(125 days)
Not Found
No
The description focuses on a hardware-based phototherapy device with a digital timer or microprocessor controller for setting treatment time/dose, with no mention of AI or ML capabilities.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "a therapeutic product designed for individuals who require ultraviolet radiation for diagnosed skin disorders."
No
The device is described as a "therapeutic product" designed for treatment (phototherapy) of diagnosed skin disorders using ultraviolet radiation, and it does not mention any function for diagnosing conditions.
No
The device description clearly states it is a "partial-body phototherapy panel ultraviolet light source" with physical components like lamps, a control panel, LCD, and buttons, indicating it is a hardware device with integrated software for control.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "therapeutic product designed for individuals who require ultraviolet radiation for diagnosed skin disorders." This indicates a treatment function, not a diagnostic one.
- Device Description: The description focuses on the delivery of ultraviolet light for treatment, not on analyzing biological samples or providing diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to treat a diagnosed condition using light therapy.
N/A
Intended Use / Indications for Use
The 4 Series Unit is a therapeutic product designed for individuals who require ultraviolet radiation for diagnosed skin disorders.
Product codes (comma separated list FDA assigned to the subject device)
FTC
Device Description
The 4 Series Unit is a partial-body phototherapy panel ultraviolet light source controlled by an integrated digital timer or a microprocessor controller. The operator interface consists of two main components: a LCD, and a Membrane with 4 buttons. When the operator sets the treatment time or the desired dose using the operator interface located on the control panel, the treatment begins by illuminating the lamps which emit ultraviolet light. The spectral output at peak wavelengths of 305nm,311nm,350nm,or 365nm depending on lamp. The 4 Series Unit is a therapeutic product designed for individuals who require ultraviolet radiation for diagnosed skin disorders.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The 4 Series Phototherapy Unit performance data is the same as that of the claimed predicate devices. The Controller, UV lamps and cabinet construction used in the production of the predicate device and the 4 Series Phototherapy Unit are identical, giving equivalent spectral/power outputs.
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.
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
§ 878.4630 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.
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KIIII172
pg 1 of 2
510(k) Summary
ਾਂ ਕ
AUG 2 9 2011
The 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92
The Daavlin Distributing Company Submitter's Name: Registration Number: 1526255 205 West Bement Street Address: Bryan, Ohio 43506 419.636.6304 Telephone: Michele Thiel Contact: Date Prepared: 31 March 2011 4 Series Phototherapy Unit Device Trade Name: 4 Series Partial- Body Phototherapy Unit Device Common Name: Class II Device Classification: FTC Product Code: CFR 878.4630 Regulation Number: Ultraviolet lamp for dermatologic/skin disorders Regulation Name: Daavlin Distributing Company Predicate Device: 1 Series Phototherapy Unit K100378 Device Description:
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K111172 pg 2 of 2
The 4 Series Unit is a partial-body phototherapy panel ultraviolet light source controlled by an integrated digital timer or a microprocessor controller. The operator interface consists of two main components: a LCD, and a Membrane with 4 buttons. When the operator sets the treatment time or the desired dose using the operator interface located on the control panel, the treatment begins by illuminating the lamps which emit ultraviolet light. The spectral output at peak wavelengths of 305nm,311nm,350nm,or 365nm depending on lamp. The 4 Series Unit is a therapeutic product designed for individuals who require ultraviolet radiation for diagnosed skin disorders.
Predicate Device Comparison:
The 4 Series Unit is constructed in the same design configuration as the predicate device, utilizing identical energy sources (UV lamps) and materials of identical composition. The 4 Series varies from the predicate device, in that the body is slightly larger and therefore contains more lamps to maintain the same performance. The intended use, general and specific indications for use, spectral output, mode of operation, labeling, accessories, and general operating principals of the 4 Series ultraviolet light-emitting medical device are the same of the predicate device. The treatment area, while still partial body, is similar , but larger on the 4 Series unit than on the predicate device.
Intended Use:
The 4 Series Unit is a therapeutic product designed for individuals who require ultraviolet radiation for diagnosed skin disorders.
Performance Data:
The 4 Series Phototherapy Unit performance data is the same as that of the claimed predicate devices. The Controller, UV lamps and cabinet construction used in the production of the predicate device and the 4 Series Phototherapy Unit are identical, giving equivalent spectral/power outputs.
Conclusion:
On the basis of the information provided in this Summary, the Daavlin Distributing Company believes the 4 Series Phototherapy Unit is substantially equivalent to the legally commercialized predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the circumference. Inside the circle is a stylized emblem featuring three angled lines that resemble a bird in flight or a symbolic representation of human services. The emblem is black, and the text is also in a dark color, providing a clear contrast against the likely white or light background.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Daavlin Distributing Company % Ms. Michele Thiel Management Representative 205 West Bement Street Bryan, Ohio 43506
AUG 2 9 2011
Re: K111172
Trade/Device Name: 4 Series Phototherapy Unit Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet lamp for dermatologic disorders Regulatory Class: II Product Code: FTC Dated: August 22, 2011 Received: August 22, 2011
Dear Ms. Thiel:
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
3
Page 2 - Ms. Michele Thiel
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 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 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 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely vours.
F. N. Malkerson
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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KIIII72
pg 1 of 1
Indication for Use
510(k) Number
4 Series Phototherapy Unit Device Name
Indications for Use
The 4- Series Unit is a therapeutic product designed for individuals who require ultraviolet radiation for diagnosed skin disorders.
Prescription Use X
OR (per 21 CFR 801.109)
Over-the-Counter Use_
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nel Rl Sl for mxm
(Division Sign-C Division of Surgical, Orthopedic, and Restorative Devices
. :0(k) Number K111172