The Exciplex 308m" is a compact handheld excimer device that emits a narrow-band UVB light at 308nm. This ultraviolet wavelength of light is known to be beneficial in the treatment of various dermatological conditions such as psoriasis and vitiligo. The UVB light is homogeneously delivered through a 5x5cm² output window at an irradiance of 100mW/cm². Treatments are performed by applying the output window over the affected area with the help of treatment tips or silicone masks to shield the surrounding healthy skin. A treatment might consist of a series of light "shots" where the device is used multiple times along the affected area.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Exciplex308nm device. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy through clinical studies with predefined acceptance criteria. Therefore, the information requested in the prompt, which typically relates to clinical trials and statistical endpoints, is not fully present in the provided document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of acceptance criteria and reported device performance in the context of a clinical study with pre-defined statistical endpoints. Instead, it describes non-clinical performance and substantial equivalence to predicate devices.

The "performance" described relates to:

Irradiance uniformity: This is mentioned as part of the testing performed.
Ability of masks and tips to block UV light: Also mentioned as testing performed.
Classification of the UV lamp: This refers to safety standards.
Software and hardware verification testing: This ensures the device functions as designed.

The acceptance of the device is based on demonstrating that these technical aspects meet relevant industry standards and that the device is substantially equivalent to existing predicate devices.

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

No clinical test set is mentioned for evaluating the device's efficacy against specific acceptance criteria. The performance data discussed are non-clinical, related to the device's technical specifications and safety.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. The document does not describe a study where experts established ground truth for a test set.

4. Adjudication Method:

Not applicable. No clinical test set requiring adjudication is mentioned.

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

No MRMC study was performed or is referenced in this document. The submission is not for an AI-assisted device in that context.

6. Standalone Performance:

The document describes the device's technical performance (e.g., irradiance, UV blocking by accessories, software/hardware function) which could be considered "standalone" in the sense of evaluating the device's intrinsic characteristics. However, this is not a standalone clinical performance study against a specific clinical ground truth.

7. Type of Ground Truth Used:

For the non-clinical performance evaluation, the "ground truth" would be the established engineering and safety standards (e.g., IEC standards, irradiance specifications).

8. Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device requiring a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable.

Summary of what is present in the document regarding "acceptance":

The acceptance of the device by the FDA is based on demonstrating substantial equivalence to existing predicate devices (K073066, K150752, K051428) in terms of:

Intended Use: "treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma."
Technological Characteristics: light source, wavelength (308nm), treatment area size (5x5cm²), fluence range.
Performance: Non-clinical testing was performed to demonstrate safety based on current industry standards. These tests include:
- Software Verification (compliance to IEC 60601-1, IEC 62304, ISO 14971)
- Electromagnetic Compatibility and Electrical Safety (compliance to IEC 60601-1, IEC60601-1-2, IEC 60601-2-57)
- Performance and usability testing (compliance to IEC 62471, IEC 62366-1, IEC 60601-1-6)
- Irradiance uniformity
- Ability of masks and tips to block UV light
- Classification of the UV lamp

The conclusion states that based on this testing, the device "does not raise new issues of safety or effectiveness compared to the predicate devices."

In essence, the "acceptance criteria" here are that the new device is functionally and safely similar enough to already cleared devices that it doesn't require a full clinical trial to prove efficacy and safety from scratch.

Summary

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October 13, 2017 Clarteis % Allison Komiyama, Ph.D., RAC AcKnowledge Regulatory Strategies, LLC 2834 Hawthorn St. San Diego, California 92104

Re: K171702

Trade/Device Name: Exciplex308nm Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet lamp for dermatologic disorders Regulatory Class: Class II Product Code: FTC, GEX Dated: September 18, 2017 Received: September 19, 2017

Dear Dr. Komiyama:

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, 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 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.

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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 (DICE) 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" (21 CFR 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 (DICE) 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,

Jennifer R. Stevenson -S3

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. 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) K171702

Device Name Exciplex308nm

Indications for Use (Describe)

The Exciplex308nm is intended to be used for the treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Clarteis

510(k) Summary K171702

DATE PREPARED

October 13, 2017

MANUFACTURER AND 510(k) OWNER

Clarteis, SAS WTC2, 120 route des macarons, 60 560 Valbonne, France Telephone: Official Contact: Laurent Meilhac, Ph.D., CEO

REPRESENTATIVE/CONSULTANT

Allison C. Komiyama, Ph.D., R.A.C. Lucie Dalet, Ph.D. AcKnowledge Regulatory Strategies, LLC Telephone: +1 (619) 208-7888 Email: akomiyama@acknowledge-rs.com

PROPRIETARY NAME OF SUBJECT DEVICE

Exciplex308nm

COMMON NAME

Light, Ultraviolet, Dermatological

DEVICE CLASSIFICATION

Ultraviolet lamp for dermatologic disorders (21 CFR 878.4630, FTC, Class II)

PREMARKET REVIEW

ODE/DSD/General Surgery Devices Branch One (GSDB1) General & Plastic Surgery

INDICATIONS FOR USE

The Exciplex3080mm is intended to be used for the treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma.

DEVICE DESCRIPTION

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Image /page/4/Picture/1 description: The image shows a logo for a company or brand named "Clarteis". The logo consists of two parts: a rounded square with a white circle inside, and the name "Clarteis" written in a cursive font. The logo is green.

delivered through a 5x5cm² output window at an irradiance of 100mW/cm². Treatments are performed by applying the output window over the affected area with the help of treatment tips or silicone masks to shield the surrounding healthy skin. A treatment might consist of a series of light "shots" where the device is used multiple times along the affected area.

PREDICATE DEVICE IDENTIFICATION

The Exciplex3080mm is substantially equivalent to the following predicates:

510(k) Number	Predicate Device Name / Manufacturer	Primary Predicate
K073066	Model 308 Dermatological Excimer System / QuantelMedical, Inc.	✓
K150752	GME ExSys 308 / GME German Medical Engineering GmbH
K051428	VTRAC Excimer Lamp System / PhotoMedex, Inc.

SUMMARY OF NON-CLINICAL TESTING

No FDA performance standards have been established for the Exciplex 38000. The following tests were performed to demonstrate safety based on current industry standards:

Software Verification: The software development and testing was executed in compliance to IEC 60601-1, IEC 62304 and ISO 14971.

Electromagnetic Compatibility and Electrical Safety: The subject device was tested in compliance to IEC 60601-1, IEC60601-1-2 and IEC 60601-2-57.

Performance and usability testing: The subject device was tested in compliance to IEC 62471, IEC 62366-1 and IEC 60601-1-6.

The results of these tests indicate that the Exciplex3080™ is substantially equivalent to the predicate devices.

EQUIVALENCE TO PREDICATE DEVICES

Clarteis believes that the Exciplex 388m : is substantially equivalent to the predicate devices based on the information summarized here:

The subject device has a similar design and dimensions, and uses similar materials as the device cleared in K073066. The subject device has the same intended use and similar technological characteristics (light source, wavelength, treatment area size, fluence range) to the devices cleared in K073066, K150752, and K051428. Any differences in technological characteristics do not raise different questions of safety and effectiveness and performance data demonstrate substantial equivalence to the predicates.

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Image /page/5/Picture/1 description: The image shows a logo with a green square with rounded corners and a white circle inside. To the right of the square is the word "Clarteis" written in a cursive font, also in green. The logo appears to be for a company or organization named Clarteis.

CONCLUSION

Based on the testing performed, including irradiance uniformity, ability of the masks and tips to block UV light, classification of the UV lamp, and software and hardware verification testing, it can be concluded that the subject device does not raise new issues of safety or effectiveness compared to the predicate devices. The similar indications for use, technological characteristics, and performance characteristics for the proposed Exciplex380m" are assessed to be substantially equivalent to the predicate devices.

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.