(24 days)
The PanaLight-BLU™ Illuminator, Model 4175 is intended to provide phototherapeutic light to the body. The PanaLight-BLU™ is generally indicated to treat dermatological indications. The PanaLight-BLU™ is specifically indicated to treat moderate inflammatory acne vulgaris.
The PanaLight-BLU™ is a compact light source that delivers a uniform distribution of narrowband blue light to the body with a spectral output at a peak wavelength of 417 +/- 5 nm. The principal parts of the system include the light unit head and floor stand with timer.
The provided text is a 510(k) Summary of Safety and Effectiveness for the DUSA PanaLight-BLU™ Illuminator, Model 4175. It explicitly states that no performance data is required for this Class II device, nor has it been requested by the Food and Drug Administration (Office of Device Evaluation).
Therefore, the study does not include acceptance criteria, specific device performance metrics, or details typically found in studies designed to prove a device meets performance criteria. The basis for clearance is substantial equivalence to predicate devices.
Given this information, a table of acceptance criteria and device performance, and details about a study proving these criteria, cannot be extracted from the provided document.
However, I can address the other points based on the document's content:
1. A table of acceptance criteria and the reported device performance:
Not applicable. The document states: "No performance data is required for this Class II device nor has it been requested by the Food and Drug Administration (Office of Device Evaluation)."
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 performance study, test set, or data provenance is mentioned as no performance data was required.
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 ground truth establishment for a test set is discussed as no performance study was required.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No adjudication method for a test set is discussed as no performance study was required.
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. The device is a blue light illuminator for phototherapy, not an AI-assisted diagnostic tool involving human readers. No MRMC study was conducted or referenced.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is a physical light source, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. No performance study requiring ground truth was conducted for this device's 510(k) clearance.
8. The sample size for the training set:
Not applicable. The device is a physical light source, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. As above, no training set or ground truth for it is relevant to this device's 510(k) submission.
Summary based on the provided document:
The DUSA PanaLight-BLU™ Illuminator, Model 4175, received 510(k) clearance based on substantial equivalence to predicate devices (BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170, and ClearLight™ Phototherapy Device, Model CL-420), rather than on specific performance data from a clinical study. The submission explicitly states that "No performance data is required for this Class II device nor has it been requested by the Food and Drug Administration (Office of Device Evaluation)." The rationale is that the PanaLight-BLU™ has the same spectral output, mode of operation, treatment area, general operating principles, and same intended use and indications for use as the predicate devices, leading to the conclusion that no significant differences exist and therefore it raises no new questions of safety or efficacy.
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DEC 1 0 2004
510(k) Summary of Safety and Effectiveness for the DUSA PanaLight-BLU™ Illuminator, Model 4175
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This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of SDMA 1990 and 21 CFR 807.92.
| Applicant & Submitter: | DUSA Pharmaceuticals, Inc. |
|---|---|
| Address: | 25 Upton DriveWilmington, MA 01887 |
| Phone: | 978-657-7500 |
| FAX: | 978-657-9193 |
| Contact Person: | Scott Lundahl |
| Preparation Date: | November 15, 2004 |
| Device Submitted: | PanaLight-BLU™ Illuminator, Model 4175 |
| Proprietary Name: | PanaLight-BLU™ |
| Common Name: | Blue Light Illuminator |
| Classification Name: | Laser surgical instrument for use in Generaland Plastic Surgery and in Dermatology.Product Code GEX |
| Predicate Devices: | BLU-U® Blue Light Photodynamic TherapyIlluminator Model 4170 and ClearLight™Phototherapy Device, Model CL-420 |
| Device Description: | The PanaLight-BLU™ is a compact lightsource that delivers a uniform distribution ofnarrowband blue light to the body with aspectral output at a peak wavelength of$417 \pm 5$ nm. The principal parts of the systeminclude the light unit head and floor stand withtimer. |
| Intended Use: | The PanaLight-BLU™ Illuminator, Model 4175is intended to provide phototherapeutic light tothe body. The PanaLight-BLU™ is generallyindicated to treat dermatological indications.The PanaLight-BLU™ is specifically indicatedto treat moderate inflammatory acne vulgaris. |
| Performance Data: | No performance data is required for this ClassII device nor has it been requested by the Foodand Drug Administration (Office of DeviceEvaluation). The PanaLight-BLU™ has thesame spectral output, mode of operation,treatment area, and general operatingprincipals as well as the same intended use. |
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the same general and specific indications for use as the predicate devices. Based on an analysis of of the overall performance characteristics, no significant differences exist and therefore the PanaLight-BLU™ raises no new questions of safety or efficacy.
- Substantial Equivalence: PanaLight-BLU™ The Illuminator is substantially equivalent to the previously cleared BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170, and to the previously cleared ClearLight™ Phototherapy Device, Model CL-420.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 0 2004
Mr. Scott Lundahl Vice President Regulatory Affairs DUSA Pharmaceuticals, Inc. 25 Upton Drive Wilmington, Massachusetts 01887
Re: K043164
Trade/Device Name: PanaLight-BIJUTM Illuminator 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: November 15, 2004
Received: November 16, 2004
Dear Mr. Lundahl:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10) use stated in the encreate) to regars and ment date of the Medical Device Amendments, or to conniner co May 20, 1976, the excordance with the provisions of the Federal Food, Drug, de vices that have boon require approval of a premarket approval application (PMA). and Costiere Hor (110. (110.) that the device, subject to the general controls provisions of the Act. The I ou may, merclore, manies are as act include requirements for annual registration, listing of general controls provisions of the rise, 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 If your device is olasbilled (600 a00 ro) als. Existing major regulations affecting your device can inay be subject to such additions, 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 i Toase oc advisod that I Dr o abount that your device complies with other requirements of the Act that I DT has made a assid regulations administered by other Federal agencies. You must or any I odetar state and the equirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K F art 607); adoling (21 CFR Part 820); and if applicable, the electronic for in the quany byevisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Scott Lundahl
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/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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INDICATIONS FOR USE STATEMENT
510(k) Number: _______________________________________________________________________________________________________________________________________________________________ (if known)
Device Name: PanaLight-BLU™ Illuminator
Indications for Use: The PanaLight-BLU™ Model 4175 is intended to provide phototherapeutic light to the body. The PanaLight-BLU™ is generally indicated to treat dermatological indications. The PanaLight-BLU™ is specifically indicated to treat moderate inflammatory acne vulgaris.
Prescription Use X (Per 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE OF ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-G Division of General, Restorative, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
§ 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.