(88 days)
Aids in the fragmentation, emulsification and removal of soft tissue in General and Plastic & Reconstructive Surgery
The VIBRA-SURGE ™ System VS2120 is comprised of a generator, operating at one of several possible standard line voltages, contained in a console which feeds a 20-22 kHz electrical signal to a surgical handpiece containing piezoceramic crystals. These crystals convert the electrical energy into mechanical motion. This mechanical motion has the same frequency of 20-22 kHz. Fragmentation of unwanted tissues occurs at the end of the tip which is hollow allowing the use of a vacuum source to remove these fragments.
The provided document is a 510(k) summary for the VIBRA-SURGE™ System VS2120 Ultrasonic Surgical Instrument. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain information regarding detailed acceptance criteria, specific device performance data from studies, sample sizes, data provenance, expert qualifications, ground truth establishment, or multi-reader multi-case studies.
Therefore, I cannot provide the requested information from the given text. The document primarily focuses on establishing substantial equivalence to previously marketed devices as part of the 510(k) premarket notification process.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robert Soloff President Sonics & Materials Inc ................ Kenosia Avenue Danbury, Connecticut 06810
JUL 25 1997
Re: K971533
Trade Name: VIBRA-SURGE™ System Model VS2120 Ultrasonic Surgical Instrument Regulatory Class: Unclassified Product Code: LFL Dated: April 23, 1997 Received: April 28, 1997
Dear Mr. Soloff:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General reguiation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the
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Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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JUL 2 5 1997
6971533
510(k) Summary - Sonics and Materials, Inc. VIBRA~SURGE™ System Model VS2120
This summary of safety and effectiveness is submitted in accordance with the requirements of 21 CFR 807 92
| Submitter: | Sonics & Materials, Inc.Kenosia AvenueDanbury, CT 06810(203)744-4400 |
|---|---|
| Contact Person: | Alan Broadwin (914) 833-2649 |
| Date Prepared: | 4/23/97 |
| Trade or Proprietary Name: | VIBRA-SURGE ™ System VS2120 |
| Common, Usual or Classification Name: | Instrument, Ultrasonic Surgical |
| Predicate Devices: | MedSonic Incorporated Alliger Ultrasonic SurgicalSystem Model AUSS-1; Valleylab CUSA® 200Series Ultrasonic Surgical Aspirator; SharplanULTRA Ultrasonic Surgical Aspirator. |
| Device Description: | The VIBRA-SURGE ™ System VS2120 is comprisedof a generator, operating at one of several possiblestandard line voltages, contained in a console whichfeeds a 20-22 kHz electrical signal to a surgicalhandpiece containing piezoceramic crystals. Thesecrystals convert the electrical energy into mechanicalmotion. This mechanical motion has the samefrequency of 20-22 kHz. Fragmentation ofunwanted tissues occurs at the end of the tip whichis hollow allowing the use of a vacuum source toremove these fragments. |
| Intended Use: | Aids in the fragmentation, emulsification and removal of softtissue in General and Plastic & Reconstructive Surgery |
| Technological Characteristics. | The VIBRA-SURGE ™ System VS2120 is similar indesign, material and operating parameters to thepredicate devices indicated above. Consequently nonew safety or efficacy issues exist and this devicewas determined to be substantially equivalent. |
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510(k) Number (if known):
Device Name:
Indications For Use:
Aids in The Removal of Soft Tissue in General Surgery and Plastic and Reconstructive Surgery
Sonics & Materials VIBRA~SURGE™ System Model VS2120
Initial Submission K971533
Ultrasonic Surgical Instrument __
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
(Division)Sign-O
Division of Gene
bcool
(Division)Sign-Off)
Division of General Restorative Devices, K971533
510(k) Number
N/A