(112 days)
The Viora V10 system is intended for dermatological procedures.
The V-ST 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 V-Form Handpiece (with BC and FC applicators) 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 V10 system is a RF multi application platform with two available treatment Handpieces:
- V-ST Handpiece Bi-polar radiofrequency (RF) Handpiece.
- · V-Form Handpiece (with BC and FC applicators) mechanical vacuum massage and Bi-polar radiofrequency (RF) Handpiece.
The Main Unit (console) provides the operational and safety function of the system. The operator can modify the treatment parameters to achieve specific tissue effects depending on individual patient's skin condition and anatomical structure.
This document describes the Viora V10 system, an RF multi-application platform intended for dermatological procedures. It leverages existing predicate devices (Viora V20 system K142093 and Viora Reaction™ system K090221) to establish substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety Standards | Complies with: |
| IEC 60601-1: Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance. | Confirmed compliance. |
| IEC 60601-1-2: Medical Electrical Equipment Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests. | Confirmed compliance. |
| IEC 60601-2-2: Medical Electrical Equipment - Part 2-2: Particular Requirements For The Basic Safety And Essential Performance Of High Frequency Surgical Equipment And High Frequency Surgical Accessories. | Confirmed compliance. |
| Effectiveness (Bench Testing) | Bench testing demonstrated that the V10 system is as safe and effective as the cleared predicate devices. |
| Substantial Equivalence | The V10 system console has similar technological characteristics as the predicate device (Viora V20). The Viora V10 V-ST Handpiece has the same intended use, technological features, and performance characteristics as the cleared Viora V20 V-ST Handpiece (K142093). The Viora V10 V-Form Handpiece (with BC and FC applicators) and the Viora Reaction™ B-contour and F-contour applicators (K090221) have identical intended use and similar technological features. |
| No New Questions of Safety & Effectiveness | Performance data demonstrates that the differences between the V10 console and the predicate do not raise any new questions of safety and effectiveness. Any differences in the V-Form Handpiece design do not raise any new questions of safety and effectiveness, as verified by performance testing. |
2. Sample size used for the test set and the data provenance
The document does not describe a specific test set with a sample size for evaluating the V10 system through human subject data. Instead, it relies on predicate device data and bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no dedicated human subject test set is described with ground truth established by experts.
4. Adjudication method for the test set
Not applicable, as no dedicated human subject test set is described.
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
No MRMC comparative effectiveness study is mentioned. This device is an RF multi-application platform, not an AI-assisted diagnostic tool typically assessed with MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is not an algorithm performing a diagnostic function. The "standalone" performance here refers to the device's functional and safety performance through bench testing, which was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the V10 system itself, the "ground truth" for demonstrating safety and effectiveness relies on:
- Compliance with recognized international standards (IEC 60601 series).
- Bench testing results comparing its performance to predicate devices.
- Demonstrated equivalence of technological characteristics and intended use to previously cleared predicate devices.
8. The sample size for the training set
Not applicable. This document describes a medical device seeking 510(k) clearance based on substantial equivalence to predicate devices, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as no training set for an AI/ML algorithm is mentioned.
§ 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.