(120 days)
These devices are UV-B and UV-A lamps intended to provide ultraviolet radiation to tan the skin.
These UV Tanning lamps are medium pressure halide lamps with a quartz glass bulb, filled with metal halide, mercury and argon gas, equipped with 2 electrodes and a socket to provide ultraviolet radiation to induce skin tanning at any part of the living human body.
The provided text describes a 510(k) premarket notification for an "Ultraviolet Sun Tanning Lamp" and focuses on demonstrating substantial equivalence to a predicate device, not on proving device performance against specific acceptance criteria through a study. Therefore, much of the requested information regarding acceptance criteria, study details, human readers, and ground truth is not present in this document.
However, I can extract the information that is available and clarify what is missing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated Requirements) | Reported Device Performance |
|---|---|
| Requirements of 21 CFR 878.4635 | Fulfilled |
| Performance Standard 21 CFR 1040.20 | Fulfilled |
| Irradiance values per nanometer (Watt/cm²/nm) over wavelength range of 200 to 400 nm | Reported in "product reports" |
| Irradiance ratios (<0.003) as required per 21 CFR 1040.20(c)(1) | Reported in "product reports" |
| Quality control | Reported in "product reports" |
| Life & reliability testings | Reported for each single lamp model in the "product reports" |
| EN 60335-2-27 "Safety of household and similar electrical appliances. Part 2: Particular requirements for appliances for skin exposure to ultraviolet and infrared radiation." | Passed all testing in accordance with national and international standards |
| Device Risk Analysis per ISO 14971 | Passed all testing in accordance with national and international standards |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The document refers to "each single lamp model" for reporting performance data in "product reports."
- Data Provenance: Not explicitly stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Ground Truth Experts: Not applicable. This device is not an AI/diagnostic device that typically requires expert consensus for ground truth. The "ground truth" here is the adherence to regulatory and performance standards.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set:
- Not applicable. This device is not an AI/diagnostic device that typically uses adjudication for performance evaluation.
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 was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device. The "performance testing" was conducted on the lamp itself.
7. The type of ground truth used:
- The "ground truth" for this device's performance is compliance with established electrical, safety, and radiation emission standards and regulations (e.g., 21 CFR 878.4635, 21 CFR 1040.20, EN 60335-2-27, ISO 14971).
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that uses training sets.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/machine learning device.
Study Description (as per the document):
The document describes a "performance testing" conducted to demonstrate that the Ultraviolet Sun Tanning Lamp meets certain regulatory and performance standards and is substantially equivalent to a predicate device.
- Objective: To verify that the lamps emit UV-B and UV-A radiation and fulfill the requirements of 21 CFR 878.4635 and the performance standard 21 CFR 1040.20. It also aimed to compare the irradiance performance of the proposed device to the predicate Unilam tanning lamp.
- Methodology: The "performance testing" involved evaluating:
- Spectral characteristics (plot of spectral irradiance 200-710 nm).
- Irradiance values per nanometer (Watt/cm²/nm) over the wavelength range of 200 to 400 nm.
- Irradiance ratios (<0.003) as required per 21 CFR 1040.20(c)(1).
- Quality control assessments.
- Life & reliability testings.
- Compliance with EN 60335-2-27 and Device Risk Analysis per ISO 14971.
- Results: The "Ultraviolet Sun Tanning Lamp devices passed all the testing in accordance with national and international standards." The results for specific measurements (spectral characteristics, irradiance values/ratios, quality control, life & reliability) are reported "for each single lamp model in the 'product reports'."
- Conclusion: The non-clinical testing and device characteristics detailed in the submission support the substantial equivalence of the device to the predicate device, specifically regarding its safety and effectiveness.
This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing detailed clinical study results typical for an AI-powered diagnostic device. The "study" here is a series of non-clinical performance and compliance tests.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
G.I.E .- Gesellschaft Fur Lichttechnische Erzeugnisse Mbh % Oliver Eikenberg, Ph.D. October 20, 2015 Senior Consultant QA & RA Emergo Group 816 Congress Avenue, Suite 1400 Austin, Texas 78701
Re: K151674 Trade/Device Name: Ultraviolet Sun Tanning Lamp Regulation Number: 21 CFR 878.4635 Regulation Name: Sunlamp products and ultraviolet lamps intended for use in sunlamp products Regulatory Class: Class II Product Code: LEJ Dated: June 19, 2015 Received: June 22, 2015
Dear Dr. Eikenberg:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Joshua
For
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K151674
Device Name Ultraviolet Sun Tanning Lamp
Indications for Use (Describe) These devices are UV-B and UV-A lamps intended to provide ultravrolet radiation to tan the skin.
Type of Use (Select one or both, as applicable)
_ Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Image /page/3/Picture/1 description: The image shows the Emergo logo, which consists of the word "EMERGO" in black, followed by a red circular logo with three white curved lines inside. Above the logo, there is the text "K151674" and "Page 1 of 3". The text is aligned to the right side of the image.
Section 5 - 510(k) Summary per 21 CFR 807.92
1. Submission Sponsor
| NAME | G.L.E. Gesellschaft für lichttechnische Erzeugnisse mbH |
|---|---|
| ADDRESS | Herzbergstraße 26 |
| CITY | Berlin |
| STATE, ZIP | Berlin, 10365 |
| COUNTRY | Germany |
| Phone: | +49 30 55766-169 |
| Fax: | +49 30 55766-499 |
| Contact: | Mr. Michael Anders, CEO |
| Email: | m.anders@narva-gle.com |
| Internet: | www.narva-gle.com |
FDA Establishment Registration No.: 3002553648
2. Submission Correspondent
Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701, USA Office Phone: (512) 327.9997 Fax: (512) 327.9998 Contact: Oliver Eikenberg, PhD, Senior Consultant, QA / RA Email: project.management@emergogroup.com
3. Date Prepared
Septmeber 14, 2015
4. Device Identification
| Trade/Proprietary Name: | Ultraviolet Sun Tanning Lamp |
|---|---|
| Common/Usual Name: | Ultraviolet lamp for tanning |
| Classification Name: | Ultraviolet lamp for tanning |
| Classification Regulation: | 21 CFR 878.4635 |
| Product Code: | LEJ |
| Device Class: | Class II |
| Review Panel: | General & Plastic Surgery |
| Guidance: | Guide for Preparing Product Reports on Sunlamps and Sunlamp Products(FORM FDA 3630 (10/14), 21 CFR 1002) |
5. Legally marketed Predicate Devices
Tanning lamps (K143043, 04/02/2015) from Unilam Co., Ltd. (Onbix Corp.), South Korea
6. Device Description
These UV Tanning lamps are medium pressure halide lamps with a quartz glass bulb, filled with metal halide, mercury and argon gas, equipped with 2 electrodes and a socket to provide ultraviolet radiation to induce skin tanning at any part of the living human body.
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Image /page/4/Picture/1 description: The image shows the word "EMERGO" in a large, sans-serif font. To the right of the word is a red, circular logo with three curved lines inside. Above the word "EMERGO" are the words "K151674" and "Page 2 of 3".
7. Indications for use/ Intended Use
These devices are UV-B and UV-A lamps intended to provide ultraviolet radiation to tan the skin.
8. Comparison of Technological Characteristics
The following table compares the UV Tanning lamp devices to the predicate devices with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.
| Proposed Device | Predicate Device | Similarities/Differences | |
|---|---|---|---|
| Product Name: | Ultraviolet Sun TanningLamp | Unilam Tanning Lamp | - |
| 510(k): | Pending | K143043 | - |
| EstablishmentRegistration | 3002553648 | 3007123863 | - |
| Product Code: | LEJ | LEJ | Same |
| Regulation Number : | 21 CFR 878.4635 | 21 CFR 878.4635 | Same |
| Device Classificationname | Ultraviolet lamp fortanning | Ultraviolet lamp for tanning | Same |
| Class: | II | II | Same |
| Device model | Various | Various | Same |
| Intended Use: | Intended to provideultraviolet radiation to tanthe skin. | Intended to provideultraviolet light to tan theskin. | Same |
| Body Location: | skin tanning at any part ofthe living human body | skin tanning at any part ofthe living human body | Same |
| TechnologicalCharacteristic: | Radiate UVA (320-400nm)and UVB (260-320nm),UVC is cut by the quartzbulb. | Radiate UVA (315-400nm)and UVB (280-315 nm)UVC is cut by the quartzbulb. | Same, just differentreference definition for UVcategorization used |
| Frequency | 50-60 Hz | 60 Hz | Similar |
| Battery Operated: | No | No | Same |
| Sterile: | N/A | N/A | N/A |
| Biocompatibility: | N/A | N/A | N/A |
| Electrical Compatibility | N/A | N/A | N/A, electric component |
Table 5-1 – Comparison of Characteristics for UV Tanning Lamp from G.L.E. versus Unilam
9. Non-Clinical Performance Data
These lamps emitting UV-B and UV-A radiation and fulfill the requirements of 21 CFR 878.4635 and the performance standard 21 CFR 1040.20.
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Image /page/5/Picture/1 description: The image shows the word "EMERGO" in a simple sans-serif font, followed by a red circular logo with three curved lines inside. Above the word, there is the text "K151674" and "Page 3 of 3". The text is in a simple sans-serif font and is aligned to the right.
Spectral characteristics, a plot of the spectral irradiance from the product in the 200-710 nm wavelength range, irradiance values per nanometer (Watt/cm²/nm) over the wavelength range of 200 to 400 nm, Irradiance ratios (<0.003) as required per 21 CFR 1040.20(c)(1), quality control and life & reliability testings are reported for each single lamp model in the "product reports" as required by FDA form 3630 (10/14), "Guide for Preparing Product Reports on Sunlamps and Sunlamp Products (21 CFR 1002)". A performance testing was conducted comparing the irradiance performance of the Ultraviolet Sun tanning Lamp from G.L.E. to the predicate Unilam tanning lamp.
The Ultraviolet Sun Tanning Lamp devices passed all the testing in accordance with national and international standards. All tanning units were tested and manufactured according to
- EN 60335-2-27 "Safety of household and similar electrical appliances. Part 2: Particular requirements for appliances for skin exposure to ultraviolet and infrared radiation."
- Device Risk Analysis per ISO 14971
10. Clinical Testing
There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device and the described tanning lamps are only a lamp component, which should be used only in combination with sunlamp products (e.g. tanning beds) equipped with an appropriate filter, to provide a source of ultraviolet tanning. In addition these types of devices, including the predicate devices, have been on the market for many years without changes in technical specifications with a proven safety and efficiency for the use of the devices. The nonclinical testing and device characteristics detailed in this submission support the substantial equivalence of the device.
11. Statement of Substantial Equivalence
By definition, a device is substantially equivalent to a predicate device has the same intended use and the same technological characteristics as the previously cleared predicate device, or has the same intended use and different technological characteristics, and it can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device.
It has been shown in this 510(k) submission that the difference between the Ultraviolet Sun tanning lamps (G.L.E.) and the predicate tanning lamp devices (Unilam) do not raise any questions regarding its safety and effectiveness. Technological product characteristics, performance testing and compliance with voluntary standards, demonstrate that the Ultraviolet Sun tanning lamp devices are substantially equivalent to the relevant aspects of the predicate device in terms of design, components, materials, principals of operation, performance characteristics, and intended use.
The Ultraviolet Sun tanning lamp devices, as designed and manufactured, are determined to be substantially equivalent to the referenced predicate device from Unilam.
§ 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.