(1093 days)
The Fiji Sun Fluorescent Tanning Unit device (FIJI Sun) is intended to provide ultraviolet light for the purpose of stimulating a tanning response in the skin.
The FIJI Sun Fluorescent Tanning Unit (FIJI SUN) is a small tabletop sunlamp product which uses four Sperti brand ultraviolet lamps (model number: FRT20TI21BUHO) manufactured for KBD. The FIJI Sun Fluorescent Tanning Unit uses a mechanical timer with a maximum timer interval of 15 minutes and a minimum timer interval of one minute. The maximum timer interval error as a percent of that interval is +/- 6%. Output performance testing and FDA performance standards were used to determine the maximum timer interval and the recommended exposure schedule which is on the device labeling and in the user instructions. Two pair of protective eye wear are supplied with the device. The spectral transmittance to the eye of the protective eyewear is 0.0008 in the wavelength range from 200 nm to 320 nm and 0.0004 in the wavelength range from 320nm to 400 nm and is sufficient over the wavelengths greater that 400nm to enable the user to see clearly enough to reset the timer. In order for the product to fulfill its function it emits UV light In the wavelength range from 290 nm to 400 nm and the emission level is one SED (100 J/m²). The minimum use distance specified in the product labeling and the user instruction is 18 inches. Adequate directions for use, warnings and contraindications are included in user instructions provided with the device and in the device labeling. There is no software contained in the device. The device is sold as Over the Counter (OTC).
This document describes a 510(k) premarket notification for the "Fiji Sun Fluorescent Tanning Unit (FIJI Sun)." This device is a tanning unit, not an AI/ML powered medical device, therefore the typical acceptance criteria and study information related to AI/ML software (like sensitivity, specificity, AUC, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable to this submission.
The "acceptance criteria" and "device performance" in this context refer to compliance with established safety and performance standards for sunlamp products.
Here's a summary of the relevant information provided:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Timer Interval | Maximum timer interval of 15 minutes, minimum of 1 minute. |
| Timer Interval Error | +/- 6% of the maximum timer interval. |
| UV Wavelength Range | Emits UV light in the wavelength range from 290 nm to 400 nm. |
| Emission Level | Emission level is one SED (100 J/m²). |
| Minimum Use Distance | 18 inches specified in product labeling and user instructions. |
| Protective Eyewear Transmittance | Spectral transmittance to the eye: 0.0008 in the wavelength range from 200 nm to 320 nm. |
| Spectral transmittance to the eye: 0.0004 in the wavelength range from 320 nm to 400 nm. | |
| Protective Eyewear Visibility | Sufficient over wavelengths greater than 400 nm to enable the user to see clearly enough to reset the timer. |
| Electrical Safety Standard | Conformance to IEC/EN 60601-1:2005 Edition 3/(R)2012 And A1:2012 (Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance). |
| Radiation Control Standard | Compliance with performance standards under Section 1040.20 of the Federal Food, Drug, and Cosmetics Act (specifically pertaining to radiation limits). |
Study Information (Applicable to Non-AI/ML Device)
- Sample size used for the test set and the data provenance: No "test set" in the context of an AI/ML study. The device itself (the Fiji Sun Fluorescent Tanning Unit) underwent performance testing to ensure compliance with relevant standards. The data provenance is internal testing performed by the manufacturer KBD, Inc.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a tanning unit involves physical measurements and compliance with regulatory limits, not expert interpretations of medical images or data.
- Adjudication method for the test set: Not applicable.
- 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/ML device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" here is objective physical measurements and established regulatory limits for UV emission, timer accuracy, and protective eyewear transmittance as defined by the Federal Food, Drug, and Cosmetics Act (specifically 21 CFR 1040.20) and international electrical safety standards (IEC/EN 60601-1).
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
In summary, the "study" demonstrating the device meets "acceptance criteria" involved specific performance testing of the physical device to ensure it conforms to established regulatory standards for sunlamp products, particularly regarding UV radiation emission, timer accuracy, and protective eyewear safety. The submission claims "Specific performance testing (spectral analysis) was done on these devices to measure irradiance" and "Specific performance testing was done on the included protective eyewear (goggles)."
§ 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.