(92 days)
Not Found
No
The summary describes a standard RF electrosurgical system with a control panel and RF generator. There is no mention of AI, ML, image processing, or any features that would suggest the use of such technologies. The performance studies focus on electrical, biocompatibility, sterility, software verification/validation, and thermal testing, none of which indicate AI/ML components.
Yes.
The device is intended for the "percutaneous treatment of facial wrinkles" which implies a therapeutic purpose. It also used for electrocoagulation and hemostasis, which are surgical therapeutic applications.
No
Explanation: The device is an electrosurgical system intended for therapeutic procedures like electrocoagulation, hemostasis, and the percutaneous treatment of facial wrinkles, not for diagnosing conditions.
No
The device description clearly lists multiple hardware components including a main body with an LCD touch screen, RF generator, power supply, handpiece, disposable micro-needle cartridge, and foot switch. The software is part of a larger hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "dermatologic and general surgical procedures for electrocoagulation and hemostasis and the percutaneous treatment of facial wrinkles". This describes a therapeutic or surgical intervention performed directly on the patient's body.
- Device Description: The description details a system that delivers radio frequency energy into tissue to cause a thermal reaction. This is a physical interaction with the body, not an analysis of a sample taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is to treat tissue directly.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes
OUH, GEI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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
- 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
- o The micro-needle cartridge is supplied sterility conforms to a Sterility Assurance Level (SAL) of 10-6:
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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,
| Mark
Trumbore -S | Digitally signed by
Mark Trumbore -S
Date: 2023.07.06
14:32:19 -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)
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 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
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-ro |
| Seongdong-Gu, Seoul, 04796 | |
| Republic of Korea | |
| Phone: | 82-2-466-0010 |
| Fax: | 82-2-466-5473 |
Official Correspondent:
| Name: | Connie Hoy |
|---|---|
| Address: | Hoy & Associates Regulatory Consulting, LLC |
| 1830 Bonnie Way | |
| Sacramento, 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
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.
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 | |
| Microneedle | ||
| Cartridge | 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
- o The micro-needle cartridge is supplied sterility conforms to a Sterility Assurance Level (SAL) of 10-6:
- 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 # | |||
| & Product | |||
| Code | 878.4400 | ||
| OUH, GEI | 878.4400 | ||
| OUH | SAME | ||
| Indication for | |||
| Use | 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 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. | The VIVACE 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 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. | SAME |
H. Comparison to the Predicate Device
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510(k) Summary
VYBE RF
| Device name | VYBE RF (Subject Device) | PREDICATE VIVACE (K193070) | Comparison |
|---|---|---|---|
| Source of | |||
| Energy | Bipolar Fractional RF | Bipolar Fractional RF | SAME |
| Delivery system | Bipolar Handpiece + Micro needle | ||
| electrodes | Bipolar Handpiece + Micro needle | ||
| electrodes | 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.