SONOTOME

K990572 · Sonokinetics, Inc. · LFL · May 21, 1999 · SU

Device Facts

• Record ID: K990572
• Device Name: SONOTOME
• Applicant: Sonokinetics, Inc.
• Product Code: LFL · SU
• Decision Date: May 21, 1999
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The SONOTOME System is intended for the following indications: Breakup and removal of soft tissues in Neurosurgery, GI and affiliated organ surgery, Urology, General surgery, Plastic and Reconstructive surgery, Orthopedic, GYN, Thoracic Surgery.

Device Story

SONOTOME™ System is a mechanical ultrasonic surgical aspirator; consists of ultrasonic power generator, reusable handpiece, and hollow titanium probe tip. Operates by converting electrical energy into ultrasonic energy at tip; causes tissue fragmentation via cavitation. Irrigation saline flow cools probe and flushes site; debris aspirated through probe tip into disposable trap between handpiece and vacuum canister. Activated by foot pedal. Used in surgical settings by physicians. Output is physical tissue removal; assists surgeons in precise tissue resection. Benefits include controlled soft tissue removal with integrated irrigation and aspiration.

Clinical Evidence

No clinical data. Bench testing only; device is unchanged from previously cleared version (K930629).

Technological Characteristics

Ultrasonic surgical aspirator; titanium probe tip; 20 kHz vibration frequency; 240 microns peak-to-peak amplitude; 10-400 ml/min irrigation flow; 5-15 in. Hg aspiration; 105-130 VAC power; self-contained console with ultrasonic, irrigation, and aspiration subsystems.

Indications for Use

Indicated for the breakup and removal of soft tissues in neurosurgery, GI, urology, general, plastic/reconstructive, orthopedic, GYN, and thoracic surgery.

Predicate Devices

• ACRYL-X™ II System (K930629)
• CUSA® 200 System (K853143, K864983, K884412, K884413, K894600, K910696)

Submission Summary (Full Text)

{0}------------------------------------------------

510K Submission

Sonokinetics SONOTOME™ System

K990572

# 510K Summary Sonokinetics

Sponsor Name 1. Sonokinetics 14 Equestrian Drive North Reading, MA 01864 Debbie Iampietro Contact Individual:

QRC Consulting Associates 7 Tiffany Trail Hopkinton.MA 01748 (508)-435-9893

- Device Name 2.
Proprietary Name: SONOTOME™ System Common/Usual Name: Ultrasonic Aspiration Device Classification Name: LFL

- Identification of Predicate or Legally Marketed Device 3. The Sonokinetics SONOTOME™ System is a mechanical ultrasonic surgical aspirator which is substantially equivalent to the following predicate devices: SonoKinetics' ACRYL-X™ II System (K930629) and ValleyLabs Inc. CUSA® 200 System (K853143, K864983, K884412, K884413, K894600, K910696).
#### 4. Device Description

The SONOTOMETM System contains three subsystems: ultrasonic energy, irrigation and aspiration. The SONOTOME™ System uses a hollow titanium tip PROBE mounted to a reusable handpiece. The ultrasonic power generator provides energy to the handle which converts it into ultrasonic energy at the tip. The irrigation and the ultrasonic energy are activated by depressing the foot pedal. The vibrating probe mounted on the hand piece is then applied to the tissue desired to be removed. The application of ultrasonic energy through the tip breaks down the tissue through a cavitation action. The resultant debris is aspirated through the probe tip and into a disposable trap between the handpiece and the vacuum canister. The flow of saline is maintained to reduce the temperature of the probe and to provide for a means of irrigation to the surgical site.

- ડ. Intended Use
The SONOTOME System is intended for the following indications: Breakup and removal of soft tissues in Neurosurgery, GI and affiliated organ surgery, Urology, General surgery, Plastic and Reconstructive surgery, Orthopedic, GYN, Thoracic.

{1}------------------------------------------------

#### 6. Comparison of Technological Characteristics

| | CUSA® NS-200<br>Valleylab Inc. | ACRYL-XTM II<br>SYSTEM<br>SonoKinetics | SONOTOMETM<br>Sonokinetics |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K# | K910696, 894600,<br>K884413, K884412 | K930629 | K930629 |
| Intended Use | Breakup and removal<br>of soft tissues in<br>Neurosurgery, GI and<br>affiliated organ<br>surgery, Urology,<br>General surgery, Plastic<br>and Reconstructive<br>surgery, Orthopedic,<br>GYN, Thoracic | Removal of<br>thermoplastic cement<br>from bones in revision<br>procedures | Breakup and removal of<br>soft tissues in<br>Neurosurgery, GI and<br>affiliated organ surgery,<br>Urology, General surgery,<br>Plastic and Reconstructive<br>surgery, Orthopedic, GYN,<br>Thoracic |
| Basic operating<br>principle | Metal tip driven by<br>ultrasound causing<br>tissue fragmentation<br>and aspiration through<br>tip | Metal tip driven by<br>ultrasound, cooling and<br>aspiration of plastic<br>through tip | Metal tip driven by<br>ultrasound causing tissue<br>fragmentation and<br>aspiration through tip |
| System console | Self-contained with<br>ultrasonic, irrigation,<br>and aspiration<br>subsystems | Self-contained with<br>ultrasonic, irrigation,<br>and aspiration<br>subsystems | Self-contained with<br>ultrasonic, irrigation and<br>aspiration subsystems |
| Amplitude of<br>vibration of tip | Adjustable up to 355<br>microns | 240 microns, peak to<br>peak | 240 microns, peak to peak |
| Vibration frequency | 23 kHz | 20 kHz | 20 kHz |
| Irrigation flow rates | 1.5-50cc/min | 10-400 ml/min | 10-400ml/min |
| Aspiration | 0-24 in. Hg | 5-15 in. Hg. | 5-15 in. Hg. |
| Disposable<br>components | Surgical Tips, suction<br>trap, irrigation/suction<br>tubing set | Surgical Tips, suction<br>trap, irrigation/suction<br>tubing set | Surgical Tips, suction trap,<br>irrigation/suction tubing<br>set |
| Power requirements | 100-120 VAC, 15amps,<br>50-60 Hz<br>200-240 VAC, 10amps,<br>50-60 Hz | 105-130 v a-c, 60 Hz,<br>500 watts | 105-130 v a-c, 60 Hz, 500<br>watts |

#### 7 Performance Testing

Since this 510K is for expanded indications only, and the device has not been modified from that cleared under K930629, no further performance testing was performed.

{2}------------------------------------------------

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure with three flowing lines representing the body and head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 1 1999

Sonokinetics, Inc. c/o Ms. Debbie Iampietro ORC Consulting Associates 7 Tiffany Trail Hopkinton, Massachusetts 01748

Re: K990572 Trade Name: SONOTOME™ System Regulatory Class: Unclassified Product Code: LFL Dated: February 22, 1999 Received: February 23, 1999

Dear Ms. Iampietro :

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.

{3}------------------------------------------------

### Page 2 - Ms. Debbie Iampietro

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

{4}------------------------------------------------

510(k) Number (if known): __ K99 05 72

SONOTOME™ System Device Name:

. . . . .

Indications For Use: The SONOTOME System is intended for the following indications: Breakup and removal of soft tissues in Neurosurgery, GI and

affiliated organ surgery, Urology, General surgery, Plastic and Reconstructive surgery, Orthopedic, GYN, Thoracic Surgery.

# (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

Division Sign-Off

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K960572

000000