EKOS MICRO-INFUSION SYSTEM

K053432 · Ekos Corp. · QEY · Dec 30, 2005 · Cardiovascular

Device Facts

• Record ID: K053432
• Device Name: EKOS MICRO-INFUSION SYSTEM
• Applicant: Ekos Corp.
• Product Code: QEY · Cardiovascular
• Decision Date: Dec 30, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5150
• 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; instrument generates/controls energy delivery to catheter. Catheter features distal tip ultrasound transducer, thermal sensor, and distal end hole for guidewire placement and fluid infusion. Used by physicians for regional/selective infusion of fluids or contrast media. Device facilitates targeted delivery of therapeutic agents or diagnostic contrast; benefits include controlled, selective administration within peripheral and neurovasculature.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, intended use, and bench testing/evaluations.

Technological Characteristics

System includes disposable infusion/ultrasound catheter and energy control instrument. Catheter features distal ultrasound transducer and thermal sensor. Designed for guidewire compatibility and fluid infusion. Connectivity and specific material standards not detailed.

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 intended for use in coronary 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

• EKOS Peripheral Infusion System (K050563)
• EKOS Micro- Infusion System (K051225)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font below.

January 7, 2022

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

Re: K053432

Trade/Device Name: EKOS Micro-Infusion System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEY, KRA

Dear Jocelyn Kersten:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated December 30, 2005. Specifically, FDA is updating this SE Letter as an administrative correction because FDA has created a new product code to better categorize your device technology.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Gregory O'Connell, OHT2: Office of Cardiovascular Devices, [phone], Gregory.Oconnell(@FDA.HHS.gov.

Sincerely,

Image /page/0/Picture/9 description: The image shows the name Gregory W. O'connell -S. It also shows that the image was digitally signed by Gregory W. O'connell -S on the date 2022.01.07. The time stamp is 13:37:47 -05'00'.

Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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DEC 3 0 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

Re: K053432

EKOS Micro-Infusion System Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II (two) Product Code: KRA Dated: December 6, 2005 Received: December 9, 2005

Dear Ms. Kersten:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(x) premained in substantially equivalent (for the indications for use stated in the enclosure) the devices marketed predicate devices marketed in interstate for use stated in the enclosure) to regally manced promoted Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Enderel Food. Drug commerce prior to May 28, 1970, the chaeffired in accordance with the Federal Food, Drug, devices that have been reclassified in accordance was a proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a previsions of the Act. The and Cosmetic Act (Act) that do not require approvate of the general controls provisions of the Act. The You may, therefore, market the device, belyer is and in annual registration, listing of
general controls provisions of the Act include requirements for and successions and general controls provisions of the Fee merade copies against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (Scc above) movements . Existing your device can
may be subject to such additional controls. Existing major regulations EDA may may be subject to such additional controls. Extrong mayor organisms be found in the Code of Pouchal Stegeral Stegeral Register.

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Page 2 -- Ms. Jocelyn Kersten

Please be advised that FDA's issuance of a substantial equivalence determination does not mean 1 Icase of advised that I Dris issuantes vith other requirements of the requirements of the Act that I DA has made a dotenmancions administered by other Federal agencies. You must of any I cacal statutes and regainments, including, but not limited to: registration and listing (21 Comply with an the Fet 6 requirements, 01); good manufacturing practice requirements as set CFR Part 6077, abonnig (DF OFF Part 820); and if applicable, the electronic forth in the quant) bystems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation some of pro regin marketing your device as described in your Section 510(k) This letter will anow you to ough mailing of substantial equivalence of your device to a legally prematication: The PDF Intelling sification 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 If you dealer specific acrioliance at [phone]. Also, please note the regulation entitled, Connect the Office of County of Court (21CFR Part 807.97). You may obtain Mitsorancing of reference to presensibilities under the Act from the Division of Small other general micrinational 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,

Blymmtma for

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 EKOS Micro-Infusion System

## Indications for Use

510(k) Number (if known): K053432

Device Name:

EKOS Micro-Infusion System

Indications for Use:

The EKOS Micro-Infusion System is intended for the controlled and selective infusion of The ENOS MICIO-Infusion Dystein is mombolytics, into the peripheral vasculature.

The EKOS Micro- Infusion System is intended for regional infusion of contrast materials into The EKOS Micro- Infusion System is intended for regroincil Infusion System may be used for selected vessels in the neurovasculature. The EN CD SD SD Sot 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)

e.g.mee

of Cardiovascular Devices

KO 53432 510(k) Number

Page 1 of 1_

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## DEC 3 0 2005

| 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>K051225 |
| 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 K051225<br>and 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. | |

## Section 4. 510(k) Summary