(45 days)
The device is intended to be used for the tanning of human skin.
The series of tanning bed/booths are available in four configurations. Units consist of LPI, Inc. branded and OEM tanning beds and booths.
- ESB -14, 16, 18, 24, and Oasis 36(booth)
- Solar Storm 16R, 24S, 24R, 24C, 32S, 32R, 32C, 36ST, 48ST(Booth)
- Solar Wave 16, 24
- . Sunco - 16XS, 24XS, 32XS, and 48Vertical (Booth)
Each configuration consists of a metal structure with lamps placed equally distant horizontally (booths) and arranged in manner to provide the tanner an even tan. The user of tanning beds lies down on the bench section and pulls down the canopy cover, which is equipped with a counterweighted gas springs/shocks in order for this section of the bed to open and close. The user of a tanning booth stands within the sections of the booth. The section of the booth (door) also has gas springs/shocks and wheels to close the door. All units have electronic type ballasts that powers the lamps. Each unit is also equipped with a settable electronic timer which is controlled by a time setting of 10, 15, or 20 minutes. Timers are also equipped with an "off" button to allow user to turn off the lamps any time prior to the duration of the set timer.
This document is a 510(k) summary for tanning units (tanning beds/booths). It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way typically expected for an AI/ML medical device. Instead, it demonstrates substantial equivalence to predicate devices and adherence to existing regulations for sunlamp products.
Therefore, many of the requested sections about specific acceptance criteria, study sizes, expert involvement, and AI performance metrics are not applicable to this document.
Here's a breakdown of the information that can be extracted from the provided text, and where the requested information is not available:
1. A table of acceptance criteria and the reported device performance
This document does not present a table of acceptance criteria for a new performance claim, nor does it report device performance in terms of metrics like sensitivity, specificity, or accuracy (which would be relevant for an AI/ML device). Instead, it confirms adherence to established standards and guidelines for sunlamp products.
The key "performance criteria" that are implicitly met are:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| UV irradiation exposure within allowable limits per 21 CFR 1040.20 and FDA Guidance letter dated August 21, 1986. | UV irradiance testing results confirm the dosage is within allowable limits. |
| Compliance of labeling and user manual contraindications/warnings with 21 CFR 1040.20. | Labeling and user manual contraindications and warnings are in compliance. |
| Timers function correctly and are set for specified intervals (10, 15, or 20 minutes). | Timers are set for the time interval and tested at 100% prior to installation. |
| Biocompatibility of materials in contact with skin. | Poly(Methyl methacrylate/Butyl acrylate) (CAS No. 25852-37-3) has been shown to be biocompatible via ISO 10993 and is identical to material in predicate devices. |
| Electrical Safety and Electromagnetic Compatibility (EMC). | IEC 60601-1 and 60601-1-2 testing were conducted and passed. |
| Software Verification and Validation. | Conducted and documented as recommended by FDA's Guidance for Industry, "Guidance for Industry, FDA Reviewers and Compliance on "Off-the-Shelf" Software used in Medical Devices." (Software considered "Minor Level of Concern"). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is not a study involving a test set of data as for an AI/ML device. The "testing" refers to quality control and compliance checks on the physical tanning units.
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. Ground truth establishment by experts is not described for this type of device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 device is a tanning unit, not an AI-assisted diagnostic or interpretive system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" implicitly used here relates to established regulatory standards and guidance for sunlamp products (e.g., maximum UV irradiance, electrical safety standards, biocompatibility standards). These are not clinical outcomes or expert consensus on clinical data.
8. The sample size for the training set
Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 19, 2018
LPI, Inc. Christopher Steadman VP Tanning Operations 506 Twin Oaks Drive Johnson City, Tennessee 37601
Re: K180576
Trade/Device Name: Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure Select) Regulation Number: 21 CFR 878.4635 Regulation Name: Ultraviolet Lamp for Tanning Regulatory Class: Class II Product Code: LEI Dated: February 28, 2018 Received: March 5, 2018
Dear Christopher Steadman:
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 device-related adverse events) (21 CFR 803); good
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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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, Jennifer R. Stevenson -S 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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Indications for Use
510(k) Number (if known) K180576
Device Name
Solar Storm/Solar Wave, Sunco, and ESB (Galaxy, Avalon, Leisure Select, Elite, Oasis and Grande)
Indications for Use (Describe) The device is intended to be used for the tanning of human skin.
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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Image /page/3/Picture/0 description: The image shows the logo for LPI Inc. The logo is red and has a reflection underneath it. The text "Inc.com" is in a smaller, lighter font than the "LPI" part of the logo. The logo is simple and modern.
501(k) Summary As required by 21 CFR 807.92(c)
Date February 28, 2018
Submitter and Contact Details
LPI, Inc. 506 Twin Oaks Drive Johnson City, TN 37601 Chris Steadman, VP Tanning Operations Phone: 423-349-2920 Email: csteadman@lpiinc.com
Device Name
Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure Select)
Device Name/Classification
Trade Name: Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure Select) Common Name: Tanning bed/booth Classification Name: Ultraviolet lamp for tanning Device Classification: Class II, 21 CFR 878.4635 Product Code: LEJ
Predicate Devices
Per the special controls for these devices and noted in the Federal Register Vol 79, No 105, dated June 2, 2014 (Docket No. FDA-2013-N-0461), LPI, Inc. tanning units listed below serve as their own predicate devices as they were on the market prior to September 2, 2014 and can demonstrate substantial equivalence.
- ESB -14, 16, 18, 24, and Oasis 36(booth)
- . Solar Storm 16R, 24S, 24R, 24C, 32S, 32R, 32C, 36ST, 48ST(Booth)
- Solar Wave 16, 24
- Sunco - 16XS, 24XS, 32XS, and 48Vertical (Booth)
Device Description
The series of tanning bed/booths are available in four configurations. Units consist of LPI, Inc. branded and OEM tanning beds and booths.
- ESB -14, 16, 18, 24, and Oasis 36(booth)
- Solar Storm 16R, 24S, 24R, 24C, 32S, 32R, 32C, 36ST, 48ST(Booth)
- Solar Wave 16, 24
- . Sunco - 16XS, 24XS, 32XS, and 48Vertical (Booth)
Each configuration consists of a metal structure with lamps placed equally distant horizontally (booths) and arranged in manner to provide the tanner an even tan. The user of tanning beds lies down on the bench section and pulls down the canopy cover, which is equipped with a counterweighted gas springs/shocks in order for this section of the bed to open and close. The user of a tanning booth stands within the sections of the booth. The section of the booth (door) also has gas springs/shocks and wheels to close the door. All units have electronic type ballasts that powers the lamps. Each unit is also equipped with a settable electronic timer which is controlled by a time setting of 10, 15, or 20 minutes. Timers are also equipped with an "off" button to allow user to turn off the lamps any time prior to the duration of the set timer.
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All tanning units meet the allowable limits of UV irradiation exposure based on limits set by the FDA performance standard 21 CFR 1040.20 and FDA Guidance letter dated August 21, 1986 titled Policy on maximum Timer internal and Exposure Schedule for Sunlamp Products.
Intended Use
The device is intended to be used for the tanning of human skin.
Comparison of Characteristics
The LPI, Inc. Branded and OEM units described above are identical to the units previously marketed as Class K devices.
Testing of UV irradiance was performed to determine a guideline for testing of units during the production. The results of these tests provide reasonable assurance that the device is designed and tested to assure conformance to the requirements for its intended use and performs comparably to the existing device. All LPI, Inc. beds/booths are considered substantially equivalent to the same predicate devices.
The labeling of devices and user manual contraindications and warnings for LPI, Inc Branded and OEM beds/booths are in compliance with the requirements of 21 CFR 1040.20.
Timers on the beds/booths are set for the time intervals of 10, 15, or 20 minutes based on the unit. All timer Units are set for the time interval and tested at 100% prior to installation.
Performance Testing
(Non-Clinical)
UV irradiance testing results performed on all lamp confirm the dosage is within allowable limits set by the FDA performance standard 21 CFR 1040.20 and FDA Guidance letter dated August 21,1986 titled "Policy on Maximum Timer internal and Exposure Schedule for Sunlamp Products.
Usability data is included with the submission.
Biocompatibility Testing
The subject devices are categorized as surface devices which only come into contact with the intact skin for a duration of less than 24 hours. The material that comes into contact with the patient's skin is Poly(Methyl methacrylate/Butyl acrylate) CAS No. 25852-37-3, which has been shown to be biocompatible via ISO 10993 and is identical to the material used in these same devices when previously sold as Class I devices.
Electrical Safety and Electromagnetic Compatibility (EMC)
IEC 60601-1 and 60601-1-2 testing were conducted on denoted devices, which were shown to pass the tests conducted.
No further testing was performed, as devices are identical to the predicate devices.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry, "Guidance for Industry, FDA Reviewers and Compliance on "Offthe-Shelf" Software used in Medical Devices." The software for this device is considered as a "Minor Level of Concern before Mitigations".
User Training
LPI has established a training completion for each purchaser of residential and commercial tanning beds and booths.
The following topics are covered at a minimum.
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-
- Use of instruction manual
-
- Consult physician regularly for skin cancer when repeatedly exposed to UV radiation
-
- Contraindicate for people under 18 Years of age
-
- Contraindicate persons must not use if skin lesions or open wounds are present
-
- Should not be used on individuals who have had skin cancer or have a family history
-
- Repeated exposure and overexposure, allowance time between tanning sessions
-
- Use of only approved eyewear during tanning session
-
- Discontinue tanning if experiencing health concerns
Conclusion
The predicate devices do not negatively affect a finding of substantial equivalence between the subject devices and are identical technologically, with a few minor aesthetic differences.
§ 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.