(105 days)
KBL Sunlamp Hybrid Products are over-the-counter tanning devices emitting ultraviolet light in the UVA and UVB region of the spectrum intended for tanning of the human skin of an adult person.
KBL Sunlamp Hybrid Products are whole-body tanning devices basically consisting of a mechanical structure equipped with artificial light sources using the hybrid light technology. The hybrid light technology produces ultraviolet radiation and radiation in the visual range of the light spectrum. The UV light is intended for irradiation of any part of the living human body to induce skin tanning. The user is lying on a bench.
The provided document is a 510(k) Pre-market Notification for KBL GmbH sunlamp products, specifically the KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, and KBL 8000 alpha hybridSun. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria for a novel AI/software medical device.
Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert adjudication, and MRMC studies, which are typically found in the context of validating performance for diagnostic or therapeutic AI/software, is not present in this document.
This document details the following for sunlamp products:
- Device Type: Sunlamp products and ultraviolet lamps intended for use in sunlamp products.
- Regulation Number: 21 CFR 878.4635
- Regulation Name: Sunlamp products and ultraviolet lamps intended for use in sunlamp products
- Regulatory Class: Class II
- Product Code: LEJ
- Indications for Use: "KBL Sunlamp Hybrid Products are over-the-counter tanning devices emitting ultraviolet light in the UVA and UVB region of the spectrum intended for tanning of the human skin of an adult person." This is identical to the predicate device.
- Comparison to Predicate: The document largely focuses on comparing the technological characteristics (number of lamps, wattage, dimensions, etc.) of the proposed devices to predicate devices (KBL 6800 alpha and KBL 7900 alpha). The evaluation states that differences are "Equivalent" or "Identical" and do not impact functionality or safety.
- Performance Data: Non-clinical performance tests were conducted to ensure compliance with relevant standards for sunlamp products, including:
- Biocompatibility testing (DIN EN ISO 10993 series)
- Electrical and mechanical safety testing (IEC 60601-1, IEC 60335-1, UL482)
- Electromagnetic compatibility testing (IEC 60601-1-2)
- Spectral emission measurement (IEC 60335-2-27)
- Software verification and validation (FDA Guidance for Software in Medical Devices)
- Performance Standards testing (21 CFR 1040.20)
- Irradiance ratio limits (21 CFR 1040.20(c)(1))
- Maximum timer intervals and exposure schedules (FDA policy)
Key takeaway: This 510(k) submission is for physical sunlamp devices, not an AI/software medical device. The "performance data" refers to compliance with safety and electrical standards for sunlamps, not the type of diagnostic performance (e.g., sensitivity, specificity) that requires the detailed study design elements you asked for. Therefore, I cannot extract the requested information from this document.
§ 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.