(121 days)
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.
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.
The provided text describes a 510(k) premarket notification for the Viora V-VR Handpiece compatible with V30, V20, V10 Systems. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific performance acceptance criteria for a new clinical claim.
Therefore, much of the requested information regarding acceptance criteria, study methodologies, sample sizes, expert involvement, and ground truth establishment, which are typical for studies validating a new clinical claim or an AI/ML device, are not present in this regulatory submission. This submission is for a modified accessory (handpiece) with similar intended use to an already cleared device, primarily relying on bench testing and software validation to show equivalence and safety, not on a new clinical study.
However, based on the information provided, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
The document outlines performance standards for safety and electrical characteristics rather than clinical efficacy metrics. The primary "acceptance criterion" demonstrated through bench testing is the capability of the V-VR Handpiece to safely maintain superficial skin therapeutic temperature between 40-45 ℃ during 14 minutes of treatment.
| Acceptance Criteria (Performance Standard) | Reported Device Performance |
|---|---|
| Electrical Safety: Conformance with IEC 60601-1:2012 | Device determined to be in conformance. |
| Electromagnetic Compatibility (EMC): Conformance with IEC 60601-1-2: 2014 | Device determined to be in conformance. |
| Non-Laser Light Source Equipment Safety (for V20, V30): Conformance with IEC 60601-2-57:2011 | Device determined to be in conformance. |
| Surgical/Therapeutic Laser Equipment Safety (for V20, V30): Conformance with IEC 60601-2-22:2007 | Device determined to be in conformance. |
| Laser Product Safety (for V20, V30): Conformance with IEC 60825-1:2014 | Device determined to be in conformance. |
| Therapeutic Temperature Maintenance for V-VR IR (Infra-Red) handpiece: Safely maintain superficial skin temperature between 40-45 ℃ during 14 minutes of treatment. | Bench testing "demonstrated that the Viora V10, V20, V30 system with V-VR Handpiece performs per its device specifications." This implicitly confirms the temperature maintenance capability. |
| Biocompatibility: Meet requirements of ISO 10993-1 for surface device with limited to transient contact. | All components coming into contact with skin (tip, electrodes) are biocompatible and meet the requirement. |
| Software Functionality: Software verification and validation testing results acceptable for software release. | Testing results were found acceptable for software release. |
| Overall Performance: Perform according to specifications and function as intended. | All performance testing demonstrated that the device performs according to specifications and functions as intended. |
2. Sample size used for the test set and the data provenance:
The document does not mention a clinical test set or patient data. The validation relies on bench testing for performance, electrical safety, EMC, and software. There is no mention of country of origin or whether data was retrospective or prospective, as it's not a data-driven clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable as no clinical test set requiring expert ground truth for a diagnostic or AI claim was conducted. The "ground truth" for the engineering and safety tests is based on established industry standards (IEC, ISO) and internal device specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable as no clinical test set requiring adjudication was conducted.
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 is not an AI/ML device for diagnostic or interpretive purposes, nor a device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a medical device (handpiece) that performs a physical therapeutic action, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
The "ground truth" for this regulatory submission is adherence to safety and performance standards (IEC, ISO), as measured by technical bench tests and software validation. For the clinical claims (temporary relief of minor muscle aches and pain, etc.), the device relies on substantial equivalence to the predicate devices which had already established these indications.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable.
Summary of the Study:
The "study" described in this 510(k) summary is primarily a series of non-clinical bench tests and engineering analyses to demonstrate that the new V-VR Handpiece, when used with existing Viora systems (V10, V20, V30), is as safe and effective as the predicate V-ST Handpiece, and meets applicable safety standards. The core argument for acceptance is substantial equivalence to already cleared devices, rather than a de novo clinical demonstration of efficacy.
The key tests performed were:
- V-VR IR temperature assessment: To verify its capability to safely maintain superficial skin therapeutic temperature (40-45 ℃ for 14 minutes).
- Electrical Safety & EMC Testing: Conformance to IEC standards (60601-1, 60601-1-2, 60601-2-57, 60601-2-22, 60825-1).
- Biocompatibility Testing: Conformance to ISO 10993-1.
- Software Verification and Validation: To ensure the software supporting the handpiece functions correctly and as intended.
The acceptance criteria are therefore implicit in meeting these standards and demonstrating performance per device specifications, without needing a separate clinical study with patient samples or expert adjudication for this specific submission.
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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
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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 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 Nameand Address: | Viora Ltd.Industrial Park Sagie 2000Migdal HaEmek, 1812003 |
|---|---|
| Contact Person: | Ms.Simona F. KrantQA/RA DirectorEmail: Simona@Vioramed.comPhone Number: +972 546739756Fax Number: +972 9955 1345 |
| EstablishmentRegistrationNumber: | 3005695724 |
| Date Prepared: | December 07, 2020 |
| Device TradeName(s): | V-VR Handpiece compatible with V30, V20, V10 Systems |
| Device CommonName: | Bipolar RF based applicator |
| Classification: | Name: Electrosurgical cutting and coagulation device andaccessories, Laser surgical instrument for use in general andplastic 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 878.4400Class: IIPanel: General and plastic surgery devices |
| PredicateDevice(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.
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Device description
| System | Description | Applications | 510(k) Clearance |
|---|---|---|---|
| V30 | Multi-application, multi-technologyplatform device intended for use in | Nd:YAG (V30) | November 18, 2016(K162363). |
| V20 | dermatologic procedures. The mainconsole unit incorporates a touch-screencontrol panel, power supply modules,cooling system, switching module andservice panel. | For V20 & V30:V-ST, V-IPL, V- and V-FORM (with BC Small,Medium and Largeapplicators) | February 19, 2016(K152611)&November 18, 2016(K162363). |
| V10 | Cooled by deionized waterbased on the well-established bipolarradiofrequency (RF) technology used forheating of soft tissues. The main consoleunit incorporates a touch-screen controlpanel, power supply modules, RFgenerator 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.
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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 | CharacteristicComparison(same/different) |
|---|---|---|---|
| Device Class | Class II | Class II | Same |
| ClassificationPanel | General and PlasticSurgery devices | General and PlasticSurgery 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 andaccessories. | Electrosurgical cutting and coagulation device andaccessories. | 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 andindication for use | The V10,V20 and V30 systems with the V-VRHandpiece is indicated for the temporary relief ofminor muscle aches and pain, temporary relief ofmuscle spasm, and temporary improvement of localblood circulation. | The V10,V20 and V30 systems with the V-ST Handpieceare indicated for the temporary relief of minor muscle achesand pain, temporary relief of muscle spasm, and temporaryimprovement 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.
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| Comparison Parameter | Subject Device:V10,V20 and V30 systems with V-VR Handpiece | Predicate Device:V10,V20 and V30 systems with V-ST handpiece | CharacteristicComparison(same/different) |
|---|---|---|---|
| System user interface | V10 & V20: 8.1-inch touch screenV30:10.4-inch touch screen | V10 & V20: 8.1-inch touch screenV30:10.4-inch touch screen | Same |
| Handpiecedimensions: | 17x25.6 cm | 14x24 cm | Different butequivalent |
| Handpiece weight | 0.625 kg | 0.75 kg | Different butequivalent |
| Electricalrequirements: | 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 levelNo Vacuum | No Vacuum | Same | |
| Software | The V10.V20 and V30 systems software supportsthe V-VR Handpieces.The software was verified and validated accordingto the FDA guidance. | According to 510(k) summariesV10: K150035V20: K152611V30: 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.
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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".
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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.
§ 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.