(121 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on established technologies like bipolar radiofrequency and a touch-screen control panel.
Yes
The device (with the V-VR Handpiece) is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation, which are therapeutic claims.
No
The device description and intended use state that it is for dermatological procedures and temporary relief of muscle aches and pain, muscle spasm, and temporary improvement of local blood circulation, all of which are therapeutic rather than diagnostic purposes.
No
The device description explicitly mentions a "main console unit" which incorporates hardware components like a touch-screen control panel, power supply modules, cooling system, and RF generator. It also describes a "V-VR Handpiece." These are physical hardware components, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use and indications for use clearly state that the system is for "dermatological procedures" and the V-VR Handpiece is for "temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation." These are all therapeutic or aesthetic applications performed directly on the patient's body.
- Device Description: The device description details a multi-application, multi-technology platform for dermatologic procedures, utilizing radiofrequency (RF) technology for heating soft tissues. This describes a physical device used for treatment, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions based on such analysis, or providing information for diagnosis.
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. This device's function falls outside of that definition.
N/A
Intended Use / Indications for Use
The Viora V10 system is intended for dermatological procedures.
The V10 system with the V-VR Handpiece is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.
The Viora V20 system is intended for dermatological procedures.
The V20 system with the V-VR Handpiece is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.
The Viora V30 system is intended for dermatological procedures.
The V30 system with the V-VR Handpiece is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.
Product codes
PBX, ISA, GEX
Device Description
Multi-application, multi-technology platform device intended for use in dermatologic procedures. The main console unit incorporates a touch-screen control panel, power supply modules, cooling system, switching module and service panel. Cooled by deionized water based on the well-established bipolar radiofrequency (RF) technology used for heating of soft tissues. The main console unit incorporates a touch-screen control panel, power supply modules, RF generator and service panel. The V-VR Handpiece is supported by Viora's V10, V20 and V30 systems.
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)
Bench testing demonstrated that the Viora V10, V20, V30 system with V-VR Handpiece performs per its device specifications and are as safe and effective as the cleared predicate devices.
V-VR IR(Infra-Red) temperature was assessed to verify capability to V-VR handpiece capability to safely maintain superficial skin therapeutic temperature between 40-45 ℃ during 14 minutes of the treatment (heating phase).
Software verification and validation testing was conducted, and results demonstrated that testing results were found acceptable for software release.
All performance testing demonstrated that the Viora V10, V20, V30 system with V-VR Handpiece performs according to specifications and functions as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Viora V30 system with VST handpiece (K162363), Viora V20 system with VST handpiece (K152611)
Reference Device(s)
Not Found
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.
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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.
December 9, 2020
Viora Ltd. Simona Krant QA/RA Director 6 Hagavish Street Netanya, 4250706 Israel
Re: K202247
Trade/Device Name: V-VR Handpiece compatible with V30, V20, V10 Systems Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: PBX, ISA, GEX Dated: September 7, 2020 Received: September 9, 2020
Dear Simona Krant:
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,
for 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) K202247
Device Name
V-VR Handpiece compatible with V30, V20, V10 Systems
Indications for Use (Describe)
The Viora V10 system is intended for dermatological procedures.
The V10 system with the V-VR Handpiece is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.
The Viora V20 system is intended for dermatological procedures.
The V20 system with the V-VR Handpiece is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.
The Viora V30 system is intended for dermatological procedures.
The V30 system with the V-VR Handpiece is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.
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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Image /page/3/Picture/0 description: The image shows the logo for VIORA, a company with the tagline "Shape the Future." Below the logo and tagline is the text "510(k) K202247", which likely refers to a regulatory submission number. The logo features a stylized, abstract design above the company name.
Page 1 of 6
510(k) Summary
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92.
| Submitter Name
and Address: | Viora Ltd.
Industrial Park Sagie 2000
Migdal HaEmek, 1812003 |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ms.Simona F. Krant
QA/RA Director
Email: Simona@Vioramed.com
Phone Number: +972 546739756
Fax Number: +972 9955 1345 |
| Establishment
Registration
Number: | 3005695724 |
| Date Prepared: | December 07, 2020 |
| Device Trade
Name(s): | V-VR Handpiece compatible with V30, V20, V10 Systems |
| Device Common
Name: | Bipolar RF based applicator |
| Classification: | Name: Electrosurgical cutting and coagulation device and
accessories, Laser surgical instrument for use in general and
plastic surgery and in dermatology (for V20 and V30 system)
Product code: PBX, ISA, GEX (for V30 system)
PBX, ISA, GEX (for V20 system)
PBX, ISA (for V10 system)
Regulation No: 21CFR 878.4400
Class: II
Panel: General and plastic surgery devices |
| Predicate
Device(s): | Viora V30 system with VST handpiece (K162363)
Viora V20 system with VST handpiece (K152611) |
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Image /page/4/Picture/0 description: The image shows the logo for VIORA, a company that is shaping the future. Below the company name is the phrase "Shape the Future". The text "510(k) K202247" is at the bottom of the image.
Page 2 of 6
Device description
| System | Description | Applications | 510(k) Clearance |
|---|---|---|---|
| V30 | Multi-application, multi-technology | ||
| platform device intended for use in | Nd:YAG (V30) | November 18, 2016 | |
| (K162363). | |||
| V20 | dermatologic procedures. The main | ||
| console unit incorporates a touch-screen | |||
| control panel, power supply modules, | |||
| cooling system, switching module and | |||
| service panel. | For V20 & V30: | ||
| V-ST, V-IPL, V- and V- | |||
| FORM (with BC Small, | |||
| Medium and Large | |||
| applicators) | February 19, 2016 | ||
| (K152611) | |||
| & | |||
| November 18, 2016 | |||
| (K162363). | |||
| V10 | Cooled by deionized water | ||
| based on the well-established bipolar | |||
| radiofrequency (RF) technology used for | |||
| heating of soft tissues. The main console | |||
| unit incorporates a touch-screen control | |||
| panel, power supply modules, RF | |||
| generator and service panel. |
The V-VR Handpiece is supported by Viora's V10, V20 and V30 systems.
Indication for Use for V-VR Handpiece compatible with V30, V20, V10 Systems
Viora V10 ,V20 and V30 systems are intended for dermatological procedures.
The V10 ,V20 and V30 systems with the V-VR Handpiece are indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.
Predicate Devices
The predicate device to Viora systems V10, V20 and V30 are the cleared V10, V20 and V30 systems themselves (please refer to the table below).
| Device name | 510k No. | Date of Clearance | Compatible Predicate Handpiece |
|---|---|---|---|
| Viora V10 | K150035 | Cleared on May 1, 2015 | V-ST |
| Viora V20 | K152611 | Cleared on February 19, 2016 | V-ST |
| Viora V30 | K162363 | Cleared on November 18, 2016 | V-ST |
The predicate device to V-ST Handpiece compatible with V30, V20, V10 Systems is V10, V20, V30 systems with V-ST handpiece,(Viora Ltd.)
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Image /page/5/Picture/0 description: The image shows the logo for VIORA, a company that is shaping the future. The logo features a stylized infinity symbol above the company name, which is written in a bold, sans-serif font. Below the company name is the tagline "Shape the Future." The text "510(k) K202247" is underlined and located at the bottom of the image.
Page 3 of 6
Substantial Equivalence to Predicate Device
| Comparison Parameter | Subject Device:
V10,V20 and V30 systems with V-VR Handpiece | Predicate Device:
V10,V20 and V30 systems with V-ST handpiece | Characteristic
Comparison
(same/different) |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|
| Device Class | Class II | Class II | Same |
| Classification
Panel | General and Plastic
Surgery devices | General and Plastic
Surgery devices | Same |
| Product code | 21CFR878.4400 (V10,V20 & V30)
21CFR878.4810 (V20 & V30) | 21CFR878.4400 (V10,V20 & V30)
21CFR878.4810 (V20 & V30) | Same |
| Regulation number | PBX, ISA (V10,V20 & V30)
GEX (V20 & V30) | PBX, ISA (V10,V20 & V30)
GEX (V20 & V30) | Same |
| Regulation description | Electrosurgical cutting and coagulation device and
accessories. | Electrosurgical cutting and coagulation device and
accessories. | Same |
| Device main components | Cleared V10,V20 and V30 systems with:
V-VR Handpiece, connector, cable handpiece. | Bipolar RF Applicator, connector, cable handpiece | Same |
| Supported technologies | The cleared V10,V20 and V30 systems include RF
(V10,V20 & V30)
IPL ( V20 & V30) and Laser(V30) | The cleared V10,V20 and V30 systems include RF
(V10,V20 & V30)
IPL ( V20 & V30) and Laser(V30) | Same |
| Intended use and
indication for use | The V10,V20 and V30 systems with the V-VR
Handpiece is indicated for the temporary relief of
minor muscle aches and pain, temporary relief of
muscle spasm, and temporary improvement of local
blood circulation. | The V10,V20 and V30 systems with the V-ST Handpiece
are indicated for the temporary relief of minor muscle aches
and pain, temporary relief of muscle spasm, and temporary
improvement of local blood circulation. | Same |
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Image /page/6/Picture/0 description: The image shows the logo for VIORA, a company that is shaping the future. Below the company name is the phrase "Shape the Future". The text "510(k) K202247" is located at the bottom of the image.
Page 4 of 6
| Comparison Parameter | Subject Device:
V10,V20 and V30 systems with V-VR Handpiece | Predicate Device:
V10,V20 and V30 systems with V-ST handpiece | Characteristic
Comparison
(same/different) |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|--------------------------------------------------|
| System user interface | V10 & V20: 8.1-inch touch screen
V30:10.4-inch touch screen | V10 & V20: 8.1-inch touch screen
V30:10.4-inch touch screen | Same |
| Handpiece
dimensions: | 17x25.6 cm | 14x24 cm | Different but
equivalent |
| Handpiece weight | 0.625 kg | 0.75 kg | Different but
equivalent |
| Electrical
requirements: | 100-240 V~ 10A 50/60 Hz (V10,V20 & V30)
100-120 V~ 10A 50/60 Hz (V20 & V30)
Single Phase | 100-240 V~ 10A 50/60 Hz (V10,V20 & V30)
100-120 V~ 10A 50/60 Hz (V20 & V30)
Single Phase | Same |
| Maximum vacuum level
No Vacuum | No Vacuum | | Same |
| Software | The V10.V20 and V30 systems software supports
the V-VR Handpieces.
The software was verified and validated according
to the FDA guidance. | According to 510(k) summaries
V10: K150035
V20: K152611
V30: K162363. | Same |
Summary of technologic characteristics
The Viora V-VR Handpiece compatible with V30, V10 Systems and the similar intended use and indication for use, identical technological features and identical performance characteristics. The VIV, V20 and V30 console has similar ecolnological characteristics as the predicate device, performance and software validation deferences between the V-VR Handpiece compatible with V30, V20, V20 Systems support and the predicate do not raise any new questions of safety and effectiveness.
The V-VR Handpiece and the predicate device intended use and similar technological features. Any differences in the V-VR Handpiece design do not raise any new questions of safety and effectiveness, as was verified by performance testing.
In conclusion, the V-VR Handpiece compatible with V30, V20, V10 Systems is substantially equivalent to its preciented that the V-ST handpiece for the V-VR handpiece appears to be an adequate predicate for this submission.
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Image /page/7/Picture/0 description: The image shows the logo for VIORA, a company with the tagline "Shape the Future." The logo features a stylized, abstract design above the company name, which is written in a bold, sans-serif font. Below the tagline, the text "510(k) K202247" is displayed, likely indicating a regulatory approval or reference number.
Page 5 of 6
Performance standards
The V-VR Handpiece compatible with V30, V20, V10 Systems comply with the following performance standards:
| System Relevance | Standard Number | Part Title |
|---|---|---|
| V10,V20,V30 | IEC 60601-1:2012 | Medical Electrical Equipment Part 1:General Requirements for Basic Safety and Essential Performance |
| V10,V20,V30 | IEC 60601-1-2: 2014 | Medical Electrical Equipment Part 1-2:General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility – Requirements and Tests. |
| V20,V30 | IEC 60601-2-57:2011 | Particular Requirements for The Basic Safety and Essential Performance of Non-Laser Light Source Equipment Intended for Therapeutic, Diagnostic, Monitoring and Cosmetic/Aesthetic Use. |
| V20,V30 | IEC 60601-2-22:2007 | Particular Requirements for Basic Safety And Essential Performance of Surgical, Cosmetic, Therapeutic and Diagnostic Laser Equipment. |
| V20,V30 | IEC 60825-1:2014 | Safety of Laser Products Part 1: Equipment Classification, And Requirements |
Electrical Safety and Electromagnetic Compatibility:
The V-VR Handpiece compatible with V30, V20, V10 Systems was determined to be in conformance with applicable IEC standards as described in the above table.
Performance Bench Tests
V-VR IR(Infra-Red) temperature was assessed to verify capability to V-VR handpiece capability to safely maintain superficial skin therapeutic temperature between 40-45 ℃ during 14 minutes of the treatment (heating phase).
Bench testing demonstrated that the Viora V10, V20, V30 system with V-VR Handpiece performs per its device specifications and are as safe and effective as the cleared predicate devices.
Biocompatibility:
The materials and biocompatibility characteristics of Viora V10, V20, V30 systems, except of the material of the new Handpiece V-VR remains the same as approved (K150035, K152611, and K162363 respectively).
Thus, all components that come into contact with the skin (tip, electrodes) are biocompatible and meet the requirement of the ISO 10993-1.
Additional biological evaluation for the V-VR Handpiece is considered to have meet the requirements for a surface device with limited to transient contact and can be considered safe and suitable for its intended use.
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Image /page/8/Picture/0 description: The image shows the logo for VIORA, a company that is "shaping the future". The logo is black and white and features the company name in large, bold letters above the tagline. Below the tagline is the text "510(k) K202247".
Page 6 of 6
Software:
Software verification and validation testing was conducted, and results demonstrated that testing results were found acceptable for software release.
All performance testing demonstrated that the Viora V10, V20, V30 system with V-VR Handpiece performs according to specifications and functions as intended.
Conclusion
The technological differences between subject and predicate devices do not raise any new questions of safety or effectiveness. The non-clinical testing, software verification and validation testing and the temperature testing on the surface of the skin were performed to evaluate the performance of Viora V10, V20, V30 system with V-VR Handpiece. Based on comparison of the technological characteristics of the devices and results of the performance testing, Viora V10, V20, V30 system with V-VR Handpiece are substantially equivalent to the predicate devices for requested intended use.