The XTRAC XL Plus Excimer Laser Phototherapy Svstem is a complete self-contained compact UV laser light source, which utilizes a XeCl gas mixture to generate dose-selected and target specific ultraviolet light at wavelength of 308 nm. The laser system consists of a keypad and display, a fiberoptic delivery system, a handpiece and a foot-switch. The laser is enclosed in a protective interlocked housing.

AI/ML Overview

This document is a 510(k) premarket notification for a device modification, not a submission for a new device requiring extensive clinical trials to establish efficacy against acceptance criteria. Therefore, the provided text does not contain information typically found in studies designed to prove a device meets specific performance acceptance criteria for a novel device.

The submission focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and conformance to established standards, rather than clinical performance metrics.

Here's a breakdown of the requested information based on the provided text, highlighting what is not applicable or not found in this specific type of 510(k):

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Conformance to EN 60601 series of standards	Testing conducted shows conformance to all relevant international EN 60601 series of standards.
Conformance to 21 CFR Part 1040.10 & 1040.11 (Laser Performance Standards)	Testing conducted shows conformance to applicable laser Performance Standards (21 CFR Part 1040.10 & 1040.11).
Conformance to UL 2601	Testing conducted shows conformance to UL 2601.
Substantial Equivalence to Predicate Device (XTRAC Excimer Laser System, model AL7000)	"Based on the intended use, the previously cleared technological characteristics of the AL7000, and the performance data documented to support the modifications, PhotoMedex believes that the XTRAC XL Plus Excimer Laser Phototherapy System is substantially equivalent to the predicate device."
Efficacy for treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma via 308 nm UVB phototherapy	"Current published data supports 308 nm UVB to be effective of providing efficacy to the currently approved indications for use, which the AL7000 has been previously cleared for." (This refers to existing knowledge about the predicate, not new performance data for this modified device).

2. Sample size used for the test set and the data provenance

Not Applicable/Not Found: This submission is a modification to an already cleared device. Performance testing referenced is related to safety, electrical, and laser standards (EN 60601, 21 CFR 1040.10 & 1040.11, UL 2601) for the modified hardware, and not clinical efficacy testing with a "test set" of patient data. Therefore, there's no mention of a clinical test set, data provenance, or sample size for such a set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable/Not Found: As there is no clinical test set for efficacy described, there's no mention of experts or their qualifications for establishing ground truth. The "ground truth" for this modification centers on regulatory compliance and substantial equivalence to an existing device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable/Not Found: No clinical test set means no adjudication method described.

5. 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

Not Applicable/Not Found: This device is a laser phototherapy system and does not involve AI or human "readers" in the diagnostic sense. Therefore, an MRMC study is irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable/Not Found: This is a hardware device (excimer laser system) for phototherapy, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For demonstrating substantial equivalence: The "ground truth" is that the predicate device (XTRAC Excimer Laser System, model AL7000) is already cleared and shown to be safe and effective for its intended use. The modified device's "ground truth" for clearance is its adherence to relevant safety and performance standards and its technological similarity to the predicate.
For efficacy: The document refers to "Current published data supports 308 nm UVB to be effective of providing efficacy to the currently approved indications for use." This implies the "ground truth" for the treatment itself comes from existing medical literature and prior clearances of similar devices, rather than new primary data generated for this specific 510(k).

8. The sample size for the training set

Not Applicable/Not Found: This 510(k) is for a hardware device modification, not a machine learning or AI algorithm. There is no concept of a "training set" in the context of this submission.

9. How the ground truth for the training set was established

Not Applicable/Not Found: As there is no training set, this question is not applicable.

Summary

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AUG - 1 2003

Ko31451

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"Special 510(k): Device Modification" XTRAC Excimer Laser, AL7000

510(k) SUMMARY PhotoMedex, Inc. XTRAC XL Plus Excimer Laser System, model AL 7000

1. GENERAL

• Submitter:	PhotoMedex, Inc.2431 Impala DriveCarlsbad, CA 92008
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Contact Person: Bob Rose .
May 5, 2003 Date Prepared: ●

2. DEVICE NAME

Classification name: (21 CFR $878.4810; Laser Surgical Instrument for use in . General and Plastic Surgery and Dermatology
Common or usual name: XeCl excimer laser .
. Trade or proprietary name: XTRAC XL Plus Excimer Laser System, model AL 7000

3. PREDICATE DEVICES

Excimer Laser

XTRAC Excimer Laser System, model AL7000 ● Photomedex, Inc. 510(k) numbers: K992914, K003705, K011382 & K020847

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"Special 510(k); Device Modification" XTRAC Excimer Laser, AL7000

4. DEVICE DESCRIPTION

5. INTENDED USE

The intended use is UVB phototherapy of targeted skin for treatment psoriasis, vitiligo, atopic dermatitis and leukoderma.

6. SUBSTANTIAL EQUIVALENCE

Current published data supports 308 nm UVB to be effective of providing efficacy to the currently approved indications for use, which the AL7000 has been previously cleared for.

The intended use for the PhotoMedex XTRAC XL Plus Excimer Laser System is within the scope of the predicate device, the current market cleared PhotoMedex AL7000 excimer laser phototherapy system. Both device types share the same methods and mechanisms to produce targeted and controlled doses of UV light to affected target areas.

The XTRAC Excimer Laser System, model AL7000 is market cleared per 510(k) numbers K992914. K003705. K011382. & K020847 for the treatment of psoriasis, viuiligo, atopic dermatitis and leukoderma.

7. PRODUCT PERFORMANCE TESTING

Testing conducted on the XTRAC XL Plus Excimer Laser Phototherapy System includes conformance to all relevant international EN 60601 series of standards and applicable laser Performance Standards (21 CFR Part 1040.10 & 1040.11), as well as UL 2601.

8. CONCLUSIONS

Based on the intended use, the previously cleared technological characteristics of the AL7000, and the performance data documented to support the modifications, PhotoMedex believes that the XTRAC XL Plus Excimer Laser Phototherapy System is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 1 2003

Mr. Bob Rose Director of RA/QA PhotoMedex, Inc. 2431 Impala Drive Carlsbad, California 92008

Re: K031451

Trade/Device Name: XTRAC XL Plus Excimer Laser System, Model AL7000 Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: May 5, 2003 Received: May 15, 2003

Dear Mr Rose:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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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Page 2 - Mr. Bob Rose

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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"Special 510(k): Device Modification" XTRAC Excimer Laser. AL7000

510(k) Number (if known): 《س½½½ /

Device Name:

XTRAC XL Plus Excimer Laser System, model AL 7000

Indications for Use:

UVB Phototherapy for psoriasis, vitiligo, atopic dermatitis, and leukoderma

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter-Use _________________________________________________________________________________________________________________________________________________________

uriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K031451

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.