(76 days)
The Polaris WR is intended for non invasive wrinkle treatment.
The Polaris WR, ST applicator is indicated for non invasive wrinkles treatment.
The Polaris WR is a device that is used for non invasive wrinkle treatment. The Polaris WR treatment is based on the principle of selective (electromagnetic) thermolysis. According to this principle, parameters of optical and RF energy (spectrum, exposure duration and energy density) are chosen and optimized to selectively heat the skin without damaging the epidermis layer.
The provided 510(k) summary for the Syneron Medical Ltd. Polaris WR / ST Applicator does not contain information about acceptance criteria or a study proving that the device meets specific acceptance criteria.
The document is a Special 510(k) submission, indicating modifications to an already cleared device (Polaris WR). The focus is on demonstrating substantial equivalence to the predicate device, specifically regarding a change in the output wavelength spectrum.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and the reported device performance: No specific acceptance criteria or performance metrics derived from a study are mentioned.
- Sample size used for the test set and the data provenance: No test set is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment process is mentioned.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: No adjudication method is mentioned.
- 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: No MRMC or AI-assisted study is described as this is a device for wrinkle treatment, not an AI diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as it's a physical treatment device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth is mentioned.
- The sample size for the training set: Not applicable as it's a physical treatment device.
- How the ground truth for the training set was established: Not applicable.
The document primarily states that:
- The device is intended for non-invasive wrinkle treatment.
- The modification involves changing the output wavelength spectrum from 780-980 nm to 700-2000 nm.
- These modifications "raise no new issues of safety or effectiveness."
This suggests that the justification for substantial equivalence relies on the nature of the modification being minor and not altering the fundamental scientific technology or intended use, rather than presenting a new clinical study with specific acceptance criteria.
{0}------------------------------------------------
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
SYNERON MEDICAL Ltd. Polaris WR / ST Applicator
This summary of safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
Syneron Medical Ltd., Tavor Bld., Submitter: Industrial Zone Yokneam Illit, Israel
Tel. +972.4.909-6200, Fax +972.4. 909-6202
Name of the Device: Polaris WR, ST Applicator
This is a Special 510(k) for the Polaris WR that was cleared Predicate Devices: under K031671.
Device Description: The Polaris WR is a device that is used for non invasive wrinkle treatment. The Polaris WR treatment is based on the principle of selective (electromagnetic) thermolysis. According to this principle, parameters of optical and RF energy (spectrum, exposure duration and energy density) are chosen and optimized to selectively heat the skin without damaging the epidermis layer.
The Polaris WR is intended for non invasive wrinkle treatment.
The modifications to the Polaris WR, ST applicator do not affect the intended use or alter the fundamental scientific technology of the device. The only device modification is changing the output wavelengths spectrum from 780-980 nm in the original Polaris WR to 700 - 2000 nm on the new Polaris WR, ST applicator.
There are no labeling changes that affect the intended use of the device. The device modifications raise no new issues of safety or effectiveness.
December 22 2005
Dr. Amir Waldman
Amir Waldren
VP regulatory & clinical affairs Syneron Medical Ltd.
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a bird or an abstract human figure with outstretched arms. The logo is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 4 2006
Syneron Medical LTD c/o Dr. Amir Waldman VP. Regulatory Affairs Sultam Industrial Park P.O. Box 550 Yokneam Elite 20692. Israel
Re: K053616
Trade/Device Name: Polaris WR, ST Applicator 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, GEI Dated: February 23, 2006 Received: February 24, 2006
Dear Dr. Waldman:
We have reviewed your Scction 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. Iisting 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 vour 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 nean 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.
{2}------------------------------------------------
Page 2 – Dr. Waldman
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) 638-204) or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmadsmamain.html
Sincerely yours,
Q.Mell
~ Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for Syneron Medical Ltd. The word "Syneron" is in a bold, sans-serif font, with the "S" stylized with a curved line extending from the top left. Below "Syneron" is the text "Medical Ltd." in a smaller, sans-serif font.
Sultam Industrial Park P.O.B. 550 Yokneam Elite 20692, Israel Tel: (972) 4 9096200 Fax: (972) 4 9096202
510(k) Number (if known) K053616.
Device Name
Indications For Use:
The Polaris WR, ST applicator is indicated for non invasive wrinkles treatment.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ (Per 21 CFR 801.109)
OR
Over The Counter Use__________________________________________________________________________________________________________________________________________________________
lmal
(Optional Format 1-2-96)
(Division Sign-Of Division of General, Restorative, and Neurological Devices
510(k) Number_ Ko 5 361 6
§ 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.