Venus VivaTM

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font. April 1, 2020 Venus Concept USA Inc. Yoni Iger Vice President, OA/RA/CA 1880 N Commerce Pkwy, Suite 2 Weston, Florida 33326 Re: K191065 Trade/Device Name: Venus Viva Device Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: March 1, 2020 Received: March 4, 2020 Dear Yoni Iger: 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. {1}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device 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 {2}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page 510(k) Number (if known) K191065 Device Name Venus Viva™ Device Indications for Use (Describe) The Venus Viva™ Device is a non-invasive device intended to be used by aesthetic physicians or dermatologists. When used with the Diamondpolar applicator, the Venus Viva™ Device is intended for use in dermatological and surgical procedures for the non-invasive treatment of moderate to severe facial wrinkles and rhytides in Fitzpatrick skin type I-IV. When used with the Viva applicator, the Venus Viva™ Device is intended for use in dermatological procedures requiring ablation and resurfacing of the skin. Type of Use (Select one or both, as applicable) □ Over-The-Counter Use (21 CFR 801 Subpart C) > Prescription Use (Part 21 CFR 801 Subpart D) PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number. Page 1 of 1 FDA PSC Publishing Services (301) 443-6740 EF FORM FDA 3881 (1/14) {3}------------------------------------------------ # 510(K) SUMMARY VENUS VIVA DEVICE 510(k) Number K191065 ### Applicant Name: Company Name: Venus Concept USA Inc. Address: 1880 N Commerce Pkwy, Suite 2 Weston, FL 33326 United States Tel: +1-888-9070115 Fax: +-888-9070115 E-mail: Yoni@venusconcept.com #### Contact Person: Official Correspondent: Dr. Yoni Iger Company Name: Venus Concept USA Inc. Tel: +1-9545489312 E-mail: Yoni@venusconcept.com Date Prepared: March 2020 Trade Name: Venus Viva TM Device Classification Name: Electrosurgical cutting and coagulation device and accessories CFR Classification section 878.4400; (Product code GEI) Classification: Class II Medical Device Classification Panel: General & Plastic Surgery Predicate Devices: Venus Viva TM SR device (K150161) Venus Legacy BX Device (K142910) Venus Concept Ltd. - Venus Viva™ Device - K191065 - Traditional 510(k) Submission {4}------------------------------------------------ #### Intended Use/Indication for Use: The Venus Viva™ Device is a non-invasive device intended to be used by aesthetic physicians or dermatologists. When used with the Diamondpolar applicator, the Venus Viva™ Device is intended for use in dermatological and surgical procedures for the non-invasive treatment of moderate to severe facial wrinkles and rhytides in Fitzpatrick skin type I-IV. When used with the Viva applicator, the Venus Viva™ Device is intended for use in dermatological procedures requiring ablation and resurfacing of the skin. #### Device Description The Venus Viva™ device consists of a console (main unit) and two applicators – Viva and Diamondpolar. The console contains a power supply unit, an RF generator (power module, on main board), a controller unit (on main board) and a touchscreen user interface and display panel. The Venus Viva™ device is a combination of the previously cleared Venus Viva™ SR (K150161), the primary predicate, and the Diamondpolar applicator that was previously cleared for the secondary predicate Venus Legacy BX (K142910). Both the Viva and Diamondpolar applicators can now be connected simultaneously to a single console, the Venus Viva™ console. #### Technological Characteristics: The Venus Viva™ is a computerized system generating RF energy and Pulsed Magnetic Fields (PMF), which are emitted into the skin. RF energy heats the tissue to trigger collagen remodeling for treatment of wrinkles and rythides or for the ablation and resurfacing of the skin. The Venus Viva™ device combines the effects of RF energy and PMF to the selected applicator. The energies provide optimal treatment results with minimal risk of side effects. {5}------------------------------------------------ #### Performance Data: Venus Concept conducted several performance tests to demonstrate that the Venus Viva™ device complies with performance standards and that it functions as intended. Performance Bench Testing: The Venus Viva™ device underwent performance testing, including software validation and device verification tests in order to evaluate the Venus Viva™ device's RF and PMF output parameters per specifications, and as compared to the predicate device's specifications. The results demonstrated that the Venus Viva™ device has the same RF and PMF output specifications and temperature stability profile as those reported for the predicate device and therefore, is substantially equivalent to the predicate device. Electrical Safety and Electromagnetic Compatibility: In addition, the device was tested per the applicable electrical safety and electromagnetic compatibility standards listed below, and all results were passing: - IEC 60601-1, (Ed. 3.1 ,2012): Medical Electrical Equipment Part 1: General . requirements for basic safety and essential performance. - IEC 60601-1-2, (Fourth Edition, 2014): Medical Electrical Equipment Part 1-2 . General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests. - IEC 60601-2-2, (Sixth Edition, 2017): Medical Electrical Equipment Part 2: . Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories. - IEC 60601-1-6, (Third Edition, 2013): Medical Electrical Equipment Part 1-6: . General requirements for basic safety and essential performance - Collateral standard: Usability. - IEC 62304, (Ed. 1.1, 2015): Medical device software Software life cycle . processes. {6}------------------------------------------------ Software Testing: The software was also subjected to verification and validation testing, and results demonstrated that the system performed as intended. These performance tests demonstrated that the device meets the system requirements and do not raise new types of safety or effectiveness concerns. #### Sterilization and Cleaning The Diamondpolar applicator of the Venus Viva™ device is not provided sterile, nor is it intended to be sterilized by the end user. Users are instructed to clean and disinfect the system components between use, per the directions provided in the User Manual. The same cleaning and disinfection instructions were previously validated for the predicate device, the company's Venus Legacy BX (K142910). The tip of the Viva applicator is for single use and has to be sterilized by autoclave prior to use. The tip is provided non-sterile and will be sterilized by the end user. The applicator tips are to be steam sterilized by autoclave per the validated parameters below: Temperature: 121°C Full cycle time: 30 minutes Dry time: 15 minutes The same steam sterilization instructions were previously validated for the predicate device, the company's Venus Viva TM SR (K150161). #### Biocompatibility The Venus Viva™ system is a surface device in limited contact (<24 hours) with intact skin. The patient-contacting parts/materials of the Venus Viva™ device are: - · Disposable tips of the Viva applicator. The tip consists of stainless steel pins sealed in a plastic base. - Chrome-coated electrodes of the Diamondpolar applicator. . The patient-contacting components were tested for cytotoxicity, sensitization, and irritation or intracutaneous reactivity as defined for surface devices in the FDA guidance and ISO 10993-1. Based on results of the conducted testing all materials were determined biocompatible for their intended use. {7}------------------------------------------------ ## Substantial Equivalence: The following table compares the Venus Viva™ device to the predicate devices with respect to intended use, technological characteristics and principles of operation, providing detailed information regarding the basis for the determination of substantial equivalence. {8}------------------------------------------------ # Venus Concept, Ltd.'s Venus Viva™ Substantial Equivalence | | Venus Viva<br>Venus Concept Ltd.<br>(K191065) | Venus Viva SR<br>Venus Concept Ltd.<br>(K150161) | Venus Legacy BX<br>Venus Concept Ltd.<br>(K142910) | |------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Class,<br>Product<br>Code,<br>Regulation | Class II, GEI, 21 CFR 878.4400 | Class II, GEI, 21 CFR 878.4400 | Class II, GEI, 21 CFR 878.4400 | | Indications<br>for Use | The Venus Viva™ Device is a non-<br>invasive device intended to be used<br>by aesthetic physicians or<br>dermatologists.<br>• When used with the Diamondpolar<br>applicator, the Venus Viva™<br>Device is intended for use in<br>dermatological and surgical<br>procedures for females for the non-<br>invasive treatment of moderate to<br>severe facial wrinkles and rhytides<br>in Fitzpatrick skin type I-IV.<br>• When used with the Viva<br>applicator, the Venus Viva™<br>Device is intended for use in<br>dermatological procedures<br>requiring ablation and resurfacing<br>of the skin. | The Venus Viva SR is intended<br>for dermatological procedures<br>requiring ablation and<br>resurfacing of the skin. | The Venus Legacy BX is a<br>noninvasive device intended for use<br>in dermatologic and general surgical<br>procedures for females for the non-<br>invasive treatment of moderate to<br>severe facial wrinkles and rhytides in<br>Fitzpatrick skin types I-IV. | | Energy Used /<br>Delivered | RF Energy<br>Pulsed Magnetic Field (PMF) | RF Energy | RF Energy<br>Pulsed Magnetic Field (PMF) | | Applicator<br>Footprint<br>Dimensions | Viva : 1.33 cm2<br>Diamondpolar: 2.9 cm2 | Viva SR: 1.33 cm2 | Diamondpolar: 2.9 cm2 | | Performance | Frequency: 1MHz, 0.46 MHz<br>Max. output energy for Viva<br>Fractional applicator: 62 mJ/pin<br>Maximal RF output power for<br>Diamondpolar Applicator: up to<br>75W<br>PMF Power: 15 Gauss (15Hz) | Frequency: 0.46 MHz<br>Max. output energy for Viva SR<br>applicator: 62 mJ/pin | Frequency: 1MHz<br>Maximal RF output power for<br>Diamondpolar Applicator: up to 75W<br>PMF Power: 15 Gauss (15Hz) | | Materials | Materials are biocompatible | Materials are biocompatible | Materials are biocompatible | | Power<br>requirements | 100-240 VAC<br>50-60Hz | 100-240 VAC<br>50-60Hz | 100-240 VAC<br>50-60Hz | {9}------------------------------------------------ {10}------------------------------------------------ As described in the comparison table above, the Venus Viva™ device has the same intended use and a combination of the indications of the previously cleared Venus devices. The device also has the same technological characteristics compared to the predicate devices. The Venus Viva™ device is a modified device of the Venus Viva™ SR device, the primary predicate previously cleared under (K150161). The design and components in the Venus Viva™ device, including the console (with power supply, RF generator, controller and display panel) and the applicator (with cable and connector to console) are similar to the design and components found in the predicate Venus Viva™ SR device. The only modification between the Venus Viva™ SR device and the Venus Viva™ device is the integration of the Diamondpolar applicator in the Venus Viva™ device. The Venus Viva™ device is basically the same device as the Venus Viva™ SR device with the addition of the Diamondpolar applicator that was previously cleared for the co-primary predicate device Venus Legacy BX (K150161). The safety features and compliance with safety standards in the Venus Viva™ device are similar to the safety features and compliance with safety standards found in both predicate devices. The patient contact materials are biocompatible in compliance with the ISO 10993 standard and similar to materials found in the predicate devices. The cleaning and disinfection instructions for the Diamondpolar applicator are consistent with the previously validated for the predicate device, the company's Venus Legacy BX (K142910). The sterilization instructions for the tip of the Viva applicator are the same steam sterilization instructions that were previously validated for the predicate device, the company's Venus Viva™ SR (K150161). In addition, the Venus Viva™ device underwent performance testing, including software validation testing, electrical safety according to IEC 60601-1 and electromagnetic compatibility testing according to IEC 60601-1-2. These performance tests demonstrated that the specifications (including RF electrical power output and PMF output) of the Venus VivaTM meet the system requirements and there are no new safety or effectiveness concerns. {11}------------------------------------------------ Furthermore, the general method of treating the patient's skin, the levels of energies used in treatment of skin, the size of treatment area and treatment zone, the active electrode area, durations of treatment, total energies delivered, are all similar to the respective methods and parameters in the predicate devices. #### Conclusions: Results of performance testing, summarized in this 510k notice, demonstrate that the Venus Viva™ device is as safe, as effective, and performs as well as or better than the legally marketed predicate devices. Venus Viva SR (K150161) and Legacy BX (K142910). Therefore, based on the same intended use and indications for use, similar technological characteristics and principles of operation, the Venus Viva™ device is substantially equivalent to its predicate devices, Venus Viva SR (K150161) and Legacy BX (K142910).