SMART TOUCH UVTHERAPY MULTIPLE MACHINE

K110912 · Daavlin Distributing Co. · FTC · Oct 20, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K110912
• Device Name: SMART TOUCH UVTHERAPY MULTIPLE MACHINE
• Applicant: Daavlin Distributing Co.
• Product Code: FTC · General, Plastic Surgery
• Decision Date: Oct 20, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4630
• Device Class: Class 2
• Attributes: Therapeutic

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 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).

Device Story

Smart Touch Multi-Machine Software controls multiple phototherapy units from a custom computer via a proprietary UV3001 interface board. System emits UV light at 311 nm (Narrow Band UVB) and 350 nm (UVA). Used in clinical settings by physicians or trained staff to manage treatment sessions for skin disorders. Software updates the control system hardware of legacy phototherapy cabinets to enable multi-unit management. Healthcare providers use the interface to direct treatment delivery; output is controlled UV radiation. Benefits include centralized management of multiple phototherapy devices, ensuring consistent treatment delivery for patients with dermatologic conditions.

Clinical Evidence

Bench testing only. No clinical data provided. Performance data is stated to be the same as or very similar to the predicate device.

Technological Characteristics

System utilizes UV lamps for phototherapy (311 nm and 350 nm). Controlled by a custom computer with a proprietary UV3001 interface board. Software-based control system manages multiple phototherapy units. No specific materials or ASTM standards cited.

Indications for Use

Indicated for treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) in patients of all skin types (I-VI). Intended for use by or under the direction of a licensed physician.

Regulatory Classification

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.

Predicate Devices

• Spectra 3 Series PC & SP Ultraviolet Phototherapy Cabinet (K063621)

Submission Summary (Full Text)

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OCT 2 0 2011

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# Daaviin

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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<br>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<br>Spectra 3 Series PC & SP<br>Ultraviolet Phototherapy Cabinet<br>K063621 |

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#### 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

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### 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

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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 [phone] or [phone] 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

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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