The UV Biotek Multi-Directional device is for individuals who require specific Ultraviolet radiation therapy for diagnosed skin disorders and is used for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (I - VI).

The UV Biotek Single Panel Unit device models 100B/80B/40B are for individuals who require specific Ultraviolet radiation therapy for diagnosed skin disorders and is used for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (I - VI)

Device Description

The UV Biotek Multi-Directional model is a phototherapy device, wall mounted with 3 lighting panels containing a total of 10 Philips TL100W/01 (narrowband UVB) or 10 Philips FS72T12/BL/HO/12 (wideband UVB) lamps. The center panel contains 6 lamps and the outer panels contain 2 lamps each, driven by standard electrical lighting systems at 120 Volts, producing 1000 Watts of primary UVB emissions within an enclosed metal (structure) and acrylic (exposure) housing, that is utilized at a the patient's home by prescription, and only with protective eyewear, as outlined in 21 CFR 892.6500. Cabinet dimensions: 85.5" high, 9" deep, 22.5" wide – when the door panels are closed. A digital AccuSafe control timer module is used to program exposure times and dosages.

The UV Biotek Single Panel device is a phototherapy device, wall mounted with a single lighting panel with an array of 4, 6, 8 or 10 Philips TL100W/01 (narrowband UVB) or Philips FS72T12/BL/HO/12 (wideband UVB) lamps, driven by standard electrical lighting systems at 120 Volts, producing 400 to 1000 Watts of primary UVB emissions within an enclosed metal (structure) and acrylic (exposure) housing, that is utilized at a the patient's home by prescription, and only with protective eyewear, as outlined in 21 CFR 892.6500.

Cabinet dimensions: 85.5" high, 5" deep, 22" wide – when door panels are closed. A digital AccuSafe control timer module is used to program exposure times and dosages.

There are 4 single panel models to choose from:
. The100B model is one metal cabinet, housing (10) Philips TL100W/01 (narrowband UVB) or Philips FS72T12/BL/HO/12 (wideband UVB) lamps.
The 80B model is one metal cabinet, housing (8) Philips TL100W/01 ● (narrowband UVB) or Philips FS72T12/BL/HO/12 (wideband UVB) lamps.
. The 60B model is one metal cabinet, housing (6) Philips TL100W/01 (narrowband UVB) or Philips FS72T12/BL/HO/12 (wideband UVB) lamps.
. The 40B model is one metal cabinet, housing (4) Philips TL100W/01 (narrowband UVB) or Philips FS72T12/BL/HO/12 (wideband UVB) lamps.

AI/ML Overview

This document is a 510(k) premarket notification for the "UV Biotek Multi-Directional and UV Biotek Single Panel (models 100B/80B/60B/40B)". It claims substantial equivalence to a predicate device, the "UV Biotek Mobile/Versa Lite (K111049)". The provided text does not contain a study with acceptance criteria or reported device performance in terms of diagnostic accuracy or clinical outcomes for the treatment of dermatologic disorders.

Instead, the document details the device's technical specifications and asserts its equivalence to a predicate device based on similar characteristics and compliance with electrical safety and EMC standards.

Therefore, the requested information about acceptance criteria for a study demonstrating efficacy and device performance cannot be extracted from this document, as such a study is not described. The performance testing mentioned specifically related to "irradiance" and "comparison to the predicate device" to "reach the recommended dose (mJ/cm2) for the treatment of psoriasis found in published scientific literature", not a clinical study proving the device meets specific efficacy acceptance criteria.

However, based on the information provided, here's what can be inferred and stated:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria for clinical efficacy (e.g., reduction in psoriasis severity scores) or diagnostic performance, nor does it report the device's performance against such criteria. The "Performance Standards" section (page 6) mentions:

"These devices have been tested under and are in compliance with performance standards that have been established for such devices under Section 878 of the Federal Food, Drug, and Cosmetics Act." (general compliance)
"All electrical and radiological products made by the applicant have been OSHA/NRTL listed, and have received constituent marks and are found to be in conformance with EN/IEC 60601-1 Electrical Safety and EN/IEC 60601-1-2:2007 EMC." (electrical and EMC safety)
"Specific performance testing was done on these devices to measure irradiance and for comparison to the predicate device. These measurements were used to reach the recommended dose (mJ/cm2) for the treatment of psoriasis found in published scientific literature." (technical measurement for dosing, not clinical outcome)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The document does not describe a clinical test set or patient data.

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. The document does not describe a clinical test set or ground truth established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. The document does not describe a clinical test set.

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 UV phototherapy device for treatment, not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a UV phototherapy device for treatment, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The document does not describe a clinical study requiring ground truth for clinical outcomes. The "performance testing" mentioned focuses on physical measurements (irradiance) rather than clinical efficacy. The basis for efficacy relies on the predicate device and "published scientific literature" for recommended doses of UV radiation for psoriasis treatment.

8. The sample size for the training set

Not applicable. The document does not describe an AI/ML model or a training set.

9. How the ground truth for the training set was established

Not applicable. The document does not describe an AI/ML model or a training set.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 15, 2014

AEGIS Regulatory Incorporated % Ms. Susan Anthoney-De Wet Medtek Lighting 2424 Dempster Drive Coralville, Iowa 52241

Re: K134009

Trade/Device Name: UV Biotek Multi-Directional and UV Biotek Single Panel (models 100B/80B/60B/40B) Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet lamp for dermatologic disorders Regulatory Class: Class II Product Code: FTC Dated: August 8, 2014 Received: September 15, 2014

Dear Ms. De Wet:

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 (reporting of medical

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device-related adverse events) (21 CFR 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,

Binita S. Ashar -S 2014.10.15 07:25:49 -04'00' 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) K134009

Device Name

UV Biotek Multi-Directional and UV Biotek Single Panel (models 100B/80B/60B/40B)

Indications for Use (Describe)

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)

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510(k) Summary

Preparation Date: October 14, 2014

1. Submitter Information: AEGIS Requlatory, Inc. Robert T. Wagner 2424 Dempster Drive Coralville, IA 52241 Tel.: 865-982-5552 Email: bob@fdalistingconsultants.com
- For Manufacturer: MedTek Lighting, Inc. Attn: Mr. Gary Richardson 3 Depot St. Hudson Falls, NY 12839 Tel.: 518-747-3310

2. General Information:

2.1 Classification Name: FTC - Ultraviolet lamp for dermatologic disorders
2.2 Common/Usual Name: UV Biotek Multi-Directional and UV Biotek Single Panel
2.3 Proprietary Names: UV Biotek Multi-Directional and UV Biotek Single Panel models 100B/80B/60B/40B
2.4 Classification: Class II
2.5 Classification Number: 878.4630
2.6 Product Code: FTC

3. Device Description:

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lighting systems at 120 Volts, producing 400 to 1000 Watts of primary UVB emissions within an enclosed metal (structure) and acrylic (exposure) housing, that is utilized at a the patient's home by prescription, and only with protective eyewear, as outlined in 21 CFR 892.6500.

Cabinet dimensions: 85.5" high, 5" deep, 22" wide – when door panels are closed. A digital AccuSafe control timer module is used to program exposure times and dosages.

There are 4 single panel models to choose from:

. The100B model is one metal cabinet, housing (10) Philips TL100W/01 (narrowband UVB) or Philips FS72T12/BL/HO/12 (wideband UVB) lamps.
The 80B model is one metal cabinet, housing (8) Philips TL100W/01 ● (narrowband UVB) or Philips FS72T12/BL/HO/12 (wideband UVB) lamps.
. The 60B model is one metal cabinet, housing (6) Philips TL100W/01 (narrowband UVB) or Philips FS72T12/BL/HO/12 (wideband UVB) lamps.
. The 40B model is one metal cabinet, housing (4) Philips TL100W/01 (narrowband UVB) or Philips FS72T12/BL/HO/12 (wideband UVB) lamps.

4. Intended Use:

The UV Biotek Multi-Directional is for individuals who require specific Ultraviolet radiation therapy for diagnosed skin disorders and is used for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (l - VI)

The UV Biotek Single Panel Unit models 100B/80B/40B are for individuals who require specific Ultraviolet radiation therapy for diagnosed skin disorders and is used for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin tvpes (I - VI)

5. Predicate Device:

These devices are substantially equivalent to the following predicate device, which is currently in safe and effective commerce:

		Predicate Chart
Device	UVBioTekMulti Directional	UVBioTek Single Panel100B/80B/60B/40B	UV Biotek Mobile/Versa Lite
Company	MedTek Lighting	MedTek Lighting	Medtek Lighting
"K" number	This submission	This submission	K111049 (predicate device)
Indications for use	For the treatment of psoriasis,vitiligo and atropic dermatitis(eczema) on all skin types (I-VI)	For the treatment ofpsoriasis, vitiligo andatropic dermatitis (eczema)on all skin types (I-VI)	For the treatment of psoriasis,vitiligo and atropic dermatitis(eczema) on all skin types (I-VI)
Power	120V - 60Hz	120V - 60Hz	120V-60Hz
Treatment SpotSize	Full Body	Full Body	Full Body, spot, scalp, hand, foot
Housing Materials	Steel, acrylic safety shield, UVlamps, timer, goggles	Steel, acrylic safety shield,UV lamps, timer, goggles	Steel, acrylic safety shield, UVlamps, timer, goggles
Energy Source	12V Power Adapter	12V Power Adapter	12V Power Adapter
Number of Lamps	10 Narrowband UVB	10, 8, 6, or 4 NB UVB	14, 8, 6, or 2 NB UVB

1. K111049- UV Biotek Mobile/Versa Lite (Medtek Lighting)

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Model Number	Philips TL100W/01	Philips TL100W/01	Philips TL20W/01
Wattage	Lamp Wattage 100W	Lamp Wattage 100W	Lamp Wattage 20W

6. Substantial Equivalence to Predicate Device:

These devices have the same technological characteristics as the cited predicate device. Both devices use the same design, material, and energy source as the cited predicate device. Minor technological differences between the proposed devices and the predicate device do not affect safety or efficacy.

After an analysis of the safety, indications, intended uses, performance features, design materials, chemical composition, energy source, power output, technological properties, treatment areas, treatment regimes and methods of operation, the manufacturer believes that no significant differences exist between the device and the predicate device listed in section 5 of this summary.

Therefore substantial equivalency is requested.

7. Performance Standards:

These devices have been tested under and are in compliance with performance standards that have been established for such devices under Section 878 of the Federal Food, Drug, and Cosmetics Act. All electrical and radiological products made by the applicant have been OSHA/NRTL listed, and have received constituent marks and are found to be in conformance with EN/IEC 60601-1 Electrical Safety and EN/IEC 60601-1-2:2007 EMC.

Specific performance testing was done on these devices to measure irradiance and for comparison to the predicate device. These measurements were used to reach the recommended dose (mJ/cm2) for the treatment of psoriasis found in published scientific literature.

Conclusion

Therefore substantial equivalency is requested.

Regulation Number and Section

§ 878.4630 Ultraviolet lamp for dermatologic disorders.

(a)
Identification. An ultraviolet lamp for dermatologic disorders is a device (including a fixture) intended to provide ultraviolet radiation of the body to photoactivate a drug in the treatment of a dermatologic disorder if the labeling of the drug intended for use with the device bears adequate directions for the device's use with that drug.(b)
Classification. Class II.