(57 days)
The Quantel 308 Excimer System is intended to be used for the treatment of psoriasis and vitiligo.
The 308 is indicated for dermatological procedures for the treatment of psoriasis and vitiligo. The lamp is a xenon-chloride excimer lamp with a wavelength of 308 nanometers. Its output power is 800 mW ±10% for 2.48 ' ? (16 cm2). It is computer controlled, and displays the treatment parameters.
The provided 510(k) summary for the Quantel Medical 308 Dermatological Excimer System (K073066) explicitly states that clinical tests were not performed or deemed necessary for this device. The manufacturer's conclusion is based on the premise that the 308 system uses the "same technology as the predicate device" (PhotoMedex VTRAC XL, K051428) and is therefore "equivalent in safety and efficacy."
As such, acceptance criteria related to clinical performance are not provided, nor is a study that proves the device meets such criteria. The "performance data" section only includes non-clinical tests regarding the lamp itself and software validation.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Clinical Efficacy/Safety: Not applicable based on substantial equivalence claim. | Not applicable; no clinical data provided. |
| Non-clinical (Lamp Output): | Output power: 800 mW ±10% |
| Non-clinical (Software): | Software has been validated. |
| Non-clinical (Electrical Safety): | Tested to ISO 60601-1 |
| Non-clinical (Electromagnetic Compatibility): | Tested to ISO 60601-1-2 |
| Technology Equivalence: Uses the same technology as the predicate device (PhotoMedex VTRAC XL, K051428). | Confirmed. |
| Intended Use Equivalence: Treatment of psoriasis and vitiligo. | Confirmed. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. No clinical test set was used for performance validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No clinical test set was used.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set was used.
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. This device is a phototherapy system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware device for phototherapy, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. No clinical ground truth was established as no clinical studies were conducted for this 510(k). The "ground truth" for the submission's approval was substantial equivalence to a predicate device.
8. The sample size for the training set
- Not applicable. No clinical training set was used.
9. How the ground truth for the training set was established
- Not applicable. No clinical training set was used.
Summary of Device Approval Approach:
The Quantel Medical 308 Dermatological Excimer System (K073066) received 510(k) clearance based on its substantial equivalence to a predicate device (PhotoMedex VTRAC XL, K051428). The core argument for safety and efficacy was that the device uses the "same technology" and has the same intended use. Therefore, clinical studies were explicitly deemed "not necessary" by the manufacturer and accepted by the FDA for this particular submission. The performance assessment was based solely on non-clinical testing for lamp output, stability, software validation, and electrical safety standards (ISO 60601-1 and ISO 60601-1-2).
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K 073066
Quantel Medical 510(k) 308 Dermatological Excimer System
510(k) Summary
(1) Submitter Information
Name: Quantel Medical
Address:
21 rue Newton - Zone du BREZET Clermont-Ferrand 63039 France
Telephone Number: 33-1-69-29-17-00
Contact Person: Dr. George Myers (Official Correspondent) Medsys Inc. 377 Route 17 S Hasbrouck Heights, NJ 07604 Telephone 201-727-1703 Fax 201-727-1708
Date Prepared: October 1, 2007
(2) Name of Device
Trade Name: 308 Excimer Lamp Phototherapy system Classification name: Ultraviolet Lamp for Dermatological Disorders
(3) Equivalent legally-marketed devices.
PhotoMedex VTRAC XL, K051428
(4) Description
The 308 is indicated for dermatological procedures for the treatment of psoriasis and vitiligo. The lamp is a xenon-chloride excimer lamp with a wavelength of 308 nanometers. Its output power is 800 mW ±10% for 2.48 ' ? (16 cm2). It is computer controlled, and displays the treatment parameters.
DEC 2 & 2007
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(5) Intended Use
. The 308 system is intended to be used for the treatment of psoriasis and vitiligo.
(6) Performance Data
(a) Non-clinical tests
The 308 has been extensively validated, both the lamp itself and the software. It has been tested to ISO 60601-1 and ISO 60601-1-2. The lamp has been tested for output power and stability, and the software has been validated.
(b) Clinical tests
Clinical tests are not necessary, since the 308 uses the same technology as the predicate device.
(c) Conclusions
The 308 is equivalent in safety and efficacy to the legally-marketed predicate devices.
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Public Health Service
DEC 2 6 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Quantel Medical, Inc. % Medsys, Inc. Mr. George Myers 377 Route 17 Hasbrouck Heights, New Jersey 07604
Re: K073066
Trade/Device Name: Model 308 Dermatological Excimer System Regulatory Number: 21 CFR 878.4630 Regulatory Name: Ultraviolet lamp for dermatologic disorders Regulatory Class: II Product Code: FTC Dated: October 25, 2007 Received: October 30, 2007
Dear Mr. Myers:
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. Iisting 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. George Myers
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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. Millman
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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Quantel Medical 308
Page 4-1
Indications for Use 510(k) Number (if known): K 073066
Device Name: Model 308 Dermatological Excimer System
Indications For Use:
The Quantel 308 Excimer System is intended to be used for the treatment of psoriasis and vitiligo.
Prescription Use Over-The-Counter Use AND/OR
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Buehrig
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_KO 33066
§ 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.