(373 days)
Not Found
Not Found
No
The device description details a simple tanning booth with fluorescent UV lamps and a timer. There is no mention of any AI or ML components, image processing, or data sets for training or testing.
No.
The device is intended for the tanning of human skin, which is not a therapeutic purpose. The documentation emphasizes compliance with FDA regulations for sunlamp products, not medical devices for treatment.
No
Explanation: The device is explicitly stated to be for "the tanning of Human Skin," which is a cosmetic purpose, not a diagnostic one. There is no mention of it being used to identify or analyze any medical conditions.
No
The device description clearly outlines a physical tanning booth with fluorescent UV lamps, a metal structure, doors, ballasts, and timers. It also mentions testing of hardware components like surfaces, electrical safety, and temperature. This is a hardware device with some software components (timer).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the tanning of Human Skin." This is a cosmetic or aesthetic purpose, not a diagnostic one.
- Device Description: The device is a tanning booth that uses UV lamps to tan skin. It does not perform any tests on samples taken from the body (in vitro).
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting markers, or providing diagnostic information about a person's health.
- Performance Studies: The performance studies focus on UV irradiance, timer accuracy, safety, and comparability to a predicate tanning device. These are not studies related to diagnostic accuracy or performance.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This tanning booth does not fit that description.
N/A
Intended Use / Indications for Use
The device is intended to be used for the tanning of Human Skin.
Product codes (comma separated list FDA assigned to the subject device)
LEJ
Device Description
The IBL 5000 tanning booth is available in two configurations, a 200W configuration that utilizes 79 inch fluorescent UV lamps and a 160W configuration that utilizes 71 inch fluorescent UV lamps. Each configuration consists of a metal structure with 50 lamps vertically arranged in a manner that surrounds the tanner so as to provide a consistent all around tan. The user stands in the center of the booth. Double doors allow entry and exit from the booth. The lamps are powered by inductive (choke) type ballasts. The duration of exposure is controlled by a user settable electronic timer. The session time can be set to any value called for on the recommended exposure schedule. Session time cannot be set longer than the maximum recommended exposure schedule time. A backup timer is provided that ensures the booth's lamps cannot operate longer than the maximum recommended exposure. A stop switch is provided within the tanning area to immediately turn off the UV lamps if needed.
The dosage of UV irradiation is within allowable limits set by the FDA performance standard 21 CFR 1040.20 and FDA Guidance letter dated August 21st 1986 titled Policy on Maximum Timer Interval and Exposure Schedule for Sunlamp Products.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Human Skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
UV Irradiance testing was performed on both configurations to establish the exposure schedule per FDA Guidelines as well as to demonstrate substantial equivalence between the IBL 5000 (160W) and the IBL 5000 (200W) units. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use and performs comparably to the existing device. The testing raised no new issues of safety or effectiveness and as such the IBL 5000 (200W) and IBL 5000 (160W) are considered substantially equivalent to the IBL 5000 (200W) predicate device.
Results of the UV irradiance testing performed on both configurations confirm that the dosage is within allowable limits set by the FDA performance standard 21 CFR 1040.20 and FDA Guidance letter dated August 21st 1986 titled Policy on Maximum Timer Interval and Exposure Schedule for Sunlamp Products.
The following additional factors were tested and/or evaluated:
- Timer Software Validation and Verification
- Biocompatibility of surfaces in contact with the tanner.
- Electromagnetic compatibility and electrical safety.
- Temperature of contact surfaces and temperature of air within tanning booth during operation.
The results from these performance evaluations demonstrated the IBL 5000 (200W) and IBL5000 (160W) tanning booths met the acceptance criteria defined in the performance standard and performed comparably to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
IBL Acquisitions Inc. Model IBL 5000
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines extending from the bottom of the profiles.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 1, 2016
IBL Acquisitions LLC % Greg Bender Managing Member Bender & Bender Project Management Services LLC 3678 Gould Dr Carmel, Indiana 46033
Re: K152405
Trade/Device Name: IBL 5000 Tanning Booth Regulation Number: 21 CFR 878.4635 Regulation Name: Ultraviolet Lamp For Tanning Regulatory Class: Class II Product Code: LEJ Dated: July 11, 2016 Received: July 15, 2016
Dear Greg Bender:
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
1
Part 807): labeling (21 CFR Part 801): medical device reporting (reporting of medical devicerelated adverse events) (21 CFR Part 803); good manufacturing practice requirements as set forth in 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 yours.
Christopher J. Ronk -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) K152405
Device Name IBL 5000 Tanning Booth
| 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 a logo with the letters "IBL" in white, set against a semi-circular orange background. The logo is surrounded by a decorative design of swirling, sun-like shapes in a lighter shade of orange, giving the impression of light or energy emanating from the central letters. The overall design is simple yet eye-catching, with a warm color palette.
IBL ACQUISITIONS INC.
510(k) Summary As required by 21 CFR 807.92(c)
| Device Name | IBL 5000 |
|---|---|
| Submitters | |
| name/contact | |
| details | IBL Acquisitions Inc. |
| 2653 Tobey Drive | |
| Indianapolis, IN 46219 |
Contact Details:
Michael Gilley
President
Tel: 317-217-1700
Fax: 317-890-0103 |
| Summary
Preparation Date | 31st July 2015 |
| Device Name &
Classification | Trade Name: IBL 5000 (200W) and IBL 5000 (160W)
Common Name: Tanning Booth
Classification Name: Ultraviolet lamp for tanning
Device Classification: Class II, 21 CFR 878.4635
Product Code: LEJ |
| Intended Use: | The device is intended to be used for the tanning of human skin. |
| Device Description: | The IBL 5000 tanning booth is available in two configurations, a 200W configuration that utilizes 79 inch fluorescent UV lamps and a 160W configuration that utilizes 71 inch fluorescent UV lamps. Each configuration consists of a metal structure with 50 lamps vertically arranged in a manner that surrounds the tanner so as to provide a consistent all around tan. The user stands in the center of the booth. Double doors allow entry and exit from the booth. The lamps are powered by inductive (choke) type ballasts. The duration of exposure is controlled by a user settable electronic timer. The session time can be set to any value called for on the recommended exposure schedule. Session time cannot be set longer than the maximum recommended exposure schedule time. A backup timer is provided that ensures the booth's lamps cannot operate longer than the maximum recommended exposure. A stop switch is provided within the tanning area to immediately turn off the UV lamps if needed.
The dosage of UV irradiation is within allowable limits set by the FDA performance standard 21 CFR 1040.20 and FDA Guidance letter dated August 21st 1986 titled Policy on Maximum Timer Interval and Exposure Schedule for Sunlamp Products. |
| Predicate Devices | IBL Acquisitions Inc. Model IBL 5000 8/08/2013
Per Federal Register Vol. 79, No 105 Monday, June 2, 2014 Page 31212
Section IV Premarket Notification. (Docket No. FDA-2013-N-0461) “any 510(k)-exempt sunlamp product or UV lamp intended for sale on or |
| | before September 2, 2014, can serve as predicates for substantial equivalence purposes." |
| | Therefore, the IBL5000 will serve as its own predicate as it was on the market prior to September 2, 2014. The Initial Product Report for the IBL 5000 was given accession reference number 1310561-000. |
| Comparison of Characteristics | The IBL 5000 (200W) is identical to its predicate version on the market prior to September 2, 2014. |
| | The IBL 5000 (160W) has the following differences. |
| | - Utilizes 71 inch UV lamps instead of 79 inch lamps
- Utilizes 160W ballasts instead of 200W ballasts
- Utilizes staggered vertical spacing of its lamps to achieve tanning across the full body length. |
| | UV Irradiance testing was performed on both configurations to establish the exposure schedule per FDA Guidelines as well as to demonstrate substantial equivalence between the IBL 5000 (160W) and the IBL 5000 (200W) units. (refer to performance testing below) The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use and performs comparably to the existing device. The testing raised no new issues of safety or effectiveness and as such the IBL 5000 (200W) and IBL 5000 (160W) are considered substantially equivalent to the IBL 5000 (200W) predicate device. |
| | Labeling, Device labeling and user manual contraindications and warnings for both configurations are in compliance with the requirements of 21 CFR 1040.20 and have been updated to comply with the recently updated regulation 21 CFR 878.4635. See Proposed Labeling section of this submittal. |
| Performance Testing (non-Clinical) | Results of the UV irradiance testing performed on both configurations confirm that the dosage is within allowable limits set by the FDA performance standard 21 CFR 1040.20 and FDA Guidance letter dated August 21st 1986 titled Policy on Maximum Timer Interval and Exposure Schedule for Sunlamp Products. |
| | The following additional factors were tested and/or evaluated. |
| | - Timer Software Validation and Verification - Biocompatibility of surfaces in contact with the tanner.
- Electromagnetic compatibility and electrical safety.
- Temperature of contact surfaces and temperature of air within tanning booth during operation. |
| | The results from these performance evaluations demonstrated the IBL 5000 (200W) and IBL5000 (160W) tanning booths met the acceptance criteria defined in the performance standard and performed comparably to the predicate device. |
| | IBL Acquisitions Inc. 2653 Tobey Drive Indianapolis, IN 46219
Phone: 317.217.1700 Fax: 317.890.0103 |
| Conclusions | Based on safety and performance testing, technological characteristics
and the intended for use of the device, the proposed IBL 5000 models
have been demonstrated to be appropriate for their intended use and are
considered to be substantially equivalent to the predicate device. |
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