SOUND VASER SYSTEM

K991791 · Sound Surgical Technologies, LLC · LFL · Aug 12, 1999 · SU

Device Facts

• Record ID: K991791
• Device Name: SOUND VASER SYSTEM
• Applicant: Sound Surgical Technologies, LLC
• Product Code: LFL · SU
• Decision Date: Aug 12, 1999
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The SoundVASER System is indicated for use in the following surgical specialties when the fragmentation, emulsification, and aspiration of soft tissue is desired: Neurosurgery, Gastrointestinal and Affiliated Organ Surgery, Urological Surgery, Plastic and Reconstructive Surgery, General Surgery, Orthopedic Surgery, Gynecological Surgery, Thoracic Surgery, and Laparoscopic Surgery.

Device Story

SoundVASER System is an ultrasonic surgical device; consists of ultrasonic generator, handpiece, probe, and suction/irrigation subsystem. Generator converts electrical energy to vibratory motion in probe; tip fragments and emulsifies soft tissue upon contact. Suction/irrigation subsystem removes fragmented tissue. Used in clinical/surgical settings by surgeons. Output is mechanical tissue fragmentation/aspiration; assists in surgical procedures requiring tissue removal. Benefits include efficient soft tissue emulsification.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and design similarity to predicate devices.

Technological Characteristics

Ultrasonic surgical system; includes generator (110/120 and 220/240 VAC), handpiece, and probe. Operates via ultrasonic vibration for tissue fragmentation. Includes integrated suction/irrigation subsystem. Class II device (Product Code LFL).

Indications for Use

Indicated for patients requiring soft tissue fragmentation, emulsification, and aspiration across neurosurgical, GI, urological, plastic/reconstructive, general, orthopedic, gynecological, thoracic, and laparoscopic surgical specialties.

Predicate Devices

• Valleylab Inc., CUSA Excel Ultrasonic Surgical Aspirator System (K981262)
• CUSA Lap Accessory (K921251)

Submission Summary (Full Text)

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Sound Surgical Technologies LLC - Creating the Perfect Wave >

1300 Plaza Court North, Suite 203, Lafayette, CO 80026 fax [phone] tel [phone] [e-mail]

# 510(k) Summary

This summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92.

> 991791 The assigned 510(k) number is:

Submitter

Sound Surgical Technologies LLC 1300 Plaza Court North, #203 Lafayette, Colorado 80026

Contact Person William W. Cimino, Ph.D.

303-926-8608 (TEL) 303-926-8615 (FAX)

Date Prepared May 24, 1999

Proprietary Name SoundVASER System

Common, Usual, or Classification Name Instrument, Ultrasonic Surgical

Classification

Class: Class II Panel: 21 CFR 878, General and Plastic Surgery Product Code: LFL

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### Predicate Devices

The SoundVASER System is similar in technical design and operation to other surgical systems with ultrasonic vibration, irrigation, and suction that the FDA has determined to be substantially equivalent to pre-amendment devices as depicted below:

- Valleylab Inc., CUSA Excel Ultrasonic Surgical Aspirator System -(K981262) and CUSA Lap Accessory (K921251)
### Device Description

The SoundVASER System is comprised of an ultrasonic generator (110/120 and 220/240 VAC, 50 & 60 Hz), an ultrasonic surgical handpiece with an ultrasonic surgical probe, and a suction/irrigation subsystem. The ultrasonic surgical handpiece converts electrical energy supplied by the ultrasonic generator into vibratory motion. The vibratory motion is applied to the ultrasonic surgical probe that is attached to the ultrasonic surgical handpiece. The vibratory motion at the tip of the ultrasonic surgical probe fragments and emulsifies contacted soft tissues. The suction/irrigation subsystem is used to remove the fragmented tissues. The suction and irrigation functions may be performed simultaneously or independently.

#### Intended Use

The SoundVASER System is indicated for use in the following surgical specialties when the fragmentation, emulsification, and aspiration of soft tissue is desired: Neurosurgery, Gastrointestinal and Affiliated Organ Surgery, Urological Surgery, Plastic and Reconstructive Surgery, General Surgery, Orthopedic Surgery, Gynecological Surgery, Thoracic Surgery, and Laparoscopic Surgery.

### Summary of Technological Characteristics

The SoundVASER System is similar with regard to design, operation, materials, methods of sterilization, and intended use to the predicate devices indicated above. Therefore, no new safety or efficacy issues are created and the SoundVASER System is substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a bird-like figure with three curved lines representing its wings or body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 12 1999

William W. Cimino, Ph.D. President Sound Surgical Technologies LLC 1300 Plaza Court North. Suite 203 Lafavette. Colorado 80026

Re: K991791 Trade Name: Sound Vaser System Regulatory Class: II Product Code: LFL Dated: May 24, 1999 Received: May 26, 1999

Dear Dr. Cimino:

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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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 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.

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#### Page 2 - William W. Cimino, Ph.D.

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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510(k) Number (if known):

ber (if known): K 991791

Device Name: SoundVASER System

### Indications for Use:

The SoundVaser System is indicated for use in the following surgical specialties when the fragmentation, emulsification, and aspiration of soft tissue is desired

- Neurosurgery -
- Gastrointestinal and Affiliated Organ Surgery -
- Urological Surgery -
- -Plastic and Reconstructive Surgery
- General Surgery -
- Orthopedic Surgery -
- Gynecological Surgery -
- Thoracic Surgery -
- Laparoscopic Surgery -

# (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K99179/

Prescription Use لل (per 2.1 CFR 801 109) (Optional Format 1-2-96) OR

Over-The-Counter Use