(186 days)
The PHAROS Excimer Laser will be indicated for use for the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma.
RA Medical Systems, Inc.'s PHAROS Excimer Laser is a medical laser that is a self-contained UV laser light source that emits a wavelength of 308 nm. The PHAROS Excimer Laser utilizes a XeCl gas mixture to generate an operator-selected dose and targetspecific UV light. The laser dose is activated by a footswitch with the therapeutic radiation emitting from a handheld device. The laser operation is key controlled and is contained within an interlocked housing.
This looks like a 510(k) premarket notification for a medical device. Based on the provided text, here's a breakdown of the requested information. It's important to note that this submission emphasizes substantial equivalence to predicate devices rather than a standalone clinical study with new acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
For this 510(k) submission, the "acceptance criteria" are based on demonstrating substantial equivalence to predicate devices, which implies that the new device (PHAROS EX-308 Excimer Laser) performs at least as well as and is as safe and effective as the existing devices for the stated indications. There are no specific quantitative performance metrics or acceptance criteria stated for the PHAROS EX-308 itself in this document, as the comparison is made against already cleared devices.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate Devices) | Reported Device Performance (PHAROS EX-308) |
|---|---|
| Same intended use as predicate devices (treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma) | Has the same intended uses as the cited predicate devices. |
| Similar or identical technology/design as predicate devices (e.g., self-contained UV laser, 308 nm wavelength, XeCl gas mixture) | Utilizes XeCl gas mixture to generate an operator-selected dose and target-specific UV light. Emits a wavelength of 308 nm. Uses similar or identical technology as the predicate devices. |
| Clinically performs equivalently to predicate devices for the specified indications | "Will clinically perform equivalent to the predicate devices." |
| Conforms to relevant applicable standards (Product Performance Testing) | "Conforms to the relevant applicable standard." |
| Does not introduce any new indications for use or raise new concerns regarding safety and effectiveness | Does not introduce any new indications for use. "Should not raise any concerns regarding the safety and effectiveness of the laser." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a separate "test set" or a new clinical study with a specific sample size for the PHAROS EX-308 to prove its effectiveness. The submission relies on the established safety and effectiveness of its predicate devices. Therefore, there is no new data provenance (e.g., country of origin, retrospective/prospective) explicitly mentioned for a test set for this specific device. The "clinical performance testing" section explicitly states: "the indications requested have been previously cleared in predicate devices."
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. Since no new clinical study data with human assessment as "ground truth" was conducted specifically for the PHAROS EX-308, information regarding experts for ground truth establishment is not provided. The "ground truth" for its effectiveness is implicitly derived from the prior clearances of the predicate devices based on their historical clinical trials (which are not detailed here).
4. Adjudication Method for the Test Set
Not applicable. As no new clinical study requiring ground truth establishment was conducted for the PHAROS EX-308, there is no mention of an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission relies on substantial equivalence to existing predicate devices rather than a new comparative effectiveness study showing improvement with AI assistance (which is not relevant for this type of laser device).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense. The "Product Performance Testing" and "Clinical Performance Testing" sections confirm that testing was done on the PHAROS EX-308 laser itself to show it conforms to standards and performs equivalently to predicate devices. This can be seen as testing the "algorithm only" (the laser's physical and technical performance) in its standalone capacity, without necessarily a human-in-the-loop performance evaluation in a new clinical trial context.
7. The Type of Ground Truth Used
The "ground truth" used is essentially the prior clearances and established safety and effectiveness of the legally marketed predicate devices. The PHAROS EX-308 is deemed substantially equivalent because it shares the same intended use and similar technology, implying it will achieve similar clinical outcomes (safety and effectiveness) as those devices, for which the "ground truth" was established in their original clearance processes (likely through clinical trials and expert consensus at the time).
8. The Sample Size for the Training Set
Not applicable. This device is a laser system, not an AI/machine learning algorithm that requires a "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for an AI/ML algorithm involved in this device.
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KO62963 510 (k) PRE-MARKET NOTIFICATION SUMMARY
General Information: This 510(k) provides notification of substantial equivalence for RA MEDICAL SYSTEMS, INC.'s PHAROS Excimer Laser, which is substantially equivalent to several previously marketed devices, including PhotoMedex's Xtrac AL7000 and AL8000, SurgiLight EX-308, and the Lumins BClear Photo Clearing System. It is intended for use in the treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma.
Submitted by: RA MEDICAL SYSTEMS, INC.
Address:
2270-L Camino Vida Roble Carlsbad, CA 92011
APR - 3 2007
Contact Person: Dean Irwin President
Date Prepared: 27 September 2006
Device Trade Name: PHAROS Excimer Laser EX-308
Device Common Name: XeCl excimer laser, excimer phototherapy laser.
Classification: Laser surgical instrument for use in general and plastic surgery and in dermatology (21 CFR §878.4810). Product Code: GEX
Predicate Device:
SurgiLight Inc. EX-308 Excimer Laser, 510(k) numbers: K993328 and K020973.
PhotoMedex XTRAC Excimer Laser, model AL7000, 510(k) numbers: K992914, K003705, K020847, and K011382 XTRAC Excimer Laser, model AL8000, 510(k) number: K041943
Lumins Inc. BClear Targeted PhotoClearing System, 510(k) numbers: K011197, K020591 and K021762.
TheraLight, Inc. Targeted UVA / UVB Phototherapy System, model UV120-2 UVA/UVB, 510(k) numbers: K024020 and K022165.
National Biological Corp. Houva 3 With PhotoSense II, 510(k) numbers K041212
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- Device Description: RA Medical Systems, Inc.'s PHAROS Excimer Laser is a medical laser that is a self-contained UV laser light source that emits a wavelength of 308 nm. The PHAROS Excimer Laser utilizes a XeCl gas mixture to generate an operator-selected dose and targetspecific UV light. The laser dose is activated by a footswitch with the therapeutic radiation emitting from a handheld device. The laser operation is key controlled and is contained within an interlocked housing.
- Intended Use: UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma.
- Substantial Equivalence: The PHAROS Excimer Laser, from both a design and clinical perspective, uses similar or identical technology as the cited predicate devices and has the same intended uses. Based upon the predicted overall performance characteristics for the PHAROS Excimer Laser, RA Medical Systems, Inc. believes that no significant differences exists between PHAROS and the cited predicate devices.
- Product Performance Testing: Testing conducted on the PHAROS EX-308 laser shows that it conforms to the relevant applicable standard.
- Clinical Performance Testing: the indications requested have been previously cleared in predicate devices. The PHAROS EX-308 does not introduce any new indications for use, and will clinically perform equivalent to the predicate devices.
- Conclusions: The PHAROS EX-308 Excimer laser uses a similar or identical technology as the predicate devices. Therefore, RA Medicals Systems, Inc.'s PHAROS Excimer laser should not raise any concerns regarding the safety and effectiveness of the laser to treat psoriasis, vitiligo, atopic dermatitis and leukoderma. Ra Medical believes that the PHAROS EX-308 is substantially equivalent to the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the caduceus.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
RA Medical Systems, Inc. % Mr. Dean Irwin 2270-L Camino Vida Roble Carlsbad, California 92011
APR - 3 2007
Re: K062963
Trade/Device Name: PHAROS EX-308 Excimer Laser System 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: March 6, 2007 Received: March 13, 2007
Dear Mr. Irwin:
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. Dean Irwin
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 (240) 276-0115. 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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): KOOO 2963
Device Name:
PHAROS EX-308 Excimer Laser System
Indications for Use:
The PHAROS Excimer Laser will be indicated for use for the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma.
Prescription use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number 11062962
§ 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.