(198 days)
The VelaSmooth, Shaper is indicated for temporary reduction of thighs circumferences.
The VelaSmooth, Shaper treatment is based on the simultaneous application of heat and mechanical manipulation to the tissue, wherein the heat is derived from light energy at a controlled infrared wavelength and from conducted RF energy, and the mechanical manipulation is derived from massage and/or vacuum.
The provided 510(k) summary for the VelaSmooth, Shaper device is very concise and primarily focuses on establishing substantial equivalence to a predicate device for the indication of temporary reduction of thigh circumferences. It does not contain the detailed information typically found in a clinical study report that would allow for a comprehensive description of acceptance criteria and the study proving it.
Specifically, the document does not provide the following information from your request:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, the effect size
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
The document states: "Based upon an analysis of the overall performance characteristic for the device, Syneron Medical Ltd. believes that no significant differences exit." This implies that a performance characteristic was assessed, but the details of what that characteristic was, how it was measured, and what the specific acceptance criteria were are not provided. The phrase "no significant differences" typically refers to substantial equivalence to a predicate device rather than meeting specific quantifiable performance metrics against pre-defined acceptance criteria in a standalone study.
Without access to the full 510(k) submission, which would likely contain a more detailed clinical summary or study report, it's impossible to answer most of your questions based only on the provided text. The summary provided is a high-level overview for regulatory filing, not a detailed scientific publication of a clinical study.
{0}------------------------------------------------
070092
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS SYNERON MEDICAL Ltd. VELASMOOTH, SHAPER
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., Industrial Park, P.O.B. 550, Yokneam Submitter: Illit, 20692, Israel.
Tel. +972-4-909-6200 ext. 591, Fax +972-4-909-6202
Name of the Device: VelaSmooth. Shaper
- Predicate Devices: VelaSmooth, Shaper is substantially equivalent to the following VelaSmooth, Shaper laser surgical device: instrument, manufactured by Syneron Medical Ltd. and subject of K050397.
- Device Description: The VelaSmooth, Shaper treatment is based on the simultaneous application of heat and mechanical manipulation to the tissue, wherein the heat is derived from light energy at a controlled infrared wavelength and from conducted RF energy, and the mechanical manipulation is derived from massage and/or vacuum.
The VelaSmooth, Shaper is indicated for temporary reduction of thighs circumferences.
Based upon an analysis of the overall performance characteristic for the device, Syneron Medical Ltd. believes that no significant differences exit. Therefore the VelaSmooth, Shaper should raise no new issues of safety or effectiveness.
January 4, 2007
Yani I.
Date
Yoni Iger, Ph.D. Director of Clinical and Regulatory Affairs Syneron Medical Ltd.
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Syneron Medical Limited % Yoni Iger, Ph.D. Director of Clinical and Regulatory Affairs Industrial Zone P.O. Box 550, Yokneam Illit 20692. Israel
JUL 27 2007
Re: K070092
Trade/Device Name: VelaSmooth, Shaper 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: NUV Dated: April 4, 2007 Received: May 21, 2007
Dear Dr. Iger:
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
{2}------------------------------------------------
Page 2 - Yoni Iger, Ph.D.
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 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Millken
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
510(k) Number (if known)__ Ko 700 9 2
Device Name VelaSmooth, Shaper.
Indications For Use:
The VelaSmooth, Shaper is indicated for temporary reduction of thighs circumferences.
(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)
Mark A. Millhurn
(Division Sign-Off) (Division of General, Restorative, and Neurological Devices
510(k) Number __
§ 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.