(207 days)
The Suncapsule Tanning Booth devices (All Models) are intended to provide ultraviolet light exposure to male and female users over the age of 18 years to produce a tanning response in the skin.
All Sun Capsule models are stand up booths utilizing UV fluorescent lamps arranged on upright walls in a hexagon pattern. Some models also include an optional changing booth. Standard industry construction materials are used including steel trusses, particle board, lighting components, pop rivets, etc. There are no unique materials other than the lamps which use length and diameter combinations that are unique to the tanning industry and not used for general lighting.
The number, length, and operating parameters of the lamps of each model differ in order to shorten or lengthen the exposure time desired by the purchaser. Each of the six walls constitutes a lighting fixture containing the lamps, sockets, ballast, wire, connectors and components associated with the lamp sizes required for the particular model. There are no other differences between the models.
A digital control timer module is used to program exposure times and the booths are utilized only with included protective eyewear, as outlined in 21 CFR 1040.20 (c).
This document is a 510(k) summary for a medical device called "Suncapsule Tanning Booth Devices (All Models)". This device is an ultraviolet lamp for tanning, classified as Class II. The document details the device, its intended use, and its substantial equivalence to predicate devices.
Here's an analysis of the provided text, particularly focusing on the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Electrical Safety | Conforms to IEC/EN 60601-1:2005 Edition 3/(R)2012 And A1:2012 |
| Electromagnetic Compatibility (EMC) | Conforms to IEC 60601-1-2 Edition 4: 2014 |
| Safety-Specific to Sunlamp Products | Conforms to UL 482: Standard for Portable Sun/Heat Lamps Edition: 9 |
| Radiation Limits | Complies with 21 CFR 1040.20 (Performance Standard For Sunlamp products and ultraviolet lamps intended for use in sunlamp products) |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Specific performance testing (spectral analysis) data is submitted in this application for each device that measured irradiance to ensure compliance with radiation limits set out in 21 CFR 1040.20."
- Test Set Sample Size: The term "each device" implies that each model of the Sun Capsule Tanning Booth Devices underwent testing to measure irradiance. The specific number of individual units tested for each model is not provided.
- Data Provenance: Not explicitly stated as retrospective or prospective, or country of origin. However, the testing was conducted by the manufacturer to demonstrate compliance with national and international standards, suggesting it was an internal validation effort.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The device's performance is measured against engineering and regulatory standards (e.g., IEC, UL, 21 CFR 1040.20), not against a human-established ground truth like expert consensus on medical images.
4. Adjudication Method for the Test Set
This information is not applicable/provided. The performance criteria are objective measurements against established engineering and regulatory standards, not subjective interpretations requiring adjudication.
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
There is no mention of an MRMC comparative effectiveness study, AI assistance, or human readers in this document. This device is a tanning booth, not an AI-powered diagnostic or assistive tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. The device is a physical product (tanning booth) and its performance is measured based on its physical properties and emissions, not an algorithm's standalone performance.
7. The Type of Ground Truth Used
The ground truth used for this device's acceptance is based on:
- Established national and international consensus standards: IEC/EN 60601-1, IEC 60601-1-2, UL 482.
- FDA performance standards: 21 CFR 1040.20, specifically for radiation limits and irradiance measurements.
8. The Sample Size for the Training Set
This information is not applicable/provided. This device is not an AI/ML model that requires a training set. Its performance is based on engineering and design specifications and physical testing.
9. How the Ground Truth for the Training Set was Established
This information is not applicable/provided as there is no training set for this type of 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.