LYSONIX IRRIGATION SYSTEM

K974233 · Lysonix, Inc. · GBX · Feb 3, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K974233
• Device Name: LYSONIX IRRIGATION SYSTEM
• Applicant: Lysonix, Inc.
• Product Code: GBX · General, Plastic Surgery
• Decision Date: Feb 3, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The LySonix Irrigation System is intended for delivery of fluids during general surgical procedures. The device is designed to operate with the LySonix 2000 Ultrasonic Surgical System or as a stand-alone irrigation system. The LySonix Irrigation System is not indicated for the administration of parenteral fluids, infusion of drugs or for any life sustaining purposes.

Device Story

LySonix Irrigation System functions as irrigation pump for general surgical procedures; delivers fluids to surgical site. Operates as stand-alone tabletop unit or integrated component of LySonix 2000 Ultrasonic Surgical System. Used in clinical/surgical settings by healthcare professionals. Provides fluid irrigation to assist surgical workflow; does not perform life-sustaining functions or drug delivery. Benefits patient by maintaining surgical site irrigation during procedures.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Irrigation pump; tabletop unit or integrated workstation module. Materials, design, and operating principles identical to predicate irrigation component.

Indications for Use

Indicated for fluid delivery during general surgical procedures. Not for parenteral fluid administration, drug infusion, or life-sustaining purposes.

Regulatory Classification

Identification

An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.

Predicate Devices

• LySonix Ultrasonic Surgical System (irrigation component)

Submission Summary (Full Text)

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K 974233

1170 Mark Avenue Carpinteria California 93013 Tel: [phone] Fax: [phone] Toll Free: 888-597-6649

#### 510(k) SUMMARY FEB - 3 1998

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

Ronald F. Lagerquist Submitted by: Regulatory Affairs Manager LySonix Inc. 1170 Mark Avenue Carpinteria, CA 93013

> Telephone: [phone] [phone] FAX:

November 10, 1997 Date Prepared:

Device Name:

Proprietary Name: LySonix Irrigation System

Common Name: Irrigation Pump

### Indication for Use:

The LySonix Irrigation System is intended for delivery of fluids during general surgical procedures. The device is designed to operate with the LySonix 2000 Ultrasonic Surgical System or as a stand-alone irrigation system.

The LySonix Irrigation System is not indicated for the administration of parenteral fluids, infusion of drugs or for any life sustaining purposes.

## Device Description:

The LySonix Irrigation System is a stand-alone version of the irrigation 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 Irrigation System is equivalent to the irrigation 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

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

FEB - 3 1998

Re: K974233 Trade Name: LySonix Irrigation System Regulatory Class: II Product Code: GBX Dated: November 10, 1997 Received: November-12, 1997 ----

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 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 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 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

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Page 2 - Mr. Lagerquist

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,

2 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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# INDICATIONS FOR USE

Applicant:

LySonix, Inc.

510(k) Number:

Device Name:

K 974233

LySonix Irrigation System

Indications For Use:

The LySonix Irrigation System is intended for delivery of fluids during general surgical procedures. The device is designed to operate with the LySonix 2000 Ultrasonic Surgical System or as a stand-alone irrigation system.

The LySonix Irrigation System is not indicated for the administration of parenteral fluids, infusion of drugs or for any life sustaining purposes.

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

Concurrence of CDRH Office of Device Evaluation (QDE)

Pioleea

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K974233

Prescription Use
Per 21 CFR 801.109

OR

Over-the-Counter