LYSONIX ASPIRATION PUMP

K980454 · Lysonix, Inc. · BTA · Mar 18, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K980454
• Device Name: LYSONIX ASPIRATION PUMP
• Applicant: Lysonix, Inc.
• Product Code: BTA · General, Plastic Surgery
• Decision Date: Mar 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LySonix Aspiration Pump System is for the suction or aspiration of fluids and tissue during surgical procedures. The device is designed to operate with the LySonix 2000 Ultrasonic Surgical System or as a stand-alone aspiration system.

Device Story

LySonix Aspiration Pump System functions as a suction/aspiration device for surgical fluids and tissue. Operates as a standalone unit or integrated with LySonix 2000 Ultrasonic Surgical System. Available as tabletop unit or part of an operative workstation. Used by surgeons in clinical/surgical settings to remove biological material during procedures. Provides vacuum-based aspiration to assist in surgical site clearance.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Aspiration pump system; tabletop or workstation form factor; mechanical suction principle. No specific materials, energy sources, or software algorithms described.

Indications for Use

Indicated for suction or aspiration of fluids and tissue during surgical procedures. No specific patient population, age, or gender restrictions provided.

Regulatory Classification

Identification

A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.

Predicate Devices

• LySonix Ultrasonic Surgical System (aspiration component)

Submission Summary (Full Text)

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K980454

## 510(k) SUMMARY

MAR 1 8 1900

· his 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92

| Submitted by: | Ronald F. Lagerquist<br>Regulatory Affairs Manager<br>LySonix Inc.<br>1170 Mark Avenue<br>Carpinteria, CA 93013<br>Telephone: [phone] |
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FAX:

February 4, 1998 Date Prepared:

## Device Name:

・・

Proprietary Name: LySonix Aspiration Pump System

Common Name: Aspiration Pump

## Indication for Use:

The LySonix Aspiration Pump System is for the suction or aspiration of fluids and tissue during surgical procedures. The device is designed to operate with the LySonix 2000 Ultrasonic Surgical System or as a stand-alone aspiration system.

[phone]

# Device Description:

The LySonix Aspiration Pump System is a stand-alone version of the aspiration component of the LySonix Ultrasonic Surgical System. The system is available as a tabletop unit or as part of an integrated Operative Workstation.

## Substantial Equivalence:

· The LySonix Aspiration Pump System is equivalent to the aspiration component of the LySonix Ultrasonic Surgical System in terms of intended use, design, operating principles, materials and performance.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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Mr. Ronald F. Lagerquist Regulatory Affairs Manager LySonix, Inc. 1170 Mark Avenue Carpinteria, California 93013

Re: K980454 LySonix Aspiration Pump System Trade Name: Requlatory Class: II Product Code: BTA and JCX Dated: February 4, 1998 Received: February 5, 1998

Dear Mr. Lagerquist:

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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent dețermination 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 (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory 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 - Mr. Lagerquist

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,

R. Slyter Rhodes
Galen M. Witter, Ph.D.

M. Witten, Ph.D., M.D. irector ivision of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE

Applicant:

LySonix, Inc.

510(k) Number:

K980454

LySonix Aspiration Pump System Device Name:

Indications For Use:

The LySonix Aspiration System is intended for the suction or aspiration of fluids and tissue during surgical procedures. The device is designed to operate with the LySonix 2000 Ultrasonic Surgical System or as a standalone aspiration system.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE)

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Division of General Restorative Devices
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Prescription Use X Per 21 CFR 801.109

OR

Over-the-Counter