LYSUS INFUSION SYSTEM

K050472 · Ekos Corp. · DRA · Mar 11, 2005 · Cardiovascular

Device Facts

• Record ID: K050472
• Device Name: LYSUS INFUSION SYSTEM
• Applicant: Ekos Corp.
• Product Code: DRA · Cardiovascular
• Decision Date: Mar 11, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1280
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Lysus® Infusion System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

Device Story

System comprises disposable infusion catheter with removable ultrasound core and control instrument. Catheter features multiple side holes for fluid delivery; ultrasound core contains up to 30 evenly spaced elements for energy delivery. Thermal sensors monitor transducer temperature in treatment zone. Used in clinical settings for peripheral vasculature infusion. Physician operates system to deliver fluids; ultrasound energy facilitates infusion. Modified version includes lubricious coating on interior of drug delivery catheter to enhance performance.

Clinical Evidence

No clinical data provided. Substantial equivalence established via bench testing and design evaluation.

Technological Characteristics

System includes infusion catheter with removable ultrasound core and control instrument. Catheter features multiple side holes and up to 30 ultrasound elements. Thermal sensors integrated for temperature monitoring. Modified design incorporates lubricious coating on catheter interior. Energy source: ultrasound. Sterilization: not specified.

Indications for Use

Indicated for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

Regulatory Classification

Identification

A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.

Predicate Devices

• Lysus® Infusion System (K041629)
• Lysus® Infusion System (K042456)

Submission Summary (Full Text)

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#### Section 4. 510(k) Summary

General Provisions

| Submitter's Name and Address: | EKOS Corporation<br>22030 20th Ave. SE<br>Suite 101<br>Bothell, WA 98021 |
|-------------------------------|--------------------------------------------------------------------------------|
| Contact Person: | Jocelyn Kersten<br>425-482-1108<br>425-482-1109 (fax)<br>[e-mail] |
| Classification Name: | Catheter, Continuous Flush (KRA) |
| Common or Usual Name: | Continuous Flush Catheter |
| Proprietary Name: | Lysus® Infusion System |
| Name of Predicate Device: | Lysus® Infusion System |
| 510(k) Reference No.: | K041629 and K042456 |

### Device Description

The system consists of a disposable infusion catheter with removable ultrasound core and an instrument that generates and controls the delivery of energy to the catheter. The infusion catheter contains multiple side holes distributed over the length of the treatment zone. The ultrasound core contains up to 30 ultrasound elements, evenly spaced over the treatment zone. Thermal sensors in the treatment zone monitor transducer temperature.

### Intended Use

The Lysus® Infusion System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

### Summary of Technological Characteristics

The proposed Lysus Infusion System is similar in construction to the previously cleared Lysus Infusion System. The modified system includes a lubricious coating on the inside of the Drug Delivery Catheter.

### Test Summary

The proposed Lysus Infusion System is considered to be substantially equivalent to the currently marketed Lysus Infusion System based on a comparison of the intended uses and designs and results of the testing and evaluations performed.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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MAR 1 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

EKOS Corporation c/o Ms. Jocelyn Kersten Director, Regulatory Affairs 22030 20th Avenue, SE, Suite 101 Bothell, WA 98021

Rc: K050472

Lysus® Infusion System Regulation Number: 21 CFR 870.1210 Regulation Name: Continous Flush Catheter Regulatory Class: Class II (two) Product Code: DRA Dated: February 24, 2005 Received: February 25, 2005

Dear Ms. Kersten:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for abornerou ar 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276- . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

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Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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SPECIAL 510(k) Notification Lysus® Infusion System

# Indications for Use

510(k) Number (if known): K050472

Device Name: Lysus® Infusion System

Indications For Use: The Lysus® Infusion System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duana R. Kirchner

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number_K 050 47 2

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