(187 days)
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.
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.
The provided text is a 510(k) summary for the Virtue RF device, an electrosurgical cutting and coagulation device. This type of FDA submission focuses on demonstrating substantial equivalence to a predicate device rather than undergoing a clinical trial to prove de novo effectiveness or meeting specific performance acceptance criteria for a novel device. As such, the document does not contain information typically found in a study demonstrating a device meets acceptance criteria involving human or animal subjects, ground truth, or statistical measures of performance like AUC, sensitivity, or specificity.
Instead, the submission demonstrates substantial equivalence primarily through:
- Bench testing: Adherence to recognized electrical safety and electromagnetic compatibility standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2) and biological compatibility (ISO 10993-1).
- Thermal effect tests: Performed on four types of tissues (liver, kidney, muscle, and skin) as guided by FDA for electrosurgical devices.
- Direct comparison of technological characteristics: Side-by-side tables comparing the proposed device's various handpieces (Smart RF, Exact RF, Deep RF) with its own predicate device (Virtue RF K202415) and other reference devices (Primaeva Medical Miratone System K082391, Agnes K192728, and Agnes K160469, though K160469 is not explicitly listed as a reference device, it appears in a comparison table for Exact RF).
Therefore, I cannot provide the detailed acceptance criteria and study information requested in the prompt, as these elements are not part of this specific type of regulatory submission. The document concludes that "Substantial equivalence is supported by the performance testing and there are no new questions of safety or effectiveness."
To explicitly address your points:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria for Bench Testing: Adherence to the listed IEC standards (e.g., meeting specific safety thresholds for electrical current, electromagnetic emissions, and biological compatibility). The "reported device performance" is that it passed these tests.
- Acceptance Criteria for Thermal Effect Tests: The criteria would be to demonstrate substantial equivalence to the predicate device in terms of thermal effects on tissues. The "reported device performance" is that the "Test shows that the VirtueRF is substantially equivalent to the predicate device."
- Acceptance Criteria for Technological Characteristics: The criteria are for the proposed device's features (Source of energy/Modality, Radiofrequency, Output energy type, Electrode type, Max Power, RF Duration, Number of Needles, Grounding Mechanism, Cooling Modality) to be "Same" or "Similar" to the predicate/reference devices, with justifications where there are differences (e.g., "Similar; same as reference device" or "Same as reference; similar to predicate device"). The "reported device performance" is detailed in the comparison tables provided in the document (pages 6-8).
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable for this type of submission. The "tests" here are bench tests on the device's hardware and thermal effects on tissues, not clinical trials on human subjects. The tissue tests would likely use an ex vivo or in vivo animal model, but details on sample size or provenance are not provided.
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. Ground truth from human experts is not used for this type of technical and bench testing-focused submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No expert adjudication is involved.
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. This device is not an AI-assisted diagnostic device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not a software algorithm; it's an electrosurgical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the thermal effect tests, the "ground truth" would be objective measurements of tissue coagulation or heating, compared to measurements from the predicate device. For technical standards, the "ground truth" is adherence to the specified parameters in the IEC and ISO standards.
8. The sample size for the training set:
- Not applicable. There is no "training set" as this is not a machine learning device.
9. How the ground truth for the training set was established:
- Not applicable.
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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
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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
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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.
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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 148Seongsui-roSeongdong-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 SystemK202415 |
| Legally Marketed Reference Device: | Primaeva Medical Miratone SystemK082391AgnesK192728 |
| Regulatory Class: | Class II Prescription Use |
| Description of the VirtueRF : | The VirtueRF device is a radio frequency output device using0.5MHz, 1MHz & 2Mhz to deliver radio frequency energy to thehuman body with 3 applicators that attach to the connectingcable. The energy is applied to the human body using steriledisposable needle arrays consisting of 36 needles, 12 needles, o1 needle.This product consists of main body, SmartRF Bipolar handpiece,DeepRF Bipolar handpiece, ExactRF Monopolar handpiece,connector cable, grounding plate for ExactRF, cooling plate forthe DeepRF, foot switch and power cord. |
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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.
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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 DeviceShenB VirtueRF | Predicate devicefor 1MHzVirtue RFK202415 | Comparison | |
| Source ofenergy/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, with100ms increments | 100ms-800ms, with100ms increments | Same |
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| Comparison for Smart RF Handpiece - 2MHZ Functionality | |||
|---|---|---|---|
| Proposed DeviceShenB VirtueRFSmart RFHandpiece | Predicate DeviceVirtue RFK202415 | Comparison | |
| Source ofEnergy/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, with100ms increments | 100ms-800ms, with100ms increments | Same |
| Comparison for ExactRF Handpiece | ||||
|---|---|---|---|---|
| Proposed DeviceVirtue RFExact RF Handpiece | Predicate DeviceVirtue RFK202415 | Reference DeviceAgnesK160469 | Comparison | |
| Source ofEnergy/Modality | Monopolar | Bipolar | Monopolar | Similar; same asreference device |
| Radiofrequency | 1MHz | 1Mhz & 2MHz | 1MHz | same |
| Electrode type | Monopolar singleneedle RF electrode | Bipolarmicroneedle | Monopolar singleneedle RF electrode | Similar; same asreference device |
| Number of Needles | 1 | 36 | 1 | Different; same asreference device |
| GroundingMechanism | Electrode plate | N/A | Disposable neutralelectrode pad | Similar toreference device |
| Max Power | 46W | 35.9W | 46W at 200Ω | Same asreference; similarto predicatedevice |
| RF Duration | 100ms-800ms, with100ms increments | 100ms-800ms,with100msincrements | 50ms - 2,000ms | Same; similar toreference device |
| Comparison for DeepRF Handpiece – 1MHz & 2MHz Functionality | |||
|---|---|---|---|
| Proposed DeviceDeep RF Handpiece- 1MHz | Predicate Device VirtueRF - 1MHzK202415 | ||
| Source ofEnergy/Modality | Bipolar | Bipolar | Same |
| Radiofrequency | 1MHz | 1MHz | Same |
| Electrode type | Bipolar microneedles with RFElectrode | Bipolar microneedleswith RF Electrode | Same |
| Max Power | 155 W at 500Ω | 35.9W | Different |
| RF Duration | 100ms-800ms, with100ms increments | 100ms-800ms, with100ms increments | Same |
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| Proposed Device - Deep RF -2MHz | Predicate DeviceVirtue RF – 2MHzK202415 | ||
|---|---|---|---|
| Source ofEnergy/Modality | Bipolar | Bipolar | Same |
| Radiofrequency | 2MHz | 2MHz | Same |
| Electrode type | Bipolar microneedles with RFElectrode | Bipolar microneedleswith RF Electrode | Same |
| Number ofNeedles | 12 or 36 | 36 | Similar |
| Max Power | 60W | 35.9W | Similar |
| RF Duration | 100ms-800ms, with100ms increments | 100ms-800ms, with100ms increments | Same |
| Comparison for DeepRF Handpiece - 0.5MHz Functionality | ||||
|---|---|---|---|---|
| Proposed Device- Deep RF0.5MHz | Predicate DeviceVirtue RF | Reference DevicePrimaevaK082391 | Comparison | |
| Source ofEnergy/Modality | Bipolar | N/A. ApprovedVirtue does nothave 0.5MHzfunctionality | Bipolar | Same |
| Radiofrequency | 0.5MHz | N/A | .46MHz | Similar |
| Electrode type | BipolarHandpiece +Micro needleelectrodes | N/A | Bipolar Handpiece +Micro needleelectrodes | Same |
| Number of Needles | 12 or 36 | N/A | 10 (3 different tips allwith 10 needles) | Similar |
| Max Power | 220W | N/A | 25W | Different |
| RF Duration | 100-800ms andcan be adjusted100ms | N/A | Adjustable 10-50 mson for every 100 ms | Same |
| Cooling Modality | Detachable TECCooling plate.Water coolingsystem insidehandpiececontrols andmaintainstemperature ofcooling plate. | N/A | Cooler controller andreusable coolercontrollerhandpiece/applicator | Similar |
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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.
§ 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.