NEUROWAVE MICRO-INFUSION SYSTEM

K062508 · Ekos Corp. · NUI · Dec 5, 2006 · Cardiovascular

Device Facts

• Record ID: K062508
• Device Name: NEUROWAVE MICRO-INFUSION SYSTEM
• Applicant: Ekos Corp.
• Product Code: NUI · Cardiovascular
• Decision Date: Dec 5, 2006
• 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, thermal sensor, and distal end hole for guidewire/fluid delivery. Instrument generates/controls energy delivery to catheter. Used in clinical settings by physicians for regional fluid infusion. Output is controlled delivery of therapeutic or contrast agents. Benefits include precise, regionalized fluid administration. Box warning: safety/effectiveness for thrombolytic therapy in neurovasculature not established; potential risk of intracranial hemorrhage.

Clinical Evidence

No clinical data. Bench testing only; electrical safety and system testing confirmed device operates as intended.

Technological Characteristics

System includes disposable infusion/ultrasound catheter and energy control instrument. Catheter components: distal ultrasound transducer, thermal sensor, distal end hole for guidewire/fluid infusion. Energy source: ultrasound. Connectivity: catheter-to-instrument interface. No software algorithm details provided.

Indications for Use

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

• NeuroWave Micro-Infusion System (K060084)
• NeuroWave Micro-Infusion System (K053437)
• NeuroWave Micro-Infusion System (K053432)

Submission Summary (Full Text)

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K062508

DEC - 5 2006

## Section 4. 510(k) Summary

General Provisions

| Submitter's Name and Address: | EKOS Corporation<br>11911 North Creek Pkwy South<br>Bothell, WA 98011 |
|-------------------------------|---------------------------------------------------------------------------------|
| Contact Person: | Jocelyn Kersten<br>425-415-3132<br>425-415-3101 (fax)<br>[e-mail] |
| Classification Name: | Ultrasound, Infusion, System (NUI) |
| Common or Usual Name: | Ultrasound Infusion Catheter |
| Proprietary Name: | NeuroWave Micro-Infusion System |
| Name of Predicate Device: | NeuroWave Micro-Infusion System |
| 510(k) Reference No.: | K060084<br>K053437<br>K053432 |

## Device Description

The system consists of a disposable infusion/ultrasound catheter and an instrument that generates and controls the delivery of energy to the catheter. The catheter contains a single ultrasound transducer, located at the distal tip, a thermal sensor 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 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.

#### Summary of Technological Characteristics

The device modifications described in this notification do not affect the technological characteristics for the Micro-Infusion System.

## Test Summary

Electrical safety and system testing confirmed the PT-2B operates as intended with the Micro-Infusion Catheters.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 5 2006

EKOS Corporation % Ms. Jocelyn Kersten Vice President, Regulatory and Clinical Affairs 11911 Northcreek Parkway South Bothell, Washington 98011

Re: K062508

Trade Name: Micro-Infusion System Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: II Product Code: NUI Dated: November 2, 2006 Received: November 6, 2006

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 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 and the limitations described below. 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.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear as a box 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 neurovasculature have not been established. Further clinical studies are necessary to ensure that use of devices to deliver thrombolytic 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 510(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 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.

If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

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

Enclosure

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# Indications for Use

510(k) Number (if known):

K062508

Device Name: 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)

Voeth
12/5/06

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