(70 days)
No
The document describes a phototherapy unit that delivers UV radiation based on pre-programmed protocols and patient characteristics, with no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is explicitly stated to be for "therapeutic treatment for individuals who require ultraviolet or visible radiation for diagnosed skin disorders" in both the "Intended Use" and "Device Description" sections.
No
The device is described as a phototherapy unit intended for therapeutic treatment of diagnosed skin disorders, not for diagnosing them.
No
The device description clearly details a physical phototherapy unit with lamps and a filtering system, indicating it is a hardware device controlled by software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device 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 or test samples from the body.
- Device Description: The description details a phototherapy unit that delivers UV radiation to the full body. This is consistent with a therapeutic device.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on sample analysis
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The ML24000 PC UVA-1 Phototherapy Unit is a therapeutic device that applies energy to the body for treatment.
N/A
Intended Use / Indications for Use
The ML24000 PC 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 (comma separated list FDA assigned to the subject device)
FTC
Device Description
The ML24000 PC 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. The ML 24000 PC UVA-1 Phototherapy Unit delivers a 360 degree full body treatment, with spectral output at peak wavelengths of 370-390 nm, through an array of 24 metal halide lamps in conjunction with a filtering system that absorbs infrared output and eliminated emissions below 320 nm. The 24 metal halide lamps are arranged in a four column modular design containing six lamps in each column.
Treatments are controlled through the Soft Touch Software interface. Access to this interface and stored information is restricted to individuals who have been established by the physician as authorized operators. Authorized operators program treatments in joules based on established treatment protocols governed by the patient's skin type, condition, minimum erythemal dose (M.E.D.), and treatment frequency.
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
Pediatric to Geriatric
Intended User / Care Setting
Hospital, Clinic, Medical Center, Private Medical Practice, or Other Professional Medical Environments under direction of 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)
Not Found
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.
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other to create a sense of depth and connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 10, 2015
Daavlin Distributing Company Ms. Michele Thiel Management Representative 205 West Bement Street, P.O. Box 626 Bryan, Ohio 43506
Re: K151795
Trade/Device Name: ML24000 PC UVA-1 Phototherapy Unit Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet lamp for dermatologic disorders Regulatory Class: Class II Product Code: FTC Dated: July 16, 2015 Received: August 12, 2015
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related
1
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
David Krause -S
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K151795
Device Name ML24000 PC UVA-1 Phototherapy Unit
Indications for Use (Describe)
The ML24000 PC 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.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------- |
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K. 510(k) Summary ·
:
| Date of Summary: | June 26, 2015 |
|---|---|
| 510(k) Submitter: | Daavlin Distributing Company |
| Contact Person: | Michele Thiel |
| Management Representative | |
| Daavlin Distributing Company | |
| 205 West Bement Street | |
| P.O. Box 626 | |
| Bryan, Ohio 43506 | |
| Phone: (419) 636-6304 Ext. 207 | |
| Fax: (419) 636-1739 | |
| Email: mthiel@daavlin.com | |
| Trade Name: | ML24000 PC UVA-1 Phototherapy Unit |
| Common Name | UVA-1 Ultraviolet Full Body Phototherapy Unit |
| Regulation Number: | 21 CFR 878.4630 |
| Classification Name: | Ultraviolet lamp for dermatologic disorders |
| Device Class: | Class II |
| Product Code: | FTC |
| Panel: | General and Plastic Surgery |
| Predicate Device: | ML24000 UVA-1 Phototherapy Unit |
| 510(k) Number: | K103708 |
| Product Code: | FTC |
| Company: | Daavlin Distributing Company |
| Device Description: | The ML24000 PC 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. The ML 24000 PC UVA-1 Phototherapy Unit delivers a 360 degree full body treatment, with spectral output at peak wavelengths of 370-390 nm, through an array of 24 metal halide lamps in conjunction with a filtering system that absorbs infrared output and eliminated emissions below 320 nm. The 24 metal halide lamps are arranged in a four column modular design containing six lamps in each column. |
Treatments are controlled through the Soft Touch Software interface. Access to this interface and stored information is restricted to individuals who have been established by the physician as authorized operators. Authorized operators program treatments in joules based on established treatment protocols governed by the patient's skin type, condition, minimum erythemal dose (M.E.D.), and treatment frequency. |
| Indications for Use: | The ML24000 PC 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. |
| Predicate Comparison: | The modified ML24000 PC UVA-1 Phototherapy Unit and the unmodified device are identical in nearly every aspect except for the incorporation of our Smart Touch Control System. Both the modified ML24000 PC UVA-1 Phototherapy Unit and the unmodified device are constructed using identical manufacturing methods, quality control operations, and are comprised of materials, components, and subassemblies which are identical or very similar in construction and composition. The modified ML24000 PC UVA-1 Phototherapy Unit and the unmodified device feature the same indications for use, patient population, application environment, lamp quantity, spectral output, labeling, treatment area, electrical requirements, ventilation requirements and device dimensions.
As previously stated the only difference between the modified ML24000 PC UVA-1 Phototherapy Unit and the unmodified device is in regards to the incorporation of our Smart Touch Control System. Our Smart Touch control system has been safely used in a closely related, legally marketed full body phototherapy unit (3 Series PC & SP Phototherapy Cabinet, K063621, 01/17/2007) which shares an identical classification regulation (CFR 878.4630), Product Code (FTC), significantly similar indications for use, and has been in commercial distribution since 01/17/2007. Beyond this modification there has been no other changes between the ML24000 PC UVA-1 Phototherapy Unit and the unmodified device |
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| Subject Device | Predicate Device | |
|---|---|---|
| Features | ML24000 PC UVA-1 Phototherapy Unit | ML24000 UVA-1 Phototherapy Unit |
| 510(k) Number | This Submission | K103708 |
| Indications for Use | The ML24000 PC 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. | 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. | ||
| Prescriptive | Yes | Yes |
| Patient Population | Pediatric to Geriatric | Pediatric to Geriatric |
| Patient Contact | There is no direct patient contact with | |
| the device during treatment - Areas of | ||
| skin are exposed to controlled | ||
| ultraviolet radiation from a distance of | ||
| approximately 9 inches (22.86 cm) | ||
| away. | There is no direct patient contact with the | |
| device during treatment - Areas of skin are | ||
| exposed to controlled ultraviolet radiation | ||
| from a distance of approximately 9 inches | ||
| (22.86 cm) away. | ||
| Anatomical Sites | Full Body | Full Body |
| Application | ||
| Environment | Hospital, Clinic, Medical Center, Private | |
| Medical Practice, or Other Professional | ||
| Medical Environments under direction | ||
| of physician | Hospital, Clinic, Medical Center, Private | |
| Medical Practice, or Other Professional | ||
| Medical Environments under direction of | ||
| physician | ||
| Dimensions | Height : 98" (249cm) Width : 49" (125 | |
| cm) Depth : 62" (158 cm) | Height : 98" (249cm) Width : 49" (125 cm) | |
| Depth : 62" (158 cm) | ||
| Power | 230V, 3~, 60Hz, 100A | 230V, 3~, 60Hz, 100A |
| Ventilation | ||
| Requirements | Minimum: 500 cfm | |
| Desired: 2000 cfm | Minimum: 500 cfm | |
| Desired: 2000 cfm | ||
| Spectral Output | 370-390 nm | 370-390 nm |
| Materials | Interior: Assembles components, | |
| ballasts, electronics housed in a metal | ||
| frame with reflective internal surfaces, | ||
| fluorescent lamps, and protective acrylic | ||
| and filter glass. | Interior: Assembles components, ballasts, | |
| electronics housed in a metal frame with | ||
| reflective internal surfaces, fluorescent lamps, | ||
| and protective acrylic and filter glass. | ||
| Exterior: Powder Coated Metal Casing | Exterior: Powder Coated Metal Casing | |
| Lamp Quantity | 24 | 24 |
| Manufacturing | ||
| Methods | Identical | Identical |
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Performance Standards: The ML24000 PC UVA-1 Phototherapy Unit performance data is the same as or very similar to that of the claimed predicate device. The ultraviolet lamps and cabinet construction used in the production of the predicate device and the ML24000 PC UVA-1 Phototherapy Unit are the same. Conclusion: In summary, the modified ML24000 PC UVA-1 Phototherapy Unit described in this submission is, in our opinion, substantially equivalent to the legally commercialized unmodified predicate device.