(162 days)
Intended to provide ultraviolet light to tan the skin
Tanning lamp is electronic products to be intended for irradiation of any part of the living human body, by ultraviolet radiation with wavelengths to induce skin tanning.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Tanning Lamp (K143043).
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It does not contain detailed information about a comprehensive clinical study to "prove the device meets acceptance criteria" in the way a novel, high-risk device might. Instead, it relies on demonstrating similar performance to a legally marketed predicate device.
Acceptance Criteria and Reported Device Performance
The core "acceptance criteria" here are based on the concept of substantial equivalence to the predicate device. This means the new device must perform comparably in key technological characteristics and safety aspects.
| Acceptance Criteria (Derived from Substantial Equivalence) | Reported Device Performance (Unilam Tanning Lamp) |
|---|---|
| Intended Use: Provide ultraviolet light to tan the skin | Intended Use: Provides ultraviolet light to tan the skin (Matches predicate) |
| Technological Characteristics: | Technological Characteristics: |
| - Radiate UVA (315 | - Radiates UVA (315 |
| - UVC cut by quartz bulb | - UVC cut by quartz bulb |
| - Power source: Ballast Cosmedico #74427 (input 220V/60Hz) | - Power source: Ballast Cosmedico #74427 (input 220V/60Hz) |
| - Frequency: 60Hz | - Frequency: 60Hz |
| - Electrical power requirements for lamp activation (comparable to predicate) | Individual test data sheets prepared; comparable electrical power requirements to predicate |
| - Lamp spectral output (comparable to predicate) | Individual test data sheets with output spectra in nm increments; comparable spectral output to predicate |
| - Lamp energy output (UVA and UVB range; comparable to predicate) | Individual test data sheets with energy output for UVA and UVB range; comparable energy output to predicate |
| - Approximate lifetime of bulbs (comparable to predicate) | Individual test data sheets with approximate lifetime of bulbs; comparable lifetime to predicate |
| - Physical dimensions and connector design (comparable to predicate) | Individual test data sheets with dimensions and connector design; comparable to predicate |
| Safety: | Safety: |
| - Not applicable for sterilization | - Not applicable for sterilization |
| - Overall safety comparable to predicate (implied by substantial equivalence and lack of new safety concerns) | Demonstrated comparable performance in non-clinical studies suggests similar safety profile to predicate |
Study Details
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Sample Size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify a numerical sample size for "test sets" in the traditional sense of a clinical trial. Instead, the "test" involved direct comparisons of the new device (Unilam UV lamps) and the predicate device (Cosmedico UV lamps) based on their intrinsic properties. It refers to "individual test data sheets" for each bulb. This implies that at least one of each relevant bulb model from Unilam and Cosmedico was tested for the specified parameters.
- Data Provenance: The studies were "Performance studies... comparing the Unilam UV lamps to the predicate Cosmedico UV lamps." This suggests the data was generated specifically for this 510(k) submission, likely in a controlled laboratory setting. The origin of the devices themselves is implied: Unilam Co., Ltd. (Republic of Korea) and NARVA LICHTQUELLEN GMBH + CO KG (predicate). The document does not specify if the tests were retrospective or prospective, but for laboratory performance testing like this, it would be prospective in relation to the submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For a device like a tanning lamp, the "ground truth" for performance is based on quantifiable physical measurements (wavelengths, energy output, electrical characteristics) conducted by qualified technical personnel using calibrated equipment, not on expert clinical consensus or interpretation in the way a diagnostic imaging device might be evaluated.
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Adjudication method for the test set:
- Not Applicable. As the "ground truth" is based on objective physical measurements, there's no need for an adjudication method involving multiple human reviewers.
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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:
- No, an MRMC comparative effectiveness study was not done. This device is a tanning lamp, which is an energy-delivering device, not a diagnostic or AI-powered device that involves "human readers" or AI assistance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an algorithm-based device.
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The type of ground truth used:
- The "ground truth" was established through objective physical measurements and technical specifications of the lamps. This includes:
- Electrical power requirements
- Spectral output (in nm increments)
- Energy output (UVA and UVB range)
- Approximate lifetime
- Physical dimensions and connector design
- The "ground truth" was established through objective physical measurements and technical specifications of the lamps. This includes:
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The sample size for the training set:
- Not Applicable. This is not an AI/machine learning device, so there is no training set in that context. The device's characteristics are determined by its manufacturing, not by being "trained" on data.
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How the ground truth for the training set was established:
- Not Applicable. As there is no training set, there is no ground truth to establish for it.
§ 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.