EndoWave Infusion System

K080392 · Ekos Corp. · QEY · Apr 30, 2008 · Cardiovascular

Device Facts

• Record ID: K080392
• Device Name: EndoWave Infusion System
• Applicant: Ekos Corp.
• Product Code: QEY · Cardiovascular
• Decision Date: Apr 30, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

EndoWave Infusion System; disposable infusion catheter with removable ultrasound core; control instrument generates/delivers energy. Catheter features multiple side holes in treatment zone; ultrasound core contains up to 30 elements; thermal sensors monitor temperature. Used in clinical setting by physicians for peripheral vasculature infusion. Device delivers fluids while ultrasound energy potentially enhances thrombolytic effect. Modification involves revised acoustic protocol; system maintains original technological characteristics.

Clinical Evidence

Bench testing only. Testing confirmed revised acoustic protocol remains safe and ultrasound core operates as required.

Technological Characteristics

Disposable infusion catheter with removable ultrasound core; instrument for energy delivery. Up to 30 ultrasound elements; thermal sensors for temperature monitoring. Modification: revised acoustic protocol.

Indications for Use

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

Regulatory Classification

Identification

An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.

Predicate Devices

• EndoWave Infusion System (K072507)
• EndoWave Infusion System (K062508)

Submission Summary (Full Text)

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K080392 page 1 of 1

SPECIAL 510(k) Notification EndoWave™ Infusion System

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

General Provisions

Submitter's Name and Address:

EKOS Corporation 11911 North Creek Parkway South Bothell, WA 98011

Catheter, Continuous Flush (KRA)

Contact Person:

Jocelyn Kersten 425-415-3132 425-415-3102 (fax) [e-mail]

Classification Name:

Regulation Number:

21 CFR §870.1210

Continuous Flush Catheter

Proprietary Name:

Name of Predicate Device:

Common or Usual Name:

EndoWave Infusion System

EndoWave Infusion System

K072507, K062508 510(k) Reference No .:

### 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 catheter temperature.

### Intended Use

The EndoWave 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 device modification described in this notification does not affect the technological characteristics for the EndoWave Infusion System.

### Test Summary

Testing confirmed the revised acoustic protocol remains safe and the ultrasound core will operate as required with the new protocol.

# APR 3 0 2008