(504 days)
The GentleWaves Consumer LED Photomodulation Device is intended/indicated for over-the-counter use in the treatment of periorbital wrinkles and rhytides.
The GentleWaves Consumer is a hand-held device consisting of a low intensity light emitting diode (LED) lamp placed in contact with the skin at a fixed distance determined by its lens cover. The device components include an LED array, a lens, a handpiece, three circuit boards, a power supply enclosure and power supply.
The provided text describes a 510(k) summary for the GentleWaves Consumer LED Photomodulation Device (K062991). However, it does not contain the information requested regarding specific acceptance criteria, a detailed study proving the device meets criteria, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies for this device.
The document indicates that the performance and safety testing obtained for the predicate device, Light BioScience, LLC's GentleWaves LED Photomodulation System (K031425), is considered "fully applicable to the GentleWaves Consumer" because the spectral content is not significantly different. A "user study" was mentioned for the GentleWaves Consumer to confirm lay users could follow instructions, but no further details on this study's methodology or results are provided beyond its existence.
Therefore, I cannot populate the table or answer the specific questions based on the provided text.
Here is the information that can be extracted, and an explanation of what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided text. The document focuses on demonstrating substantial equivalence to a predicate device rather than defining specific performance acceptance criteria for this new device. | The device demonstrates "no significant difference in spectral content as compared to the cleared GentleWaves device (K031425)." Additionally, a user study confirmed "lay users were able to use the GentleWaves Consumer in accordance with its instructions for use." |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified for the user study. For the primary performance claim, it relies on data from the predicate device (K031425), but the provenance of that predicate device's data is also not detailed here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. It's unclear if expert-established ground truth was even used for the user study.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: 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:
- MRMC Study: No, an MRMC comparative effectiveness study involving AI assistance is not mentioned for this device. This device is an LED photomodulation device for wrinkles, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable and not mentioned. This is a therapeutic device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: For the "user study," the ground truth likely related to the ability of lay users to successfully operate the device according to instructions. The specific type (e.g., direct observation, survey results) is not detailed. For the efficacy claim, it relies on the predicate device's established efficacy, but the ground truth for that is not provided here.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable. This is not an AI/algorithm-based device requiring a training set.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable. This is not an AI/algorithm-based device.
Summary of Device's Performance Claims (based on the provided text):
The GentleWaves Consumer LED Photomodulation Device's performance is primarily established by its substantial equivalence to its predicate device, the GentleWaves LED Photomodulation System (K031425).
- Key Performance Claim: No significant difference in spectral content between the GentleWaves Consumer and the predicate GentleWaves device. This implies that the therapeutic effect, based on light emission, is assumed to be equivalent.
- User Study: A user study was conducted to confirm that lay (over-the-counter) users could operate the device correctly per its instructions. No specific results, sample sizes, or methods beyond its existence are detailed in this summary.
The document emphasizes that because the new device's technological characteristics (specifically spectral content) are not significantly different from the predicate, the established safety and performance data of the predicate can be applied to the new device.
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510(k) SUMMARY
Light BioSciences, LLC's
GentleWaves Consumer LED Photomodulation Device (K062991)
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Light BioScience, LLC 933 First Colonial Road, Suite 204 Virginia Beach, Virginia 23454
(757) 425-6900 Phone: Facsimile: (757) 425-3127
[5]] 15 [2
Richard Krupnick Contact Person:
Date Prepared: September 29, 2006
Name of Device and Name/Address of Sponsor
GentleWaves Consumer LED Photomodulation Device
Light BioScience, LLC 933 First Colonial Road, Suite 204 Virginia Beach, Virginia 23454
Common or Usual Name
Lamp, nonheating
Classification Name
Surgical powered laser instrument
Predicate Devices
Light BioScience, LLC's GentleWaves LED Photomodulation System (K031425)
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Intended Use / Indications for Use
The GentleWaves Consumer LED Photomodulation Device is intended/indicated for over-the-counter use in the treatment of periorbital wrinkles and rhytides.
Technological Characteristics
The GentleWaves Consumer is a hand-held device consisting of a low intensity light emitting diode (LED) lamp placed in contact with the skin at a fixed distance determined by its lens cover. The device components include an LED array, a lens, a handpiece, three circuit boards, a power supply enclosure and power supply.
Performance Data
Performance testing of the GentleWaves Consumer demonstrates no significant difference in spectral content as compared to the cleared GentleWaves device (K031425). Thus, performance and safety testing obtained for the cleared GentleWaves is fully applicable to the GentleWaves Consumer. In addition, a user study was performed to confirm that lay users were able to use the GentleWaves Consumer in accordance with its instructions for use.
Substantial Equivalence
The GentleWaves Consumer is as safe and effective as the GentleWaves LED Photomodulation System. The GentleWaves Consumer has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the GentleWaves Consumer and its predicate device raise no new issues of safety or effectiveness. In addition, the difference in indication as an OTC device does not affect the device's therapeutic effect. Thus, the GentleWave Consumer is substantially equivalent.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image contains the text "Public Health Service". The text is written in a simple, sans-serif font. The words are arranged horizontally, with "Public" and "Health" on the first line and "Service" on the second line.
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged in a circular fashion around the symbol. The logo is black and white.
AUG 18 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Light Bioscience, L.L.C. % Hogan & Hartson, L.L.P. Mr. Jonathan S. Kahan 555 Thirteenth Street Northwest Washington, District of Columbia 20004
Re: K062991
Trade/Device Name: Gentlewaves™ Consumer LED Photomodulation Device 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: OHS Dated: February 15, 2008 Received: February 15, 2008
Dear Mr. Kahan:
This letter corrects our substantially equivalent letter of June 26, 2008.
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 (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 (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
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Page 2 - Mr. Jonathan S. Kahan
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 continue 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Milker
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use Statement
510(k) Number (if known): K062991
Device Name: GentleWaves Consumer LED Photomodulation Device
Indications for Use:
The GentleWaves Consumer LED Photomodulation Device is intended/indicated for over-the-counter use in the treatment of periorbital wrinkles and rhytides.
Prescription Use (Part 21 C.F.R. 801 Subpart D) AND/OR
Over-The-Counter Use_X_ (21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Millerman
(Division Sign-Off) (Division Sign-on) Restorative,
Division of General, Restorative, Division of Cological Devices
510(k) Number K06294
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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.