(20 days)
The Polaris LV is intended for use in dermatology for treatment of vascular lesions.
The Polaris LV is a device that is used for treatment of vascular lesions. The Polaris LV 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 damage to the hair follicle without damaging the surrounding tissues.
This 510(k) summary describes a Special 510(k) for the Polaris LV / LVA Applicator, which involves an increase in the laser energy density output. The submission explicitly states that the modifications do not affect the intended use or alter the fundamental scientific technology and raise no new issues of safety or effectiveness. As such, the document primarily focuses on the device description and its substantial equivalence to a predicate device, rather than detailed performance studies with acceptance criteria for a new clinical claim. Therefore, much of the requested information regarding acceptance criteria and performance studies (like sample sizes for test sets, ground truth establishment, expert qualifications, MRMC studies, and standalone performance) is not present in the provided text.
However, based on the information provided, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria or report specific performance metrics from a study designed to measure the device's efficacy against such criteria for the modified device. The basis for approval is primarily "Predicate Device (PD)" and "Bench Test Data (BTD)".
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated for this Special 510(k). The regulatory review focuses on the modifications not raising new safety or effectiveness issues. | The device's modified optical fluence (increased from 140 to 350 J/cm²) is considered safe and effective by demonstrating substantial equivalence to predicate devices and through bench testing. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document does not describe a clinical test set or study with human subjects for this Special 510(k) submission. The approval is based on "Predicate Device" and "Bench Test Data".
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 applicable, as no clinical test set with ground truth establishment by experts is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set with adjudication 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 device is a laser applicator for treating vascular lesions, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a laser applicator for treatment, not an algorithm. However, "Bench Test Data (BTD)" was used, which represents standalone testing of the device's physical performance characteristics (e.g., energy output).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable for clinical efficacy in this submission. For the bench testing, the "ground truth" would be the device's measured physical parameters (e.g., actual energy output) compared against engineering specifications and predicate device parameters.
8. The sample size for the training set
Not applicable. No training set is mentioned as this device is not an AI algorithm.
9. How the ground truth for the training set was established
Not applicable. No training set is mentioned.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENES
SYNERON MEDICAL Ltd. Polaris LV / LVA 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 LV , LVA Applicator
This is a Special 510(k) for the Polaris LV that was cleared Predicate Devices: under K030186.
Device Description: The Polaris LV is a device that is used for treatment of vascular lesions. The Polaris LV 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 damage to the hair follicle without damaging the surrounding tissues.
The Polaris LV is intended for use in dermatology for treatment of vascular lesions.
The modifications to the Polaris LV do not affect the intended use or alter the fundamental scientific technology of the device. The only device modification is increasing the laser energy density output, still with in the range of predicate devices.
There are no labeling changes that affect the intended use of the device. The device modifications raise no new issues of safety or effectiveness.
August 22 20005
tuir Waldman
Dr. Amir Waldman
VP regulatory & clinical affairs Syneron Medical Ltd.
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Name of Manufacturer: Synergy Medical Ltd.
Laser Model Name and Number: Polaris LV
Laser Type: -(Circle all that apply)-
Alexandrite, Argon, CO₂, Copper-Vapor, (Diode), Dye, Nd:YAG, Erb: Y
Hol: YAG, Krypton, Ruby, KTP/532, Excimer, HENE, Accessory, Other_
Indications in this Application: Treatment for dermatological Vascular
lesions.
List of Examples:
| Labels | Values |
|---|---|
| FDA Document Control Number | K 052324 |
| FDA Product Code | GEX |
| Reviewer Computer Initials | SPB |
| Date of Clearance Letter |
Basis of Approval: -(Circle all that apply)-
Predicate Device (PD), Clinical Data (CD), Animal Data (AD
Specifications (SPECS), Bench Test Data (BTD), Historical Informati
(HI), Other
Description of Laser:
Operation Modes: -(Circle all that apply)-
CW, (Pulsed), Q-Switched, Mode Locked, Contact, Free beam, Other
Wavelength(s) in Nanometers: 780-980
Power/Energy Range (watts/joules): 350 J/cm² (optical) + 100 J/cm³ (RF) Pul
Width: 100 msec Repetiti
Rate: 1 Hz Delivery System(s
Laser beam is transmitted through the light guide out of the applicator.
Comments: Laser and RF Energy are combined for the treatment.
This special 510(K) is for enhancing the optical fluence from 140 to
350 J/cm²
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three heads facing to the left, and two wavy lines below the eagle. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circle around the eagle.
SEP 1 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Amir Waldman VP Regulatory & Clinical Affairs Syneron Medical Ltd., Tavor Building Industrial Zone P.O.B. 550 Yokneam Illit, Israel 20692
Re: K052324 Trade/Device Name: Polaris LV, LVA 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: August 22, 2005 Received: August 25, 2005
Dear Dr. Waldman:
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 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 forth in the quality systems (OS) 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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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/dsma/dsmamain.html
Sincerely yours,
Barbara Borlund
for
Mark N. Melkerson 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
510(k) Number (if known): K US 2324
Device Name: Polaris LV, LVA Applicator
Indications For Use: The Polaris LV is intended for use in dermatology for treatment of vascular lesions.
Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
Shatiav Buchup for WXM
(Division Division of General, Restorative, and Neurological Devices
510(k) Number K052324
Page 1 of
§ 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.