EKOS PERIPHERAL INFUSION SYSTEM

K033214 · Ekos Corp. · QEY · Oct 14, 2003 · Cardiovascular

Device Facts

• Record ID: K033214
• Device Name: EKOS PERIPHERAL INFUSION SYSTEM
• Applicant: Ekos Corp.
• Product Code: QEY · Cardiovascular
• Decision Date: Oct 14, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

The EKOS Peripheral Infusion System is a catheter-based device used for the controlled infusion of fluids, such as thrombolytics, into the peripheral vasculature. The system comprises a disposable infusion/ultrasound catheter and an external instrument that generates and controls energy delivery. The catheter features a distal ultrasound transducer, a thermal sensor, and a distal end hole for guide wire placement and fluid delivery. The device is operated by a physician in a clinical setting. By delivering ultrasound energy alongside the infusion, the system facilitates the targeted administration of therapeutic fluids, potentially improving the treatment of peripheral vascular conditions.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and design comparisons.

Technological Characteristics

The system consists of a disposable infusion/ultrasound catheter and an external control instrument. The catheter includes a distal ultrasound transducer and a thermal sensor. The device is designed for peripheral vascular infusion.

Indications for Use

Indicated for controlled and 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

• EKOS Peripheral Infusion System (K030637)

Submission Summary (Full Text)

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January 7, 2022

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

Re: K033214

Trade/Device Name: EKOS Peripheral 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 October 14, 2003. 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,

Digitally signed by Gregory W. Gregory W. O'connell -2 O'connell -S Date: 2022.01.07 13:30:30 -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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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 4 2003

EKOS Corp. c/o Ms. Jocelyn Kersten 22030 20th Ave SE, Suite 101 Bothell, WA 98021

Re: K033214 EKOS Peripheral Infusion System Regulation Number: 21 CFR 870.1210 Regulation Name: Catheter, Continuous Flush Regulatory Class: Class II Product Code: KRA Dated: October 2, 2003 Received: October 3, 2003

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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.

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

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Page 2 – Ms. Jocelyn Kersten

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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamain.html

Sincerely yours,

Dma Xluseku fr
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 Peripheral Infusion System

## Section 3. Indication for Use

| 510(k) Number | K033214 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | EKOS Peripheral Infusion System |
| Indications for<br>Use | The EKOS Peripheral Infusion System is intended for the controlled and<br>selective infusion of physician-specified fluids, including thrombolytics,<br>into the peripheral vasculature. |

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over The Counter Use_________

(Optional Format 1-2-96)

Dva Leslu

510(K

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K033214

1

OCT 1 4 2003

## Section 4. 510(k) Summary

| General<br>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 Peripheral Infusion<br>System |
| Name of<br>Predicate Device | Predicate Device<br>EKOS Peripheral Infusion System | 510(k) Reference No.<br>K030637 |
| Device<br>Description | The system consists of a disposable infusion/ultrasound catheter and an<br>instrument that generates and controls the delivery of energy to the<br>catheter. The catheter contains a single ultrasound transducer, located at<br>the distal tip, a thermal sensor and a distal end hole for placement over a<br>guide wire and fluid infusion. | |
| Intended Use | The EKOS Peripheral Infusion System is intended for the controlled and<br>selective infusion of physician-specified fluids, including thrombolytics,<br>into the peripheral vasculature. | |
| Summary of<br>Technological<br>Characteristics | The proposed EKOS Peripheral Infusion System is similar in construction<br>and materials to the previously cleared EKOS Peripheral Infusion System. | |
| Test Summary | The proposed EKOS Peripheral Infusion System is considered to be<br>substantially equivalent to the currently marketed EKOS Peripheral<br>Infusion System based on a comparison of the intended uses and designs<br>and results of the testing and evaluations performed. | |