(90 days)
K063621, K0050695
Not Found
No
The document describes a microprocessor-controlled phototherapy unit that delivers a selected dose of UVA-1 light. There is no mention of AI, ML, image processing, or any data-driven decision-making processes beyond the selection of a dose by the operator.
Yes
The device is described as a "medical ultraviolet light source" intended for "treatment of atopic dermatitis (eczema)". Its function is to deliver phototherapy, which is a therapeutic intervention.
No
The device is described as a phototherapy unit intended for the treatment of atopic dermatitis, not for diagnosing it.
No
The device description explicitly states it is a "microprocessor controlled full body ultraviolet light source" and uses "Philips CLEO HPA 1018 Medium Pressure Lamps," indicating it is a hardware device that delivers light therapy.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Device Function: The ML24000 UVA-1 Phototherapy Unit is a device that delivers ultraviolet light directly to the patient's body for therapeutic treatment of a skin condition (atopic dermatitis). It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "treatment of atopic dermatitis (eczema)" using a "medical ultraviolet light source." This is a therapeutic application, not a diagnostic one.
Therefore, based on the provided information, the ML24000 UVA-1 Phototherapy Unit is a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The ML24000 UVA-1 Phototherapy Unit is a full body medical ultraviolet device, which is intended for the treatment of atopic dermatitis (eczema) on all skin types (I - VI).
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 atopic dermatitis (eczema). 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, whereby 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
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 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)
K063621, K0050695
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
DEC 1 7 2008
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:
Address:
419.636.6304
David W. Swanson
September 11, 2008
ML24000 UVA-1 Phototherapy Unit
1526255
205 West Bement Street Bryan, Ohio 43506
Telephone:
Contact:
Date Prepared:
Device Trade Name:
Device Common Name:
Device Classification:
Product Code:
Regulation Number:
Regulation Name:
Predicate Device:
CFR 878.4630
Class II
FTC
Ultraviolet lamp for dermatologic/skin disorders
UVA-1 Ultraviolet Full Body Phototherapy Unit
Daavlin Distributing Company 3 Series PC & SP Phototherapy Cabinet Ultraviolet Phototherapy Cabinet
1
Daavlin Distributing Company Flex Controlled Phototherapy Equipment 3 Series X Ultraviolet Phototherapy Cabinet K0050695
. . . . .
1.0
:
: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :
and the comments of the
: : :
: 上
the state of the subjects
: and and the comments of
: 上一篇: 上一篇:
1
.
: :
11 - 11 - 11 - 11 - 11 - 11
.
- 1
. .
: 上一: 1
:
11.1 : : : and the country of the county . . .
1.1 . :
,一
: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :
1999 - 1999 - 1999
the state of the state
. . . . . .
:
1
.
,
이 사용 -
. .
2
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 atopic dermatitis (eczema). 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, whereby 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 configuration 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 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 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 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 the treatment of atopic dermatitis (eczema) on all skin types (I - VI).
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 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Daavlin Distributing Company % Ms. Tara Mansur Regulatory Affairs Coordinator 205 West Bement Street P.O. Box 626 Bryan, Ohio 43506
DEC 1 7 2008
Re: K082731
Trade/Device Name: ML24000 UVA-1 Phototherapy Unit Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet lamp for dermatologic disorders Regulatory Class: II Product Code: FTC Dated: September 12, 2008 Received: September 18, 2008
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 (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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. Millman
- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indication for Use
510(k) Number K 082731
ML24000 UVA-1 Phototherapy Unit Device Name
Indications for Use
The ML24000 UVA-1 Phototherapy Unit is a full body medical ultraviolet device, which is intended for the treatment of atopic dermatitis (eczema) on all skin types (I - VI).
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)
Mark A. Mulkerson
(Division Shou-Ca) (Division of General, Restorative, Divisiou of Secological Devices 08 27 3
510(k) Number