(98 days)
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.
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. The UV-B radiation is primarily responsible for more long-term tanning results. Traditional UV light with the addition of (beauty) red light results in a natural looking tan. Optimal tanning results are achieved due to the synergistic combination of light spectra.
The provided text is a 510(k) summary for sunlamp products (Ergoline Inspiration 550 Hybrid Technology and Ergoline Planet Fitness 42/4 Hybrid Light Technology). It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific performance criteria through a clinical study or complex AI validation.
Therefore, many of the requested details, such as those related to AI algorithm performance (e.g., sample size for test/training sets, expert ground truth, MRMC study, standalone performance, validation of ground truth), are not present in this document because they are not applicable to the type of device and regulatory submission described.
The "performance testing" mentioned in the document refers to compliance with established electrical, mechanical, and safety standards for sunlamp products, not an AI-driven diagnostic or treatment device.
Here's an analysis based on the available information and an explanation of why other requested information is not present:
Device Description: Sunlamp products (Ergoline Inspiration 550 Hybrid Technology, Ergoline Planet Fitness 42/4 Hybrid Light Technology, and their variants).
Intended Use: Exclusively for aesthetic tanning of human skin, for one person at a time, at the age of 18 or above.
Regulatory Class: Class II
Predicate Device: Ergoline Inspiration 600 Dynamic Performance (K151400)
1. Table of Acceptance Criteria and Reported Device Performance:
The "acceptance criteria" for this type of device, as demonstrated in a 510(k), are primarily related to meeting established safety and performance standards for sunlamp products and demonstrating substantial equivalence to a predicate device. There aren't "performance metrics" in the typical sense of accuracy, sensitivity, or specificity as one would see for a diagnostic AI.
| Acceptance Criteria (as implied by 510(k) process for this device type) | Reported Device Performance (from "Summary of performance testing" and comparison table) |
|---|---|
| Compliance with U.S. Performance Standard 21 CFR 1040.20 | The proposed devices are in compliance with U.S. performance standard 21CFR 1040.20. |
| Biocompatibility | Tested in accordance with ISO 10993-series. (Implied compliance, details not given) |
| Electrical and Mechanical Safety | Tested in accordance with IEC 60601-1. (Implied compliance, details not given) |
| Electromagnetic Compatibility (EMC) | Tested in accordance with IEC 60601-1-2. (Implied compliance, details not given) |
| Maintenance of Irradiance Ratio per 1040.20 | Fulfilled (for both proposed and predicate devices). |
| Max Exposure Time | 12 minutes (Identical to predicate). |
| Identical Intended Use/Indications for Use as Predicate | Identical. |
| No New Potential Hazards or Safety Risks Introduced | Device comparison and testing imply no new hazards. |
| All Special Controls Fulfilled | All Special Controls are fulfilled. |
2. Sample size used for the test set and the data provenance:
- Not applicable / Not provided. This document describes a submission for a sunlamp and does not involve AI or a complex test set of patient data. The "testing" refers to lab-based compliance testing of the physical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. No patient data test set or ground truth establishment by experts for performance evaluation (e.g., diagnostic accuracy) is described.
4. Adjudication method for the test set:
- Not applicable / Not provided. No test set requiring expert adjudication for AI performance.
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:
- No. This is a sunlamp product, not an AI-assisted diagnostic device. MRMC studies are not relevant here.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This relates to an AI algorithm, which is not part of this device or submission type.
7. The type of ground truth used:
- Not applicable. No ground truth in the context of diagnostic accuracy is relevant. The "ground truth" for this device would be its adherence to specified physical and electrical parameters and safety standards, as verified through laboratory testing against those standards.
8. The sample size for the training set:
- Not applicable / Not provided. No AI training set is mentioned as part of this device submission.
9. How the ground truth for the training set was established:
- Not applicable / Not provided. No AI training set.
Summary of the Study (as described in the document):
The "study" presented in this 510(k) summary is not a clinical study in the traditional sense, nor is it an AI performance validation study. Instead, it is a design verification and validation process to demonstrate that the new sunlamp devices are substantially equivalent to a previously cleared predicate device and that they comply with applicable U.S. and international safety and performance standards.
The core of the "proof" the device meets acceptance criteria lies in:
- Comparison to Predicate Device: Showing that the proposed devices have identical intended use and similar technological characteristics, with any differences not raising new questions of safety or effectiveness. Key differences (e.g., number of lamps, wattage) are addressed by stating that irradiance characteristics are comparable and safety has been confirmed by corresponding tests.
- Compliance with Recognized Standards: Stating that the devices have been tested and comply with:
- U.S. Performance Standard 21 CFR 1040.20 (Sunlamp Products)
- ISO 10993-series (Biocompatibility)
- IEC 60601-1 (Electrical and Mechanical Safety)
- IEC 60601-1-2 (Electromagnetic Compatibility)
The document concludes that the proposed devices are substantially equivalent to the predicate, do not introduce new indications or hazards, and fulfill all Special Controls.
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JK-Holding GmbH Juergen Gerstenmeier Executive Director Research & Development Koehlershohner Strabe 60 Windhagen, 53578 DE
May 10, 2019
Re: K190173
Trade/Device Name: Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / Sound 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: April 24, 2019 Received: April 26, 2019
Dear Juergen Gerstenmeier:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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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 device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Jennifer Stevenson, Acting Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190173
Device Name
Ergoline Inspiration 550 Hybrid Technology Ergoline Planet Fitness 42/4 Hybrid Light Technology
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
|X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary of Safety and Effectiveness
In accordance with the requirements of the Safe Medical Device Act, JK-HOLDING GmbH herewith submits a Summary of Safety and Effectiveness.
This 510(k) summary for the Ergoline Inspiration 550 Hybrid Technology / Ergoline Planet Fitness 42/4 Hybrid Light Technology and their further private label sunlamp products meets the requirements of 21 CFR 807.92
| Submitter information: | JK-HOLDING GmbHKoehlershohner Strasse 6053578 WindhagenGermanyPhone: +49 (0) 2224 / 818-0Fax: +49 (0) 2224 / 818-116 |
|---|---|
| Facility: | JK-Products GmbHRottbitzer Strasse 6953604 Bad HonnefGermanyEstablishment Registration Number: 9615023Owner/Operator Number: 9034303 |
| Official Correspondent: | Juergen GerstenmeierKoehlershohner Strasse 6053578 WindhagenGermanyPhone: +49 (0) 2224 / 818-330Email: juergen.gerstenmeier@de.jk-group.net |
| US Agent (Contact): | Kevin HartJK PRODUCTS & SERVICES, INC.411 West Washington Ave Suite BJonesboro, AR 72401Phone: 870-2682862Fax: 870 9359046Email: Kevin.Hart@Jkamerica.com |
| Date Prepared: | April 18th, 2019 |
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Device(s) Identification:
| Device trade name: | Ergoline Inspiration 550 Hybrid TechnologyErgoline Planet Fitness 42/4 Hybrid Light Technology |
|---|---|
| Common name: | Sunlamp product |
The following table presents the different variants of the Ergoline Inspiration 550 Hybrid Technology / Ergoline Planet Fitness 42/4 Hybrid Light Technology sunlamp product. All variants use the same basic device technology and differ only in effect lighting, comfort features and private labelling. All variants use the hybrid light technology.
| Model-No.: | Variant Name: |
|---|---|
| JK 126 / 42-4 HT | Ergoline Inspiration 550 Hybrid Technology / Sound |
| JK 126 / 42-4 HT AC | Ergoline Inspiration 550 Hybrid Technology / AC / Sound |
| JK 126 / 42-4 HT | Ergoline Planet Fitness 42/4 Hybrid Light Technology / Sound |
The basic products can be upgraded with conversion kits, consisting of stickers with the private label naming, to Soltron, Palm Beach Tan or further private label sunlamp products. The conversion kit only serves to label the basic product as a Soltron, Palm Beach Tan or further private label sunlamp product. It does not alter any technical specification or aspect of the devices.
Classification of the device:
| Device Classification Name: | Booth, Sun Tan |
|---|---|
| Product Code: | LEJ |
| C.F.R. Section.: | 878.4635 |
| Classification Panel: | General & Plastic Surgery |
| Device Class: | Class II |
Device Description:
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. The UV-B radiation is primarily responsible for more long-term tanning results. Traditional UV light with the addition of (beauty) red light results in a natural looking tan. Optimal tanning results are achieved due to the synergistic combination of light spectra.
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Indications for use:
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.
Legally Marketed Predicate device:
| Device Name: | Ergoline Inspiration 600 Dynamic Performance |
|---|---|
| Model No.: | JK 126 / 42-4 AC |
| 510k number: | K151400 |
| Device Classification Name: | Booth, Sun Tan |
| Product Code: | LEJ |
| C.F.R. Section.: | 878.4635 |
| Classification Panel: | General & Plastic Surgery |
| Device Class: | Class II |
Comparison to predicate device:
The following table presents the comparison of technological characteristics, functions and parameters of the identified predicate device and the proposed devices.
| Parameter | Proposed deviceJK 126 / 42-4 HTJK 126 / 42-4 AC | Predicate deviceJK 126 / 42-4 AC | Evaluation |
|---|---|---|---|
| IntendedUse/Indications for Use | This sunlamp productis intendedexclusively foraesthetic tanning ofthe human skin, forone person at a time,at the age of 18 orabove. | This sunlamp productis intendedexclusively forcosmetic tanning ofthe human skin, forone person at a time,at the age of 18 orabove. | Identical |
| Number of body lamps | 42 (28 UV lamps and14 UV+Red Lightlamps) | 42 (all UV lamps) | Similar:The irradiancecharacteristics arecomparable. The safetyhas been confirmedadditionally bycorresponding tests inaccordance with IEC62471.In terms of functionalityand safety there is noimpact due to thisdifference. |
| Parameter | Proposed deviceJK 126 / 42-4 HTJK 126 / 42-4 HT AC | Predicate deviceJK 126 / 42-4 AC | Evaluation |
| Watts | Canopy: 160Bench: 180 | 200 | Similar:The lamp wattage isless with the proposeddevice due to the useof different electroniclamp ballasts and amore efficient lamp-ballast system. |
| Lamp item description | Canopy: GENESISType U HybridPerformance 160 W(UV light) andGENESIS Type RHybrid Performance -160 W(Mix of UV+Red Light)Bench: GENESISType U HybridPerformance 180 W(UV light) andGENESIS Type RHybrid Performance -180 W(Mix of UV+Red Light) | GENESIS VHP12Dynamic Power200 W | Similar:The irradiancecharacteristics arecomparable. The safetyhas been confirmedadditionally bycorresponding tests inaccordance with IEC62471.In terms of functionalityand safety there is noimpact due to thisdifference |
| Number of HighPressure Facial lamps | 4 | 4 | Identical |
| Watts | 400 | 400 | Identical |
| Lamp item description | Ergoline Ultra 520W | Ergoline Ultra 520W | Identical |
| Filter | Ultra Performance862H | Ultra Performance862H | Identical |
| Number of LowPressure Facial lamps | 3 | 3 | Identical |
| Watts | 8 | 8 | Identical |
| Parameter | Proposed deviceJK 126 / 42-4 HTJK 126 / 42-4 HT AC | Predicate deviceJK 126 / 42-4 AC | Evaluation |
| Lamp item description | Genesis Type RHybrid 8W (Mix ofUV+Red Light) | Genesis VHP B-PowerE9 8W | Similar:The irradiancecharacteristics arecomparable. Thesafety has beenconfirmed additionallyby corresponding testsin accordance with IEC62471.In terms of functionalityand safety there is noimpact due to thisdifference |
| Electrical requirements | 230V 3Ø or 230V 2Ø | 230V 3Ø or 230V 2Ø | Identical |
| Total powerconsumption [Watts] | 11200 | 13200 | Similar:The total powerconsumption is lesswith the proposeddevice due to the useof different electroniclamp ballasts. Theirradiancecharacteristics arecomparable. |
| Number of wires | 4 3Ø or 3 2Ø | 4 3Ø or 3 2Ø | Identical |
| Max exposure time | 12 | 12 | Identical |
| Irradiance ratio inaccordance with1040.20 | fulfilled | fulfilled | Identical |
| Electrical safety | IEC 60601-1 | IEC 60601-1 | Identical |
| Electromagneticcompatibility | IEC 60601-1-2 | IEC 60601-1-2 | Identical |
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Attachment 10
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Summary of performance testing:
The proposed devices have been tested in respect to biocompatibility in accordance with the ISO 10993-series, electrical and mechanical safety in accordance with IEC 60601-1 and EMC in accordance with IEC 60601-1-2.
The proposed devices are in compliance with U.S. performance standard 21CFR 1040.20
Conclusion:
JK Holding GmbH believes that the proposed devices are substantially equivalent to the legally marketed predicate device. Also, all Special Controls are fulfilled. The proposed devices do not introduce new indications for use, have the same technological characteristics and do not introduce new potential hazards or safety risks.
§ 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.