EKOS PERIPHERAL INFUSION SYSTEM

K030637 · Ekos Corp. · QEY · Jul 22, 2003 · Cardiovascular

Device Facts

• Record ID: K030637
• Device Name: EKOS PERIPHERAL INFUSION SYSTEM
• Applicant: Ekos Corp.
• Product Code: QEY · Cardiovascular
• Decision Date: Jul 22, 2003
• Decision: SESE
• Submission Type: Traditional
• 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 an infusion catheter system designed to deliver ultrasound energy via a transducer element at the distal catheter tip. It is used to deliver physician-specified fluids or agents into the peripheral vasculature. The device is operated by clinicians in a clinical setting. By delivering ultrasound energy during the infusion process, the system facilitates the delivery of therapeutic agents. The healthcare provider uses the system to manage fluid delivery, potentially improving the efficacy of thrombolytic therapy in peripheral vascular applications.

Clinical Evidence

Preclinical bench and animal studies were conducted. These studies demonstrated that the device performance meets design specifications and is safe and effective for its intended use. No human clinical trial data is reported.

Technological Characteristics

Infusion catheter system featuring a distal tip transducer element for ultrasound energy delivery. Designed for controlled, selective fluid infusion into peripheral vasculature.

Indications for Use

Indicated for patients requiring 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

• Renegade Hi-Flo Microcatheter (K000177)
• TurboTracker 18 Infusion Catheter (K960806)
• FasTracker Infusion Catheter (K926243)
• Trellis Infusion System (K023514)
• Pulse Spray Infusion System PRO Infusion Catheter (K950907)
• PV 0.018 F/X (K944004)

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: K030637

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 July 22, 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 -S O'connell -S Date: 2022.01.07 13:28:57 -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

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 2 2003

EKOS Corp. c/o Ms. Jocelyn Kersten 22030 2011 Ave SE, Suite 101 Bothell, WA 98021

Re: K030637

EKOS Peripheral Infusion System Regulation Number: 21 CFR 870.1210 Regulation Name: Catheter, Continuous Flush Regulatory Class: Class II (two) Product Code: KRA Dated: June 20, 2003 Received: June 23, 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.

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Page 2 - Ms. Jocelyn Kersten

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 (OS) 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 vours.

I. Deletti

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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510(k) Notification

### 1.10 Indications for Use Statement

#### EKOS Corporation 22030 20th Ave. SE, Suite 101 Bothell, WA 98021

## Indications for Use Statement

510(k) Number (if known):

EKOS Peripheral Infusion System Device Name:

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (Per 21 CFR 801.109) | X |
|---------------------------------------|---|
| OR | |
| Over-The-Counter Use | |

Division Sign-Off
Division of Cardiovascular Devices

| 510(k) Number | K030637 |
|---------------|---------|
|---------------|---------|

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EKOS Peripheral Infusion System

16030637 510(k) Notification

## JUL 2 2 2 2003

# 9.0 510(k) Summary

| Applicant Name: | EKOS Corporation |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 22030 20th Ave. SE, Suite 101<br>Bothell, WA 98021 |
| Contact Person: | Jocelyn Kersten<br>Regulatory Affairs Manager |
| Telephone: | [phone] X 287 |
| Fax: | [phone] |
| Device: | EKOS Peripheral Infusion System |
| Classification: | CFR 870.1210 - Continuous Flush Catheter |
| Panel: | Cardiovascular |
| Product Code: | KRA |
| Intended Use: | The Peripheral Infusion System is intended for the controlled and<br>selective infusion of physician-specified fluids, including<br>thrombolytics, into the peripheral vasculature. |
| Device Description: | The EKOS Peripheral Infusion System is an infusion catheter<br>system designed to deliver ultrasound energy through a transducer<br>element at the distal catheter tip. This device is intended to deliver<br>physician-specified agents or fluids into the peripheral vasculature. |
| Predicate Basis: | The EKOS Peripheral Infusion System is substantially equivalent<br>to other legally marketed devices. These devices include<br>Boston Scientific Corporation: Renegade Hi-Flo Microcatheter (K000177)Boston Scientific Corporation: TurboTracker 18 Infusion Catheter (K960806)Boston Scientific Corporation: FasTracker Infusion Catheter (K926243)Bacchus Vascular, Inc.: Trellis Infusion System (K023514)AngioDynamics: Pulse Spray Infusion System PRO Infusion Catheter (K950907)JoMed: PV 0.018 F/X (K944004) |
| Performance: | EKOS has conducted preclinical bench and animal studies with the |

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Peripheral Infusion System. These studies demonstrate that the performance of the Peripheral Infusion System meets its design specifications and is safe and effective for its intended use.