(156 days)
The LH-75 Phototherapy System is intended for use, by or under the direction of a physician, in UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and leucoderma.
The LH-75 Phototherapy System is intended for use on all skin types (I -VI).
Not Found
The provided 510(k) summary for the LH-75 Phototherapy System does not contain information about specific acceptance criteria or a study designed to prove the device meets such criteria.
The 510(k) process primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring formal clinical trials with pre-defined acceptance criteria and reported performance metrics in the same way a PMA (Premarket Approval) would.
Therefore, many of the requested details about acceptance criteria, study sample sizes, expert involvement, and ground truth establishment are not typically found in a 510(k) submission for a device like this.
However, based on the information provided, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Not provided. The document describes the device and its intended use, but does not list specific performance metrics with acceptance criteria and corresponding reported performance from a study. 510(k)s for this type of device often rely on electrical safety, EMC, and photometric output testing to demonstrate substantial equivalence, rather than clinical performance metrics with defined acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not provided. No clinical performance study is described that would have a test set.
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/Not provided. Since no clinical performance study with a test set is described, there's no mention of experts or ground truth establishment for such a set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable/Not provided. No clinical performance study with a test set is 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 provided. This device is a phototherapy system, not an AI-assisted diagnostic device. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. This is a hardware device for phototherapy, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable/Not provided. No clinical performance study requiring ground truth is described in the 510(k) summary. The "ground truth" for a phototherapy device would generally relate to its ability to emit specific UV dosages and wavelengths, and its safety, rather than diagnostic accuracy.
8. The sample size for the training set
- Not applicable/Not provided. This device is a physical phototherapy system, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable/Not provided. As above, no training set is relevant for this type of device.
Summary based on the 510(k) Document:
The 510(k) summary for the LH-75 Phototherapy System focuses on demonstrating substantial equivalence to predicate devices (TheraLight, Inc. UV1 20-2 UVA / UVB Phototherapy System, Lerner Medical Devices, Inc. LH-75T Phototherapy System, Daavlin Distributing Co. 3 Series Phototherapy Cabinet, Daavlin Distributing Co. Flex Controlled Phototherapy Equipment).
The "study" implied by a 510(k) is the comparison to predicate devices, focusing on technological characteristics, indications for use, and safety/performance data (often non-clinical, such as electrical safety, EMC, and photometric output testing) to show that the new device is as safe and effective as the predicate. The document does not detail specific acceptance criteria or results from a dedicated clinical performance study with human subjects, as would be expected for a PMA or for certain novel devices requiring such evidence.
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1091568
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510(k) Summary
NOV – 5 2009
This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92.
| Date: | May 27, 2009 |
|---|---|
| Submitter's name: | Lerner Medical Devices, Inc. |
| Submitter's Address: | 1545 Sawtelle Ave. Suite 36Los Angeles, CA 90025 |
| Submitter's Telephone: | (310) 914 0091 |
| Submitter's Fax: | (310) 914 0095 |
| Contact Person: | Zafirios F. Gourgouliatos, Ph.D.,Chief Science OfficerManagement Representative |
| Device Trade Name: | LH-75 Phototherapy System |
| Device Common Name: | Targeted UVB Phototherapy System |
| Device Classification Name: | Ultraviolet lamp for dermatologic / skin disorders |
| Regulation Number: | 878.4630 |
| Product Code: | FTC |
| Classification: | Device Class II |
| Establishment Reg. Number: | 3006793564 |
| List of Predicate Devices: | TheraLight, Inc.UV1 20-2 UVA / UVB Phototherapy SystemK022165, K024020, |
| Lerner Medical Devices, Inc.LH-75T Phototherapy SystemK090097 | |
| Daavlin Distributing Co.3 Series Phototherapy CabinetK063621 | |
| Daavlin Distributing Co.Flex Controlled Phototherapy EquipmentK050695 |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
NOV - 5 2009
Lemer Medical Devices, Inc. % Zafirios Gourgouliatos, Ph.D. Chief Science Officer and Management Representative 1545 Sawtelle Boulevard. Suite 36 Los Angeles, California 90025
Re: K091568
Trade/Device Name: LH-75 Phototherapy System Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet lamp for dermatologic disorders Regulatory Class: Class II Product Code: FTC Dated: October 23, 2009 Received: November 02, 2009
Dear Dr. Gourgouliatos:
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 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
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Page 2 - Zafirios Gourgouliatos, Ph.D.
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrh/mdr/ 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
For
Mark N. Mello
Mark N. Melker Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number ________________________________________________________________________________________________________________________________________________________________
Device Name: LH-75 Phototherapy System
The LH-75 Phototherapy System is intended for use, by or under the direction of a physician, in UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and leucoderma.
The LH-75 Phototherapy System is intended for use on all skin types (I -VI).
X O OR Over-the-Counter Use __________________________________________________________________________________________________________________________________________________ Prescription Use __________ (per 21 CFR 801.109)
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-C Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091568
§ 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.