VIBRA-SURGE SYSTEM MODEL VS2120

K971533 · Sonics & Materials, Inc. · LFL · Jul 25, 1997 · SU

Device Facts

• Record ID: K971533
• Device Name: VIBRA-SURGE SYSTEM MODEL VS2120
• Applicant: Sonics & Materials, Inc.
• Product Code: LFL · SU
• Decision Date: Jul 25, 1997
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• 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.

Indications for Use

Indicated for the removal of soft tissue in general surgery and plastic and reconstructive surgery.

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)

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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.<br>Kenosia Avenue<br>Danbury, CT 06810<br>[phone] |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Alan Broadwin [phone] |
| Date Prepared: | 4/23/97 |
| Trade or Proprietary Name: | <i>VIBRA-SURGE</i> ™ System VS2120 |
| Common, Usual or Classification Name: | Instrument, Ultrasonic Surgical |
| Predicate Devices: | MedSonic Incorporated Alliger Ultrasonic Surgical<br>System Model AUSS-1; Valleylab CUSA® 200<br>Series Ultrasonic Surgical Aspirator; Sharplan<br>ULTRA Ultrasonic Surgical Aspirator. |
| Device Description: | The <i>VIBRA-SURGE</i> ™ System VS2120 is comprised<br>of a generator, operating at one of several possible<br>standard line voltages, contained in a console which<br>feeds a 20-22 kHz electrical signal to a surgical<br>handpiece containing piezoceramic crystals. These<br>crystals convert the electrical energy into mechanical<br>motion. This mechanical motion has the same<br>frequency of 20-22 kHz. Fragmentation of<br>unwanted tissues occurs at the end of the tip which<br>is hollow allowing the use of a vacuum source to<br>remove these fragments. |
| Intended Use: | Aids in the fragmentation, emulsification and removal of soft<br>tissue in General and Plastic & Reconstructive Surgery |
| Technological Characteristics. | The <i>VIBRA-SURGE</i> ™ System VS2120 is similar in<br>design, material and operating parameters to the<br>predicate devices indicated above. Consequently no<br>new safety or efficacy issues exist and this device<br>was 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)

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510(k) Number