EKOS ULTRASOUND INFUSION SYSTEM

K041826 · Ekos Corp. · NUI · Apr 27, 2005 · Cardiovascular

Device Facts

• Record ID: K041826
• Device Name: EKOS ULTRASOUND INFUSION SYSTEM
• Applicant: Ekos Corp.
• Product Code: NUI · Cardiovascular
• Decision Date: Apr 27, 2005
• Decision: SESU
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Indications for Use

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

Infusion catheter system designed for delivery of contrast materials into neurovasculature; incorporates transducer element at distal catheter tip to deliver ultrasound energy. Used by clinicians in clinical settings. Device facilitates controlled, regional infusion. Potential patient benefit includes targeted delivery of contrast agents for diagnostic imaging. Safety and effectiveness for thrombolytic therapy in neurovasculature not established; labeling includes warning regarding potential for adverse events such as intracranial hemorrhage.

Clinical Evidence

No clinical data provided. Evidence consists of preclinical bench and animal studies demonstrating that the device meets design specifications and is safe and effective for its intended use.

Technological Characteristics

Infusion catheter system featuring a distal tip transducer element for ultrasound energy delivery. Designed for neurovascular access. Technical specifications and materials are not detailed beyond the presence of the ultrasound transducer component.

Indications for Use

Indicated for regional infusion of contrast materials into selected neurovasculature vessels. 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 (K030637)
• Boston Scientific Corporation: Magic Infusion Catheter (K923368 & K023351)
• Boston Scientific Corporation: Renegade Hi-Flo Microcatheter (K000177)
• Boston Scientific Corporation Turbo-Tracker Microcatheter (K960806)
• BioSphere Medical EmboCath Hydrophilic Infusion Catheter (K003105)

Reference Devices

• Spencer Technologies TCD 100M Transcranial Doppler (K002533)

Submission Summary (Full Text)

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041826

## 9.0 510(k) Summary

.

| Applicant Name: | EKOS Corporation | APR 27 2005 |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Address: | 22030 20th Ave. SE, Suite 101<br>Bothell, WA 98021 | |
| Contact Person: | Jocelyn Kersten<br>Director, Regulatory Affairs | |
| Telephone: | [phone] X 287 | |
| Fax: | [phone] | |
| Device: | EKOS Micro-Infusion System | |
| Classification: | CFR 870.1210 - Continuous Flush Catheter | |
| Panel: | Cardiovascular | |
| Product Code: | KRA | |
| Intended Use: | The EKOS Micro-Infusion System is intended for regional<br>infusion of contrast materials into selected vessels in the<br>neurovasculature. The EKOS Micro-Infusion System may be used<br>for controlled, regional infusion into selected vessels and is not<br>intended for use in the coronary vasculature. | |
| Device Description: | The EKOS Micro-Infusion System is an infusion catheter system<br>designed to deliver ultrasound energy through a transducer element<br>at the distal catheter tip. This device is intended to deliver<br>angiographic contrast material into the neurovasculature. | |
| Predicate Basis: | The EKOS Micro-Infusion System is substantially equivalent to<br>other legally marketed devices. These devices include | |
| | EKOS Peripheral Infusion System (K030637) Boston Scientific Corporation: Magic Infusion Catheter (K923368 & K023351) Boston Scientific Corporation: Renegade Hi-Flo Microcatheter (K000177) Boston Scientific Corporation Turbo-Tracker Microcatheter (K960806) BioSphere Medical EmboCath Hydrophilic Infusion Catheter (K003105) Spencer Technologies TCD 100M Transcranial Doppler | |

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(K002533)

EKOS has conducted preclinical bench and animal studies with the Performance: EKOS Micro-Infusion System. These studies demonstrate that the performance of the EKOS Micro-Infusion System meets its design specifications and is safe and effective for its intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with three curved lines representing its wings or feathers. The eagle is facing to the right.

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

APR 2 7 2005

Re: K041826

Trade Name: EKOS Micro-Infusion System Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: II Product Code: NUI Dated: March 2, 2005 Received: March 3, 2005

Dear Ms. Kersten:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your Section 9 ro(s) premaince is substantially equivalent (for the indications felerenced above and nave used.
for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regally management date of the Medical Device American Frank Food. Days commerce prior to May 28, 1970, the characted and of the Federal Food. Drug, devices that nave been reclassified in accessed in a market the device, subject to the general controls and Cosment Act (7tcl). "Tou may, thereflect below. The general controls provisions of the provisions of the Act and the minutions desorved over of devices, good manufacturing practice, Act fictuale requireritions against misbranding and adulteration.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this avol u I he Office of Device Evaluation has decemblace in the proposed labeling and that such use device will be used for an michaed as the rasition 513(i)(1)(E) of the Act, the following could cause harm. Therefore, in accordance with became of ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( device's labeling:

"The safety and effectiveness of the EKOS Micro-Infusion System for thrombolytic therapy in " The safety and effectivelless of the EROS finners interest of endics are necessary to ensure the neurovasculature nave not been exadonsilou. The neurovasculature does not result in an that use of devices to defree 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. Please note that the above labore 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 I he I DA Iniding of substantial equive and permits your device to proceed to the uc vice results in a classification 101 Jour device as described in your Section market. "This letter will anon-you to evigation 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), if your device is classified too about of . Existing major regulations affecting your device can be it may be subject to adultions, 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 I least be advised that I Dris issuality that your device complies with other requirements of the Act that I DA has made a deceminations administered by other Federal agencies. You must or any I catal statures and regulaties, including, but not limited to: registration and listing (21 Comply with an the Act 810 cm Part 801); good manufacturing practice requirements as set CFR Part 807), adoling (21 CFR Part 820); and if applicable, the electronic ronth in the quany by 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 specific information actuact the Office of Compliance at [phone]. Also, de vice (21 CFR Part 001), priuse SMisbranding by reference to premarket notification' (21 prease note the regulation onears, "Atlocracion on your responsibilities under the Cl K ratt 607.27): "Pouring Joseph 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.

Sincercly yours.

Sincerely yours,

Dr. Rita Tillman, Ph.D.

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

Enclosure

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## Indications for Use

510(k) Number (if known): K041826

Device Name: EKOS Micro-Infusion System

Indications For Use:

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 into selected vessels in the near ordecantly of the selected vessels and is not intended for use in the coronary vasculature.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Evaluation (SDA)