(413 days)
Sunlamp product intended for use to tan the skin.
HPO Exotic: This model is a high pressure stand up appliance with tanning lamps located in four vertical columns. The high pressure lamps have a double filter: one blue cobalt filter in the inner part and one acrylic filter in the outer. The 1000 W lamps have an additional clear glass filter between the blue filters and the acrylic. The body frame is all in metal and it closes where it is possible all the electrical components. The body frame is covered by plastic thermoformed panels.
LP1: These suntan beds are three models with the same frame, aesthetic and with many common electrical parts. All the beds use the same low pressure lamps, the difference is the presence or not of the facial lamps. There are three versions: LP1-32/32EL, LP1-35/35EL, LP1-45/45EL. In all models the low pressure lamps are separated from the person by acrylic panels. The high pressure lamps have a double glass filter, one blue cobalt filter in the inner part and one clear filter in the outer. Every blue filter has a control switch. If the door is opened during the session or the filters are removed, the control switch interrupts the power supply on the control board and all lamps switch off. The body frame is all in metal and it closes where it is possible all the electrical components. The body frame is covered by plastic thermoformed panels.
LP2: This model is a bed with low pressure lamps in the base. The facial has 3 high pressure lamps. The low pressure lamps are separated from the person by acrylic panels. The high pressure lamps have a double glass filter: one blue cobalt filter in the inner part and one clear filter in the outer. Each blue filter has a control switch. If the door is opened during the session or the filter breaks the control switch interrupts the power supply and the lamp switches off.
LP3: These suntan beds are two models with the same frame, aesthetic and with many common electrical parts. The new models are similar to the current LP3, only the number of lamps was changed. There are two models: LP3-110 and LP3-140. Both models are beds with low pressure tanning lamps in the canopy and in the base and high pressure lamps in the facial area. The low pressure lamps are separated from the person by acrylic panels. The high pressure lamps have a double glass filter: one blue cobalt filter in the inner part and one clear filter in the outer.
Mastersun: This model is a bed with a high pressure tanning lamps located in five horizontal columns placed around the person body. Three columns are in the canopy, and two are in the bed, under the acrylic panel. The high pressure lamps have a double glass filter one blue cobalt filter in the inner part and one clear filter in the outer.
Vega: This model is a booth with low pressure lamps: the machine is mainly composed of three curved panels, two fixed and one is the door. Each panel has a set low pressure lamps separated from the person by acrylic panels.
The provided text is a 510(k) summary for several sunlamp products. It contains information about the device description, indications for use, comparison to predicate devices, and performance testing. However, it does not describe any acceptance criteria or a study proving a device meets those criteria in the context of a diagnostic or AI-powered medical device.
The document discusses:
- The devices: Various models of sunlamps (HPO Exotic, LP1, LP2, LP3, MasterSun 360, MasterSun 360 New Reflector, Vega Lux).
- Their intended use: To tan the skin.
- Their classification: Class II, Product Code LEJ (Ultraviolet Lamp For Tanning).
- Predicate devices: Other sunlamp models that were 510(k) exempt or previously cleared. The document explicitly states "The subject and predicate devices are identical."
- Performance: "The subject devices were tested to be in conformity with Performance Standard 21 CFR 1040.20. They are identical to the predicate." It also mentions "Usability data is included with the submission to support the conversion of indications from Rx to OTC."
- Biocompatibility: The polymethyl methacrylate (PMMA) material in contact with skin has been shown to be biocompatible via European standard 30993 (ISO 10993). No additional testing was done as the devices are identical to the predicate.
- Electrical safety and EMC: Testing was conducted, and devices passed. No additional testing was performed, as the devices are identical to the predicate.
- Software Verification and Validation: Conducted for "moderate" level of concern software.
Therefore, I cannot provide the requested information about acceptance criteria and a study proving a device meets them, as this document does not contain such details for a diagnostic or AI-driven medical device. The context of this document is a 510(k) submission for tanning lamps, which are physical devices regulated for safety standards (like UV emission and electrical safety) rather than diagnostic accuracy.
There is no information on:
- A table of acceptance criteria and reported device performance (in the context of diagnostic accuracy).
- Sample size used for a test set or data provenance.
- Number of experts or their qualifications for ground truth.
- Adjudication method for a test set.
- MRMC comparative effectiveness study or human reader improvement with AI.
- Standalone (algorithm only) performance.
- Type of ground truth (e.g., pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
§ 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.