← Product Code LFL · K971533 # VIBRA-SURGE SYSTEM MODEL VS2120 (K971533) _Sonics & Materials, Inc. · LFL · Jul 25, 1997 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K971533 ## Device Facts - **Applicant:** Sonics & Materials, Inc. - **Product Code:** LFL - **Decision Date:** Jul 25, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## Intended Use Aids in the fragmentation, emulsification and removal of soft tissue in General and Plastic & Reconstructive Surgery ## Device Story VIBRA-SURGE™ System VS2120 is an ultrasonic surgical instrument; consists of a console generator and a surgical handpiece. Generator provides 20-22 kHz electrical signal to piezoceramic crystals in handpiece; crystals convert electrical energy into mechanical motion at same frequency. Hollow tip fragments/emulsifies soft tissue; integrated vacuum source removes fragments. Used by surgeons in clinical settings for soft tissue removal. Benefits include efficient tissue fragmentation and aspiration. ## Clinical Evidence No clinical data provided; substantial equivalence based on technological characteristics and design similarity to predicate devices. ## Technological Characteristics System includes console generator and handpiece with piezoceramic crystals. Operates at 20-22 kHz frequency. Mechanical motion generated via piezoelectric conversion. Hollow tip design for vacuum-assisted aspiration. No software or complex algorithms described. ## Predicate Devices - MedSonic Incorporated Alliger Ultrasonic Surgical System Model AUSS-1 - Valleylab CUSA® 200 Series Ultrasonic Surgical Aspirator - Sharplan ULTRA Ultrasonic Surgical Aspirator ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around it. Inside the circle is a stylized image of an eagle with three lines representing its wings and head. 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 {1}------------------------------------------------ ﺮ ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ 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 {2}------------------------------------------------ ## 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 Avenue
Danbury, 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 Surgical
System Model AUSS-1; Valleylab CUSA® 200
Series Ultrasonic Surgical Aspirator; Sharplan
ULTRA Ultrasonic Surgical Aspirator. | | Device Description: | 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. | | Intended Use: | Aids in the fragmentation, emulsification and removal of soft
tissue in General and Plastic & Reconstructive Surgery | | Technological Characteristics. | The VIBRA-SURGE ™ System VS2120 is similar in
design, material and operating parameters to the
predicate devices indicated above. Consequently no
new safety or efficacy issues exist and this device
was determined to be substantially equivalent. | {3}------------------------------------------------ 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 __ (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) (Division)Sign-O Division of Gene bcool (Division)Sign-Off) Division of General Restorative Devices, k971533 510(k) Number --- **Source:** [https://fda.innolitics.com/device/K971533](https://fda.innolitics.com/device/K971533) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com