(56 days)
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.
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 160-electrode pins. The 160-pin tip was previously cleared within Venus Viva SR (K150161).
This document is a 510(k) Summary for the Venus Viva MD™ device, indicating it is a submission to the FDA to demonstrate substantial equivalence to previously cleared predicate devices. The information provided heavily focuses on comparing technological characteristics and safety standards rather than detailed acceptance criteria and a specific study proving those criteria are met in the traditional sense of a clinical trial for diagnostic performance.
However, I can extract the relevant information regarding performance testing and how substantial equivalence was established, which acts as the "proof" for regulatory clearance.
1. A table of acceptance criteria and the reported device performance
Based on the document, the "acceptance criteria" are not explicitly stated with numerical targets in a table format as one might find for a diagnostic algorithm's sensitivity/specificity. Instead, the acceptance criteria are implicitly that the Venus Viva MD™ device must perform similarly to its predicate devices and meet relevant safety and electrical standards. The reported device performance is that these similarities were confirmed.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Technological Equivalence: Same RF and PMF output parameters per specifications as predicate devices. | Bench Testing: "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." |
| Functional Equivalence (Ablation/Resurfacing): Appropriate ablation dimensions and healing for skin resurfacing with Viva MD applicator. | Animal Testing: "Overall, the treated sites in both pin tip groups [80-pin and 160-pin] 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: Compliance with IEC 60601-1 (Ed. 3.1) and related standards. | Electrical Safety and Electromagnetic Compatibility: "In addition, the system was tested per the applicable electrical safety and electromagnetic compatibility standards listed [IEC 60601-1:2012 Ed. 3.1, IEC 60601-1-2:2014 Ed. 4, IEC 60601-2-2:2017 Ed. 6, IEC 60601-1-6: 2013 Ed.3.1], and all results were passing." |
| EMC: Compliance with IEC 60601-1-2 (Ed. 4). | Electrical Safety and Electromagnetic Compatibility: "In addition, the system was tested per the applicable electrical safety and electromagnetic compatibility standards listed... IEC 60601-1-2:2014 Ed. 4... and all results were passing." |
| HF Surgical Equipment Safety: Compliance with IEC 60601-2-2 (Ed. 6). | Electrical Safety and Electromagnetic Compatibility: "In addition, the system was tested per the applicable electrical safety and electromagnetic compatibility standards listed... IEC 60601-2-2:2017 Ed. 6... and all results were passing." |
| Usability: Compliance with IEC 60601-1-6 (Ed. 3.1). | Electrical Safety and Electromagnetic Compatibility: "In addition, the system was tested per the applicable electrical safety and electromagnetic compatibility standards listed... IEC 60601-1-6: 2013 Ed.3.1... and all results were passing." |
| Software Functionality: Software performs as intended and complies with IEC 62304. | Software Testing: "The software was also subject to verification and validation testing, and results demonstrated that the system performed as intended." Also: "IEC 62304:2015 Medical device software Software life cycle processes." (This implies compliance was tested and met, though "passing" is not explicitly stated as for other standards). |
| Biocompatibility: Patient contact materials are biocompatible (ISO 10993). | Safety Features: "The patient contact materials are biocompatible in compliance with the ISO 10993 standard and similar to materials found in the predicate devices." (Implies compliance was met as they are similar and biocompatible). |
| Cleaning & Sterilization: Consistency with validated methods for predicate devices. | Cleaning and Disinfection Instructions: "The cleaning and disinfection instructions for the Diamondpolar applicator are consistent with the previously validated for the predicate device... Sterilization instructions for the detachable tips of the Viva MD applicator are the same sterilization instructions that were previously validated for the predicate device..." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Bench Testing: No specific "sample size" is mentioned for RF and PMF output parameter testing. This typically involves instrument calibration and performance checks, not patient data.
- Animal Testing: The study involved "porcine skin." The number of animals or specific treatment sites is not specified. The provenance would be the location where the animal study was conducted, which is not stated (likely a research lab). It's a prospective study in an animal model.
- Electrical Safety, EMC, Usability, Software Testing: These are engineering and software validation tests, not clinical studies with patient data. No "sample size" in the context of patients is relevant.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Animal Testing (Histology): For the animal study, the ground truth was established histologically. This implies a pathologist reviewed the tissue samples. The number of experts and their qualifications are not specified in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Animal Testing: No information is provided regarding an adjudication method. Histological review is generally performed by a single pathologist or might be peer-reviewed, but methods are not detailed here.
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 device is an electrosurgical cutting and coagulation device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not applicable and was not conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This is a physical medical device (console and applicators), not a standalone algorithm. Performance is based on its physical and electrical outputs and biological effects, as demonstrated in bench and animal testing.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Animal Testing: Pathology (histological evaluation of ablated skin and healing).
- Bench/Engineering/Software Testing: Ground truth is defined by engineering specifications, validated test protocols, and international standards (e.g., IEC 60601 series).
8. The sample size for the training set
- Not applicable. This is a medical device clearance submission, not an AI/ML algorithm that requires a training set in the conventional sense. The "training" for the device's design would come from engineering principles and prior predicate device designs.
9. How the ground truth for the training set was established
- Not applicable as it's not an AI/ML algorithm requiring a training set.
§ 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.