The ExSys 308 is an ultratraviolet light system designed to be used in Dermatological practice for the treatment of psoriasis and vitiligo. The ExSys 308 System consists of a base unit (touch screen, mains switch, key switch, Emergency Stop button, speaker), which controls an applicator unit. The applicator unit contains the UV light source. The model number is ExSys 308. The ExSys 308 System includes the following accessories: Power cord, optional foot switch, laser protective goggles, applicator holder, and set of treatment tips. The treatment tip (a distance spacer) is the only patient contacting part of the system. There are no single use parts in the ExSys 308 System.

AI/ML Overview

This document is a 510(k) premarket notification for the GME ExSys 308 System, an ultraviolet light device for dermatological disorders. It aims to demonstrate substantial equivalence to a predicate device, the Quantel 308 Dermatological Excimer System. The information provided focuses on the device's technical specifications and safety testing, typical for a substantial equivalence claim under 510(k) for a Class II device. It does not contain a clinical study with acceptance criteria and device performance as typically understood for AI/ML device evaluations.

Therefore, the following points address what can be extracted from the provided text, and explicitly states where information is not available given the nature of this submission.

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) submission is for a physical medical device (UV lamp) and focuses on demonstrating substantial equivalence to a predicate device based on technical specifications and safety standards, rather than clinical performance metrics typically associated with AI/ML systems (e.g., sensitivity, specificity, accuracy).

Characteristic	Acceptance Criteria (Predicate Device K090762 Specifications)	Reported Device Performance (GME ExSys 308)
Indications for Use	Treatment of psoriasis and vitiligo	Treatment of psoriasis and vitiligo
Wavelength	308 nm +/- 4nm	308 nm +/- 4nm
Light Source	XeCl excimer lamp produces monochromatic UVB light	XeCl excimer lamp produces monochromatic UVB light
Light Delivery	Light source in the Applicator handpiece	Light source in the Applicator handpiece
Cooling of Light Source	Integrated air cooling	Integrated air cooling
Maximum Beam Power	800mW	875mW (Greater than or equal to predicate)
Maximum Beam Power Density	50 mW/cm²	50 mW/cm²
Beam Class	III	III
Pulse Duration	1-120 seconds	1-40 seconds (Within predicate's range)
Applied Part Safety Class	Type B	Type B
Electrical Requirements	100V - 240V	100V - 240V
Power Calibration Method	Internal, automatic	Internal, automatic
Duty Cycle	100%	100%
Display	Touch Screen Control Panel	Touch Screen Control Panel
Illumination Homogeneity	Not explicitly stated for predicate in comparison table, but standards apply	Less than +/-20% deviation from illumination homogeneity (acceptance criterion from nonclinical testing)
Treatment Tip Transmission	Not explicitly stated for predicate in comparison table, but standards apply	No measurable unwanted transmission around the Treatment Tip (acceptance criterion from nonclinical testing)

Note: For devices subject to 510(k), "acceptance criteria" are generally derived from demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through comparison of technical specifications and adherence to recognized standards. Clinical performance metrics like sensitivity/specificity are not typically required for this type of device.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable. This submission does not involve a "test set" in the context of an AI/ML algorithm evaluation using patient data. It describes nonclinical safety and performance testing of a physical device.
Data Provenance: Not applicable. The testing described is nonclinical (e.g., electrical safety, optical performance).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Number of Experts & Qualifications: Not applicable. Ground truth, in the context of clinical expert consensus, is not relevant to the nonclinical testing described for this device.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. No clinical test set or adjudication process is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with evaluating AI interpretation or diagnostic assistance systems used by human readers, which is not the nature of this physical device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Standalone Study: No, a standalone study (in the context of an algorithm's performance) was not done. The device is a direct treatment tool, not an AI/ML diagnostic or interpretive algorithm. The reported performance refers to the physical output and safety of the UV light system itself.

7. Type of Ground Truth Used

Type of Ground Truth: For the nonclinical performance and safety testing, the "ground truth" refers to established engineering standards (e.g., IEC 60601-2-57, EN 60601-1, EN 60601-1-2) and the known specifications and performance of the predicate device. The illumination homogeneity and treatment tip transmission were evaluated against defined technical limits.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device does not employ an AI/ML algorithm that requires a "training set."

9. How Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable, as there is no training set for an AI/ML algorithm.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

GME German Medical Engineering GmbH Mike Johnson M.D. Philosopher's River LLC P.O. Box 106 Willow Creek, Montana 59760

July 31, 2015

Re: K150752

Trade/Device Name: GME ExSys 308 Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet lamp for dermatologic disorders Regulatory Class: Class II Product Code: FTC Dated: June 30, 2015 Received: July 2, 2015

Dear Dr. Johnson:

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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/ResourcesforYou/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,

Joshua C. Nipper -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) K150752

Device Name GME ExSys 308

Indications for Use (Describe)

The GME ExSys 308 System is intended to be used for the treatment of psoriasis and vitiligo. It is to be used on intact skin only.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Section 5

510(k) Summary

This 510(k) Summary is submitted in accordance with the requirements of 21 CFR 807.87 and 807.92. Summary preparation date 07-31-2015 [21 CFR 807.92(a)(1)].

Applicant Name and Address [21 CFR 807.92(a)(1)] A.

GME German Medical Engineering GmbH.

Grimmstrasse 23

Bavaria, Germany 90491

Tel: +49 9131 934159 10

Fax: +49 9131 934159 99

B. Contact Information

Philosopher's River llc

P O Box 106

Willow Creek, MT 59760

Tel: 406-209-3039

Fax: 406 2093039

Contact person: Mike Johnson M.D.

mike(@philosophersriver.com

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C. Device Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]

Trade Name: ExSys 308 System Device Common Name: Ultraviolet Light for Dermatology Classification Name: Light, Ultraviolet, Dermatological 21 CFR 878.4630 Product Code: FTC Device Classification: Class II

D. Predicate Devices [21 CFR 807.92(a)(3)]

The ExSys 308 System uses similar technology and physical output characteristics as the following predicate devices: K090762 LEDA from Quantel Derma GmbH

E. Device Description [21 CFR 807.92(a)(4)]

The ExSys 308 is an ultratraviolet light system designed to be used in Dermatological practice for the treatment of psoriasis and vitiligo.

The ExSys 308 System consists of a base unit (touch screen, mains switch, key switch, Emergency Stop button, speaker), which controls an applicator unit. The applicator unit contains the UV light source. The model number is ExSys 308.

The ExSys 308 System includes the following accessories: Power cord, optional foot switch, laser protective goggles, applicator holder, and set of treatment tips.

The treatment tip (a distance spacer) is the only patient contacting part of the system. There are no single use parts in the ExSys 308 System.

F. Principle of Operation: The UVB light penetrates the skin and modulates the immune system and stimulates melanocytes to produce melanin.

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Device Specifications and Comparison to Predicates [21 CFR 807.92(a)(6)] G.

The ExSys 308 is compared to the predicate, the Quantel Medical 308 Dermatological Excimer System. The indications for use and intended use for the ExSys 308 are identical to the Quantel Medical 308 Dermatological Excimer System. Below is a comparison table.

Characteristic	GME ExSys 308 System	Quantel 308 DermatologicalExcimer System
	"ExSys 308"	"Quantel 308"
Applicable510(k)sPanel/	NA	K090762
Product Code/RegulationNumber	FTC21 CFR 878.4630	FTC21 CFR 878.4630
Indications forUse Statement	The GME ExSys 308 System isintended to be used for thetreatment of psoriasis andvitiligo.	The Quantel 308 Excimer System isintended to be used for the treatment ofpsoriasis and vitiligo.
Mode ofOperation	Continuous light source	Continuous light source
Wavelength	308 nm+/-4nm	308 nm+/-4nm
Light Source	XeCl excimer lamp producesmonochromatic UVB light	XeCl excimer lamp producesmonochromatic UVB light
Light Delivery	Light source is in theApplicator handpiece	Light source is in the Applicatorhandpiece
Cooling of LightSource	Integrated air cooling	Integrated air cooling
Treatment AreaSize	50x35mm2	40x40mm2
Maximum BeamPower	875mW	800mW
Maximum BeamPower Density	50 mW/cm2	50 mW/cm2

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Beam Class	III	III
Pulse Duration	1 - 40 seconds	1-120 seconds
Applied PartSafety Class	Type B	Type B
PatientContacting Parts	Distance Spacer made fromaluminum and PMMA	Distance tips made of several materials:Quartz glass, aluminum, rubber
Controls	Footswitch or handswitch	Handswitch
ElectricalRequirements	100V - 240V	100V - 240V
PowerCalibrationMethod	Internal, automatic	Internal, automatic
SterilizationAspects	Applicator is disinfectedbetween patients.	Applicator is disinfected betweenpatients.
MED DoseDetermination	Menu driven	Menu driven
Duty Cycle	100%	100%
Dosage Controls	Dosage (or energy densityJ/cm²), pulse duration	Dosage (or energy density J/cm²), pulseduration
Display	Touch Screen Control Panel	Touch Screen Control Panel

H. Indications for Use [21 CFR 807.92(a)(5)]

The GME ExSys 308 System is intended to be used for the treatment of psoriasis and vitiligo. It is to be used on intact skin only.

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I. Performance Data [21 CFR 807.92(b)(2)]

Noncinical testing of performance and safety was directed by IEC 60601-2-57: Ed. 1.0, without deviation from the standard. A report of this testing was submitted. In addition, validation testing of illumination homogeneity and Treatment Tip transmission were performed. The submitted report demonstrated a less than +/-20% deviation from illumination homogeneity and no measurable unwanted transmission around the Treatment Tip. Third party testing for EN 60601-1 and EN 60601-1-2 was performed to provide further evidence of safety.

This preclinical testing demonstrates that in terms of performance and safety, the ExSys 308 System is equivalent to the predicate device, K090762 LEDA from Quantel Derma GmbH.

J. Conclusion [21 CFR 807.92(b)(3)]

The GME ExSys 308 was found to be substantially equivalent to the predicate device, the 308 Dermatological Excimer System from Quantel Medical, in terms of technology, function and intended use. The indications for use are identical to the previously cleared device (K073066) Quantel Medical 308 Dermatological Excimer System. We believe that there are no new questions of safety or efficacy raised by the introduction of the GME ExSys 308 System.

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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.