(112 days)
The Viora V-total™ is intended for dermatological procedures.
The ST handpiece is indicated for the treatment of relief of minor muscle aches and pain, relief of muscle spasm and temporary improvement of local blood circulation.
The 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, rosace, erytherna of rosacea, angiomas and spider 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 Nd: YAG Laser handpiece with wavelength 1064 mm comes with 4 different applicator spot diameters: 2x4, 3.5 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 telangiecasias (venulectasias), reticular veins (0.1-4.0 mm dia.) of the leg, rosseea, venus lake, leg 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), cale-aulait macules, sebortheic 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 and perioral 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 pseudofolioulitis barber (FFB).
The Viora V-total™ system is a multi application, multi-technology platform with four available treatment handpieces (applicators):
- . ST Bi-polar radiofrequency (RF) handpiece
- Intense pulsed light (IPL) handpiece .
- Long pulse neodymium-doped yttrium aluminum (Nd:YAG) laser handpiece .
The Viora V-total™ device is a multi-application, multi-technology platform for dermatological procedures.
Here's an analysis of the provided information regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria or a specific table with reported device performance metrics in the format usually seen for medical devices with measurable performance outcomes (e.g., sensitivity, specificity, accuracy for diagnostic devices).
Instead, the submission for V-total™ relies on demonstrating substantial equivalence to previously cleared predicate devices. The "acceptance criteria" are implied to be that the V-total™ is as safe and effective as the predicate devices and complies with relevant safety standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| As safe and effective as cleared predicate devices | Claimed substantial equivalence based on similar clinical and technological parameters and established safety/efficacy of predicate devices. |
| Compliance with relevant safety standards (IEC 60601-1, 60601-1-2, 60601-2-2, 60601-2-22, 60825-1, 60601-2-57) | Explicitly states: "V-total™ complies with" all listed IEC standards. |
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly states that no new animal or clinical studies were conducted for the Viora V-total™ device to determine its safety and efficacy. Therefore, there is no "test set" in the traditional sense for this submission. The basis for safety and efficacy relies entirely on the established performance of the predicate devices.
- Sample Size for Test Set: Not applicable (no new clinical studies performed).
- Data Provenance: Not applicable (reliance on existing data from predicate devices and scientific literature, not new data from this device).
3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications:
Since no new clinical studies were performed for the V-total™ device, there were no experts recruited specifically to establish ground truth for a test set related to this submission. The ground truth for the predicate devices' studies would have been established by medical professionals in those respective studies.
4. Adjudication Method for the Test Set:
Not applicable, as no new clinical test set was used for the V-total™ device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study was performed or referenced for this device. The device is a physical therapy/aesthetic device, not a diagnostic imaging device that would typically involve human readers interpreting results.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. This device is a treatment system that requires operation by a human professional (practitioner) and does not involve an "algorithm only" performance that can be evaluated separately from human interaction in a diagnostic sense.
7. Type of Ground Truth Used:
The "ground truth" for the V-total™'s safety and efficacy claims is implicitly based on:
- Clinical Efficacy/Outcomes Data from Predicate Devices: The submission relies on the established clinical results, safety profiles, and indications for use of the predicate devices for their respective technologies (ST applicator, IPL, Nd:YAG laser). These predicate devices would have undergone their own studies where treatment outcomes (e.g., hair reduction, lesion clearance, muscle pain relief) served as the ground truth.
- Scientific Literature: The document mentions that the safety and efficacy of RF bipolar energy treatments are "well established in scientific research and literature."
Therefore, the ground truth is essentially derived from previously established clinical outcomes and scientific consensus through the predicate device pathway.
8. Sample Size for the Training Set:
Not applicable. The V-total™ is not an AI/machine learning model where a "training set" would be used to develop an algorithm. Its development relies on established engineering principles and the existing designs/technologies of identified predicate devices.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this device in the context of an AI/ML model.
§ 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.