(98 days)
Tanning Bed Systems are intended to provide tanning of the human skin.
The primary technical components of sunlamp products are whole body tanning devices consisting of a mechanical frame with Ultraviolet (UV) lamps providing an artificial source of UV radiation. The UV light is intended for irradiation of the human body to induce skin tanning. The user of the proposed devices device either lies in the horizontal tanning bed or stands in the vertical tanning booth.
Skin tanning varies with skin type and as the UV sources intensities with characteristic UV-A and UV-B proportions result in cosmetic tanning of the human skin.
The UV-A proportion primarily generates a superficial tan, which appears rapidly and is intensive but fades more rapidly. The UV-B radiation is primarily responsible for more longterm tanning results.
This document describes ProSun International LLC's submission for their sunlamp products, establishing substantial equivalence to previously marketed predicate devices. This is a 510(k) submission for tanning bed systems, which are classified as Class II medical devices. The document does not describe an AI/ML powered device, therefore the typical acceptance criteria and study data for AI/ML devices involving human readers, test sets, ground truth, and training sets are not applicable.
Instead, the acceptance criteria for these devices revolve around compliance with established performance standards and safety regulations for sunlamp products.
Here's a breakdown of the requested information, adapted to the context of this device:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (FDA Performance Standards & Guidance) | Reported Device Performance (Summary of Performed Tests) |
|---|---|
| Biocompatibility: In accordance with DIN EN ISO 10993 | Non-clinically tested in accordance with DIN EN ISO 10993. |
| Electrical and Mechanical Safety: In accordance with IEC 60601-1 (IEC 60335-2-27 and UL 482) | Non-clinically tested in accordance with IEC 60601-1 (IEC 60335-2-27 and UL 482). |
| EMC (Electromagnetic Compatibility): In accordance with IEC 60601-1-2 (CISPR 14-1 and 14-2) | Non-clinically tested in accordance with IEC 60601-1-2 (CISPR 14-1 and 14-2). |
| Spectral Emissions: Measured in accordance with IEC 6033-2-27 and 21 CFR 1002, 1010-1050 | Spectral emissions of all sunlamp products were measured (test procedure in accordance with IEC 6033-2-27 and 21 CFR 1002, 1010-1050). |
| Irradiance Ratio Limits: In accordance with 21 CFR 1040.2(c)(1) | Irradiance ratio limits of all proposed sunlamp products are in accordance with 21 CFR 1040.2(c)(1). |
| Software Verification & Validation: According to FDA's "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices" (if applicable) | Non-clinically tested for software verification & validation testing according to FDA's "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices" (implying compliance, as the devices are presented as being substantially equivalent). |
| Maximum Timer Intervals and Exposure Schedules: Determined according to FDA's "Policy on maximum timer interval and exposure schedule for sunlamp products." | The maximum timer intervals and exposure schedules have been determined according to FDA's "Policy on maximum timer interval and exposure schedule for sunlamp products." (The table in section 1.5.6 on page 6 details the "Max Exposure Min." for each model, ranging from 9 to 20 minutes, which represents the device's adherence to these schedules). |
| Performance Standards Testing: In accordance with 21 CFR 1040.20 | Performance Standards testing in accordance with 21 CFR 1040.20. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as this is not an AI/ML study involving a test set of data. The devices themselves are the "test set" and their performance is evaluated against regulatory standards. The testing described is primarily non-clinical, evaluating the physical device characteristics and compliance with electrical, mechanical, and radiation emission standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. The "ground truth" for sunlamp products relies on established engineering and medical device safety standards and regulations (e.g., IEC, UL, 21 CFR). Expert review would be conducted by regulatory bodies and internal engineering teams to ensure compliance, rather than clinical experts establishing a ground truth for a diagnostic AI.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. This is not a study requiring adjudication of interpretations from multiple readers.
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
This information is not applicable. This submission is for sunlamp products, not a device with AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. These are physical sunlamp devices, not software algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is the set of established safety and performance standards, regulations, and internationally recognized testing procedures for sunlamp products. This includes:
- 21 CFR 878.4635 (Regulation for Ultraviolet Lamp for Tanning)
- 21 CFR 1040.20 (Performance standards for sunlamp products)
- 21 CFR 1002, 1010-1050 (Electronic product radiation control)
- IEC 60601-1 (Medical electrical equipment - General requirements for basic safety and essential performance)
- IEC 60335-2-27 (Household and similar electrical appliances - Safety - Part 2-27: Particular requirements for appliances for skin exposure to ultraviolet and infrared radiation)
- UL 482 (Standard for Portable Sun/Health Lamps)
- DIN EN ISO 10993 (Biological evaluation of medical devices)
- CISPR 14-1 and 14-2 (Electromagnetic compatibility for household appliances, electric tools and similar apparatus)
- FDA Guidance documents (e.g., "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices" and "Policy on maximum timer interval and exposure schedule for sunlamp products")
8. The sample size for the training set
This information is not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable. There is no training set for this 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.