(202 days)
Not Found
No
The summary describes a software system for controlling phototherapy devices, focusing on hardware control and spectral output. There is no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies.
Yes
The device is intended for the "treatment of psoriasis, vitiligo and atopic dermatitis (eczema) on all skin types (I-VI)", indicating a therapeutic purpose.
No
The device is described as a "medical ultraviolet light source system" intended for "treatment of psoriasis, vitiligo and atopic dermatitis (eczema)". Its purpose is therapeutic, not diagnostic.
No
The device description explicitly states that the software is used to control multiple phototherapy devices from a custom-built computer containing a UV3001 interface board supplied by Daavlin, indicating the presence of dedicated hardware components beyond just software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is a "medical ultraviolet light source system" for the "treatment of psoriasis, vitiligo and atopic dermatitis (eczema)". This describes a therapeutic device, not a diagnostic one.
- Device Description: The description reinforces that the software controls "multi phototherapy devices" with specific UV wavelengths for the "treatment of diagnosed skin disorders". This further confirms its therapeutic purpose.
- Lack of Diagnostic Language: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device provides treatment using light, which falls outside the scope of an IVD.
N/A
Intended Use / Indications for Use
"The Smart Touch Multiple Machine Phototherapy System can be connected to the following Daavlin models:
3 Series Models 311-48, 311-24, 311/350-24/24, 350-48, 350-24
M Series Models 311-10, 350-10, 311/350-04/06
The Smart Touch Multiple Machine Phototherapy System is a medical ultraviolet light source system, 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 (I-VI)."
Product codes (comma separated list FDA assigned to the subject device)
FTC
Device Description
The Smart Touch Multi Machine Software is used to control multi phototherapy devices from a custom built computer containing a UV3001 interface board supplied by Daavlin (schematics located in Device Specification of this 510(k) submission), with spectral output at peak wavelengths of 311 nm (Narrow Band UVB) and 350 nm (UVA). An "off the shelf" replacement is not possible. Replacement can ONLY be obtained by Daavlin. It is intended for use by or under the direction of a physician, for the treatment of diagnosed skin disorders such as psoriasis, vitiligo, and atopic dermatitis (eczema).
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
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 Smart Touch Multi Machine Software performance data is the same as or very similar to that of the claimed predicate device. The control system hardware used is the same.
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.
0
OCT 2 0 2011
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Daaviin
ﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻌﺘﺒﺮ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ
KCI 0.912
Multi-Machine Software 510(k)
510(k) Summary
The 510(k) Summary is submitted in accordance with 21 CFR Part 820, Section 820.3
| 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: | March 29, 2011 |
| Device Trade Name: | Smart Touch Multi-Machine Software |
| Device Common Name: | Multi Machine Software |
| Device Classification: | Class II |
| Product Code: | FTC |
| Regulation Number: | CFR 878.4630 |
| Regulation Name: | Ultraviolet treatment for dermatologic/skin disorders |
| Predicate Device: | Daavlin Distributing Company |
| Spectra 3 Series PC & SP | |
| Ultraviolet Phototherapy Cabinet | |
| K063621 |
1
Device Description:
The Smart Touch Multi Machine Software is used to control multi phototherapy devices from a custom built computer containing a UV3001 interface board supplied by Daavlin (schematics located in Device Specification of this 510(k) submission), with spectral output at peak wavelengths of 311 nm (Narrow Band UVB) and 350 nm (UVA). An "off the shelf" replacement is not possible. Replacement can ONLY be obtained by Daavlin. It is intended for use by or under the direction of a physician, for the treatment of diagnosed skin disorders such as psoriasis, vitiligo, and atopic dermatitis (eczema).
Predicate Device Comparison:
The Smart Touch Multi Machine Software is constructed in the same design configuration as the predicate device, utilizing identical energy sources (UV lamps) and materials of identical composition. The Smart Touch Multi Machine Software's only variation from the predicate device, is in that the control system hardware and software has been updated to utilize current technology and control multiple units. The intended use, general and specific indications for use, spectral output, mode of operation, labeling, treatment area, and general operating principals of the Smart Touch Multi Machine Software are the same as those of the predicate device.
Intended Use:
"The Smart Touch Multiple Machine Phototherapy System can be connected to the following Daavlin models:
3 Series Models 311-48, 311-24, 311/350-24/24, 350-48, 350-24
M Series Models 311-10, 350-10, 311/350-04/06
The Smart Touch Multiple Machine Phototherapy System is a medical ultraviolet light source svstem. 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 (I-VI)."
Performance Data:
The Daavlin Smart Touch Multi Machine Software performance data is the same as or very similar to that of the claimed predicate device. The control system hardware used is the same.
Conclusion:
On the basis of the information provided in this Summary, the Daavlin Distributing Company believes the Smart Touch Multi Machine Software is substantially equivalent to the legally commercialized predicate device
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized design featuring a symbol that resembles an abstract caduceus or a stylized human figure, with three parallel lines forming the upper part and a wavy line at the bottom.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 2 0 2011
The Daavlin Distributing Company % Ms. Michele Thiel 205West Bement Street Bryan, Ohio 43506
Re: K110912
Trade/Device Name: Smart Touch Multi-Machine Software Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet lamp for dermatologic disorders Regulatory Class: Class II Product Code: FTC Dated: September 21, 2011 Received: September 27, 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
3
Page 2 - Ms. Michele Thiel
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.
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/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/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Erie Keith
A-Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
KII0912
Indication for Use
510(k) Number
Smart Touch Multi-Machine Software Device Name
Indications for Use
"The Smart Touch Multiple Machine Phototherapy System can be connected to the following Daavlin models:
3 Series Models 311-48, 311-24, 311/350-24/24, 350-48, 350-24
M Series Models 311-10, 350-10, 311/350-04/06
The Smart Touch Multiple Machine Phototherapy System is a medical ultraviolet light source system, 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 (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)
Neil R.P. Ogden for mam
(Division Size 8m
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K110912