(237 days)
Intended to provide ultraviolet light to tan the skin.
The uwe sun tanning beds/booths consist of several essential parts. These parts differ between the bed and the booth models. The beds consist of a lying area and a canopy. The booth consists of a cabin and a door. Both sunlamp products contain the same electronic components like the main board and the relay board, fans, lamps etc. The most significant differences are the decorating design elements and the implemented features like "Body Mist" and "Aroma". These constitute the several looks of the beds and booths. The primary technical components of a tanning device are an artificial source of UV radiation, a variety of filters and reflectors as well as a mechanical structure with a defined active surface. Different tanning results can be achieved in varying strength tanning devices. This is due to the different strength UV lamps and the different UV-A and UV-B proportions of the UV radiation. 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 long-term tanning results. The disadvantage of the UV-B radiation is that the tan does not become visible until one or two days after visiting the tanning salon. Therefore, the appropriate tanning device is to be selected depending on the desired tanning goal.
The provided text is a 510(k) summary for ultraviolet tanning beds/booths. It does not contain information about acceptance criteria or a study that proves a device meets such criteria in the context of a medical AI or diagnostic device that would typically have performance metrics like sensitivity, specificity, accuracy, etc.
Instead, this document focuses on demonstrating substantial equivalence to existing predicate devices for ultraviolet tanning beds/booths, as per FDA regulations for Class II exempt devices reclassified from Class I. The "performance" discussed relates to compliance with recognized safety and performance standards rather than diagnostic accuracy.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's an analysis based on the information available:
- A table of acceptance criteria and the reported device performance
- The document states: "The bundled uwe sun tanning beds/booths comply with the applicable safety and performance standards and therefore are safe and effective for their intended use."
- It also states: "The maximum irradiance of all devices fulfill the requirements of FDA 21 CFR 1040.20."
- And: "The bundled uwe sun tanning beds/booths meet the requirements of the applicable FDA-recognized standards, specifically the IEC 60601-1:2005 and IEC 60601-1-2:2007 standards, and hazard analyses conforming to ISO 17491:2007 have been conducted to assure proper mitigations of risk of hazards leading to harm."
- Acceptance Criteria (General): Compliance with applicable safety and performance standards (e.g., FDA 21 CFR 1040.20, IEC 60601-1:2005, IEC 60601-1-2:2007, ISO 17491:2007).
- Reported Device Performance: The device
compliesandmeets the requirementsof these standards. - Specific, quantifiable criteria (like sensitivity/specificity for a diagnostic device) are not present.
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Compliance with FDA 21 CFR 1040.20 (Maximum Irradiance) | All devices fulfill the requirements. |
| Compliance with IEC 60601-1:2005 (Electrical Safety) | Devices meet the requirements. |
| Compliance with IEC 60601-1-2:2007 (EMC) | Devices meet the requirements. |
| Compliance with ISO 17491:2007 (Hazard Analysis) | Hazard analyses conducted to assure proper mitigations of risk. |
| Safety and Effectiveness for Intended Use | Safe and effective. |
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Sample size used for the test set and the data provenance
- The document implies that the "test set" consists of the specific models listed (P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUS). These are the devices being submitted.
- No information is provided on a "sample size" in the conventional sense of a clinical or retrospective study. The testing refers to engineering and quality assurance measures on the devices themselves.
- Data Provenance: Not applicable in the context of clinical data. It's direct testing of the manufactured devices.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This device is a tanning bed, not a diagnostic tool requiring expert interpretation for ground truth. Ground truth here refers to compliance with engineering and safety standards validated by technical testing.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No adjudication method is mentioned as this is not a diagnostic study.
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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 a diagnostic device involving human readers or AI assistance.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an algorithm or AI device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this product's acceptance is based on adherence to recognized safety and performance standards (e.g., maximum irradiance levels, electrical safety, electromagnetic compatibility, hazard analyses, functional verification).
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The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set.
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How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device.
§ 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.