(109 days)
This sunlamp product is intended exclusively for aestetic tanning of the human skin, for one person at a time, at the age of 18 or above.
The primary technical components of sunlamp products are artificial sources of UV radiation as well as a mechanical structure with a defined active surface. UV lamps emit different UV-A and UV-B proportions of the UV radiation. The UV-A proportion primarily generates a superficial tan, which appears rapidly and is intensive but also fades more rapidly. UV-B radiation is primarily responsible for more long-term tanning results. The Ergoline Sunrise 7200 Hybrid Light Technology / Hybrid Technology provides tanning results by combining traditional UV light with red light in a synergistic combination of light spectra.
The provided text is a 510(k) summary for a sunlamp product. This type of document is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific acceptance criteria through a clinical study in the way an AI diagnostic device would.
Therefore, many of the requested sections about clinical study details (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable to this document as it describes a Class II sunlamp product, not an AI/ML-driven medical device.
The document primarily focuses on demonstrating that the new device, Ergoline Sunrise 7200 Hybrid Technology, is substantially equivalent to a legally marketed predicate device (Sunrise 6200 and Sunrise 7200, K173565) by comparing their technological characteristics, intended use, and compliance with relevant safety standards.
Here's an attempt to answer the questions based on the available information, noting the inapplicability of some points:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device, "acceptance criteria" and "reported device performance" are primarily demonstrated through compliance with established safety and performance standards rather than specific diagnostic metrics. The document asserts compliance with these standards.
| Acceptance Criteria/Standard | Reported Device Performance/Compliance |
|---|---|
| Intended Use/Indications for Use (Substantial Equivalence) | Identical: "This sunlamp product is intended exclusively for aesthetic tanning of the human skin, for one person at a time, at the age of 18 or above." |
| Number of body lamps (Comparison to Predicate) | Similar (Proposed: 34 UV lamps and 14 UV+Red Light lamps; Predicate: 48 UV lamps). Safety confirmed by IEC 62471 tests. Functionality and safety not impacted. |
| Watts (Lamps) | Identical (200W for both proposed and predicate UV lamps). |
| Lamp item description (Comparison to Predicate) | Similar (Proposed: GENESIS Type U Hybrid Performance - 200 W (UV light) and GENESIS Type R Hybrid Performance - 200 W (Mix of UV+Red Light); Predicate: GENESIS VHP9 Smart Performance 200 W). Safety confirmed by IEC 62471 tests. Functionality and safety not impacted. |
| Number of Beauty Light LEDs | Different (Proposed: 60 (3x20); Predicate: none). Safety confirmed by IEC 62471 tests. Functionality and safety not impacted. |
| Watts (Beauty Light LEDs) | Different (Proposed: 45 (3x15); Predicate: none). No impact on safety. |
| Max exposure time [min] | Identical (9 minutes). |
| Electrical requirements | Identical (230V 3Ø or 230V 2Ø). |
| Total power consumption [Watts] | Similar (Proposed: 10600W; Predicate: 9500W). Higher due to different electronic lamp ballasts, performance not impaired. |
| Rated overcurrent protection device (circuit breaker) | Identical (40A / 3-pole 3Ø or 70A / 2-pole 2Ø). |
| Number of wires | Identical (4 3Ø or 3 2Ø). |
| Irradiance ratio in accordance with 1040.20 | Fulfilled (for both proposed and predicate). |
| Electrical safety (IEC 60601-1) | Identical (Compliant for both proposed and predicate). |
| Electromagnetic compatibility (IEC 60601-1-2) | Identical (Compliant for both proposed and predicate). |
| Biocompatibility (ISO 10993-series) | Proposed devices tested and in compliance. |
| U.S. performance standard 21CFR 1040.20 | Proposed devices tested and in compliance. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable: This document describes a sunlamp product, not an AI/ML diagnostic or predictive device that typically uses "test sets" of data. The "testing" referred to is for compliance with electrical, mechanical, and safety standards like IEC 62471, IEC 60601-1, IEC 60601-1-2, ISO 10993, and 21 CFR 1040.20. These are engineering/device performance tests, not clinical studies with patient data.
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)
- Not Applicable: As above, this is not an AI/ML diagnostic device requiring expert-established ground truth from clinical data. Compliance is assessed against technical standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: No clinical "test set" and thus no adjudication method for ground truth determination.
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
- Not Applicable: This is not an AI-assisted diagnostic device, so no MRMC study would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is a sunlamp product, not an algorithm, so "standalone performance" in this context is irrelevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable: The "ground truth" for this device's compliance is defined by the technical specifications and safety standards (e.g., measured irradiance levels, electrical safety parameters, biocompatibility test results). It is not based on clinical outcomes, pathology, or expert consensus on a diagnosis.
8. The sample size for the training set
- Not Applicable: This is a physical sunlamp product and does not involve AI/ML models that require a training set.
9. How the ground truth for the training set was established
- Not Applicable: As there is no training set, this question is not applicable.
§ 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.