYBE RF II is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.Microneedle Array Handpiece (1MHz): The Microneedle Array	The Virtue RF System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.Smart RF Handpiece: The Smart RF Handpiece with 1 MHz functionality is intended for use in	The VYBE RF Electrosurgical System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis and the percutaneous treatment facial wrinkles for use with Fitzpatrick Skin Type I to Skin Type Vwhen using the	Same. The Virtue RF includes additional indications for the Deep RF handpiece, which is not included in this submission. The indications for use for the subject device specifies the power level under which the wrinkles indication is allowable.

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

510(K) Summary

Vybe RF II System

Handpiece with 1MHz functionality isintended for use indermatologic andgeneral surgicalprocedures forelectrocoagulationand hemostasis. Atpower less than 36W,the Microneedle ArrayHandpiece with 1MHz functionality isintended for thepercutaneoustreatment of facial	dermatologic and generalsurgical procedures forelectrocoagulation andhemostasis, and thepercutaneous treatment offacial wrinkles. TheVirtueRF System for facialwrinkles is intended for usewith Skin types I-V. TheSmart RF Handpiece with 2MHz functionality isintended for use indermatologic and generalsurgical procedures forelectrocoagulation andhemostasis. The Smart RFwith 2MHz functionality isnot intended to treatwrinkles.	1MHz setting. The 2MHzsetting has not beenevaluated for use in thepercutaneous treatment offacial wrinkles and isintended for use indermatologic and generalsurgical procedures forelectrocoagulation andhemostasis.
wrinkles in Skin TypesI-V.Microneedle Array(2MHz): TheMicroneedle ArrayHandpiece with 2MHz functionality isintended for use indermatologic andgeneral surgicalprocedures forelectrocoagulationand hemostasis. TheMicroneedle Arrayhandpiece with 2MHzfunctionality is notintended to treatwrinkles.	Exact RF Handpiece: TheExact RF Handpiece with1MHz functionality isintended for use indermatologic and generalsurgical procedures forelectrocoagulation andhemostasis. The Exact RFHandpiece is not intendedto treat wrinkles.

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

Page 4 of 7

K241535	One Pin Exact Handpiece: The One Pin Exact handpiece with 1MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The One Pin Exact Handpiece is not intended to treat wrinkles.
---------	--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	--

Specification	Subject Device – VYBE RF IIMicroneedle ArrayHANDPIECE (SH-TIP)	Predicate Device - Virtue RFSMART RF HANDPIECE	Reference Device –VYBE RF	Comparison
Modality	Bipolar fractional RF	Bipolar fractional RF	Bipolar fractional RF	Same
Radiofrequency	1MHz, 2MHz	1MHz, 2MHz	1MHz, 2MHz	Same
Electrode Type	Bipolar microneedle	Bipolar microneedle	Bipolar microneedle	Same
Number ofneedles	36	36	36	Same
Max power	59 W @ 1 MHz30 W @ 2MHz	35.9 W @ 1 MHz25 W @ 2MHz	59W	Different. The maxpower output is higherfor the subject devicethan for the predicate.See discussion below.
RF Duration	100ms-800ms, with 100msincrements	100ms-800ms, with 100msincrements	100ms-800ms, with100ms increments	Same

{8}------------------------------------------------

K241535

510(K) Summary

Vybe RF II System

Same
Max 3.5mm depth
Microneedle length
Microneedle spacing
Microneedle density

Specification	Subject Device – VYBE RF II ONE PIN EXACT HANDPIECE	Predicate Device - Virtue RF EXACT RF HANDPIECE	Reference Device - VYBE RF	Comparison
Modality	Monopolar Fractional RF	Monopolar Fractional RF	N/A	Same
Radiofrequency	1 MHz	1 MHz	N/A	Same
Electrode Type	Monopolar single needle RF electrode	Monopolar single needle RF electrode	N/A	Same
Number of needles	1	1	N/A	Same
Max power	46 W	46 W	N/A	Same
RF Duration	100ms-800ms, with 100ms increments	100ms-800ms, with 100ms increments	N/A	Same
Grounding Mechanism	Disposable Neutral electrode pad	Neutral electrode plate	N/A	Different. The grounding mechanism is the same, the materials and reuse are different.

{9}------------------------------------------------

510(K) Summary Vybe RF II System K241535

Performance Testing

Verification and validation activities were successfully completed and establish that the Vybe RF II performs as intended. Testing included the following:

. IEC 60601-1:2005 + A1:2012; Medical Electrical Equipment- Part 1: General Requirements For Basic Safety And Essential Performance
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 60601-2-2:2017; 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 62304:2006+A1:2015; Medical Device Software Life Cycle Processes ●
EN ISO 14971:2012; Medical Devices Application Of Risk Management To Medical ● Devices
IEC 60601-1-6:2010, AMD1:2013, AMD2:2020- Medical Electrical Equipment Part 1-6: General requirements for safety- collateral standard: Usability

Software verification and validation testing was conducted, and documentation provided in accordance with FDA's Guidance or the Content of Premarket Submissions for Software Contained in Medical Devices.

Bench testing was performed to verify the accuracy of the output of RF energy. Histopathology testing was conducted to demonstrate the thermal effect of the device. A test summary is provided below.

Histopathology Testing Summary

In vitro testing of the VYBE RF II Radiofrequency Microneedling device (Test Device), equipped with VYBE RF Microneedle Array handpiece (HP) and SH-TIP cartridges, and operated at 1 and 2 MHz frequencies was performed. Testing was performed on three different types of tissue recommended by the FDA: ex vivo kidney (bovine), and skin (Yucatan mini-pig, abdomen site). "FDA guidance for Industry for Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery" recommends conducting testing at minimum, medium (default), and maximum (highest) power settings. The Test Device can be operated at two different frequencies 1- and 2 MHz. It is also operated at power levels from 1 to 10 with level 1 as the minimum and 10 maximum (highest) power level for both frequencies. Therefore, testing was performed at levels 1, 5, and 10 for both frequencies with the longs pulse width available on the device to demonstrate a 'worst case.'

The study demonstrated the ability of the Test Device to achieve consistent thermal damage profiles in line with the target treatment. Thus, it can be concluded that treatment by such a device at the appropriate testings will possess a desirable clinical treatment effect.

Clinical Evidence - N/A. No clinical studies were conducted as part of this submission.

Biocompatibility – Patient contacting materials have been determined to be biocompatible.

{10}------------------------------------------------

510(K) Summary Vybe RF II System K241535

Discussion

The VYBE RF II shares the same indications for use, technological characteristics, and handpieces as the Predicate device, the Virtue RF System. The main difference between the two devices is the maximum power achieved with the 36 needle handpiece and disposable tip. The Vybe RF II has a higher maximum power while using the same 36 needle tip, but the same power level as the reference device (the previously cleared Vybe RF). The single needle tip is identical to the predicate device except for the type of neutral electrode used. Thermal testing, biocompatibility testing, essential performance testing, and IEC testing demonstrate the VYBE RF II is safe and effective and can be considered substantially equivalent to the predicate 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.