(110 days)
The Polaris DS / Comet is indicated for hair removal, permanent hair reduction. The Polaris DS / Comet is intended for use on all skin types, (Fitzpatrick skin type I-VI), including tanned skin.
The Polaris DS / Comet is a device indicated for hair removal, permanent hair reduction. The Polaris DS is intended for use on all skin types, (Fitzpatrick skin type I-VI), including tanned skin. The Polaris DS / Comet 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 for K041959 regarding the Polaris DS / Comet device is very brief and primarily focuses on establishing substantial equivalence to predicate devices for its intended use of hair removal and permanent hair reduction across all skin types. It does not contain the detailed information required to answer most of the questions about acceptance criteria and a specific study proving device performance.
Based only on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The provided 510(k) summary does not contain any explicit acceptance criteria or reported device performance metrics from a clinical study. It states that "Based upon an analysis of the overall performance characteristic for the device, Syneron Medical Ltd. believes that no significant differences present. Therefore the Polaris DS / Comet should raise no new issues of safety or effectiveness." This statement is a general declaration of equivalence rather than a report of specific performance against defined acceptance criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe any specific test set or clinical study, and therefore no sample size, data provenance, or study design (retrospective/prospective) is mentioned.
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)
No test set or ground truth establishment is described in the provided text. Therefore, this information is not available.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
No test set requiring adjudication is described in the provided text. Therefore, this information is not available.
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
The device is a medical laser system for hair removal, not an AI or imaging diagnostic device that would involve "human readers" or AI assistance in the way a MRMC study typically applies. Therefore, this type of study is not applicable to this device. The provided text also makes no mention of any AI component.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is also more relevant to AI/diagnostic algorithms. The Polaris DS / Comet is a therapeutic device. Therefore, a "standalone algorithm performance" study is not applicable in the context of this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Since no specific study or test set is described, the type of ground truth used is not mentioned.
8. The sample size for the training set
The document does not describe any training set, as it doesn't detail a machine learning or AI-based component of the device.
9. How the ground truth for the training set was established
As no training set is mentioned, information on how its ground truth was established is not available.
Summary of what is present:
- Device Name: Polaris DS / Comet
- Intended Use: Hair removal, permanent hair reduction on all skin types (Fitzpatrick I-VI), including tanned skin.
- Predicate Devices: Polaris DS (K024064), Polaris WR (K031671), LightSheer (K003614), Mythos 500 (K030805).
- Mechanism: Selective (electromagnetic) thermolysis using optical and RF energy to damage hair follicles without harming surrounding tissues.
- Conclusion of 510(k) Summary: Substantially equivalent to predicate devices, raising no new issues of safety or effectiveness.
Conclusion: The provided 510(k) summary is extremely high-level and serves the purpose of establishing substantial equivalence without detailing specific clinical study results, performance metrics, or method validation. For a device like a laser for hair removal, especially one cleared through the 510(k) pathway, detailed efficacy and safety data from clinical trials with specific acceptance criteria might be found in other sections of the 510(k) submission not included in this "Summary of Safety and Effectiveness."
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS SYNERON MEDICAL Ltd. POLARIS DS / Comet
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., Sultam Industrial park, P.O.B. 550, Submitter: Yokneam Elite 20692, Israel. Tel. +972-4-909-7424 ext. 7604, Fax +972-4-909-7417
Name of the Device: Polaris DS / Comet
- The Polaris DS /Comet is substantially equivalent to a Predicate Devices: combination of four laser powered surgical instruments (21 CFR 878.4810, procode GEX): Polaris DS, manufactured by Syneron Medical Ltd. and subject of K024064. Polaris WR, manufactured by Syneron Medical Ltd. and subject of K031671. LightSheer, manufactured by Lumenis Inc. and subject of K003614. Mythos 500, manufactured by Msq Ltd. and subject of K030805
- Device Description: The Polaris DS / Comet is a device indicated for hair removal, permanent hair reduction. The Polaris DS is intended for use on all skin types, (Fitzpatrick skin type I-VI), including tanned skin. The Polaris DS / Comet 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 DS is intended for use in dermatology for hair removal, permanent hair reduction. The Polaris DS is intended for use on all skin types, (Fitzpatrick skin type I-VI), including tanned skin.
Based upon an analysis of the overall performance characteristic for the device, Syneron Medical Ltd. believes that no significant differences present. Therefore the Polaris DS / Comet should raise no new issues of safety or effectiveness.
July 15 2007
Amelia Weber
Dr. Amir Waldman, Director regulatory affairs Syneron medical Ltd.
Date
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 8 2004
Dr. Amir Waldman Director, Regulatory Affairs Syneron Medical Ltd. Sultam Industrial Park P.O.B 550 Yokneam Elite 20692. Israel
Re: K041959 Trade/Device Name: Polaris DS / Comet Regulation Number: 21 CFR 878.4810, 21 CFR 878.4400 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology, Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEX, GEI Dated: October 21, 2004 Received: October 25, 2004
Dear Dr. Waldman:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encrobare) to regary to regars and the Medical Device Amendments, or to conninered province with the provisions with the provisions of the Federal Food, Drug, de necs that have been require approval of a premarket approval application (PMA). and Cosmeter Act (1107 market the device, subject to the general controls provisions of the Act. The r ou may, dictions provisions of the Act include requirements for annual registration, listing of general bonus provisions of visitive, 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 If your device to such additional controls. Existing major regulations affecting your device can may or subject to back additions, 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 I tease be activities that I Driseanter over device complies with other requirements of the Act that I Dri has Intacted and regulations administered by other Federal agencies. You must of any I cataled and registments, including, but not limited to: registration and listing (21
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Page 2 - Dr. Amir Waldman
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set OI It I all 607); adoling (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (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) This icher will anow you to organ finding of substantial equivalence of your device to a legally prematicate 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 If you desire specific advice 10. 900 and 11. Also, please note the regulation entitled, Contact the Office or Comparket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other geleral informational 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,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known)_ K_041959
Device Name___ Polaris DS / Comet.
Indications For Use:
The Polaris DS / Comet is indicated for hair removal, permanent hair The Fouris DS / Comet is intended for use on all skin types, (Fitzpatrick skin type I-VI), including tanned skin.
(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__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Miriam C. Provost
(Division Division of Ge Rest - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - and Neurological Devices.
510(k) Number K041959
§ 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.