(177 days)
The Solarc/SolRx E-Series Ultraviolet Phototherapy Lamp Family is a wall-mounted or self-supporting ultraviolet phototherapy lamp unit used for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema). It is intended for use as a spot or full-body treatment device. It is intended for use on all skin types. (I -VI)
This device is intended for Prescriptive Use only, per Part 21 CFR 801 Subpart D.
A new family of medical devices that can be used singly, or ganged together in any number and combination of models. The devices use various numbers and lengths of tubular ultraviolet fluorescent bulbs. The model numbering system for single devices is as follows: Ehn0t-waveband-suffix. The proposed device is constructed primarily of sheet metal, and has provision for connecting additional lighting banks. The proposed device can be made in 2-foot, 4-foot and 2-metre lengths. The proposed device has provision for ultraviolet reflective side panel doors. The treatment area of the proposed device can be reduced by using the "Face Shield" accessory. The proposed device uses low pressure mercury vapor fluorescent ultraviolet bulbs. The proposed device uses 2 to 12 bulbs per device, or multiples thereof when devices are ganged together. The proposed device uses a digital countdown timer. The proposed device has a keyed switchlock or timer password entry to prevent unauthorized usage, wire guards or an acrylic window to reduce the chance of bulb breakage, and FDA compliant ultraviolet protective goggles.
The provided text is a 510(k) Summary for a medical device called the Solarc/SolRx E-Series Ultraviolet Phototherapy Lamp Unit Family. This document is a premarket notification to the FDA to demonstrate that the new device is substantially equivalent to legally marketed predicate devices.
The document does not include information about specific acceptance criteria or a study proving the device meets those criteria in the way you've outlined for performance studies. Instead, it focuses on demonstrating substantial equivalence to existing devices, primarily by comparing intended use, technological characteristics, and safety features.
Therefore, many of your requested items, such as a table of acceptance criteria and reported performance, sample sizes for test sets, ground truth establishment, MRMC studies, or standalone performance, are not present in this type of submission. This device is a phototherapy lamp, and its "performance" is generally related to its ability to emit specific UV light, which would be covered by technical specifications rather than diagnostic accuracy metrics.
Here's a breakdown of what can be extracted and what is not available from the provided text, based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
Not available. The document states that the device "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 a general statement about substantial equivalence, not a report of specific performance metrics against defined acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable/Not available. This is a device for delivering UV light therapy, not a diagnostic or AI-based device that would typically have a "test set" in the context of clinical performance evaluation. The substantial equivalence argument relies on comparison to predicate devices, not on a new clinical study with a test set of patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable/Not available. See point 2.
4. Adjudication Method for the Test Set
Not applicable/Not available. See point 2.
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/Not available. This device is a UV phototherapy lamp and does not involve AI or human "readers" interpreting output in a diagnostic context. Therefore, an MRMC study is not relevant to its regulatory submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable/Not available. This device is a physical phototherapy lamp, not an algorithm.
7. The Type of Ground Truth Used
Not applicable/Not available. The submission focuses on demonstrating that the new device has "the same intended use and similar technical characteristics" as predicate devices, and that it is "as safe and effective." The "ground truth" here is essentially that the predicate devices are already deemed safe and effective for their intended use.
8. The Sample Size for the Training Set
Not applicable/Not available. This device is a hardware product, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not available. See point 8.
Summary of what the document does provide regarding substantial equivalence:
The document argues for substantial equivalence by comparing the proposed device to several predicate devices (e.g., Solarc/SolRx 1000 Series, Daavlin "7-Series," National Biological Corp. "Foldalite-32") across several characteristics:
- Intended Use: Identical – phototherapeutic treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) in home, physician's office, or clinic.
- Design Concept: Constructed primarily of sheet metal, with provision for connecting additional lighting banks, similar to predicate devices.
- Treatment Area & Anatomical Sites: Available in 2-foot, 4-foot, and 2-meter lengths for partial or full-body treatment (excluding eyes), similar to predicate devices. Includes reflective side panel doors and a "Face Shield" accessory, comparable to predicate features.
- Type of Ultraviolet Bulbs: Uses low-pressure mercury vapor fluorescent UV bulbs comparable to predicate devices in spectral distribution, irradiance levels, ballasts, and circuitry.
- Quantity of Ultraviolet Bulbs: Uses 2 to 12 bulbs per device (or multiples when ganged), within electrical current limits, compared to predicate devices using 1 to 48 bulbs.
- Electrical Rating: Voltage and frequency ratings are comparable, meeting industry and medical device standards for high voltage breakdown, current leakage, and EMC.
- Timer: Uses a digital countdown timer technically comparable to predicate devices.
- User's Manual: Written for layman users, provides comprehensive exposure guidelines, and is at least as effective as predicate devices.
- Safety Features: Includes a keyed switchlock or timer password, wire guards or an acrylic window, and FDA compliant UV protective goggles, all comparable to predicate device features.
- Regulatory Requirements: Designed and manufactured according to FDA GMP and ISO13485 (Solarc Systems Inc. is ISO-13485:2003 certified).
The core of the submission is that because these characteristics are similar or equivalent, the new device is "as safe and effective" as legally marketed predicate devices and "does not raise different questions regarding safety and effectiveness." There is no detailed performance study presented because the device type and the regulatory pathway chosen (510(k)) emphasize comparison to existing devices rather than de novo clinical efficacy trials for a novel technology.
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K107.204
APR 2 7 2011
Image /page/0/Picture/2 description: The image shows the logo for Solar Arc Systems Inc. The logo features the word "SOLARC" in bold, sans-serif font, with a stylized swoosh extending from the bottom of the "S" and curving upwards over the word. Below "SOLARC", the words "SYSTEMS INC." are printed in a smaller, sans-serif font. The logo is black and white.
510(k) Summary
Date: Oct26, 2010
Trade Name: Solarc / SolRx E-Series Ultraviolet Phototherapy Lamp Unit Family
A new family of medical devices that can be used singly, or ganged together in any number and combination of models. The devices use various numbers and lengths of tubular ultraviolet fluorescent bulbs. The model numbering system for single devices is as follows: Ehn0t-waveband-suffix , where:
E = A constant indicating the E-Series and standing for "Expandable".
h = The nominal height of the device in inches divided by ten; where h=2 for 24" (2-foot) high devices, h=4 for 48" (4-foot) high devices, h=7 for 72" (6-foot) high devices, and h=8 for 80" (2-metre) high devices.
n = The number of bulbs in the device; with the only exceptions being "9" for 10-bulb devices (such as E790), and "92" for 12-bulb devices (such as E792).
0 = A constant (zero); except for 12-bulb devices where this is a "2", such as the "E792". t = The device type, either "M" for a "Master" device, or "A" for an "Add-on" device.
waveband = either "UVBNB" for UVB-Narrowband, "UVB" for UVB-Broadband, "UVA" for UVA, and "UVA1" for UVA-1.
suffix = any or all of: "CR" for Clinic Rated devices, "AW" for devices equipped with a clear Acrylic Window in lieu of wire guards, "SD" for reflective Side Doors and "RB" for internal Reflector Bulbs.
Common Name: Ultraviolet Phototherapy Lamp Unit
Classification: 21 CFR 878.4630, Product Code FTC
Intended Use: Phototherapeutic treatment of psoriasis, vitiligo, and atopic dermatitis (eczema)
Solarc Systems Inc., 1515 Snow Valley Road, Minesing, ON, Canada LOL 1Y0 Applicant: Contact: Bruce Elliott, P.Eng., President Solarc Systems Inc.
Contact. Bruce Elliott, P.Eng., President Solarc Systems Inc.
Phone: 705 730 2048 Fax: 705 730 0684 Email: belliott@solarcsys.ca
Email: belliott@solarcsystems.com Phone: 705-739-3048 = 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 the following predicate devices:
Solarc/SolRx 1000 Series [510(k)# K935572]
Solarc/SolRx 500 Series [510(k)# K031800]
Solarc/SolRx 100 Series [510(k)#: K061589]
Daavlin "7-Series" and "2-Series" [510(k)# K854498 "Spectra 724"]
National Biological Corp. (NBC) "Foldalite-32" [510(k)#: K827890]
National Biological Corp. (NBC) "Panosol 3D" [510(k)#: uncertain]
National Biological Corp. "Panosol II… with optional wings" [510(k)#: uncertain]
lt 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:
Intended Use
As with all the predicate devices, the proposed device is intended for medical ultraviolet phototherapy delivered in the patient's home, at a physician's office or in a hospital's clinic; for the treatment of psoriasis, vitiligo, and eczema (atopic dermatitis).
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K 103204
Image /page/1/Picture/1 description: The image shows the logo for SOLARc SYSTEMS INC. The logo is black and white and features the company name in bold, sans-serif font. Above the company name is a curved line. The words "SYSTEMS INC." are in a smaller font size and are located below the main company name.
Design Concept
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The proposed device is constructed primarily of sheet metal, and has provision for connecting additional lighting banks, as do two of the predicate devices.
Treatment Area & Anatomical Sites
The proposed device can be made in 2-foot, 4-foot and 2-metre lengths; for partial or full body treatment excluding the eyes, as are the predicate devices. The proposed device has provision for ultraviolet reflective side panel doors, as does at least one of the predicate devices. The treatment area of the proposed device can be reduced by using the "Face Shield" accessory, which is similar to the aperture plate system of the Solarc/SolRx 100 Series predicate device.
Type of 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, irradiance levels, ballasts and related circuitry.
Quantity of Ultraviolet Bulbs
The proposed device uses 2 to 12 builss per device, or multiples thereof when devices are ganged together, within electrical current limits. The predicate devices use 1 to 48 bulbs.
Electrical Rating
The voltage and frequency ratings are comparable. High voltage breakdown, current leakage, and electro-magnetic compatibility specifications meet current industry and medical device standards.
Timer
The proposed device uses a digital countdown 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.
Safety Features
The proposed device has a keyed switchlock or timer password entry to prevent unauthorized usage, wire guards or an acrylic window to reduce the chance of bulb breakage, and FDA compliant ultraviolet protective goggles; all comparable to one or more of the predicate devices.
Requiatory Requirements
The proposed device is designed and will be manufactured according to the FDA Good Manufacturing Practices and ISO13485. Solarc Systems Inc. is ISO-13485:2003 certified.
Conclusion
On the basis of the information provided, Solarc Systems Inc. believes that the proposed device is substantially equivalent to legally commercialized predicate devices.
End of 510(k) Summary
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Solarc Systems Inc. % Mr. Bruce Elliott 1515 Snow Valley Road Minesing, Ontario Canada LOL 1 Y 3
APR 2 7 2011
Re: K103204
Trade/Device Name: Solarc/SolRx E-Series Ultraviolet Phototherapy Lamp Unit Family and Accessories Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet lamp for dermatologic disorders Regulatory Class: Class II Product Code: FTC Dated: April 11, 2011 Received: April 12, 2011
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 interest 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, Or to 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 misbrandijng and adulteration. Please note: CDRH does not evaluate information related to contractly and 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.
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Page 2 - Mr. Bruce Elliott
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as st 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 100-1050,
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Prati 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 Small Manufacturers, International and Consumer Assistance at its tollorn the (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Ais B. nh
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K103204 510(k) Number (if known):
Device Name: Solarc / SolRx E-Series Ultraviolet Phototherapy Lamp Unit Family
Indications for Use:
The Solarc/SolRx E-Series Ultraviolet Phototherapy Lamp Family is a wall-mounted or self-supporting ultraviolet phototherapy lamp unit used for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema). It is intended for use as a spot or full-body treatment device. It is intended for use on all skin types. (I -VI)
This device is intended for Prescriptive Use only, per Part 21 CFR 801 Subpart D.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R. Dahlen for mxm
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K03204
Page 1 of /
§ 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.