(187 days)
No
The provided text describes a radio frequency output device for electrocoagulation and hemostasis, with no mention of AI or ML technology in the intended use, device description, or performance studies.
Yes
The device is used for electrocoagulation, hemostasis, and the percutaneous treatment of facial wrinkles, which are medical treatments aimed at improving or restoring health/function.
No
The device is intended for therapeutic procedures such as electrocoagulation, hemostasis, and the treatment of facial wrinkles using radiofrequency energy, not for diagnosing medical conditions.
No
The device description explicitly lists hardware components such as a main body, handpieces, connector cable, grounding plate, cooling plate, foot switch, and power cord, indicating it is not a software-only device.
Based on the provided information, the Virtue RF System is not an In Vitro Diagnostic (IVD) device.
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." These are all procedures performed directly on the human body for therapeutic purposes.
- Device Description: The description details a system that delivers radio frequency energy to the human body using needles and handpieces. This is a direct intervention on the patient.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Virtue RF System does not perform any such analysis of specimens.
Therefore, the Virtue RF System is a therapeutic medical device, not an IVD.
N/A
Intended Use / Indications for Use
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 1MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles. The VirtueRF Electrosurgical System for facial wrinkles is intended for use with Skin Types I-V.
The Smart RF Handpiece with 2MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The with 2MHz functionality is not intended to treat wrinkles.
Exact RF Handpiece:
The Exact RF Handpiece with 1MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The Exact RF Handpiece is not intended to treat wrinkles.
Deep RF Handpiece:
The Deep RF Handpiece with 1MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The Deep RF handpiece with 1MHz functionality is not intended to treat wrinkles.
The Deep RF Handpiece with 2MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The Deep RF handpiece with 2MHz functionality is not intended to treat wrinkles.
The Deep RF Handpiece with 0.5MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The Deep RF handpiece with 0.5MHz functionality is not intended to treat wrinkles.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The VirtueRF device is a radio frequency output device using 0.5MHz, 1MHz & 2Mhz to deliver radio frequency energy to the human body with 3 applicators that attach to the connecting cable. The energy is applied to the human body using sterile disposable needle arrays consisting of 36 needles, 12 needles, o 1 needle.
This product consists of main body, SmartRF Bipolar handpiece, DeepRF Bipolar handpiece, ExactRF Monopolar handpiece, connector cable, grounding plate for ExactRF, cooling plate for the DeepRF, foot switch and power cord.
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
Prescription Use
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)
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.
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.
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). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
November 23, 2021
ShenB Co Ltd % Connie Hoy Consultant Hoy and Associates 3916 N. Potsdam Ave. #4676 Sioux Falls, South Dakota 57104
Re: K211562
Trade/Device Name: Virtue RF Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: October 19, 2021 Received: October 20, 2021
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 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).
Sincerely,
Long Chen, Ph.D. for Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211562
Device Name
Virtue RF
Indications for Use (Describe)
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 1MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles. The VirtueRF Electrosurgical System for facial wrinkles is intended for use with Skin Types I-V.
The Smart RF Handpiece with 2MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The with 2MHz functionality is not intended to treat wrinkles.
Exact RF Handpiece:
The Exact RF Handpiece with 1MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The Exact RF Handpiece is not intended to treat wrinkles.
Deep RF Handpiece:
The Deep RF Handpiece with 1MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The Deep RF handpiece with 1MHz functionality is not intended to treat wrinkles.
The Deep RF Handpiece with 2MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The Deep RF handpiece with 2MHz functionality is not intended to treat wrinkles.
The Deep RF Handpiece with 0.5MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The Deep RF handpiece with 0.5MHz functionality is not intended to treat wrinkles.
| Type of Use (Select one or both, as applicable) | |
|---|---|
|X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
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 148 |
| Seongsui-ro | |
| Seongdong-Gu, Seoul , KR 04796 | |
| Contact Person: | Bora Kim |
| Contact Information: | kimbora@shenb.com |
| +82-70-4814-2978 | |
| Preparation Date: | November 18, 2021 |
| Device Trade Name: | VirtueRF |
| Common Name: | Electrosurgical, cutting & coagulation & accessories |
| Regulation Name: | Electrosurgical cutting and coagulation device and accessories |
| Regulation Number: | 21 CFR 878.4400 (Product Code: GEI) |
| Legally Marketed Predicate Device: | Virtue RF System |
| K202415 | |
| Legally Marketed Reference Device: | Primaeva Medical Miratone System |
| K082391 | |
| Agnes | |
| K192728 | |
| Regulatory Class: | Class II Prescription Use |
| Description of the VirtueRF : | The VirtueRF device is a radio frequency output device using |
| 0.5MHz, 1MHz & 2Mhz to deliver radio frequency energy to the | |
| human body with 3 applicators that attach to the connecting | |
| cable. The energy is applied to the human body using sterile | |
| disposable needle arrays consisting of 36 needles, 12 needles, o | |
| 1 needle. | |
| This product consists of main body, SmartRF Bipolar handpiece, | |
| DeepRF Bipolar handpiece, ExactRF Monopolar handpiece, | |
| connector cable, grounding plate for ExactRF, cooling plate for | |
| the DeepRF, foot switch and power cord. |
5
Intended use / Indication for Use of Virtue RF :
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 dermatologic and general surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles. The VirtueRF System for facial wrinkles is intend for use with Skin types I-V.
The Smart RF Handpiece with 2 MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The Smart RF with 2MHz functionality is not intended to treat wrinkles.
Exact RF Handpiece:
The Exact RF Handpiece with 1MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The Exact RF Handpiece is not intended to treat wrinkles.
Deep RF Handpiece:
The Deep RF Handpiece with 1MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The Deep RF handpiece with 1MHz frequency is not intended to treat wrinkles.
The Deep RF Handpiece with 2MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The Deep RF handpiece with 2MHz frequency is not intended to treat wrinkles.
The Deep RF Handpiece with 0.5MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The Deep RF handpiece with 0.5MHz frequency is not intended to treat wrinkles.
6
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.
Comparison to the predicate and reference devices:
| Comparison for Smart RF handpiece - 1MHz functionality | |||
|---|---|---|---|
| Proposed Device | |||
| ShenB VirtueRF | Predicate device | ||
| for 1MHz | |||
| Virtue RF | |||
| K202415 | Comparison | ||
| Source of | |||
| energy/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 | 35.9 W | 35.9 W | Same |
| RF Duration | 100ms-800ms, with | ||
| 100ms increments | 100ms-800ms, with | ||
| 100ms increments | Same |
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| Comparison for Smart RF Handpiece - 2MHZ Functionality | |||
|---|---|---|---|
| Proposed Device | |||
| ShenB VirtueRF | |||
| Smart RF | |||
| Handpiece | Predicate Device | ||
| Virtue RF | |||
| K202415 | Comparison | ||
| Source of | |||
| Energy/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, with | ||
| 100ms increments | 100ms-800ms, with | ||
| 100ms increments | Same |
| Comparison for ExactRF Handpiece | ||||
|---|---|---|---|---|
| Proposed Device | ||||
| Virtue RF | ||||
| Exact RF Handpiece | Predicate Device | |||
| Virtue RF | ||||
| K202415 | Reference Device | |||
| Agnes | ||||
| K160469 | Comparison | |||
| Source of | ||||
| Energy/Modality | Monopolar | Bipolar | Monopolar | Similar; same as |
| reference device | ||||
| Radiofrequency | 1MHz | 1Mhz & 2MHz | 1MHz | same |
| Electrode type | Monopolar single | |||
| needle RF electrode | Bipolar | |||
| microneedle | Monopolar single | |||
| needle RF electrode | Similar; same as | |||
| reference device | ||||
| Number of Needles | 1 | 36 | 1 | Different; same as |
| reference device | ||||
| Grounding | ||||
| Mechanism | Electrode plate | N/A | Disposable neutral | |
| electrode pad | Similar to | |||
| reference device | ||||
| Max Power | 46W | 35.9W | 46W at 200Ω | Same as |
| reference; similar | ||||
| to predicate | ||||
| device | ||||
| RF Duration | 100ms-800ms, with | |||
| 100ms increments | 100ms-800ms, | |||
| with | ||||
| 100ms | ||||
| increments | 50ms - 2,000ms | Same; similar to | ||
| reference device |
| Comparison for DeepRF Handpiece – 1MHz & 2MHz Functionality | |||
|---|---|---|---|
| Proposed Device | |||
| Deep RF Handpiece- 1MHz | Predicate Device Virtue | ||
| RF - 1MHz | |||
| K202415 | |||
| Source of | |||
| Energy/Modality | Bipolar | Bipolar | Same |
| Radiofrequency | 1MHz | 1MHz | Same |
| Electrode type | Bipolar microneedles with RF | ||
| Electrode | Bipolar microneedles | ||
| with RF Electrode | Same | ||
| Max Power | 155 W at 500Ω | 35.9W | Different |
| RF Duration | 100ms-800ms, with | ||
| 100ms increments | 100ms-800ms, with | ||
| 100ms increments | Same |
8
| | Proposed Device - Deep RF -
2MHz | Predicate Device
Virtue RF – 2MHz
K202415 | |
|------------------------------|-------------------------------------------|-------------------------------------------------|---------|
| Source of
Energy/Modality | Bipolar | Bipolar | Same |
| Radiofrequency | 2MHz | 2MHz | Same |
| Electrode type | Bipolar microneedles with RF
Electrode | Bipolar microneedles
with RF Electrode | Same |
| Number of
Needles | 12 or 36 | 36 | Similar |
| Max Power | 60W | 35.9W | Similar |
| RF Duration | 100ms-800ms, with
100ms increments | 100ms-800ms, with
100ms increments | Same |
| Comparison for DeepRF Handpiece - 0.5MHz Functionality | ||||
|---|---|---|---|---|
| Proposed Device |
- Deep RF
0.5MHz | Predicate Device
Virtue RF | Reference Device
Primaeva
K082391 | Comparison |
| Source of
Energy/Modality | Bipolar | N/A. Approved
Virtue does not
have 0.5MHz
functionality | Bipolar | Same |
| Radiofrequency | 0.5MHz | N/A | .46MHz | Similar |
| Electrode type | Bipolar
Handpiece +
Micro needle
electrodes | N/A | Bipolar Handpiece +
Micro needle
electrodes | Same |
| Number of Needles | 12 or 36 | N/A | 10 (3 different tips all
with 10 needles) | Similar |
| Max Power | 220W | N/A | 25W | Different |
| RF Duration | 100-800ms and
can be adjusted
100ms | N/A | Adjustable 10-50 ms
on for every 100 ms | Same |
| Cooling Modality | Detachable TEC
Cooling plate.
Water cooling
system inside
handpiece
controls and
maintains
temperature of
cooling plate. | N/A | Cooler controller and
reusable cooler
controller
handpiece/applicator | Similar |
9
Conclusion: The proposed VirtueRF is the same system as the FDA cleared VirtueRF (K202415) and adds 2 additional handpieces, each with their own disposable cartridges. The indications for use and the technological characteristics are the same as the predicate device and the reference devices. Substantial equivalence is supported by the performance testing and there are no new questions of safety or effectiveness.