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 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).

AI/ML Overview

The provided text describes a 510(k) submission for the "Smart Touch Multi-Machine Software" by The Daavlin Distributing Company. This submission aims to demonstrate substantial equivalence to a predicate device, the "Spectra 3 Series PC & SP Ultraviolet Phototherapy Cabinet (K063621)".

Here's an analysis of the acceptance criteria and the study (or lack thereof) based on the provided information:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (from submission or inferred)	Reported Device Performance
Intended Use	Same as predicate device (treatment of psoriasis, vitiligo, and atopic dermatitis on all skin types (I-VI)).	"The intended use... of the Smart Touch Multi Machine Software are the same as those of the predicate device."
Spectral Output	Peak wavelengths of 311 nm (Narrow Band UVB) and 350 nm (UVA), same as predicate.	"utilizing identical energy sources (UV lamps)...spectral output...are the same as those of the predicate device."
Mode of Operation	Same as predicate device.	"Mode of operation...are the same as those of the predicate device."
Labeling	Same as predicate device.	"labeling...are the same as those of the predicate device."
Treatment Area	Same as predicate device.	"treatment area...are the same as those of the predicate device."
General Operating Principles	Same as predicate device.	"general operating principals...are the same as those of the predicate device."
Control System Functionality	Updated to utilize current technology and control multiple units, while maintaining safety and effectiveness equivalent to the predicate.	"the control system hardware and software has been updated to utilize current technology and control multiple units."
Device Configuration	Constructed in the same design configuration as the predicate.	"The Smart Touch Multi Machine Software is constructed in the same design configuration as the predicate device."
Energy Sources/Materials	Identical energy sources (UV lamps) and materials of identical composition.	"utilizing identical energy sources (UV lamps) and materials of identical composition."

Study Information

Based on the provided document, the "study" conducted for this 510(k) submission is a comparison to a predicate device rather than a new performance study with a dedicated test set, training set, or expert ground truth adjudication as one would expect for an AI/ML device.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. The document does not describe a performance study with a test set that generates specific performance metrics like sensitivity, specificity, or accuracy. The submission relies on claiming substantial equivalence based on the device's fundamental design, intended use, and technological characteristics being very similar to a legally marketed predicate device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- N/A. No ground truth establishment by experts is described, as no specific performance study requiring such assessment was conducted for this submission.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. No adjudication method is mentioned, as there is no test set in the context of an AI/ML performance evaluation.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. An MRMC study was not done. This device is software for controlling phototherapy devices, not an AI/ML diagnostic or assistive tool that would typically involve human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is not an AI/ML algorithm in the context of typical standalone performance evaluation. The "software" is a control system for hardware. The document states: "The 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." This implies that the performance is derived from the established safety and effectiveness of the predicate device's hardware and the similar control system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A. No new ground truth data was generated or used. The "ground truth" for this submission is effectively the established safety and effectiveness of the predicate device, which the new device is claimed to be substantially equivalent to due to identical or very similar operating principles and components.
The sample size for the training set:
- N/A. There is no mention of a training set, as this is not an AI/ML device that undergoes machine learning training.
How the ground truth for the training set was established:
- N/A. As there is no training set, there is no ground truth establishment for it.

Summary of Device Evaluation Method

The submission for the Daavlin Smart Touch Multi-Machine Software relies on demonstrating substantial equivalence to an existing predicate device (Daavlin Spectra 3 Series PC & SP Ultraviolet Phototherapy Cabinet K063621). The core argument is that the new software is an update to the control system of a device that is already deemed safe and effective, and that its fundamental characteristics, intended use, and operational principles remain unchanged. Therefore, a separate, extensive clinical or performance study with new data, test sets, or expert ground truths was not deemed necessary by the submitter (and implicitly accepted by the FDA for clearance). The performance data cited is comparative, referencing the predicate device's established performance rather than new empirical data for the software itself.

Summary

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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 StreetBryan, 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 CompanySpectra 3 Series PC & SPUltraviolet Phototherapy CabinetK063621

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Device Description:

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

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

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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 (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

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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

Prescription Use X

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

Regulation Number and Section

§ 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.