(43 days)
Not Found
No
The device description and performance summary focus on the hardware (UV light source, microprocessor control) and its function (delivering a specified dose of light) based on user input, with no mention of AI or ML algorithms for image processing, diagnosis, or treatment planning.
Yes
The device is intended for the treatment of various medical conditions (psoriasis, vitiligo, and atopic dermatitis) using phototherapy, indicating its therapeutic purpose.
No
The device is described as a "phototherapy device" intended for the "treatment of psoriasis, vitiligo, and atopic dermatitis (eczema)". Its function is to deliver UV light for therapeutic purposes, not for diagnosis.
No
The device description clearly states it is a "full body phototherapy device" and a "medical ultraviolet cabinet" with "fluorescent ultraviolet light source" and "fluorescent tubes," indicating it is a hardware device that emits light for treatment.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body. The intended use and device description clearly state that this device is a phototherapy cabinet used for treating skin conditions (psoriasis, vitiligo, and atopic dermatitis) on the full body of a patient. It directly interacts with the patient's body using light, not by analyzing samples.
- There is no mention of analyzing biological samples. The description focuses on delivering specific doses of UV light to the patient's skin.
Therefore, this device falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The 3 Series PC & SP, full body phototherapy device, is a medical ultraviolet cabinet, which is intended for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (1 - VI).
Product codes
FTC
Device Description
The 3 Series PC & SP phototherapy cabinet is a microprocessor controlled full body fluorescent ultraviolet light source, with spectral output at peak wavelengths of 311 nm (Narrow Band UVB) and 350 nm (UVA). It is intended for use by or under the direction of a physician, for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema). The desired dose is selected using the operator interface located on the front panel of the device. The 3 Series delivers full body phototherapy, whereby fluorescent tubes, which surround the patient, deliver the specified dose of UVA and/or UVB light.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
full body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
by or under the direction of a physician
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 Daavlin 3 Series PC & SP full body phototherapy cabinet performance data is the same as or very similar to that of the claimed predicate device. The ultraviolet light tubes and cabinet construction used in the production of the predicate device and the 3 Series PC & SP device are the same.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
|K06362/
Page 163
510(k) Summary
The 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92
| Submitter's Name: | The Daavlin Distributing Company |
|---|---|
| Registration Number: | 1526255 |
| Address: | 205 West Bement Street |
| Bryan, Ohio 43506 | |
| Telephone: | 419.636.6304 |
| Contact: | David W. Swanson |
| Date Prepared: | October 30, 2005 |
| Device Trade Name: | 3 Series PC & SP Phototherapy Cabinet |
| Device Common Name: | Ultraviolet Phototherapy Cabinet |
| Device Classification: | Class II |
| Product Code: | FTC |
| Regulation Number: | CFR 878.4630 |
| Regulation Name: | Ultraviolet lamp for dermatologic/skin disorders |
| Predicate Device: | Daavlin Distributing Company |
| Spectra 300 Series | |
| Ultraviolet Phototherapy Cabinet | |
| K828654 |
1
Page 2 of 2
Daavlin Distributing Company 3 Series S Phototherapy Cabinet Ultraviolet Phototherapy Cabinet K042502
2
Ko6362/
Page 383
Device Description:
The 3 Series PC & SP phototherapy cabinet is a microprocessor controlled full body fluorescent ultraviolet light source, with spectral output at peak wavelengths of 311 nm (Narrow Band UVB) and 350 nm (UVA). It is intended for use by or under the direction of a physician, for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema). The desired dose is selected using the operator interface located on the front panel of the device. The 3 Series delivers full body phototherapy, whereby fluorescent tubes, which surround the patient, deliver the specified dose of UVA and/or UVB light.
Predicate Device Comparison:
The 3 Series PC & SP phototherapy cabinet is constructed in the same design configuration as the predicate device, utilizing identical energy sources (UV lamps) and materials of identical composition. The 3 Series varies from the predicate device, in that the control system hardware and software of the 3 Series has been updated to utilize current technology. The intended use, general and specific indications for use, spectral output, mode of operation. labeling, treatment area, and general operating principals of the 3 Series PC & SP are the same or similar to those of the predicate device.
Intended Use:
The Daavlin 3 Series PC & SP full body phototherapy cabinet is a medical ultraviolet light source, which is intended for use by or under the direction of a licensed physician for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (1 - VI).
Performance Data:
The Daavlin 3 Series PC & SP full body phototherapy cabinet performance data is the same as or very similar to that of the claimed predicate device. The ultraviolet light tubes and cabinet construction used in the production of the predicate device and the 3 Series PC & SP device are the same.
Conclusion:
On the basis of the information provided in this Summary, the Daavlin Distributing Company believes the 3 Series PC & SP full body phototherapy cabinet is substantially equivalent to the legally commercialized predicate device
3
Image /page/3/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 featuring four abstract human figures connected by flowing lines, representing the department's focus on health and human well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 17 2007
The Daavlin Distributing Company % Ms. Tara Mansur Management Representative 205 West Bement Street P.O. Box 626 Bryan, Ohio 43506
Re: K063621
Trade/Device Name: 3 Series PC & SP Phototherapy Cabinet Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet lamp for dermatologic disorders Regulatory Class: II Product Code: FTC Dated: November 16, 2006 Received: December 5, 2006
Dear Ms. Mansur:
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
4
Page 2 – Ms. Tara Mansur
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.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Mark N Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Ko6362/
Indication for Use
510(k) Number
3 Series PC & SP Phototherapy Cabinet Device Name
Indications for Use
The 3 Series PC & SP, full body phototherapy device, is a medical ultraviolet cabinet, which is intended for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (1 - VI).
Prescription Use X
ાર
Over-the-Counter Use
(per 21 CFR 801 109)
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number V063621