(35 days)
The Aurora SR is intended for use in dermatology for superficial benign vascular and pigmented lesion treatment.
The Aurora SR is a device that is used for superficial benign vascular and pigmented lesion treatment. The Aurora SR treatment is based on a principle of selective thermolysis. According to this principle, parameters of optical and RF energy (spectrum, exposure duration and energy density) are chosen (and optimized) to selectively damage (destroy) vascular and pigmented lesions without damaging the surrounding tissues.
This is a 510(k) summary for a Special 510(k) for the Syneron Medical Ltd. Aurora SR device. The provided document is a regulatory submission for a medical device and does not contain information about acceptance criteria or a study proving device performance against such criteria.
The document states that the modifications to the Aurora SR (an increase in RF energy output) "do not affect the intended use or alter the fundamental scientific technology of the device" and "raise no new issues of safety or effectiveness." This implies that the device's safety and effectiveness were considered established by the predicate device (K022266).
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample size and data provenance for the test set.
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- MRMC comparative effectiveness study results.
- Standalone performance study results.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
These details are typically found in a full efficacy study report, which is not part of this 510(k) summary. The purpose of a 510(k) Special submission is to demonstrate that a modified device is substantially equivalent to a legally marketed predicate device, often without requiring new clinical trials if the modifications do not significantly change safety or effectiveness.
{0}------------------------------------------------
AUG = 1 2003
K 031993
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS SYNERON MEDICAL Ltd. AURORA SR
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., Appolo Bld., Submitter: Industrial Zone Yoqneam Illit, Israel Tel. +972.4.909-7424, Fax +972.4. 909-7417
Name of the Device: Aurora SR
| Predicate Devices: | This is a Special 510(k) for the Aurora SR that was clearedunder K022266 |
|---|---|
| Device Description: | The Aurora SR is a device that is used for superficial benignvascular and pigmented lesion treatment. The Aurora SRtreatment is based on a principle of selective thermolysis.According to this principle, parameters of optical and RFenergy (spectrum, exposure duration and energy density) arechosen (and optimized) to selectively damage (destroy)vascular and pigmented lesions without damaging thesurrounding tissues. |
The Aurora SR is intended for use in dermatology for superficial benign vascular and pigmented lesion treatment.
The modifications to the Aurora SR do not affect the intended use or alter the fundamental scientific technology of the device. The only device modification an increase in the RF energy output. There are no labeling changes that affect the intended use of the device. The device modifications raise no new issues of safety or effectiveness.
24 June 2003
Date
Mr. Moshe Mizrahy
CEO
Syneron Medical Ltd.
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 1 2003
Dr. Amir Waldman Director, Regulatory Affairs Syneron Medical Ltd. Apollo Bld. Industrial Zone P.O Box 550 Yogneam Illit, 20692 Israel
Re: K031993 Trade/Device Name: Aurora SR Regulation Number: 21 CFR 878.4810, 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: June 24, 2003 Received: July 2, 2003
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. 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 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 (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. Amir 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 (301) 594-4659. 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,
Muriam 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
{3}------------------------------------------------
K 031993 510(k) Number
Device Name
こ
Indications For Use: (separate page)
The Aurora SR is indicated for superficial benign vascular and pigmented lesion 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__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Miriam C. Provost
Division of General, Restorative and Neurological Devices
510(k) Number K031993
§ 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.