(87 days)
The Viora V30 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, 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-tern stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
The V-Nd: Y AG Handpiece with wavelength 1064 nm comes with 4 different applicator spot diameters: 2x4, 3.5 .5 and 9.5 mm.
The three smaller spot sizes (2x4, 3.5, 5.5 mm) are intended for:
· Benign vascular lesions such as, but not limited to treatment of: port wine stains, hemangiomas, Warts, superficial and deep telangiectasias (venulectasias), reticular veins (0.1-4.0 mm dia.) of the leg, rosacea, venus lake, leg veins, spider veins, poikiloderma of civatte and angiomas.
· Benign cutaneous lesions, such as, but not limited to: warts, scars, striae and psoriasis.
· Benign pigmented lesions such as, but not limited to: lentigos (sun spots), cafe-aulait macules, seborrheic keratosis, nevi and nevus of Ota, chloasma, verrucae, skin tags and keratosis.
· Pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
• The non-ablative treatment of facial wrinkles, such as, but not limited to: periocular wrinkles.
The Handpiece with a spot size of 9.5 mm is also intended for treatment of:
· Laser skin resurfacing procedures for the treatment of: acne scars and wrinkles. Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
• The Handpiece with a spot size of 9.5 mm is also is intended for removal of 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 of pseudofollicultis barbae (PFB).
The V-Form Handpiece (with BC Small, Medium and Large 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 V20 and V10 systems with V-Form Handpiece (with BC Small, Medium and Large applicators) are 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 V30 system is a multi-application, multi-technology platform device intended for use in dermatologic procedures.
The main console unit incorporates a touch-screen control panel, power supply modules, cooling system, switching module and service panel. The system includes four Handpieces and footswitch. The V30 system is cooled by deionized water. The Viora V30 system is available with four treatment Handpieces:
- V-ST Handpiece Bi-polar radiofrequency (RF) Handpiece .
- V-IPL Handpiece Intense pulsed light (IPL) Handpiece ●
- V-ND:YAG Handpiece Long pulse neodymium-doped yttrium aluminum ● laser Handpiece
- V Form Handpiece with BC Small, BC Medium and BC Large applicators .
The V- Form BC Medium applicator is Bi-polar radiofrequency (RF) applicator.
The applicator is supported by Viora's V10, V20 and V30 systems.
The provided text is a 510(k) summary for the Viora V30 system, V-form Handpiece Bc Medium Applicator. It states that the device is substantially equivalent to previously cleared predicate devices and therefore does not rely on new clinical studies or acceptance criteria beyond those established for the predicates. The document primarily focuses on demonstrating substantial equivalence based on identical intended use, technological characteristics, and performance characteristics to previously cleared devices.
Therefore, many of the requested items (acceptance criteria, specific study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or available from this document as it explicitly states that animal and clinical studies are not required.
However, I can extract the following information:
1. A table of acceptance criteria and the reported device performance:
Since no new clinical or performance acceptance criteria are mentioned for the V30 system or V-Form Handpiece BC Medium applicator beyond adherence to general medical device standards and equivalence to predicates, the table would reflect this.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and Effectiveness | Demonstrated by substantial equivalence to predicate devices (Viora V-total system (K133837), Viora V20 system (K152611), Viora V10 system (K150035)). No new safety or efficacy issues raised due to identical intended use and similar technological/performance characteristics. |
| Compliance with Standards | Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-2-57, IEC 60601-2-22, and IEC 60825-1. |
| Bench Testing Performance | Bench testing demonstrated that the V30 system (with the V-Form Handpiece) and the V-Form Handpiece BC Medium applicator are as safe and effective as the cleared predicate devices. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not Applicable. The document explicitly states: "Viora believes that animal and clinical studies are not required to determine the safety and efficacy of the V30 system with the V- Form Handpiece and of the V-Form Handpice BC Medium applicator" due to the technological parameters being well within those of previously cleared systems. Therefore, no new test set was used for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. No new test set requiring expert ground truth was created for this submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No new test set required adjudication.
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 is a medical device for dermatological procedures (laser, IPL, RF), not an AI-assisted diagnostic tool involving human readers. No MRMC study was performed or is relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device (laser, IPL, RF system), not an algorithm or AI. Standalone algorithm performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable. No new ground truth for a test set was established for this submission. The substantial equivalence relies on previously established safety and efficacy of predicate devices.
8. The sample size for the training set:
- Not Applicable. This submission is for a physical medical device and not an AI/ML algorithm. Therefore, there is no training set in the context of machine learning.
9. How the ground truth for the training set was established:
- Not Applicable. As per point 8, there is no training set mentioned in the context of this device.
§ 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.