(85 days)
The Viora V10 system is intended for dermatological procedures. The V10 system with V-FC Handpiece is indicated for delivering non thermal RF combined with massage, Relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation and Temporary reduction in the appearance of cellulite.
The Viora V20 system is intended for dermatological procedures. The V20 system with V-FC Handpiece is indicated for delivering non thermal RF combined with massage, Relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation and Temporary reduction in the appearance of cellulite.
The Viora V30 system is intended for dermatological procedures. The V30 system with V-FC Handpiece is indicated for delivering non thermal RF combined with massage, Relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation and Temporary reduction in the appearance of cellulite.
The V-FC Handpiece is supported by Viora's V10, V20 and V30 systems. The V10, V20 and V30 systems are multi-application, multi-technology platform devices 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 document does not contain information about specific acceptance criteria related to a diagnostic or AI-based device's performance metrics (e.g., sensitivity, specificity, AUC) or a study proving that such criteria were met.
Instead, this document is a 510(k) Premarket Notification from the FDA, asserting substantial equivalence for the Viora V30, V20, V10 systems with the V-FC Handpiece to previously cleared predicate devices. The "performance criteria" and "study" described are focused on proving that the new handpiece and system configurations are as safe and effective as the existing predicate devices for their indicated uses.
Therefore, I cannot populate the requested table or answer most of the questions as they pertain to a type of study and acceptance criteria not present in this regulatory document.
However, I can extract information related to the device's technical performance and safety testing.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
As noted, the document does not present acceptance criteria in terms of diagnostic performance metrics. The "performance" discussed is primarily related to safety and maintaining therapeutic temperature.
| Acceptance Criteria (Internal/Safety-focused) | Reported Device Performance |
|---|---|
| Maintain superficial skin therapeutic temperature between 39-42 °C during 14 minutes of treatment. | "The V-FC handpiece can be easily operated to ensure therapeutic body temperature between 39-42 ℃, while treating in operating room temperature between 10° C to 30° C..." |
| System stops RF energy delivery if the handpiece IR sensor detects body temperature above 47°C. | "In cases of temperature decreasing below 39C or increasing above 42C the practitioner investigator was able to react immediately to increase /decrease the RF power. In addition to increase the safety profile, the system software is designed in such way that once the handpiece IR sensor detects body temperature above 47C. the system stops delivery of RF energy." |
| Compliance with Electrical Safety and Electromagnetic Compatibility (e.g., IEC 60601-1, IEC 60601-1-2). | "The V-FC Handpiece compatible with V30, V20, V10 Systems was determined to be in conformance with applicable IEC standards..." |
| Biocompatibility of skin-contacting components (tip, electrodes) meeting ISO 10993-1 requirements. | "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-FC 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." |
| Software verification and validation demonstrating acceptable results for release and performance to specifications. | "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-FC Handpiece performs according to specifications and functions as intended." |
| As safe and effective as predicate devices. | "In conclusion, the V-FC Handpiece compatible with V30, V20, V10 Systems is substantially equivalent to its predicate device." "The differences do not raise any new issues of safety or effectiveness." |
2. Sample size used for the test set and the data provenance
The document mentions "Dedicated tests were performed during three days" to assess temperature maintenance. It refers to "participants" but does not specify the number of human participants for this test. It also mentions "previous ex-vivo tests on the chicken breast" for the 47°C safety cutoff.
- Sample Size (human): Not specified, only refers to "participants."
- Sample Size (ex-vivo): Not specified (e.g., number of chicken breasts).
- Data provenance: The testing was done internally as part of the safety and performance verification for the 510(k) submission. No specific country of origin is mentioned for these particular tests, but the submitter Viora Ltd. is based in Netanya, Israel. It's a prospective internal test for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the document describes safety and performance bench tests and not a clinical diagnostic performance study requiring expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the document does not describe a diagnostic study with a test set requiring adjudication.
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
This information is not applicable. This is a device for dermatological procedures involving RF and massage, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is a physical medical device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document describes safety and performance bench tests where "ground truth" was based on:
- Measured temperature: Using an integrated IR thermometer and LED indications.
- System response: Observing if the system stopped RF energy delivery when a certain temperature threshold was reached (tested on chicken breast).
- Compliance with defined standards: Such as IEC and ISO for electrical safety, EMC, and biocompatibility.
8. The sample size for the training set
This information is not applicable. This is not an AI/machine learning device that would require a training set.
9. How the ground truth for the training set was established
This information is not applicable.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of the symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
May 21, 2020
Viora Ltd. Ms. Simona Krant, QA/RA Director 6 Hagavish Street Netanya, 4250706 Israel
Re: K200468
Trade/Device Name: V30 system, V20 system, V10 system, V-FC Handpiece Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories
Regulatory Class: Class II Product Code: PBX, GEX Dated: April 07, 2020 Received: April 15, 2020
Dear Ms. 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.
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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 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. 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) K200468
Device Name
V-FC Handpiece compatible with V30, V20, V10 Systems
Indications for Use (Describe)
The Viora V10 system is intended for dermatological procedures.
The V10 system with V-FC Handpiece is indicated for delivering non thermal RF combined with massage, Relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation and Temporary reduction in the appearance of cellulite.
The Viora V20 system is intended for dermatological procedures.
The V20 system with V-FC Handpiece is indicated for delivering non thermal RF combined with massage, Relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation and Temporary reduction in the appearance of cellulite.
The Viora V30 system is intended for dermatological procedures.
The V30 system with V-FC Handpiece is indicated for delivering non thermal RF combined with massage, Relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation and Temporary reduction in the appearance of cellulite.
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 that is focused on shaping the future. The logo features the company name in bold, uppercase letters, with the tagline "Shape the Future" underneath. Below the logo is the text "510(k) K200468", which likely refers to a regulatory approval or certification number.
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.6 Hagavish StreetNetanya, Israel 4250706Israel |
|---|---|
| Contact Person: | Ms. Simona F. KrantQA/RA DirectorEmail: Simona@Vioramed.comPhone Number: +972 9955 1344Fax Number: +972 9955 1345 |
| EstablishmentRegistrationNumber: | 3005695724 |
| Date Prepared: | May 21, 2020 |
| Device TradeName(s): | V-FC Handpiece compatible with V30, V20, V10 Systems |
| Device CommonName: | Bipolar RF based applicator |
| Classification: | Name: Laser surgical instrument for use in general and plastisurgery and in dermatology and Electrosurgical cutting andcoagulation device and accessories.Product code: GEX, PBX, ISA (for V30 system)GEX, PBX, ISA (for V20 system)PBX, ISA (for V10 system)Regulation No: 21CFR878.4810, 21CFR878.4400Class: IIPanel: General and plastic surgery devices |
| PredicateDevice(s): | Viora V30 system with V-FORM handpiece (K162363)Viora V20 system with V-FORM handpiece (K152611)Viora V10 system with V-FORM handpiece (K150035) |
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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 text "Shape the Future". The text "510(k) K200468" is at the bottom of the image.
| 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). |
| For V20 & V30: | |||
| V20 | dermatologic procedures. The mainconsole unit incorporates a touch-screencontrol panel, power supply modules,cooling system, switching module andservice panel.Cooled by deionized water | V-ST, V-IPL, V- and V-FORM (with BC Small,Medium and Largeapplicators) | February 19, 2016(K152611)&November 18, 2016(K162363). |
| V10 | based 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. | V-ST and V-FORM (withBC Small and Largeapplicators) | May 1, 2015(K150035)&November 18, 2016(K162363). |
The V-FC Handpiece is supported by Viora's V10, V20 and V30 systems.
Indication for Use for V-FC Handpiece compatible with V30, V20, V10 Systems
The Viora V10 system is intended for dermatological procedures.
The V10 system with V-FC Handpiece is indicated for delivering non thermal RF combined with massage. Relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation and Temporary reduction in the appearance of cellulite.
The Viora V20 system is intended for dermatological procedures.
The V20 system with V-FC Handpiece is indicated for delivering non thermal RF combined with massage. Relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation and Temporary reduction in the appearance of cellulite.
The Viora V30 system is intended for dermatological procedures.
The V30 system with V-FC Handpiece is indicated for delivering non thermal RF combined with massage, Relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation and Temporary reduction in the appearance of cellulite.
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-FORM |
| Viora V20 | K152611 | Cleared on February 19, 2016 | V-FORM |
| Viora V30 | K162363 | Cleared on November 18, 2016 | V-FORM |
The predicate device to V-FC Handpiece compatible with V30, V20, V10 Systems is V10, V20, V30 systems with V-FORM handpiece.(Viora Ltd.) including BC large, small and medium applicators.
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Image /page/5/Picture/0 description: The image shows the logo for VIORA, a company with the tagline "Shape the Future." The logo features a stylized graphic above the company name. Below the tagline is the text "510(k) K200468", which likely refers to a regulatory submission number.
Substantial Equivalence to Predicate Device
| ComparisonParameter | Subject Device:V10,V20 and V30 systems with V-FCHandpiece | Predicate Device:V10,V20 and V30 systems with V-FORMhandpiece | 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 deviceand accessories. | Electrosurgical cutting and coagulation device andaccessories. | Same |
| Device maincomponents | Cleared V10,V20 and V30 systems with:V-FC Handpiece, connector, cable handpiece. | Bipolar RF Applicator, connector, cable handpiece | Same |
| Supportedtechnologies | The cleared V10,V20 and V30 systemsinclude 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 V-FCHandpiece are intended for delivering nonthermal RF combined with massage, relief ofminor muscle aches and pain, relief of musclespasm, temporary improvement of local bloodcirculation and temporary reduction in theappearance of cellulite. | The V10,V20 and V30 systems with V-FORMhandpiece are intended for delivering non thermal RFcombined with massage, relief of minor muscle achesand pain, relief of muscle spasm, temporaryimprovement of local blood circulation and temporaryreduction in the appearance of cellulite | Same |
| ComparisonParameter | Subject Device:V10,V20 and V30 systems with V-FCHandpiece | Predicate Device:V10,V20 and V30 systems with V-FORMhandpiece | 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 | 23x23 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 vacuumlevel | Up to 450 mbar | Up to 500 mbar | Different butequivalent |
| Software | The V10,V20 and V30 systems softwaresupports the V-FC Handpieces.The software was verified and validatedaccording to the FDA guidance. | According to 510(k) summariesV10: K150035V20: K152611V30: K162363. | Same |
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Image /page/6/Picture/0 description: The image shows the logo for VIORA. The logo consists of a stylized graphic above the word "VIORA" in a bold, sans-serif font. Below the word "VIORA" is the tagline "Shape the Future" in a smaller, lighter font. The graphic above the wordmark appears to be an abstract design, possibly representing a stylized infinity symbol or a flowing shape.
5100k) K20046
Summary of technologic characteristics
The Vora V-FC Handpiece compatible with V30, V10 Systems and the intended use and indivation for use, identical technological features and identical performance characteristics. The V20 console has similat technological characteristics as the predicate device, performance and software validation data the differences between the V-FC Handpiece compatible with V30, V20, V20 Systems support and the predicate do not raise any new questions of safety and effectiveness.
The V-FC Handpiece and the predicate device intended use and similar technological features. Any differences in the V-FC Handpiece design do not raise any new questions of safety and effectiveness, as was verified by performance testing.
In conclusion, the V-FC Handpiece compatible with V30, V20, V10 Systems is substant to its predicate device. Therefore, we concluded that the V-FORM for the V-FC 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 the company name in a bold, sans-serif font, with the tagline in a smaller font underneath. Above the company name is a stylized graphic element that resembles an infinity symbol or a stylized strand. The text "510(k) K200468" is located below the tagline.
Performance standards
The V-FC 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-FC 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
Dedicated tests were performed during three days to assess the V-FC handpiece capability to safely maintain superficial skin therapeutic temperature between 39-42 °C during theopoetic 14 minutes of treatment.
The integrated IR thermometer indicating the skin temperature over the system GUI screen and LED's temperature indication on the handpiece provided the practitioner ongoing monitoring. In cases of temperature decreasing below 39C or increasing above 42C the practitioner investigator was able to react immediately to increase /decrease the RF power.
In addition to increase the safety profile, the system software is designed in such way that once the handpiece IR sensor detects body temperature above 47C. the system stops delivery of RF energy. Since reaching body temperature above 43C was painful these was not tested on the participants. However, previous ex-vivo tests on the chicken breast did tested temperature above 47C (CRF-2). In this test the system stopped RF energy delver once detected 47C and the meat returned to lower temperature about 30 sec post the break.
According to the collected data from these tests it can be concluded that the V-FC handpiece can be easily operated to ensure therapeutic body temperature between 39-42 ℃, while treating in operating room temperature between 10° C to 30° C and according the device specifications and are as safe and effective as the cleared predicate devices.
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Image /page/8/Picture/0 description: The image shows the logo for VIORA, a company that is focused on 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) K200468" is at the bottom of the image.
Biocompatibility:
The materials and biocompatibility characteristics of Viora V10, V30 systems, except of the material of the new Handpiece V-FC remains the same as approved (K150035, K152611, and K162363 respectively).
Thus, all components that come into contact with the skin (tip, electrodes) are bio-
compatible and meet the requirement of the ISO 10993-1.
Additional biological evaluation for the V-FC 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.
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-FC Handpiece performs according to specifications and functions as intended.
Clinical Study
Since the technological parameters of the Viora V10, V20, V30 system with V-FC Handpiece is well within the parameters of the previously cleared V30. V20 and V10 systems. Viora believes that pre-clinical and clinical studies are not required to determine the safety and efficacy of the Viora V10, V20, V30 system with V-FC Handpiece.
Conclusion
The non-clinical data further support the safety of the device, and software verification and validation testing demonstrate that the Viora V10, V20, V30 system with V-FC Handpiece is expected to perform as intended in the specified use conditions. Based on the technological characteristics of the devices and the intended use, Viora believes that the Viora V10, V20, V30 system with V-FC Handpiece is substantially equivalent to the predicate devices. The differences do not raise any new issues 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.