(151 days)
No
The summary describes a radio frequency output device for electrosurgical procedures and wrinkle treatment. There is no mention of AI, ML, image processing, or any data-driven decision-making processes. The performance studies focus on electrical safety, electromagnetic compatibility, and thermal effects, not algorithmic performance.
Yes
The device is intended for clinical use in dermatologic and general surgical procedures, including electrocoagulation, hemostasis, and the percutaneous treatment of facial wrinkles, all of which are therapeutic interventions.
No
The device description and indications for use clearly state that the VirtueRF Electrosurgical System is intended for surgical procedures involving electrocoagulation, hemostasis, and the percutaneous treatment of facial wrinkles, which are all therapeutic interventions, not diagnostic ones.
No
The device description explicitly states it is a "radio frequency output device" with a "main body, Needle Bipolar RF (Smart RF) handpiece cable, foot switch and power cord," indicating it is a hardware device that delivers energy.
Based on the provided information, the VirtueRF Electrosurgical System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- VirtueRF Functionality: The description clearly states that the VirtueRF device delivers radio frequency energy to the human body using needles. This is an in vivo (within the living body) procedure, not an in vitro (outside the living body) test.
- Intended Use: The intended uses are for dermatologic and general surgical procedures involving electrocoagulation, hemostasis, and the percutaneous treatment of facial wrinkles. These are all procedures performed directly on the patient's body.
Therefore, the VirtueRF Electrosurgical System is a therapeutic device used for surgical and dermatological treatments, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The VirtueRF Electrosurgical System has separate indications for use for each of its functionalities: 1MHz and 2MHz.
1MHz Indications for use: Intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles. The VirtueRF Electrosurgical System is intended for use with Skin Types I-V.
2MHz Indications for use: Intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The 2mHz frequency is not intended to treat wrinkles.
Product codes
GEI
Device Description
The VirtueRF device is a radio frequency output device using 1MHz & 2Mhz to deliver radio frequency energy to the human body with an applicator attached to the connecting cable. The energy is applied to the human body using a sterile disposable needle array consisting of 36 needles. This product consists of main body, Needle Bipolar RF (Smart RF) handpiece cable, 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
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
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
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January 22, 2021
ShenB Co Ltd % Connie Hoy Consultant Hoy and Associates 3916 N. Potsdam Ave #4676 Sioux Falls, South Dakota 57104
Re: K202415
Trade/Device Name: VirtueRF Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: November 29, 2020 Received: December 1, 2020
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/cdrl/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.
1
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 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 (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. 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
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Indications for Use
510(k) Number (if known) K202415
Device Name
VirtueRF
Indications for Use (Describe)
The VirtueRF Electrosurgical System has separate indications for use for each of its functionalities: 1MHz and 2MHz.
1MHz Indications for use
Intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles. The VirtueRF Electrosurgical System is intended for use with Skin Types I-V.
2MHz Indications for use
Intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The 2mHz frequency is not intended to treat wrinkles.
| 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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510K Summary K202415
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: | Mr. Oskar Lee |
| Telephone: | 82 70.4912.2702 - phone |
| oskar@shenb.com | |
| Preparation Date: | January 22, 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: | Vivace Electrosurgical System |
| K150409 | |
| Legally Marketed Reference Device: | Secret RF |
| K182355 | |
| Regulatory Class: | Class II Prescription Use |
| Description of the VirtueRF : | The VirtueRF device is a radio frequency output device |
| using 1MHz & 2Mhz to deliver radio frequency energy to the | |
| human body with an applicator attached to the connecting | |
| cable. The energy is applied to the human body using a | |
| sterile disposable needle array consisting of 36 needles. | |
| This product consists of main body, Needle Bipolar RF | |
| (Smart RF) handpiece cable, foot switch and power cord. | |
| Intended use of VirtueRF : | The VirtueRF Electrosurgical System has separate |
| indications for use for each of its functionalities: | |
| 1MHz and 2MHz. | |
| 1MHz Indications for use: Intended for use in | |
| dermatologic and general surgical procedures for | |
| electrocoagulation and hemostasis, and the | |
| percutaneous treatment of facial wrinkles. The | |
| VirtueRF Electrosurgical System is intended for use | |
| with Skin Types I-V. |
5
510K Summary K202415
2MHz Indications for use: Intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The 2mHz frequency is not intended to treat wrinkles.
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.
Technical Specifications / Indications for Use Comparison:
| Comparison for 1MHz Functionality | |||
|---|---|---|---|
| Proposed Device | |||
| ShenB VirtueRF | Predicate device | ||
| for 1MHz | |||
| Vivace | |||
| Electrosurgical | |||
| System | 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 | 35.9W | 61 w | Same |
| RF Duration | 100ms-800ms, with | ||
| 100ms increments | 100ms-800ms, with | ||
| 100ms increments | Same |
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510K Summary K202415
| Comparison for 2MHz Functionality | |||
|---|---|---|---|
| Proposed Device | |||
| ShenB VirtueRF | Reference device | ||
| for 2MHz | |||
| Secret RF | 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 | 50ms - 950ms | Similar |
Conclusion: The VirtueRF and the predicate device relevant to 1MHz functionality, the Vivace Electrosurgical System, have the same indications for use and the same technological characteristics. The VirtueRF and the reference device relevant to 2MHz functionality, the Secret RF, have the same indications for use and nearly identical technological characteristics. The RF duration for the proposed VirtueRF (100ms-800ms) varies from the Secret RF only in that it is a subset of the Secret RF Duration. Therefore, VirtueRF substantially equivalent to both the predicate device and the reference device and there are no new questions of safety or effectiveness.