(105 days)
The Viora V20 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-IPL Handpiece with wavelengths 415-1200nm (with 5 different filters) is indicated for the treatment of:
- Moderate inflammatory acne vulgaris.
- Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles).
- Cutaneous lesions including warts, scars and striae.
- Benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas, poikiloderma of Civatte and venous malformations.
- Removal unwanted hair. It is also intended for permanent reduction in unwanted hair. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
The Viora V20 system is a RF and IPL multi application platform with two available treatment Handpieces:
V-ST Handpiece: Bi polar radiofrequency (RF) Handpieces
V-IPL Handpiece: Intense Pulsed Light (IPL) 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. The Foot Switch is used for system activation.
The provided text describes the Viora V20 System, a medical device, and its substantial equivalence to a predicate device (Viora V-total, K133837). However, the document does not contain the kind of detailed information typically found in a study demonstrating how a device meets specific acceptance criteria based on performance data.
Instead, this document is a 510(k) summary for the FDA, focusing on establishing substantial equivalence to a previously cleared device. It asserts that because the V20 system's technological parameters are "well within" the cleared Viora V-total system and the handpieces are "exactly the same," animal and clinical studies are not required to determine its safety and efficacy.
Therefore, many of the requested categories of information cannot be extracted from this document, as a standalone performance study with detailed acceptance criteria and results is not presented here.
Here's a breakdown based on the available information:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Not explicitly stated as such, but inferred from the claims) | Reported Device Performance (as stated in the document) |
|---|---|
| Intended Use Equivalence: The V20 system should have the same intended use as the predicate device. | The V20 system and its predicate have the same intended use. |
| Indications for Use Equivalence: The V20 system's indications for use should be the same as the predicate device. | The V20 system and its predicate have the same indications for use (for ST and IPL Handpieces). |
| Technological Features Equivalence: The V20 system should have similar technological features to the predicate device. | The V20 system and the predicate device have similar technological features. The V-ST and V-IPL Handpieces are exactly the same as the cleared Viora V-total ST and IPL Handpieces (K133837). |
| Safety and Effectiveness (No New Issues): Any differences in software and system design should not raise new issues of safety and effectiveness. | "Any differences in the software and in the system design do not raise any new issues of safety and effectiveness, as was verified by performance testing." |
| Compliance with Standards: The V20 system must comply with relevant medical electrical equipment standards. | The V20 system complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, and IEC 60601-2-57. |
| Effectiveness (Bench Testing): Bench testing should demonstrate the V20 system is as safe and effective as the cleared predicate devices. | "Bench testing demonstrated that the V20 system is as safe and effective as the cleared predicate devices." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. The document states that "animal and clinical studies are not required" to determine safety and efficacy due to technological equivalence. The mention of "performance testing" and "bench testing" does not specify sample sizes or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. Since clinical studies or specific performance evaluations with a "test set" and "ground truth" (in the typical sense of expert review of patient data) were deemed unnecessary for this 510(k) submission, this information is absent.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. See point 3.
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:
- Not applicable. This device is an aesthetic and dermatological treatment system (IPL/RF), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical system with handpieces for treatment, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not applicable / Not provided. The basis for clearance relies on substantial equivalence to a predicate device, which implies that the prior device's established safety and efficacy serve as the "ground truth" for the current device's performance claims. No new, specific ground truth creation for the V20 system itself is detailed.
8. The sample size for the training set:
- Not applicable / Not provided. This document does not describe the development of a machine learning algorithm or an AI model that would require a training set.
9. How the ground truth for the training set was established:
- Not applicable / Not provided. See point 8.
In summary: The provided text is a regulatory submission focused on substantial equivalence. It asserts that the V20 system is substantially equivalent to a previously cleared device (Viora V-total K133837) due to identical intended use, indications for use, and handpiece technology, along with compliance with performance standards and positive bench testing. It explicitly states that clinical studies were not required for this determination, which means the detailed performance study information requested is not present in this document.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.