(49 days)
The Venus Versa PRO System is a multi-application device intended to be used in aesthetic and cosmetic procedures.
The SR515 and SR580 IPL applicators are indicated for the following:
· Treatment of benign pigmented epidermal and cutaneous lesions including: hyperpigmentation, melasma, ephelides (freckles), lentigines, nevi, and cafe-au-lait macules.
· Treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, angiomas, poikiloderma of civatte, leg veins and venous malformations.
The HR650, HR650XL, and HR690XL IPL applicators are indicated for the removal of unwanted hair and to effect stable long-term or permanent hair reduction for skin types I-IV. Permanent hair reduction is defined as the longterm stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
The Venus Concept ACDUAL applicator is intended to be used for the treatment of acne vulgaris.
The Diamondpolar and Octipolar applicators are non-invasive devices intended for use in dermatologic and general surgery procedures for females for the non-invasive treatment of moderate to severe facial wrinkles in Fitzpatrick skin types I-IV.
The Viva MD applicator is intended for dermatological procedures requiring ablation and resurfacing of the skin.
The Venus Versa PRO System is comprised of a console (controller/CPU) and ten detachable handpieces (applicators) and two disposable tips. The system can deliver three types of energies to the patient's skin using the associated ten applicators:
- Intense Pulsed Light (IPL)
- Magnetic Pulse (MP2)
- Radiofrequency (RF)
The provided document is a 510(k) summary for the Venus Versa PRO System. It outlines the device's technical characteristics and compares them to a predicate device and a reference device to demonstrate substantial equivalence. Crucially, this document explicitly states that no clinical studies were deemed necessary because the changes were minor and did not introduce new safety or effectiveness issues.
Therefore, I cannot provide details on acceptance criteria and a study proving the device meets them based on this document alone, as no such clinical study was performed or required for this 510(k) submission.
However, I can extract and summarize the information typically requested for such a description, framing it within the context of why certain elements (like performance metrics, sample sizes, expert adjudication, MRMC studies, and detailed ground truth establishment for a test set) are absent here.
Here's a breakdown of the requested information, explaining what is present in the document and what is not due to the nature of this 510(k) submission:
Acceptance Criteria and Study Proving Device Meets Acceptance Criteria for Venus Versa PRO System (K232192)
Based on the provided 510(k) summary, the substantial equivalence determination for the Venus Versa PRO System was primarily based on technical equivalence to a predicate device (Venus Versa System, K153717) and a reference device (Venus Viva MD Device, K201164), rather than a new clinical performance study with defined acceptance criteria for a novel device or AI.
The document states: "Based on the similarities in the safety and effectiveness profiles of the subject and the predicate, no clinical studies were deemed needed to support this submission." This indicates that the "acceptance criteria" were met by demonstrating that the Venus Versa PRO System did not introduce new safety or effectiveness concerns compared to its legally marketed predecessors and that its technical specifications were largely identical or within acceptable ranges.
1. Table of Acceptance Criteria and Reported Device Performance
Since no new clinical performance study was conducted for this 510(k) submission, there isn't a table of "acceptance criteria" and "reported device performance" in the traditional sense of a clinical trial for a novel device or an AI.
Instead, the "acceptance criteria" were implicit in demonstrating substantial equivalence through technical comparisons. The "reported device performance" is essentially the device's adherence to those technical specifications, which are identical or equivalent to the predicate devices.
| Feature / Characteristic | Acceptance Criteria (from Predicate/Reference) | Reported Device Performance (Venus Versa PRO System) |
|---|---|---|
| Intended Use | Identical to Predicate/Reference | Identical |
| Regulation Class | Class II, ONF, GEX, GEI | Class II, ONF, GEX, GEI |
| Energy Type (IPL) | Identical to Predicate | Identical (IPL) |
| IPL Spectrum | Identical to Predicate | Identical (Lesions, Hair Removal, Acne spectra) |
| Frequency (IPL) | Identical to Predicate | Identical (Up to 3 Hz / Up to 2 Hz) |
| Spot Size (IPL) | Identical to Predicate | Identical (10x30mm, 20x30mm) |
| Pulse Duration (IPL) | Identical to Predicate | Identical (5-20ms, 20-50ms) |
| Energy Density (IPL) | Identical to Predicate | Identical (5-25 J/cm², 5-20 J/cm²) |
| Energy Type (RF/MP2) | Identical to Predicate | Identical (Bipolar RF, PMF) |
| Max RF Output Power (RF/MP2) | Identical to Predicate | Identical (Diamondpolar: 75W, Octipolar: 150W) |
| RF Output Frequency (RF/MP2) | Identical to Predicate | Identical (1 MHz) |
| Magnetic Pulse Frequency | Identical to Predicate | Identical (15 Hz) |
| Magnetic Field | Identical to Predicate | Identical (Up to 15 Gauss) |
| Energy Type (Fractional RF) | Identical to Predicate/Reference | Identical (Fractional RF) |
| Max RF Energy (Viva MD) | 62 mJ/pin (160 pin tip) | 62 mJ/pin (160 pin tip) |
| 124 mJ/pin (80 pin tip from Reference) | 124 mJ/pin (80 pin tip) | |
| Max RF Output Power (Viva MD) | Identical to Predicate/Reference | Identical (8W) |
| Energy Density (Viva MD) | Identical to Predicate/Reference | Identical (7.5 J/cm²) |
| Tip Number of Pins (Viva MD) | 160 pins (from Predicate) | 160 pins |
| 80 pins (from Reference) | 80 pins | |
| RF Output Frequency (Viva MD) | Identical to Predicate/Reference | Identical (0.46 MHz) |
| Electrical Safety (IEC 60601-1) | Compliance with standard | Confirmed compliance (changes did not affect results) |
| EMC (IEC 60601-1-2) | Compliance with standard | Confirmed compliance (changes did not affect results) |
| Bench Testing (80 pin tip) | Deliver same output power as predicate | Verified and passed |
| Software Verification & Validation | Function as intended | Performed and passed |
| Biocompatibility | Same product material as predicate | Confirmed same material |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable as no clinical test set was used for performance evaluation in this 510(k) due to the nature of the submission (demonstrating substantial equivalence through technical comparisons). Bench testing was conducted for the 80 pin tip.
- Data Provenance: Not applicable for a clinical test set. The technical data is generated internally from Venus Concept Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no clinical test set requiring expert ground truth was used for this 510(k). The regulatory decision was based on technical equivalence.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as no clinical test set requiring adjudication was used for this 510(k).
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 a laser/light-based medical instrument for aesthetic procedures, not an AI-assisted diagnostic device. Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a hardware system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable for a clinical performance study. The "ground truth" for this submission was the established safety and effectiveness of the legally marketed predicate and reference devices, as well as bench test results for the specific new feature (80-pin tip).
8. The sample size for the training set:
- Not applicable. This document describes a medical device (laser/light system), not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. This document describes a medical device (laser/light system), not an AI/ML algorithm.
§ 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.