(31 days)
The Levia Phototherapy System is intended for use in UVB phototherapy for the treatment of psoriasis including scalp psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and leucoderma.
The Levia Phototherapy System is intended for use on all skin types (I -VI).
The Levia Phototherapy System is an ultraviolet Light Source and energy delivery system. The System emits UV-B (290-320 nm) light for use in phototherapy and allows delivery of controlled doses. The desired dose is selected using controls on the panel of the Light Source and activated with a switch on the panel or remotely by a foot switch. A Spot Handpiece and a Fiber-optic Brush allow for selective treatment of skin lesions without exposure to neighboring, healthy tissues. The Spot Handpiece and Fiber-optic Brush connect to Light Source with a flexible Light Guide. The system is powered by a common household AC outlet. Protective eyewear is supplied with the system.
The provided text describes a 510(k) premarket notification for the Levia Phototherapy System, a device intended for UVB phototherapy. The submission aims to establish substantial equivalence to predicate devices, rather than presenting a study proving performance against defined acceptance criteria in the way a clinical trial for a novel AI device might.
Therefore, the requested information elements (1-9) which are typically associated with AI/software device studies demonstrating performance against acceptance criteria, are largely not applicable or cannot be extracted from this documentation for the Levia Phototherapy System. The document focuses on demonstrating substantial equivalence to existing, legally marketed devices.
Here's an analysis based on the provided text, highlighting what is present and what is not:
Acceptance Criteria and Study Details for Levia Phototherapy System
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance |
|---|---|
| Spectral output within UVB range of 290-320 nm | "The Levia Phototherapy System emits UVB light within the spectral band of 290 -320 nm similar to that of the predicate device Panosol II UVB-206 device." "Performance data were submitted as part of the 510(k) application to confirm that the spectral output of the Levia System is between 290 and 320 nm..." |
| Similar technological specifications to predicate devices | "Other performance data included in the application show that the technological specifications are similar to those of the claimed predicate devices." |
| Indications for Use (treatment of specific dermatologic conditions and all skin types I-VI) | The "Indications for Use" section states: "The Levia Phototherapy System is intended for use in UVB phototherapy for the treatment of psoriasis including scalp psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and leucoderma. The Levia Phototherapy System is intended for use on all skin types (I -VI)." This aligns with the conditions that predicate UVB phototherapy systems are indicated for, implying similar efficacy for these conditions. |
| Safety and Effectiveness (no new questions raised by differences from predicate) | "Lerner Medical Devices, Inc. believes that this difference [Fiber-optic Brush] is an added convenience and does not raise new questions about safety or effectiveness." This is a statement of belief, not empirical data from a study. |
2. Sample size used for the test set and the data provenance:
- Not applicable. This submission is based on engineering and performance characteristics comparing the device to predicates, not a clinical study with a test set of patients or data samples. The "Performance Data" mentioned refers to engineering measurements of spectral output and technological specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No expert ground truth establishment for a test set is described.
4. Adjudication method for the test set:
- Not applicable. No test set or adjudication method 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. This is a hardware medical device (phototherapy system), not an AI or imaging diagnostic device that would involve human readers or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a phototherapy system and does not involve an algorithm with standalone performance.
7. The type of ground truth used:
- Not applicable, or inferred. The "ground truth" for this device's submission is effectively the established performance and safety profile of the predicate devices. The Levia System's spectral output and technological specifications are compared to these known and accepted benchmarks.
8. The sample size for the training set:
- Not applicable. No training set for an algorithm is relevant to this device submission.
9. How the ground truth for the training set was established:
- Not applicable. No training set or ground truth establishment for a training set is relevant.
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K040062 1 of 2
FEB 1 3 2004
510(k) Summary
This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92.
| Date: | December 12, 2003 |
|---|---|
| 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., President |
| Device Trade Name: | Levia Phototherapy System |
| Device Common Name: | Targeted UVB Phototherapy System |
| Device Classification Name: | Ultraviolet lamp for dermatologic / skin disorder |
| Regulation Number: | 878.4630 |
| Product Code: | FTC |
| Classification: | Device Class II |
| Establishment Reg. Number: | Not obtained yet |
| List of Predicate Devices: | TheraLight, Inc.UV1 20-2 UVA / UVB Phototherapy SystemK022165, K024020, |
| Lumenis, Ltd.BClear UVB Phototherapy SystemK020591, K021762 | |
| National Biological, Corp.Handisol Wound HealingK982082 | |
| National Biological, Corp.Panosol II UVB-206K904427 |
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K040042 2 of 2
Device Description:
The Levia Phototherapy System is an ultraviolet Light Source and energy delivery system. The System emits UV-B (290-320 nm) light for use in phototherapy and allows delivery of controlled doses. The desired dose is selected using controls on the panel of the Light Source and activated with a switch on the panel or remotely by a foot switch. A Spot Handpiece and a Fiber-optic Brush allow for selective treatment of skin lesions without exposure to neighboring, healthy tissues. The Spot Handpiece and Fiber-optic Brush connect to Light Source with a flexible Light Guide. The system is powered by a common household AC outlet. Protective eyewear is supplied with the system.
Indications for Use:
The Levia Phototherapy System is intended for use in UVB phototherapy for the treatment of psoriasis including scalp psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and leucoderma.
The Levia Phototherapy System is intended for use on all skin types (I -VI).
Substantial Equivalence:
The Levia Phototherapy System emits UVB light within the spectral band of 290 -320 nm similar to that of the predicate device Panosol II UVB-206 device (K904427). This light has been shown to be safe and effective in the treatment of scalp psoriasis.
The major difference between the Levia Phototherapy System and the cited predicate devices is the Fiber-optic Brush used to treat affected areas of the skin that is covered by hair. Lerner Medical Devices, Inc. believes that this difference is an added convenience and does not raise new questions about safety or effectiveness.
Performance Data:
Performance data were submitted as part of the 510(k) application to confirm that the spectral output of the Levia System is between 290 and 320 nm, which is similar to spectra emitted by predicate devices. Other performance data included in the application show that the technological specifications are similar to those of the claimed predicate devices.
Conclusion:
On the basis of the information provided in this summary, Lerner Medical Devices, Inc. believes the Levia Phototherapy System is substantially equivalent to legally commercialized 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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure with three wavy lines representing the body and head.
Public Health Service
FEB 1 3 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Lerner Medical Devices, Inc. c/o Mr. Ned E. Devine, Jr. Entela, Inc. 3033 Madison Avenue, SE Grand Rapids, Michigan 49548
Re: K040062
Trade/Device Name: Levia Phototherapy System Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet lamp for dermatologic disorders Regulatory Class: II Product Code: FTC Dated: January 22, 2004 Received: January 29, 2004
Dear Mr. Devinc:
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 Devicc 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); labcling (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. Ned E. Devine, Jr.
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. 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
K040062 510(k) Number (if known):
Device Name: Levia Phototherapy System
The Levia Phototherapy System is intended for use in UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and leucoderma.
The Levia Phototherapy System is intended for use on all skin types (I -VI).
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (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)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number K040062
§ 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.