All Models in this submission are phototherapy products designed for individuals who require specific Ultraviolet radiation therapy for the treatment of psoriasis.

Device Description

A family of 4 Home UV Phototherapy Sources consisting of the 672 BD Jordan Light©, and the three versions of the S2000 Series, ie., the S-2400, the S-2600, and the S-2800.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Home UV Phototherapy Sources) and primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study outlining acceptance criteria and device performance in the context of an AI/algorithm-driven medical device.

Therefore, many of the requested categories for AI/algorithm performance are not applicable to this document. The document describes the device's characteristics and compares them to predicate devices to establish safety and effectiveness for their intended use.

Here's an attempt to answer the questions based on the available information, noting where the information is absent or not relevant given the nature of the submission:

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

This document does not present acceptance criteria and reported device performance in the manner typically seen for an AI/algorithm-driven device. Instead, it asserts substantial equivalence based on similar technical characteristics and intended use compared to predicate devices. The "performance" described is in terms of design features and regulatory compliance rather than metrics like sensitivity, specificity, or accuracy.

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (as described in the 510(k) Summary)
Intended Use: Treatment of psoriasis.	Same area of intended treatment (single shaped panels or connected panels for half-body exposure).
Ultraviolet Bulbs: Use of specified UV fluorescent tubes from accredited manufacturers.	Uses same specialty fluorescent tubes (FS-72 SL-UVB, FS-72-HO-UVB, FS-72-TL-01/100W/TL-01, F-72-HO-UVA) from accredited manufacturers (Voltarc, Light Sources, Philips Lighting).
Electrical Rating: Similar power requirements to predicate units.	AC power requirements (voltage and current) similar to predicate units. All electrical components (except digital timer) commercially available and UL listed.
Digital Timer: Accurate and compatible with predicate device timers.	Digital timer has an exposure time range from 1 second to 9 minutes 59 seconds, accurate to +/- 1 second, technically compatible with predicate timers, and UL Listed.
Manuals: Effective in guiding physicians and patients.	Physician's Technical Manual provides pertinent technical data. Patient treatment manuals (Wide Band and Narrow Band UVB) guide setup and treatment, considered "at least as effective" as predicate device manuals.
Safety Features: Prevention of unauthorized usage, tube protection, UV goggles, alerting/shutdown mechanisms.	Keyswitch for unauthorized usage prevention, wireguards to protect tubes, FDA compliant UV goggles supplied. Digital Timer emits audible "beeps" at 30-second intervals and includes a supplemental circuit to shut down at 10 minutes.
Regulatory Compliance: Designed and manufactured according to FDA GMP.	Designed and manufactured according to FDA Good Manufacturing Practices.

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. This is a 510(k) submission for conventional phototherapy devices, not an AI/algorithm-driven device that would involve test sets or data provenance in this context. The demonstration of substantial equivalence relies on comparing technical specifications and intended use to existing devices, not on performance data from a specific patient cohort or test set.

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. This type of information is pertinent to studies involving expert review for AI/algorithm performance, which is not described in this 510(k) submission.

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

Not applicable. No test set or expert adjudication related to algorithm performance is mentioned or relevant to this type of device submission.

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. The device is a phototherapy source, not an AI-assisted diagnostic or therapeutic tool. No MRMC study or AI assistance is mentioned.

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

Not applicable. This device does not involve an algorithm.

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

Not applicable. The concept of "ground truth" in the context of an AI/algorithm's performance on a dataset is not relevant to this submission. The "truth" for this device lies in its physical specifications, safety features, and functional equivalence to legally marketed predicate devices for treating dermatologic conditions like psoriasis.

8. The sample size for the training set

Not applicable. There is no AI/algorithm for which a training set would be required for this device.

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

Not applicable. As there is no AI/algorithm, there is no training set or ground truth in that context.

Summary

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Kos 2660

OCT 1 7 2005

510(k) Summary

This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807,92

Date:	September 26, 2005
Applicant:	The Richmond Light Co., Inc., 2301 Falkirk Drive, Richmond, VA 23236
Contact:	Alex M. Clarke, Ph.D.
Telephone:	(804) 276-0559
Fax:	(804) 276-5378
E-Mail:	trlc@trlc.com
Device Name	A family of 4 Home UV Phototherapy Sources consisting of the 672 BD Jordan Light©, and the three versions of the S2000 Series, ie., the S-2400, the S-2600, and the S-2800.
Common Name:	Home UV Phototherapy Device
Device Classification:	Class II
Product Code:	FTC
Regulation Number:	CFR 876.4630
Regulation Name:	Ultraviolet lamp for dermatologic/skin disorders.

The Richmond Light Co., Inc, declares that, to the best of its knowledge, the proposed family has the same use and similar technical characteristics as the predicate devices: The Richmond Light Co., Inc. 648B (K812446), the National Biological Panasol 4 and 6 foot units (K904426, -27, -28), and the Daaviin Spectra 724 Series, Ultraviolet Phototherapy Device (K854498)

The submitted devices can be demonstrated to be as safe and effective as the legally marketed predicate devices and do not vary in any significant degree in the safety and effectiveness from the predicate devices, for instance:

The devices have the same area of intended treatment, being single shaped panels or l-Treatment Areas: a connected configuration of panels meant for half body (front/back or side/side) exposure.

The devices use the same speciality fluorescent tubes manufactured with a quartz 2 -Ultraviolet bulbs: tube and suitable phosphor as the predicate devices. All tubes are from accredited manufacturers (Voltarc, Light Sources, Philips Lighting) designated FS-72 SL-UVB (in the 672B), FS-72-HO-UVB (S-2000 Series, Broad Band). FS-72 -TL-01and 100W/TL-01 [Philips Narrow Band] (S-2000 Series Narrow Band), and F-72-HO-UVA (S-2000 Series UVA). These tubes are available on prescription from The Richmond Light Co., Inc., Daavlin Distributing, and National Biological Co, as well as other phototherapy device manufacturers and distributors.

[The Richmond Light Co., Inc., 510(k) Notification, September 26, 2005]

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052660

The AC power requirements (Voltage and current) requirements are similar to the 3 -Electrical Rating .: predicate units. Electrical components (with the exception of the digital time) are all commercially available. All electrical components are Underwriters Laboratory listed.

The digital timer is manufactured to specifications supplied by The Richmond Light 4 -Digital Timer: Company, has an exposure time range from 1 second to 9 minutes 59 seconds, is accurate to +/- 1 second, and is technically compatible to the timers in the predicate devices. The Digital Timer is UL Listed.

Manuals are supplied at two levels. A Physician's Technical Manual is supplied 5 -Manuals: only to physicians, having all of the pertinent technical information and data for all of the units supplied by The Richmond Light Company to allow the physician to prescribe a suitable exposure time for the individual patient. Patient treatment manuals are supplied for Wide Band and Narrow Band UVB treatments separately, specific to the unit ordered. These, while not "talking down" to the patient, are meant to lead them by the hand through the setup of the unit and their treatment, specifically for psoriasis. The Richmond Light Co. feels these manuals are at least as effective as those of the predicate devices.

As in the predicate devices, a keyswitch is provided to allow the owner to prevent 5 -Safety Features: unauthorized usage, wireguards protect the tubes to prevent the patient or others from accidentally coming into physical contact with the tubes, and FDA compliant ultraviolet goggles are supplied. Additionally, the Digital Timer emits audible "beeps" at 30 second intervals to aid the patient in keeping alert and monitoring the time of exposure. It also has a supplemental circuit to shut down the unit at 10 minutes.

The submitted devices are designed and manufactured according to the 6 -Regulatory Requirements: FDA Good Manufacturing Practices ..

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three bars instead of one.

OCT 17 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Alex M. Clarke, Ph.D. President The Richmond Light Co., Inc. 2301 Falkirk Drive Richmond, Virginia 23236

Re: K052660

Trade/Device Name: Model 672-BD, Home UVB Light Source (Jordan Light®) Model 2400, 4 (6 foot) HO lamp Light Source Model 2600, 6 (6 foot) HO lamp Light Source Model 2600, 8 (6 foot) HO lamp Light Source Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet lamp for dermatologic disorders Regulatory Class: II Product Code: FTC Dated: September 26, 2005 Received: September 28, 2005

Dear Dr. Clarke:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2- Alex M. Clarke, Ph.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

signature

So Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Statement of Indications for Use:

510(k) Number (if know): _____________________________________________________________________________________________________________________________________________________

Device Names:

Model 672-BD, Home UVB Light Source (Jordan Light®)

Model 2400, 4 (6 foot) HO lamp Light Source

Model 2600, 6 (6 foot) HO lamp Light Source

Model 2800, 8 (6 foot) HO lamp Light Source

All Models in this submission are phototherapy products designed for individuals who require specific Ultraviolet radiation therapy for the treatment of psoriasis..

Prescription Use: X (Part 21 CFR 801 Subpart D) AND/OR

Over-The Counter Use: (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE OF ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number_Los 2666

[The Richmond Light Co., Inc., 510(k) Application, September 26, 2005]

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.