EKOS MICRO-INFUSION SYSTEM

K051225 · Ekos Corp. · NUI · Jun 10, 2005 · Cardiovascular

Device Facts

• Record ID: K051225
• Device Name: EKOS MICRO-INFUSION SYSTEM
• Applicant: Ekos Corp.
• Product Code: NUI · Cardiovascular
• Decision Date: Jun 10, 2005
• Decision: SESU
• Submission Type: Special
• Regulation: 21 CFR 870.1200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EKOS Micro- Infusion System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature. The EKOS Micro- Infusion System is intended for regional infusion of contrast materials into selected vessels in the neurovasculature. The EKOS Micro- Infusion System may be used for controlled, regional infusion into selected vessels and is not intended for use in the coronary vasculature.

Device Story

System comprises disposable infusion/ultrasound catheter and control instrument; catheter features distal ultrasound transducer and thermal sensor for energy delivery control; used for controlled, selective fluid infusion (thrombolytics/contrast) into peripheral or neurovasculature; operated by physicians in clinical settings; instrument manages energy delivery to catheter; output allows physician-directed regional therapy; benefits include controlled, targeted delivery of therapeutic or diagnostic agents.

Clinical Evidence

No clinical data provided. Substantial equivalence based on bench testing and design comparison. FDA required specific labeling warning regarding lack of established safety/effectiveness for thrombolytic therapy in neurovasculature.

Technological Characteristics

Disposable infusion/ultrasound catheter with distal ultrasound transducer and thermal sensor. Energy source: control instrument for ultrasound energy delivery. Form factor: catheter with distal end hole for guide wire and fluid infusion. Connectivity: not specified. Sterilization: not specified.

Indications for Use

Indicated for controlled, selective infusion of physician-specified fluids (including thrombolytics) into peripheral vasculature and regional infusion of contrast materials into neurovasculature. Not for use in coronary vasculature.

Regulatory Classification

Identification

An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

Predicate Devices

• EKOS Peripheral Infusion System (K050563)
• EKOS Micro- Infusion System (K041826)

Submission Summary (Full Text)

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SPECIAL 510(k) Notification EKOS Micro-Infusion System

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

| 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 | EKOS Micro- Infusion System |
| Name of Predicate<br>Device | Predicate Device<br>EKOS Peripheral Infusion System<br>EKOS Micro- Infusion System | 510(k) Reference Nos.<br>K050563<br>K041826 |
| Device Description | The system consists of a disposable infusion/ultrasound catheter and an instrument<br>that generates and controls the delivery of energy to the catheter. The catheter<br>contains a single ultrasound transducer, located at the distal tip, a thermal sensor<br>and a distal end hole for placement over a guide wire and fluid infusion. | |
| Intended Use | The EKOS Micro- Infusion System is intended for the controlled and selective<br>infusion of physician-specified fluids, including thrombolytics, into the peripheral<br>vasculature. | |
| | The EKOS Micro- Infusion System is intended for regional infusion of contrast<br>materials into selected vessels in the neurovasculature. The EKOS Micro- Infusion<br>System may be used for controlled, regional infusion into selected vessels and is not<br>intended for use in the coronary vasculature. | |
| Summary of<br>Technological<br>Characteristics | The proposed EKOS Micro- Infusion Catheter is similar in construction and<br>materials to the EKOS Micro- Infusion Catheter previously cleared under K041826. | |
| | The proposed EKOS Micro- Infusion Catheter is identical to the EKOS Peripheral<br>Infusion Catheter cleared under K050563. | |
| Test Summary | The proposed EKOS Micro- Infusion System is considered to be substantially<br>equivalent to the currently marketed EKOS Micro- Infusion System based on a<br>comparison of the intended uses and designs and results of the testing and<br>evaluations performed. | |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

#### Public Health Service

JUN 1 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Jocelyn Kersten Director, Regulatory Affairs EKOS Corporation 22030 20th Avenue SE, Suite 101 Bothell, Washington 98021

Re: K051225

Trade Name: EKOS Micro-Infusion System Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: II Product Code: NUI Dated: May 11, 2005 Received: May 12, 2005

Dear Ms. Kersten:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becally is (a) the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the energency to stg-enactment date of the Medical Device Amendments, or to conninered pror to trial) 2011-17-17 (1) accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls and Cosment the Act and the limitations described below. The general controls provisions of the provisions of the Arc and for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this The Office will be used for an intended use not identified in the proposed labeling and that such use device win be used for an meeting accordance with Section 513(i)(1)(E) of the Act, the following Courd cause ham. "Therefore, x warning, immediately following the indications for use, in the device's labeling:

"The safety and effectiveness of the EKOS Micro-Infusion System for thrombolytic therapy in The sately and creceiveness of the Erablished. Further clinical studies are necessary to ensure the neurovasculature nave not been setuis therapy into the neurovasculature does not result in an increased incidence of adverse events (e.g., intracranial hemorrhage)."

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### Page 2 - Ms. Jocelyn Kersten

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 5 l0(k) premarket notification if the limitation statement described above is added to your labeling.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r tease be advised that I broundevice complies with other requirements of the Act that I Dr has made a as a lowed regulations administered by other Federal agencies. You must of any I catal statutes and registments, 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 forth in the quality of sections (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific information about the application of other labeling requirements to your If you desire spoonne mornheaven coutact the Office of Compliance at [phone]. Also, de note the regulation entitled, "Misbranding by reference to premarket notification" (21 prease note the regaration other general information on your responsibilities under the Of It Far 6011977). 2008 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 vours,

Neele

Donna-Bea Tillman, Ph.D. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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SPECIAL 510(k) Notification EKOS Micro-Infusion System

# Indications for Use

510(k) Number (if known): K(151225

Device Name:

EKOS Micro-Infusion System

Indications for Use:

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

The EKOS Micro- Infusion System is intended for regional infusion of contrast materials into selected vessels in the neurovasculature. The EKOS Micro- Infusion System may be used for controlled, regional infusion into selected vessels and is not intended for use in the coronary 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)

(Division Sign-Off) Division of General, Restorative and Neurological Devices

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510(k) Number K051225