(539 days)
No
The document describes a standard electrosurgical system using radio frequency energy and does not mention any AI or ML components or capabilities. The software testing mentioned is standard for medical devices and does not indicate AI/ML.
Yes.
The device is intended for the "percutaneous treatment of facial wrinkles," which is a therapeutic rather than a diagnostic purpose. It also performs "electrocoagulation and hemostasis" in dermatologic and general surgical procedures, which are therapeutic functions.
No
Explanation: The VIVACE Electrosurgical System is described as being for "electrocoagulation and hemostasis and the percutaneous treatment of facial wrinkles." These are therapeutic procedures, not diagnostic ones. The device delivers radio frequency current to generate an electro thermal reaction for tissue coagulation, which is a treatment modality. There is no mention of the device being used to identify or analyze a condition or disease.
No
The device description clearly outlines 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 device delivers RF energy through these hardware components. While software verification and validation were performed, the device is not solely software.
Based on the provided text, the VIVACE Electrosurgical System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for dermatologic and general surgical procedures for electrocoagulation, hemostasis, and the percutaneous treatment of facial wrinkles. These are all procedures performed directly on the patient's body.
- Device Description: The device delivers radio frequency energy into tissue to cause thermal reactions. This is a therapeutic or surgical intervention, not a test performed on samples outside the body.
- No mention of analyzing biological samples: The description focuses on the device's interaction with tissue in vivo (within the living body). There is no mention of collecting or analyzing biological samples like blood, urine, or tissue biopsies.
- Performance Studies: The performance studies described are related to electrical safety, biocompatibility, sterility, shelf life, software validation, and thermal effects on tissue. These are typical evaluations for devices used directly on patients, not for IVDs which would involve analytical and clinical performance studies related to the accuracy of measurements or diagnoses from samples.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The VIVACE Electrosurgical System does not fit this definition.
N/A
Intended Use / Indications for Use
The VIVACE 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
GEI, OUH
Device Description
The VIVACE Electrosurgical System is comprised of the following components:
- The system main body, consisting of:
- LCD touch screen control panel
- High-frequency generating output section (main P.C.B board or RF Generator)
- Power supply component Switch Mode Power Supply (SMPS)
- The accessories to the device include:
- Handpiece with Handpiece Connector
- Disposable micro-needle cartridge (electrode) for insertion into Handpiece
- Foot switch
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 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
Face (dermal for facial wrinkles)
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 VIVACE Electrosurgical System, the following evaluations were completed following standards and FDA guidance documents. All acceptance criteria were met:
- Electrical Testing per:
- IEC 60601-1:2005/(R)2012, A1:2012
- IEC 60601-1-2:2014, Ed. 4.0
- IEC 60101-2-2:2017, Ed. 6.0
- IEC 60601-1-6:2010 +A1 2013
- IEC 62366:2007/AMD 1:2014
- Biocompatibility Testing per:
- ISO 10993-1:2009
- ISO 10993-5:2009
- ISO 10993-10:2010
- Sterility Testing:
- The micro-needle cartridge is supplied sterile and 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
- The micro-needle cartridge is supplied sterile and sterility conforms to a Sterility Assurance Level (SAL) of 10-6:
- Shelf Life and Packaging Testing per:
- ASTM F1980-16
- ASTM F1929-15
- ASTM F88/F88M-15
- Software Verification and Validation Testing:
- 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:
- 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.
- The ex vivo animal study utilized a porcine tissue model and standardized H&E staining techniques to visualize and measure thermally damaged profile data through Nitro Blue Tetra Chlorine (NBTC) and H&E histological evaluation of VIVACE System treated tissue specimens. The VIVACE microneedling device showed consistent formation of measurable thermal lesions for highest energy level settings in the treatment porcine tissue at a temperature close to physiological.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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). On the left is the Department of Health & 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.
April 26, 2021
ShenB Co Ltd. % Rachel Lord Director RA/OA Aesthetics Biomedical 4602 N 16th St Suite 300 Phoenix, Arizona 85016
Re: K193070
Trade/Device Name: VIVACE Electrosurgical Device Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: April 3, 2021 Received: April 5, 2021
Dear Rachel Lord:
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 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 statutes and
1
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 (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-devices/medical-device-safety/medical-device-reporting-mdr-howreport-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) 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-devices/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
2
Indications for Use
510(k) Number (if known) K193070
Device Name Vivace Electrosurgical System
Indications for Use (Describe)
The VIVACE 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| [X] Prescription Use (Part 21 GER 801 Subpart D) | Over-The-Counter Use (21 CER 801 Subpart C) |
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3
510(k) Summary
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: | Rachel Lord |
|---|---|
| Address: | Aesthetics Biomedical |
| 4602 North 16th Street, Suite 300 | |
| Phoenix, AZ 85016 | |
| Phone: | (201) 841-7975 |
| Email: | rlord@aestheticsbiomed.com |
Establishment Reg. No.: 3010226575
April 2, 2020 Date Prepared:
4
B. DEVICE NAME
| Trade Name: | VIVACE |
|---|---|
| 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, GEI |
| Classification Panel: | General and Plastic Surgery |
C. PREDICATE DEVICE
The VIVACE Electrosurgical System is substantially equivalent to the existing VIVACE Electrosurgical System (primary predicate), K150409. The Secret RF Device K170325 is the reference device to support the 2MHz functionality.
D. INTENDED USE
The VIVACE 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 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 VIVACE Electrosurgical System is comprised of the following components:
- . The system main body, consisting of:
- LCD touch screen control panel O
- 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
5
and hand piece are not disposable micro-needle cartridge (electrode) is supplied sterile and is for single patient use only and cannot be re-sterilized.
F. TECHNOLOGICAL SPECIFICATIONS
The VIVACE Electrosurgical System is substantially equivalent to the primary predicate device, 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 | 80 VA | |
| Maximum Power | 36W ± 10% (load resistance $500\Omega$ ) | |
| Accuracy of the output | 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 VIVACE 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
- 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 o
- Biocompatibility Testing per: ●
- ISO 10993-1:2009 о
- o ISO 10993-5:2009
- ISO 10993-10:2010 o
- Sterility Testing: ●
- o The micro-needle cartridge is supplied sterile and sterility conforms to a Sterility Assurance Level (SAL) of 10-6:
- ISO 11135:2014 트
- I ISO 11138-1:2017
- l ISO 11138-2:2017
- I ISO 11737-1:2018
- I ISO 11737-2:2019
- I ISO 10993-7:2008
- o The micro-needle cartridge is supplied sterile and sterility conforms to a Sterility Assurance Level (SAL) of 10-6:
6
- Shelf Life and Packaging Testing per: ●
- o ASTM F1980-16
- o ASTM F1929-15
- o ASTM F88/F88M-15
- Software Verification and Validation Testing: ●
- Software verification and validation testing were conducted as recommended by O 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: ●
- Testing of the thermal effects on tissue was completed in accordance with о FDA's Guidance for Industry and FDA Staff "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery", issued March 9, 2020.
- The ex vivo animal study utilized a porcine tissue model and standardized H&E o staining techniques to visualize and measure thermally damaged profile data through Nitro Blue Tetra Chlorine (NBTC) and H&E histological evaluation of VIVACE System treated tissue specimens. The VIVACE microneedling device showed consistent formation of measurable thermal lesions for highest energy level settings in the treatment porcine tissue at a temperature close to physiological.
7
H. SUMMARY OF SUBSTANTIAL EQUIVALENCE
The subject VIVACE Electrosurgical System is substantially equivalent to the primary predicate, the VIVACE Electrosurgical System (K150409). The Secret RF Device K 170325 is the reference device to support the 2MHz functionality. The below table VIVACE technological characteristics to the predicate devices.
| Device name | VIVACE (Subject Device) | PRIMARY PREDICATE
VIVACE (K150409) | REFERENCE PREDICATE
Secret RF (K170325) | Difference/Risks/Notes |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | ShenB Co., Ltd. | ShenB Co., Ltd. | ILOODA CO., LTD | Different Manufacturer for Reference
Predicate (Secret RF) |
| Classification #
& Product
Code | 878.4400
OUH, GEI | 878.4400
OUH | 878.4400
GEI, OUH | NO DIFFERENCE |
| Indication for
Use | 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. | Intended for use in dermatologic
and general surgical procedures for
electrocoagulation and hemostasis,
and the percutaneous treatment of
facial wrinkles. This Vivace
Electrosurgical System is intended
for use with Skin Type I to Skin
Type V. | Secret RF is intended for use in
dermatologic and general surgical
procedures for electro-coagulation
and hemostasis. | NO DIFFERENCE |
| Source of
Energy | Bipolar Fractional RF | Bipolar Fractional RF | Bipolar Fractional RF | NO DIFFERENCE |
| Delivery system | Bipolar Handpiece + Micro needle
electrodes | Bipolar Handpiece + Micro needle
electrodes | Bipolar Handpiece + Micro needle
electrodes | NO DIFFERENCE |
| RF Frequency | 1MHz (±10%) | 1MHz (±10%) | N/A | • Additional (lower) frequency setting
in comparison to existing VIVACE
frequency |
| | 2MHz (±10%) | N/A | 2MHz (±10%) | • NO DIFFERENCE from Secret RF2
MHz frequency |
| Max power | 1MHz: 36 W (Load resistance 500Ω) | 1MHz: 61.5 W (Load resistance
500Ω) | N/A | • VIVACE has a slightly lower output
as the predicate VIVACE, when using |
| Device name | VIVACE (Subject Device) | PRIMARY PREDICATE
VIVACE (K150409) | REFERENCE PREDICATE
Secret RF (K170325) | Difference/Risks/Notes |
| | 2MHz: 23.3 W (Load resistance
$500Ω$ ) | N/A | 2 MHz: Max 25W± 10% (Load
resistance $500Ω$ ) | the 1 MHz setting.
• VIVACE has a slightly lower output
than the predicate Secret RF device,
when using the 2 MHz setting. |
| Connected
electrodes | 36 Electrodes | 36 Electrodes | MTR-AC-25 (25 Electrodes) or
MTR-AC-64 (64 Electrodes) | • NO DIFFERENCE from existing
Vivace device
• Within Electrode Range of Secret RF
device |
| User interface | LCD touch screen control panel | LCD touch screen control panel | LCD touch screen control panel | NO DIFFERENCE |
| Electrical
Requirements | 120VAC, 50/60Hz | 120VAC, 50/60Hz | 120VAC, 50/60Hz, 3-1A | NO DIFFERENCE |
| Intensity | 1-10 Level (1 Step) | 1-10 Level (1 Step) | 0-10 Level (2/5/10 STEP) | • NO DIFFERENCE from existing
Vivace device
• NO DIFFERENCE in range of
intensity levels from existing Secret RF
device |
| Weight
(Without Arm) | 24kg | 24kg | 40kg | • NO DIFFERENCE from existing
Vivace device
• Lighter than Secret RF device |
| Needle insert
depth | 0.53.5mm (0.1mm step) | 0.53.5mm (0.1mm step) | 0.5~3.5mm (0.1 step) | NO DIFFERENCE |
8
CONCLUSION I.
The subject VIVACE device, when used with the 2 MHz setting, is identical to the predicate and reference devices (K170325 and K150409) with respect to the principles of operation, technological characteristics, as well as performance characteristics. Non-clinical testing was conducted to evaluate the performance of subject device in comparison to the predicate devices and results have demonstrated substantial equivalence of the predicates in terms of safety and effectiveness for the intended use.