(88 days)
The Venus Versa System is a multi-application device intended to be used in aesthetic 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, HR690, 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 the non-invasive treatment of moderate to severe facial wrinkles and rtides in Fitzpatrick skin types I-IV.
The Viva applicator is intended for dermatological procedures requiring ablation and resurfacing of the skin.
The Venus Versa System is comprised of a console (controller/CPU) and ten detachable handpieces (applicators). The system can deliver three types of energies to the patient's skin using the associated applicators:
- Intense Pulsed Light (IPL); ●
- Radiofrequency (RF); .
- Magnetic Pulse (MP2). .
The following ten handpieces are included with the device system: SR515, SR580, HR650, HR690, HR650XL, HR690XL, ACDUAL, Diamondpolar, Octipolar, and Viva.
The provided document is a 510(k) summary for the Venus Versa System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific clinical acceptance criteria through a standalone study with a predefined ground truth and expert adjudication. Therefore, much of the requested information (like specific acceptance criteria based on clinical efficacy, sample sizes for training/test sets, expert qualifications, or MRMC comparative effectiveness studies) is not typically found or required in a 510(k) summary for this class of device and type of submission.
The document primarily focuses on demonstrating substantial equivalence based on technological characteristics and bench testing (system verification testing) rather than clinical performance data against specific endpoints.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria described are largely related to technical specifications and safety, not clinical efficacy. The reported performance refers to the device meeting these technical specifications.
| Acceptance Criteria (Technical/Safety) | Reported Device Performance |
|---|---|
| Electromagnetic Compatibility (EMC) per AAMI/ANSI ES60601-1, IEC 60601-1-2 | All results were passing. |
| Electrical Safety per IEC 60601-2-2, and IEC 60601-2-57 | All results were passing. |
| Biocompatibility of patient-contacting materials per ISO 10993-5 | Established biocompatibility of materials; all results were passing. |
| Validation of cleaning, disinfection, and sterilization parameters | Validated in testing; all results were passing. |
| Software validation | Software was appropriate for release. |
| IPL Applicators: | |
| Measured fluence at each wavelength matches expected value within defined acceptance criterion | Measured fluence levels at each wavelength were within expected values; passing results for each applicator (tested in 5 J/cm² increments). |
| Light guide temperatures meet expected values | Fluke measured temperatures of each applicator met specifications; passing results. |
| Spectral region defined by the filter for each wavelength (SR515, SR580, HR650, HR690, ACDUAL) | Test results demonstrated that the spectral region is defined by the filter; passing results. |
| Diamondpolar & Octipolar Applicators: | |
| Measured RF voltage within expected values | Within expected values; met pass criteria. |
| Electromagnetic field density within expected values | Within expected values; met pass criteria. |
| System temperature within expected values | Within expected values; met pass criteria. |
| Viva Applicator: | |
| Measured output power (pulse width, pulse amplitude) within expected values | Within expected values; met pass criteria. |
| Overall Versa applicators and system meet technical and mechanical requirements | All results were passing. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe "test sets" in the context of clinical data for performance evaluation. The "testing" mentioned refers to engineering and safety verification on the device itself. Therefore, specific sample sizes for clinical test sets or data provenance (country, retrospective/prospective) are not applicable to the information provided for this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
This information is not applicable as the document describes technical verification and safety testing, not clinical studies requiring expert-established ground truth.
4. Adjudication Method for the Test Set
This information is not applicable as there is no mention of a clinical test set requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The submission relies on demonstrating substantial equivalence to predicate devices based on technological characteristics and safety (bench testing), not comparative clinical efficacy with human readers.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)
This information is not applicable as the Venus Versa System is a physical device (multi-application aesthetic system), not an AI algorithm. Its performance is inherent in its operation, not an "algorithm only" in the sense of AI.
7. Type of Ground Truth Used
The "ground truth" for the performance evaluation described would be engineering and manufacturing specifications/standards. For example, the "truth" for fluence measurement is the expected fluence value, and the "truth" for biocompatibility is conformance to ISO 10993-5. There is no clinical or pathological "ground truth" established from patient data mentioned in this submission for proving performance.
8. Sample Size for the Training Set
This information is not applicable. There is no mention of a "training set" as the device is a physical system, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated above.
Summary of Device Acceptance and Study:
The Venus Versa System gained acceptance (clearance) through the 510(k) pathway by demonstrating substantial equivalence to previously cleared predicate devices. The "study" proving this involves:
- Comparison of Technical Characteristics: Showing that the Venus Versa System's intended use, indications for use, technological characteristics (energy type, IPL spectrum, frequency, spot size, pulse duration, energy density), and principles of operation are similar to its predicate devices, with minor differences that do not raise new safety or effectiveness concerns.
- Bench Testing / System Verification: Conducting a series of engineering, safety, and performance evaluations on the device itself. This included:
- Electromagnetic Compatibility (EMC) testing.
- Electrical Safety testing.
- Biocompatibility testing of patient-contacting materials.
- Validation of cleaning, disinfection, and sterilization parameters.
- Software validation.
- Specific system verification for each applicator type (IPL, Bipolar RF & PMF, Fractional RF) to ensure measured outputs (e.g., fluence, RF voltage, output power, temperature) met predefined technical specifications and expected values.
In essence, the "acceptance criteria" were regulatory requirements for safety and performance equivalence to predicate devices, and the "study" was a combination of documentation outlining feature similarity and rigorous engineering verification testing. Clinical efficacy for specific indications, while implied by equivalence to predicates, was not proven through new clinical trials with patient cohorts described 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.