(64 days)
K0100378, K041212
K0100378, K041212
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on microprocessor control and lamp technology for delivering a specified dose, with no mention of AI/ML for diagnosis, treatment planning, or other functions.
Yes
The device is described as "intended for therapeutic treatment for individuals who require ultraviolet or visible radiation for diagnosed skin disorders."
No
The device is described as a "therapeutic treatment" unit for "diagnosed skin disorders," indicating its purpose is treatment rather than diagnosis.
No
The device description explicitly states it is a "full body medical ultraviolet device" and a "microprocessor controlled full body ultraviolet light source" that uses "Philips CLEO HPA 1018 Medium Pressure Lamps" to deliver phototherapy. This indicates it is a hardware device with embedded software for control, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "therapeutic treatment for individuals who require ultraviolet or visible radiation for diagnosed skin disorders." This describes a treatment device, not a device used to diagnose a condition by examining samples from the body.
- Device Description: The description details a "full body ultraviolet light source" that delivers light to the patient for treatment. It does not mention any analysis of biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The device is clearly described as a therapeutic phototherapy unit used for treating skin conditions by applying light to the patient's body. This falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ML24000 UVA-1 Phototherapy Unit is a medical ultraviolet light source, which is intended for use by or under the direction of a licensed physician for therapeutic treatment for individuals who require ultraviolet or visible radiation for diagnosed skin disorders.
The ML24000 UVA-1 Phototherapy Unit is a full body medical ultraviolet device, which is intended for use, by or under the direction of a physician, for therapeutic treatment for individuals who require ultraviolet or visible radiation for diagnosed skin disorders.
Product codes
FTC
Device Description
The ML24000 UVA-1 Phototherapy Unit is a microprocessor controlled full body ultraviolet light source, with spectral output at peak wavelengths of 370-390 nm. It is intended for use by or under the direction of a physician, for the treatment of diagnosed skin disorders. The desired dose is selected using the operator interface located on the front panel of the device. The ML24000 UVA-1 Phototherapy Unit delivers full body phototherapy, wherebv Philips CLEO HPA 1018 Medium Pressure Lamps, which surround the patient, deliver the specified dose of UVA-1.
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
Physician, licensed 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 ML24000 UVA-1 Phototherapy Unit performance data is the same as or very similar to that of the claimed predicate devices. The UV lamps and cabinet construction used in the production of the predicate device and the ML24000 UVA-1 Phototherapy Unit are similar.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K0100378, K041212
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
FEB 2 2 2011
长103708
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: | Michele Thiel |
| Date Prepared: | September 28, 2010 |
| Device Trade Name: | ML24000 UVA-1 Phototherapy Unit |
| Device Common Name: | UVA-1 Ultraviolet Full Body Phototherapy Unit |
| 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 |
| 1 Series Phototherapy Cabinet Ultraviolet | |
| Phototherapy Cabinet | |
| K0100378 |
1
National Biological corporation Houva III Phototherapy System With PhotoSense II Exposure Control K041212
Device Description:
The ML24000 UVA-1 Phototherapy Unit is a microprocessor controlled full body ultraviolet light source, with spectral output at peak wavelengths of 370-390 nm. It is intended for use by or under the direction of a physician, for the treatment of diagnosed skin disorders. The desired dose is selected using the operator interface located on the front panel of the device. The ML24000 UVA-1 Phototherapy Unit delivers full body phototherapy, wherebv Philips CLEO HPA 1018 Medium Pressure Lamps, which surround the patient, deliver the specified dose of UVA-1.
Predicate Device Comparison:
The ML24000 UVA-1 Phototherapy Unit is constructed in the same design confiquration as the predicate devices, utilizing similar energy sources (UV lamps) and materials of similar and/or identical composition. The ML24000 UVA-1 Phototherapy Unit varies from the HOUVA predicate device, in that the UV lamps used in the ML24000 device have a peak wavelength of 365nm, instead of a peak wavelength of 350nm. Specifically, on the Houva Predicate Device, the output spectrum is 320-400nm with a peak at 350nm, and the ML24000 has an output spectrum of 340nm to 400nm with a peak at 365nm. The 1-series predicate device has lamps with a spectral peak at 365nm, exactly the same as the ML24000. The intended use, general and specific indications for use, mode of operation, labeling, treatment area, and general operating principals of the ML24000 UVA-1 Phototherapy Unit are the same or similar to those of the predicate device.
Intended Use:
The ML24000 UVA-1 Phototherapy Unit is a medical ultraviolet light source, which is intended for use by or under the direction of a licensed physician for therapeutic treatment for individuals who require ultraviolet or visible radiation for diagnosed skin disorders.
Performance Data:
The ML24000 UVA-1 Phototherapy Unit performance data is the same as or very similar to that of the claimed predicate devices. The UV lamps and cabinet
2
construction used in the production of the predicate device and the ML24000 UVA-1 Phototherapy Unit are similar.
Conclusion:
On the basis of the information provided in this Summary, the Daavlin Distributing Company believes the ML24000 UVA-1 Phototherapy Unit is substantially equivalent to the legally commercialized predicate devices.
3
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three curved lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
The Daavlin Distributing Company % Ms. Michele Thiel Regulatory Affairs Coordinator 205 West Bement Street Bryan, Ohio 43506
FEB 22 201
Re: K103708
Trade/Device Name: ML24000 UVA-I Phototherapy Unit and MED Test Kit Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet lamp for dermatologic disorders Regulatory Class: Class II Product Code: FTC Dated: February 09, 2011 Received: February 14, 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. Ilsting 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
4
Page 2 - Mr. Michael Thiel
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 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.
lf you desire specific advice for your device on our labeling regulation (21 CFR Part 801), plcase go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html 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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indication for Use
510(k) Number
Device Name ML24000 UVA-1 Phototherapy Unit
Indications for Use
The ML24000 UVA-1 Phototherapy Unit is a full body medical ultraviolet device, which is intended for use, by or under the direction of a physician, for therapeutic treatment for individuals who require ultraviolet or visible radiation for diagnosed skin disorders.
Prescription Use X
OR
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)
Neil RPDglen for mxm
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
. 510(k) Number K103708