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510(k) Data Aggregation
(224 days)
This sunlamp product is intended exclusively for aesthetic tanning of the human skin, for one person at a time, at the age of 18 or above.
The primary technical components of sunlamp products are artificial sources of UV radiation and a mechanical structure. Different UV sources intensities with characteristic UV-A and UV-B proportions result in cosmetic tanning of the human skin. The UV-A proportion primarily generates a superficial tan, which appears rapidly and is intensive but also fades more rapidly. The UV-B radiation is primarily responsible for more longterm tanning results.
This document is a 510(k) summary for the Ergoline Prestige 1600 Hybrid Performance sunlamp product. It compares the proposed device to a predicate device, the Ergoline/Prestige 1400 Intelligent Performance, to demonstrate substantial equivalence.
Here's an analysis based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are primarily based on demonstrating substantial equivalence to a legally marketed predicate device (Ergoline/Prestige 1400 Intelligent Performance) and compliance with relevant safety and performance standards. The "Evaluation" column in the comparison table serves as the reported device performance against these criteria.
| Acceptance Criteria / Parameter | Reported Device Performance (Ergoline Prestige 1600 Hybrid Performance) |
|---|---|
| Intended Use | "This sunlamp product is intended exclusively for cosmetic tanning of the human skin, for one person at a time, at the age of 18 or above." (Identical to Predicate) |
| Number of body lamps | 52 (38 UV lamps, 14 UV+red light lamps) - Similar: The irradiance characteristics are still comparable as provided under section 18. The safety has been confirmed additionally by corresponding tests in accordance with IEC 62471. In terms of functionality and safety there is no impact due to this difference. |
| Watts (Body lamps) | 200 (Identical to Predicate) |
| Lamp item description (Body lamps) | GENESIS Type U Hybrid Performance - 200 W (UV light), GENESIS Type R Hybrid Performance - 200 W (red light) - Similar: The irradiance characteristics are still comparable as provided under section 18. The safety has been confirmed additionally by corresponding tests in accordance with IEC 62471. In terms of functionality and safety there is no impact due to this difference. |
| Number of High Pressure Facial lamps | 4 (Identical to Predicate) |
| Watts (High Pressure Facial lamps) | 520 (Identical to Predicate) |
| Lamp item description (High Pressure Facial lamps) | Ergoline Ultra 520W (Identical to Predicate) |
| Filter (High Pressure Facial lamps) | Ultra Performance 412 (Identical to Predicate) |
| Number of UV-B Facial lamps | 3 (Identical to Predicate) |
| Watts (UV-B Facial lamps) | 8 (Identical to Predicate) |
| Lamp item description (UV-B Facial lamps) | Genesis Type R Hybrid 8W (Similar to Predicate) |
| Number of Shoulder lamps | 2 (Identical to Predicate) |
| Watts (Shoulder lamps) | 240 (Identical to Predicate) |
| Lamp item description (Shoulder lamps) | Ergoline Ultra 250W (Identical to Predicate) |
| Filter (Shoulder lamps) | Ultra Performance 912 (Identical to Predicate) |
| Max exposure time [min] | 10 (Identical to Predicate) |
| Electrical requirements | 230V 3Ø or 230V 2Ø (Identical to Predicate) |
| Total power consumption [watts] | 17,600 W - Similar: less power consumption due to the use of electronic ballasts instead of magnetic ballasts. Performance is not impaired. |
| Rated overcurrent protection device (circuit breaker) | 70A / 3-pole 3Ø or 100A / 2-pole 2Ø (Identical to Predicate) |
| Number of wires | 4 3Ø or 3 2Ø (Identical to Predicate) |
| Irradiance ratio in accordance with 1040.20 (max. 0.003) | Fulfilled - Identical (refer to section 18 for bench test reports) |
| Electrical safety | IEC 60601-1 (Identical to Predicate) |
| Electromagnetic compatibility | IEC 60601-1-2 (Identical to Predicate) |
| Biocompatibility | Tested in accordance with ISO 10993-series |
| Compliance with U.S. performance standard 21CFR 1040.20 | In compliance |
| Does not introduce new indications for use | True (Identical to Predicate) |
| Has the same technological characteristics | Primarily true, with justified minor differences that do not impact safety or effectiveness. |
| Does not introduce new potential hazards or safety risks | True (Based on testing and comparison to Predicate) |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of clinical data for algorithmic performance. This device is a physical sunlamp, and the comparison is primarily based on technical specifications and compliance with established standards rather than diagnostic performance using a data set.
The testing mentioned (e.g., biocompatibility) refers to laboratory and bench testing of the components and the device itself, not a clinical study on human subjects with a test set of cases.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a device that generates diagnostic outputs requiring expert ground truth establishment.
4. Adjudication method for the test set
Not applicable.
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 not an AI/CADe/CADx device where human reader performance with or without AI assistance would be relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device.
7. The type of ground truth used
For the safety and performance evaluations, the "ground truth" is adherence to established international and national standards (e.g., IEC 60601-1, IEC 60601-1-2, ISO 10993-series, 21 CFR 1040.20) and the technical specifications of a predicate device. This is a form of benchmarking against established standards and predicate device characteristics.
8. The sample size for the training set
Not applicable. This device does not involve machine learning or a training set.
9. How the ground truth for the training set was established
Not applicable.
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