The Solarc/SolRx 500 Series is an ultraviolet phototherapy lamp unit used for the physician prescribed treatment of psoriasis, vitiligo, atopic dermatitis (eczema). It is intended for use as a spot treatment device, or as a hand & foot device. It is intended for use on all skin types. (I-VI)

Device Description

A new medical device family consisting of 5 models: 510UVB-NB, 520UVB-NB, 530UVB-NB, 540UVB-NB, 550UVB-NB. The proposed device uses low pressure mercury vapor fluorescent ultraviolet bulbs. It has a digital timer, a keyed switchlock, wire bulb guards, FDA compliant ultraviolet protective goggles, and a removable hood.

AI/ML Overview

The provided text is a 510(k) summary for the Solarc/SolRx 500 Series Ultraviolet Phototherapy Lamp Unit Family. This document is a premarket notification to the FDA to demonstrate substantial equivalence to legally marketed predicate devices, not a study proving the device meets specific acceptance criteria in the sense of a clinical or performance study with numerical metrics.

Therefore, the specific information requested in the prompt, such as acceptance criteria, reported device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment, is not present in this document.

The 510(k) summary instead details areas of comparison to predicate devices to establish substantial equivalence. It focuses on similar intended use and technical characteristics.

Here’s a breakdown of what can be inferred from the document in relation to your request, and what is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing: There is no table of quantitative acceptance criteria or reported (numerical) device performance metrics in the provided text.

Present (Implicit Acceptance Criteria): The document establishes "comparability" to predicate devices as the primary acceptance criterion for substantial equivalence. The "reported performance" is essentially the statement that the device is comparable in various aspects to the predicates.

Acceptance Criterion (Implicit)	Reported Device Performance (Claimed Comparability)
Intended Use: Same as predicate devices.	"The proposed device family has the same intended use... as predicate devices."
Technical Characteristics: Similar to predicate devices.	"The proposed device family has... similar technical characteristics as predicate devices."
Safety & Effectiveness: As safe and effective as predicates.	"It can be demonstrated that the proposed device is as safe and effective as the legally marketed devices..."
Treatment Area: Comparable to predicate devices.	"The proposed device has a treatment area of approximately 2 square feet and is comparable to the predicate devices, with treatment areas of 3 to 4 square feet."
Ultraviolet Bulbs: Comparable to predicate devices.	"The proposed device uses low pressure mercury vapor fluorescent ultraviolet bulbs that are comparable to that of the predicate devices, as are the spectral distribution and irradiance levels."
Electrical Rating: Comparable to predicate devices.	"The voltage, frequency, current ratings and other electrical characteristics are comparable. High voltage breakdown and current leakage specifications meet current industry and medical device standards."
Digital Timer: Technically comparable to predicate devices.	"The proposed device uses a digital timer that is technically comparable to that of the predicate devices."
User's Manual: At least as effective as predicate devices.	"The User's Manual... is at least as effective as the predicate devices."
Safety Features: Comparable to predicate devices.	"The proposed device has a keyed switchlock..., wire bulb guards..., and FDA compliant ultraviolet protective goggles; all comparable to those of the predicate device."
Regulatory Compliance: Designed and manufactured to standards.	"The proposed device is designed and will be manufactured according to the FDA Good Manufacturing Practices and ISO13485. Solarc Systems Inc. is ISO 13485 certified."

2. Sample Size Used for the Test Set and Data Provenance:

Missing: No "test set" in the context of a performance study is described. The comparison is made against existing predicate devices and industry standards.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Missing: Not applicable for this type of submission. Ground truth in a clinical sense is not being established or validated.

4. Adjudication Method:

Missing: Not applicable.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

Missing: No MRMC study was conducted or reported. This submission does not involve AI or human reader performance.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

Missing: Not applicable. This is a phototherapy lamp, not an algorithm.

7. Type of Ground Truth Used:

Missing (in the clinical study sense): The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices and adherence to relevant industry and regulatory standards.

8. Sample Size for the Training Set:

Missing: Not applicable. There is no concept of a "training set" for this type of device comparison.

9. How the Ground Truth for the Training Set Was Established:

Missing: Not applicable.

In summary: The provided document is a 510(k) summary demonstrating substantial equivalence of a phototherapy lamp to predicate devices. It does not contain the details of a clinical performance study with specific acceptance criteria, sample sizes, and expert validation as would be found for, for instance, an AI-powered diagnostic device. The "proof" is based on comparing technical characteristics and intended use to already approved devices and adhering to manufacturing standards.

Summary

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031800 ""

Image /page/0/Picture/1 description: The image shows the logo for Solar Arc Systems Inc. The word "SOLARC" is written in a bold, sans-serif font, with a curved line above it. Below "SOLARC" is the text "SYSTEMS INC." in a smaller, sans-serif font. The logo is in black and white.

SEP 1 0 2003

510(k) Summary

Date:	June 8,2003
Device Name:	Solarc / SolRx 500 Series Ultraviolet Phototherapy Lamp Unit Family
	A new medical device family consisting of 5 models:
	510UVB-NB, 520UVB-NB, 530UVB-NB, 540UVB-NB, 550UVB-NB
Common Name:	Ultraviolet Phototherapy Lamp Unit
Applicant:	Solarc Systems Inc., 12 Parker Court, Barrie, ON, Canada L4N 2A6
Contact:	Bruce Elliott, P.Eng., President Solarc Systems Inc.
Phone:	705-739-8279
Fax:	705-739-9684

Solarc Systems Inc. declares that, to the best of its knowledge, the proposed device family has the same intended use and similar technical characteristics as predicate devices: National Biological Hand/Foot, and National Biological Panosol II 2 foot.

It can be demonstrated that the proposed device is as safe and effective as the legally marketed devices and does not raise different questions regarding safety and effectiveness than the predicate devices. This is based on the following areas of comparison between the proposed device and the referenced predicate devices:

Treatment Area & Anatomical Sites:

The proposed device can be used for both spot and hand & foot treatment, as can the predicate devices. The proposed device has a treatment area of approximately 2 square feet and is comparable to the predicate devices, with treatment areas of 3 to 4 square feet.

Ultraviolet Bulbs

The proposed device uses low pressure mercury vapor fluorescent ultraviolet bulbs that are comparable to that of the predicate devices, as are the spectral distribution and irradiance levels. The ballasts and related circuitry are also comparable.

Electrical Rating

The voltage, frequency, current ratings and other electrical characteristics are comparable. High voltage breakdown and current leakage specifications meet current industry and medical device standards.

Digital Timer

The proposed device uses a digital timer that is technically comparable to that of the predicate devices.

User's Manual

The User's Manual is written for the layman user and provides comprehensive exposure guidelines. It is at least as effective as the predicate devices.

510(k) Submission - Solarc/SolRx 500 Series Ultraviolet Phototherapy Lamp Unit

Page 13

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K 031800 4/2

Image /page/1/Picture/1 description: The image shows the logo for Solar Arc Systems Inc. The logo features the word "SOLARC" in bold, sans-serif font, with a curved line extending from the bottom left of the "S" and arching over the top of the word. Below "SOLARC" and slightly to the right, the words "SYSTEMS INC." are printed in a smaller, sans-serif font.

Safety Features

The proposed device has a keyed switchlock to prevent unauthorized usage, wire bulb guards to reduce the chance of bulb breakage and FDA compliant ultraviolet protective goggles; all comparable to those of the predicate device. In addition, the proposed device has a removable hood to minimize light leakage when used for hand & foot treatments.

Requlatory Requirements

The proposed device is designed and will be manufactured according to the FDA Good Manufacturing Practices and ISO13485. Solarc Systems Inc. is ISO 13485 certified.

End of 510(k) Summary

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers. To the left of the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 0 2003

Mr. Bruce Elliott, P. Eng. President Solarc Systems, Inc. 12 Parker Court Barrie, Ontario Canada L4N 2A6

Re: K031800

Trade/Device Name: Solarc/SolRx 500 Series Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet lamp for dermatologic disorders Regulatory Class: II Product Code: FTC Dated: June 9, 2003 Received: June 12, 2003

Dear Mr. Elliott:

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 - Mr. Bruce Elliott, P. Eng.

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 (301) 594-4659. 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/dsma/dsmamain.html

€

Sincerely yours,

Miriam C. Provost

for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/0 description: The image shows the logo for Solar Arc Systems Inc. The logo features the word "SOLARC" in bold, stylized letters, with a curved line above it. Below "SOLARC" are the words "SYSTEMS INC." in a smaller, sans-serif font. The logo is black and white.

Statement of Indications for Use

510(k) Number K031800

Device Name:

Solarc / SolRx 500 Series Ultraviolet Phototherapy Lamp Unit Family A new medical device family consisting of 5 models: 510UVB-NB, 520UVB-NB, 530UVB-NB, 540UVB-NB, 550UVB-NB

Miriam C. Provost

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

510(k) Number K 031800

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.