(46 days)
The LumiPhase-R ™ is indicated for treatment of wrinkles, rhytids and fine lines in the periorbital region.
The LumiPhase-R system delivers visible light at a wavelength of 660 nanometers. This LED device consists of three interconnected sections: the base which houses the power supply, the articulated arm and the treatment head consisting of the controller, the ventilation (heat sink) system, the LED based optics and the positioning system.
The provided 510(k) summary for the Opusmed Inc. LumiPhase-R™ device does not contain specific acceptance criteria or a detailed study description with performance metrics that would allow for a complete answer to your request.
Here's a breakdown of what can and cannot be extracted from the provided text based on your questions:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated. The document mentions "Results were acceptable" for clinical studies but does not provide quantitative targets or thresholds.
- Reported Device Performance: Not explicitly stated in quantitative terms. The document highlights the general finding that the device's performance is "equivalent to the predicate devices" and "did not raise any new issues of safety and effectiveness."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for the test set: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective or prospective).
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 specified. The document only states that "Clinical studies were conducted" but provides no details on how outcomes were assessed or by whom.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
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
- None. This device is a light-based therapeutic device, not an AI-assisted diagnostic or assistive device that would involve human readers interpreting results. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. The LumiPhase-R™ is a light therapy device, not an algorithm or AI system. Its performance is related to its physical effects rather than its interpretive accuracy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not specified. The document generally refers to "Clinical studies" and "results were acceptable," implying some form of clinical assessment of wrinkle reduction. However, the specific method (e.g., blinded expert photographic assessment, patient-reported outcomes, objective measurement like profilometry) is not disclosed.
8. The sample size for the training set
- Not applicable. This device is not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable for the same reason as #8.
Summary of Findings from the 510(k) Summary:
The provided document focuses on demonstrating substantial equivalence to predicate devices (Omnilux Revive K030426 and GentleWaves LED Photomodulation Device K031425) rather than providing detailed de novo performance data with specific acceptance criteria.
The key statements regarding performance are:
- "Clinical studies were conducted to provide assurance that the performance of the device is equivalent to the predicate devices."
- "Results were acceptable and did not raise any new issues of safety and effectiveness."
- "The LumiPhase-R device, as designed, is as safe and effective as the predicate devices, and the device is determined to be substantially equivalent to the referenced predicate devices."
This means the FDA cleared the device based on its similarity in intended use and technological characteristics to already approved devices, and general statements of acceptable clinical performance, without requiring specific quantitative metrics or detailed study reporting in this 510(k) summary.
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510(k) Summary of Safety and Effectiveness
051255
Opusmed Inc. LumiPhase-R™
JUL 0 1 2005
| 510(k)Summary | This summary of 510(k) safety and effectiveness information isbeing submitted in accordance with the requirements of 21 C.F.R.§ 807.92. |
|---|---|
| SubmissionCorrespondant: | Emergo Group Inc.2454 McMullen Booth Road, Suite 427Clearwater, FL 33759 USA |
| Phone: | 727-797-4727 |
| Fax: | 727-797-4757 |
| Contact: | Mr. Ian Gordon |
| e-mail: | igordon@emergogroup.com |
| SubmissionSponsor: | Opusmed Inc.3333 Graham Boulevard, Suite 306Mount-Royal, (Quebec) H3R 3L5Canada |
| Date Prepared | May 6, 2005 |
| Name of device | LumiPhase-R™ |
| ClassificationNames | Laser surgical instrument for use in general and plasticsurgery and in dermatology |
| DeviceClassification | Regulatory Class: IIProduct Code: GEXClassification Panels: General & Plastic SurgeryRegulation Number: 21 C.F.R. 878.4810 |
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s1255
| 510(k) Summary of Safety and Effectiveness |
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| Opusmed Inc.LumiPhase-R™ | |
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Predicate Device(s)
| 510(k)# | Device | Manufacturer |
|---|---|---|
| K030426 | Omnilux Revive | Photo Therapeutics Limited |
| K031425 | GentleWaves LED Photomodulation Device | Light BioScience L.L.C. |
Device Description
The LumiPhase-R system delivers visible light at a wavelength of 660 nanometers. This LED device consists of three interconnected sections: the base which houses the power supply, the articulated arm and the treatment head consisting of the controller, the ventilation (heat sink) system, the LED based optics and the positioning system.
Indications
The LumiPhase-R ™ is indicated for treatment of wrinkles, rhytids and fine lines in the periorbital region.
Nonclinical Performance
The LumiPhase-R was tested and complies with IEC 60825-1 Laser Safety Testing. The LumiPhase-R will comply with IEC 60601-1-2 and CAN/CSA c22.2, No. 601.1-M90.
In vitro testing and bench testing was performed and determined to be acceptable. Based upon an analysis of the overall performance characteristics for the device, Opusmed Inc. believes that no significant differences exist. Therefore, the LumiPhase-R raises no new issues of safety or effectiveness.
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Opusmed Inc. LumiPhase-R™ Clinical Performance Clinical studies were conducted to provide assurance that the performance of the device is equivalent to the predicate devices. Results were acceptable and did not raise any new issues of safety and effectiveness. Conclusion By definition, a device is substantially equivalent when the device has the same intended use and the same technological characteristics as the predicate device, or has the same intended use and different technological characteristics. But, it can be demonstrated that the device is as safe and effective as the predicate device and the new device does not raise different questions regarding safety and effectiveness as compared to the predicate device. The differences between the Opusmed LuminPhase-R and the predicate devices cited do not raise any different questions regarding safety and effectiveness. The LumiPhase-R device, as designed, is as safe and effective as the predicate devices, and the device is determined to be substantially equivalent to the referenced predicate devices.
Koj 1255
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a symbol. The symbol is a stylized representation of a human figure with outstretched arms, suggesting care and protection. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Opusmed Incorporated C/o Mr. Ian Gordon Emergo Group Incorporated 2454 McMullen Booth Road, Suite 427 Clearwater, Florida 33759
JUL 0 1 2005
Re: K051255
Trade/Device Name: LumiPhase-RTM 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: May 9, 2005 Received: May 18, 2005
Dear Mr. Gordon:
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 such additional controls. Existing major regulations iffecting 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. Ian Gordon
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/industry/support/index.html.
Sincerely yours,
Signature
Miriam C. Provost, Ph.D. Acting 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
K051255 510(k) Number (if known):
LumiPhase-R ™ Device Name:
Indications for Use:
The LumiPhase-R ™ is indicated for treatment of wrinkles, rhytids and fine lines in the periorbital region.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Division Sign-Off) Division of General, Restorative ്
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§ 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.