(253 days)
The Omnilux Clear-U is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne on the face
The Omnilux Clear-U is a source of high spectral purity It provides uniform or "hotspot" free illumination The outputs are pre-tuned to a particular wavelength with a narrow spectral bandwidth The red output of the Omnilux Clear-U is 633 + 6 nm, and the blue output is 415 ± 5 nm The Omnilux Clear-U device itself contains a selector switch (red/off/blue), the LED array assembly, and arrangements for aur cooling A separate, universal, power supply converts mains AC power to the DC power requred by the Omnilux Clear-U Treatment time is controlled by the operator
The provided text describes the 510(k) summary for the Omnilux Clear-U device, which is an LED array for treating mild to moderate acne. However, it does not include acceptance criteria for device performance or a study that directly proves the device meets specific performance criteria in terms of clinical efficacy.
Instead, the submission relies heavily on demonstrating substantial equivalence to predicate devices (Omnilux Revive, Omnilux blue, Omnilux revive/Omnilux blue combination) by arguing that "no significant differences exist" and therefore "raises no new issues of safety or effectiveness."
The "Performance Data" section mentions two tests related to user comprehension and usability, but these are about the user interface and labeling, not the therapeutic efficacy of the light treatment itself.
Here's a breakdown based on the information available and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided document, there are no specific performance-based acceptance criteria for the clinical efficacy regarding acne treatment explicitly stated, nor is there reported device performance against such criteria.
The document focuses on usability and safety, as well as substantial equivalence to predicate devices.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Clinical Efficacy: (e.g., reduction in acne lesions by X% in Y weeks) | Not provided in the document. The submission relies on substantial equivalence to predicate devices for efficacy claims. |
| Usability Test Critical Objectives Comprehension Rate | Minimum comprehension rate of 88% at 95% confidence level |
| Self-Selection Test Critical Objectives Comprehension Rate | Minimum comprehension rate of 93% at 95% confidence level |
| Overall Performance Characteristics Analysis | Performed (stated to be a basis for belief in no significant differences), but specific results or metrics are not detailed. |
2. Sample Size Used for the Test Set and Data Provenance
- Self-Selection Test: A "sample representative population" was used. The exact sample size is not specified, but it was sufficient to determine a minimum comprehension rate of 93% at a 95% confidence level.
- Usability Test: A "sample representative population" was used. The exact sample size is not specified, but it was sufficient to determine a minimum comprehension rate of 88% at a 95% confidence level.
Data Provenance: Not explicitly stated, but given the submitter's address (Carlsbad, California) and the context of a 510(k) submission to the FDA, it is highly likely these tests were conducted in the United States. The document does not specify if these were retrospective or prospective studies; however, usability and self-selection tests are typically prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable for the reported tests. The self-selection and usability tests evaluate user comprehension and ability to use the device based on labeling, not clinical outcomes that would require expert ground truth.
4. Adjudication Method for the Test Set
Not applicable. No expert adjudication methods (like 2+1, 3+1) are described as the tests were user comprehension/usability evaluations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. The document does not mention any MRMC study. The comparison is made to predicate devices based on perceived "no significant differences" rather than a direct comparative effectiveness study involving human readers or clinicians.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. The Omnilux Clear-U is a therapeutic light device, not an AI or algorithm. Therefore, "standalone (algorithm only)" performance is not applicable. The device itself is the standalone therapy.
7. The Type of Ground Truth Used
For the usability and self-selection tests, the "ground truth" was likely defined by pre-established correct answers or critical objectives of the product labeling, against which user responses were measured for comprehension. For instance, correctly identifying the treatment duration or safety warnings.
For the inherent therapeutic claims, the "ground truth" (or basis of equivalence) relied on the established safety and effectiveness profile of the predicate devices, which would have been supported by their own clinical data (not detailed in this specific 510(k) summary).
8. The Sample Size for the Training Set
Not applicable as this is not an AI/ML device that requires training.
9. How the Ground Truth for the Training Set was Established
Not applicable as this is not an AI/ML device that requires training.
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K081307 Pg 1 of 2
510(k) Summary of Safety and Effectiveness for the Photo Therapeutics Limited Omnilux_Plus
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
1. General Information
JAN 1 6 2009
| Submitter: | Photo Therapeutics Inc2720 Loker Avenue WestCarlsbadCaliforniaCA 92010 |
|---|---|
| Contact Person: | Sue DarcyCEOPhoto Therapeutics Inc2720 Loker Avenue WestCarlsbadCaliforniaCA 92010Tel: 760.607.0488Fax: 760.607.0288Email: steve.hutson@omnilux.co.uk |
| Summary Preparation Date: | 18 th May 2007 |
| Amended: | 20 th July 2007 (Contact Person corrected) |
- Names
| Device Name: | Omnilux Clear-U |
|---|---|
| Classification Name: | Laser Instrument, Surgical Powered - General and PlasticSurgery - Class II, OLP |
Although this device is not a laser and is intended for OTC use, the manufacturer thinks this is the closest applicable classification name.
3. Predicate Devices
Omnilux Revive (K030426), Omnilux blue (K030883), Omnilux revive/Omnilux blue combination (K043329).
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4. Device Description
The Omnilux Clear-U is a source of high spectral purity It provides uniform or "hotspot" free illumination The outputs are pre-tuned to a particular wavelength with a narrow spectral bandwidth The red output of the Omnilux Clear-U is 633 + 6 nm, and the blue output is 415 ± 5 nm The Omnilux Clear-U device itself contains a selector switch (red/off/blue), the LED array assembly, and arrangements for aur cooling A separate, universal, power supply converts mains AC power to the DC power requred by the Omnilux Clear-U Treatment time is controlled by the operator
5. Indications for Use
The Omnilux Clear-U is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne on the face The target patient population for the Omnilux Clear-U is the same as that for the predicate devices, however the Omnilux Clear-U 1s designed for home use
6. Performance Data
Photo Therapeutics Limited believes that no significant differences exist between the previously approved Omnilux revive (K030426), Omnilux blue (K030883), Omnilux revive/Omnilux blue combination (K043329) and the Omnilux Clear-U Therefore, the Omnilux Clear-U raises no new issues of safety or effectiveness
This belief is based upon
- An analysis of the overall performance characteristics for the device .
- The results of a self-selection test (carried out on a sample representative . population using the product labeling) which showed a mınımum comprehension rate for the critical objectives of 93% at the 95% confidence level
- The results of a usabılıty test (carried out on a sample representative population . using the product labeling) which showed a minimum comprehension rate for the critical objectives of 88% at the 95% confidence level
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 6 2009
Photo Therapeutics, Inc % Ms Sue Darcy CEO 2720 Loker Avenue West Carlsbad, California 92010
Re K081307 Trade/Device Name Omnilux Clear-U 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 OLP Dated December 23, 2008 Received December 29, 2008
Dear Ms Darcy
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 regustration, Insting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteratıon
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
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Page 2 - Ms Sue Daicy
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
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 Brometric'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 Assıstance 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. Mulhearn
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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K081307 pg 1041
Device Name
Indications for Use
The Omnilux Clear-U is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne on the face
Prescription Use (Per 21 CFR 801 109)
で
יר
AND/OR
Over the Counter Use &
1
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K081307
§ 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.