(56 days)
No
The summary describes a device that uses RF and PMF energy for skin treatments. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on energy output, ablation dimensions, healing, electrical safety, and software validation, none of which indicate AI/ML functionality.
Yes
The device is described as being used for "dermatological procedures requiring ablation and resurfacing of the skin" and "non-invasive treatment of moderate to severe facial wrinkles and rhytides," which are therapeutic interventions.
No
The device is described as being used for dermatological procedures involving ablation, resurfacing, and the treatment of wrinkles, which are therapeutic rather than diagnostic applications.
No
The device description explicitly states it consists of a console (main unit) and two applicators, including hardware components like a power supply, RF generator, PMF generator, controller unit, and touchscreen. It is a physical device with software controlling its operation, not a software-only device.
Based on the provided information, the Venus Viva MD™ device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for dermatological procedures requiring ablation and resurfacing of the skin, and for the non-invasive treatment of facial wrinkles and rhytides. These are procedures performed directly on the patient's body.
- Device Description: The description details a console, applicators, RF and PMF generators, and a user interface. This is consistent with a device used for physical treatment, not for analyzing samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (like blood, urine, tissue, etc.) in vitro (outside the body). IVDs are designed to provide information about a patient's health status based on the analysis of these samples.
- Performance Studies: The performance studies described involve bench testing of device parameters, animal testing on skin, electrical safety, and software testing. These are typical for a device used for physical treatment, not for an IVD which would involve studies related to analytical and clinical performance on biological samples.
In summary, the Venus Viva MD™ is a therapeutic device used for aesthetic and dermatological treatments directly on the patient's skin, not a diagnostic device used to analyze samples in vitro.
N/A
Intended Use / Indications for Use
The Venus Viva MD™ is a non-invasive device intended to be used by aesthetic-related physicians or dermatologists.
- When used with the Viva MD applicator, the Venus Viva MD™ device is intended for use in dermatological procedures requiring ablation and resurfacing of the skin.
- When used with the Diamondpolar applicator, the Venus Viva MD™ device is intended for use in dermatological and surgical procedures for females for the non-invasive treatment of moderate to severe facial wrinkles and rhytides in Fitzpatrick skin type I-IV.
Product codes
GEI
Device Description
The Venus Viva MD™ device consists of a console (main unit) and two applicators: Viva MD applicator and Diamondpolar applicator. The console contains a power supply unit, RF generator (power module, on main board), PMF generator, a controller unit (on main board), a touchscreen user interface and display panel.
The Venus Viva MD™ 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 MD and Diamondpolar applicators can now be connected simultaneously to a single console, the Venus Viva MD™ console.
Additionally, the Viva MD applicator is supplied with single use detachable tips with 80- or 160electrode pins. The 160-pin tip was previously cleared within Venus Viva SR (K150161).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin (for dermatological procedures, and facial wrinkles and rhytides).
Indicated Patient Age Range
Not Found (Specified for "females" for the Diamondpolar applicator, but no age range is given).
Intended User / Care Setting
aesthetic-related physicians or dermatologists.
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)
Performance - Bench Testing: The Venus Viva MD™ device underwent performance testing, including software validation and device verification tests in order to evaluate the Venus Viva MD™ 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 MD™ device has the same RF and PMF output specifications as those reported for the predicate devices and therefore, is substantially equivalent to the predicates with respect to device performance.
Performance - Animal Testing: The animal study was conducted to histologically compare average ablation dimensions and healing of ablated zones in porcine skin when treated with an 80-pin tip and 160-pin tip of the Venus Viva MD™ system. Overall, the treated sites in both pin tip groups showed that the skin was ablated and thereafter passed resurfacing and desired healing with complete re-epithelialization of the epidermis and the beginnings of new collagen synthesis.
Electrical Safety and Electromagnetic Compatibility: In addition, the system was tested per the applicable electrical safety and electromagnetic compatibility standards listed below, and all results were passing.
- IEC 60601-1:2012 Ed. 3.1, Medical electrical equipment Part 1: General . requirements for basic safety and essential performance
- IEC 60601-1-2:2014 Ed. 4, General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-2-2:2017 Ed. 6 Medical electrical equipment Part 2: Particular ● requirements for basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
- IEC 60601-1-6: 2013 Ed.3.1, General requirements for basic safety and essential . performance - Collateral standard: Usability
- IEC 62304:2015 Medical device software Software life cycle processes .
Software Testing: The software was also subject 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 related safety or effectiveness concerns.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
0
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June 26, 2020
Venus Concept USA Inc. Dr. Yoni Iger Vice President Quality Assurance/Regulatory Affairs/Clinical Affairs 1880 N Commerce Pkwy, Suite 2 Weston, Florida 33326
Re: K201164
Trade/Device Name: Venus Viva MD Device Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: April 28, 2020 Received: May 1, 2020
Dear Dr. 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.
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.
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
Indications for Use
510(k) Number (if known) K201164
Device Name
Venus Viva MD™
Indications for Use (Describe)
The Venus Viva MD™ is a non-invasive device intended to be used by aesthetic-related physicians or dermatologists.
- · When used with the Viva MD applicator, the Venus Viva MD™ device is intended for use in dermatological procedures requiring ablation and resurfacing of the skin.
- · When used with the Diamondpolar applicator, the Venus Viva MD™ device is intended for use in dermatological and surgical procedures for females for the non-invasive treatment of moderate to severe facial wrinkles and rhytides in Fitzpatrick skin type I-IV.
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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510(k) SUMMARY - K201164
Venus Viva MD™
| Applicant Name: | Venus Concept USA Inc.
1880 N Commerce Pkwy,
Ste 2, Weston, FL33326, USA
Tel: +1 888 907-0115 |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Dr. Yoni Iger
Vice President Quality Assurance/Regulatory Affairs/Clinical Affairs
Venus Concept USA Inc.
Yoni@venusconcept.com |
| Date Prepared: | June 24, 2020 |
| Trade Name: | Venus Viva MD™ |
| Classification Name: | 21 CFR 878.4400 Electrosurgical cutting and coagulation device and
accessories |
| Product Code: | GEI |
| Classification: | Class II Medical Device |
| Classification Panel: | General & Plastic Surgery |
| Predicate Device: | Venus Viva SR Device (K150161)
Venus Legacy BX Device (K142910) |
Intended Use/Indication for Use:
The Venus Viva MD™ is a non-invasive device intended to be used by aesthetic-related physicians or dermatologists.
- When used with the Viva MD applicator, the Venus Viva MD™ device is intended for . use in dermatological procedures requiring ablation and resurfacing of the skin.
- When used with the Diamondpolar applicator, the Venus Viva MD™ device is intended . for use in dermatological and surgical procedures for females for the non-invasive treatment of moderate to severe facial wrinkles and rhytides in Fitzpatrick skin type I-IV.
4
Device Description:
The Venus Viva MD™ device consists of a console (main unit) and two applicators: Viva MD applicator and Diamondpolar applicator. The console contains a power supply unit, RF generator (power module, on main board), PMF generator, a controller unit (on main board), a touchscreen user interface and display panel.
The Venus Viva MD™ 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 MD and Diamondpolar applicators can now be connected simultaneously to a single console, the Venus Viva MD™ console.
Additionally, the Viva MD applicator is supplied with single use detachable tips with 80- or 160electrode pins. The 160-pin tip was previously cleared within Venus Viva SR (K150161).
Technological Characteristics:
The Venus Viva MD™ is a computerized system generating Radiofrequency (RF) energy and Pulsed Magnetic Fields (PMF), which are emitted into the Venus Viva MD™ device delivers RF energy to the patient's skin with the use of the Viva MD applicator or a combination of RF and PMF energies with the use of the Diamondpolar applicator. The Venus Viva MDTM, when operated with the Viva MD applicator. is designed to deliver radiofrequency energy to the skin in a non-homogenous manner, via an array of multi-electrode pins. The array delivers RF energy to the skin, resulting in heating of skin directly below and in contact with the electrodes, to temperatures leading to ablation and resurfacing of the skin. The energy generates heating that ablates within the epidermis, papillary and reticular dermis, triggering slow collagen remodeling.
Each RF electrode and its surrounding PMF coil of the Diamonpolar applicator of the Venus Viva MD™ device simultaneously emits RF and PMF energy. RF-energy induced heat is to cause the dermal collagen to contract, producing an anti- wrinkle effect. The non-ablative heat in the dermal tissue triggers a second delayed effect in which collagen fibers are built, enhancing the anti-wrinkle and anti-rhytides effect. The PMF energy provokes skin tissue for extra collagen production and amplifies the RF induced effect.
Performance Data:
Venus Concept conducted several performance tests to demonstrate that the Venus Viva MD™ device complies with performance standards and that it functions as intended.
Performance - Bench Testing: The Venus Viva MD™ device underwent performance testing, including software validation and device verification tests in order to evaluate the Venus Viva MD™ 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 MD™ device has the same RF and PMF output specifications as those reported for the predicate devices and
5
therefore, is substantially equivalent to the predicates with respect to device performance.
Performance - Animal Testing: The animal study was conducted to histologically compare average ablation dimensions and healing of ablated zones in porcine skin when treated with an 80-pin tip and 160-pin tip of the Venus Viva MD™ system. Overall, the treated sites in both pin tip groups showed that the skin was ablated and thereafter passed resurfacing and desired healing with complete re-epithelialization of the epidermis and the beginnings of new collagen synthesis.
Electrical Safety and Electromagnetic Compatibility: In addition, the system was tested per the applicable electrical safety and electromagnetic compatibility standards listed below, and all results were passing.
- IEC 60601-1:2012 Ed. 3.1, Medical electrical equipment Part 1: General . requirements for basic safety and essential performance
- . IEC 60601-1-2:2014 Ed. 4, General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-2-2:2017 Ed. 6 Medical electrical equipment Part 2: Particular ● requirements for basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
- IEC 60601-1-6: 2013 Ed.3.1, General requirements for basic safety and essential . performance - Collateral standard: Usability
- IEC 62304:2015 Medical device software Software life cycle processes .
Software Testing: The software was also subject 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 related safety or effectiveness concerns.
Substantial Equivalence:
The following table compares the Venus Viva MD™ 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.
6
| | Venus Viva MDTM
Venus Concept Ltd. | Venus Viva SR
Venus Concept Ltd.
(K150161) | Venus Legacy BX
Venus Concept Ltd.
(K142910) |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Class,
Product
Code,
Regulation | Class II, GEI, 21 CFR 878.4400 | Class II, GEI, 21 CFR 878.4400 | Class II, GEI, 21 CFR 878.4400 |
| Indications
for Use | The Venus Viva MDTM Device is a
non-invasive device intended to be
used by aesthetic-related physicians
or dermatologists.
• When used with the Diamondpolar
applicator, the Venus VivaTM
Device is intended for use in
dermatological and surgical
procedures for females 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 VivaTM
Device is intended for use in
dermatological procedures
requiring ablation and resurfacing
of the skin. | The Venus Viva SR is intended
for dermatological procedures
requiring ablation and
resurfacing of the skin. | The Venus Legacy BX is a
noninvasive device intended for use
in dermatologic and general surgical
procedures for females for the non-
invasive treatment of moderate to
severe facial wrinkles and rhytides in
Fitzpatrick skin types I-IV. |
| Energy Used /
Delivered | RF Energy
Pulsed Magnetic Field (PMF) | RF Energy | RF Energy
Pulsed Magnetic Field (PMF) |
| | Venus Viva MDTM
Venus Concept Ltd. | Venus Viva SR
Venus Concept Ltd.
(K150161) | Venus Legacy BX
Venus Concept Ltd.
(K142910) |
| Applicator
Footprint
Dimensions | Viva MD: 1.33 cm2 (160-pin tip)
1.33 cm2 (80-pin tip)
Diamondpolar: 2.9 cm2 | Viva SR: 1.33 cm2(160-pin tip) | Diamondpolar: 2.9 cm2 |
| Performance | Frequency: 1MHz, 0.46 MHz
Max. output energy for Viva
Fractional applicator: 62 mJ/pin
Maximal RF output power for
Diamondpolar Applicator: up to
75W
PMF Power: 15 Gauss (15Hz) | Frequency: 0.46 MHz
Max. output energy for Viva SR
applicator: 62 mJ/pin | Frequency: 1MHz
Maximal RF output power for
Diamondpolar Applicator: up to 75W
PMF Power: 15 Gauss (15Hz) |
| Materials | Materials are biocompatible | Materials are biocompatible | Materials are biocompatible |
| Power
requirements | 100-240 VAC
50-60Hz | 100-240 VAC
50-60Hz | 100-240 VAC
50-60Hz |
Table 1. Venus Concept, Ltd.'s Venus Viva MD™ Substantial Equivalence
7
8
As described in the comparison table above, the subject Venus Viva MD™ and the predicates Venus Viva SR device (K150161) and Venus Legacy BX device (K142910) share the same intended use and the same underlying technology with similar technological characteristics and principles of operation. The design and components in the Venus Viva MD™ 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 modifications between the Venus Viva SR device and the Venus Viva MD™ device is the integration of the Diamondpolar applicator and an addition of the 80-pin tip in the Venus Viva MD™ device. The Diamondpolar applicator was previously cleared for the additional predicate device Venus Legacy BX (K150161) and the 80-pin tip presenting minor design changes while preserving the same characteristics such as total output energy, active treatment area and materials if compared to the 160-pin tip cleared previously for the primary predicate Venus Viva SR device (K150161).
The combination of two of the predicate applicators into a single device and any differences between the Venus Viva MD™ and its predicates (K150161, K142910) were carefully evaluated and it was concluded that they do not present any new questions of safety or effectiveness.
The safety features and compliance with safety standards of the Venus Viva MD™ 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). Sterilization instructions for the detachable tips of the Viva MD applicator are the same sterilization instructions that were previously validated for the predicate device, the company's Venus Viva SR (K150161).
Furthermore, the Venus Viva MD™ device underwent performance testing, including bench testing, software validation testing, electrical safety according to IEC 60601-1, electromagnetic compatibility testing according to IEC 60601-1-2 and others. These performance tests in addition to a bench test demonstrated that the differences in the technological characteristics between the subject and predicate devices do not raise new types of safety or effectiveness concerns.
Conclusions:
Therefore, based on the same intended use and indications for use, similar technological characteristics and principles of operation, the Venus Viva MD™ device is substantially equivalent to its predicate devices Venus Viva SR device (K150161) and Venus Legacy BX Device (K142910).