(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.
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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.
§ 878.4635 Sunlamp products and ultraviolet lamps intended for use in sunlamp products.
(a)
Identification. A sunlamp product is any device designed to incorporate one or more ultraviolet (UV) lamps intended for irradiation of any part of the living human body, by UV radiation with wavelengths in air between 200 and 400 nanometers, to induce skin tanning. This definition includes tanning beds and tanning booths. A UV lamp intended for use in sunlamp products is any lamp that produces UV radiation in the wavelength interval of 200 to 400 nanometers in air.(b)
Classification. Class II (special controls). The special controls for sunlamp products and UV lamps intended for use in sunlamp products are:(1) Conduct performance testing that demonstrates the following:
(i) Device meets appropriate output performance specifications such as wavelengths, energy density, and lamp life; and
(ii) Device's safety features, such as timers to limit UV exposure and alarms, function properly.
(2) Demonstrate that device is mechanically safe to prevent user injury.
(3) Demonstrate software verification, validation, and hazard analysis.
(4) Demonstrate that device is biocompatible.
(5) Demonstrate that device is electrically safe and electromagnetically compatible in its intended use environment.
(6)
Labeling —(i)Sunlamp products. (A) The warning statement below must appear on all sunlamp products and must be placed in a black box. This statement must be permanently affixed or inscribed on the product when fully assembled for use so as to be legible and readily accessible to view by the person who will be exposed to UV radiation immediately before the use of the product. It shall be of sufficient durability to remain legible throughout the expected lifetime of the product. It shall appear on a part or panel displayed prominently under normal conditions of use so that it is readily accessible to view whether the tanning bed canopy (or tanning booth door) is open or closed when the person who will be exposed approaches the equipment and the text shall be at least 10 millimeters (height). Labeling on the device must include the following statement: Attention: This sunlamp product should not be used on persons under the age of 18 years. (B) Manufacturers shall provide validated instructions on cleaning and disinfection of sunlamp products between uses in the user instructions.
(ii)
Sunlamp products and UV lamps intended for use in sunlamp products. Manufacturers of sunlamp products and UV lamps intended for use in sunlamp products shall provide or cause to be provided in the user instructions, as well as all consumer-directed catalogs, specification sheets, descriptive brochures, and Web pages in which sunlamp products or UV lamps intended for use in sunlamp products are offered for sale, the following contraindication and warning statements:(A) “Contraindication: This product is contraindicated for use on persons under the age of 18 years.”
(B) “Contraindication: This product must not be used if skin lesions or open wounds are present.”
(C) “Warning: This product should not be used on individuals who have had skin cancer or have a family history of skin cancer.”
(D) “Warning: Persons repeatedly exposed to UV radiation should be regularly evaluated for skin cancer.”
(c)
Performance standard. Sunlamp products and UV lamps intended for use in sunlamp products are subject to the electronic product performance standard at § 1040.20 of this chapter.