(130 days)
No
The document describes a UV light system for treating skin conditions and does not mention any AI or ML components or functionalities.
Yes
The device is intended for the "treatment of psoriasis and vitiligo," indicating a therapeutic purpose.
No
This device is described as a treatment device for psoriasis and vitiligo using ultraviolet light, not a diagnostic device.
No
The device description explicitly states it is an "ultratraviolet light system" consisting of a base unit and an applicator unit containing a UV light source, along with various hardware accessories. This clearly indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of psoriasis and vitiligo using ultraviolet light. IVDs are used for the diagnosis of diseases or conditions by examining samples taken from the human body (like blood, urine, tissue).
- Device Description: The device is a light system that applies UV light to intact skin. It does not involve the analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
The device is a therapeutic device used for light therapy on the skin.
N/A
Intended Use / Indications for Use
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.
Product codes
FTC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intact skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dermatological practice
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines representing hair or clothing. The profiles are arranged in a way that suggests unity and connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
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
1
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.
5
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 Dermatological
Excimer System |
|---------------------------------------|-------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| | "ExSys 308" | "Quantel 308" |
| Applicable
510(k)s
Panel/ | NA | K090762 |
| Product Code/
Regulation
Number | FTC
21 CFR 878.4630 | FTC
21 CFR 878.4630 |
| Indications for
Use Statement | The GME ExSys 308 System is
intended to be used for the
treatment of psoriasis and
vitiligo. | The Quantel 308 Excimer System is
intended to be used for the treatment of
psoriasis and vitiligo. |
| Mode of
Operation | Continuous light source | Continuous light source |
| 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 is in the
Applicator handpiece | Light source is in the Applicator
handpiece |
| Cooling of Light
Source | Integrated air cooling | Integrated air cooling |
| Treatment Area
Size | 50x35mm2 | 40x40mm2 |
| Maximum Beam
Power | 875mW | 800mW |
| Maximum Beam
Power Density | 50 mW/cm2 | 50 mW/cm2 |
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| Beam Class | III | III |
|---|---|---|
| Pulse Duration | 1 - 40 seconds | 1-120 seconds |
| Applied Part | ||
| Safety Class | Type B | Type B |
| Patient | ||
| Contacting Parts | Distance Spacer made from | |
| aluminum and PMMA | Distance tips made of several materials: | |
| Quartz glass, aluminum, rubber | ||
| Controls | Footswitch or handswitch | Handswitch |
| Electrical | ||
| Requirements | 100V - 240V | 100V - 240V |
| Power | ||
| Calibration | ||
| Method | Internal, automatic | Internal, automatic |
| Sterilization | ||
| Aspects | Applicator is disinfected | |
| between patients. | Applicator is disinfected between | |
| patients. | ||
| MED Dose | ||
| Determination | Menu driven | Menu driven |
| Duty Cycle | 100% | 100% |
| Dosage Controls | Dosage (or energy density | |
| J/cm²), pulse duration | Dosage (or energy density J/cm²), pulse | |
| duration | ||
| 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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