EKOS PERIPHERAL INFUSION SYSTEM

• K Number: K033214
• Device Name: EKOS PERIPHERAL INFUSION SYSTEM
• Manufacturer: EKOS CORP.
• Date Cleared: 2003-10-14 ( 11 days)
• Product Code: QEY KRA
• Regulation Number: 870.5150

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 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.

Predicate Devices

K030637

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a system for controlled fluid infusion using ultrasound and thermal sensing, with no mention of AI or ML in the device description, intended use, or performance studies.

Therapeutic

Yes
The device is intended for the infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature, which is a therapeutic intervention.

Diagnostic

No

Explanation: The device is described as an "infusion system" intended for "controlled and selective infusion of physician-specified fluids." Its components are an infusion/ultrasound catheter and an instrument to deliver energy to the catheter, facilitating fluid delivery. There is no mention of it being used to detect, diagnose, or monitor a disease or condition, which are characteristic functions of a diagnostic device.

SaMD (Software as a Medical Device)

No

The device description explicitly states the system consists of a disposable infusion/ultrasound catheter and an instrument that generates and controls energy, indicating hardware components are integral to the device.

IVD (In Vitro Diagnostic)

Based on the provided information, the EKOS Peripheral Infusion System is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is for the controlled and selective infusion of fluids into the peripheral vasculature. This is a direct interaction with the patient's body (in vivo), not the examination of specimens taken from the body (in vitro).
• Device Description: The device consists of a catheter and an instrument for delivering energy. This describes a system for delivering therapy or substances directly into the body.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on specimens, or providing diagnostic information based on laboratory analysis.

IVD devices are used to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The EKOS Peripheral Infusion System's function is to deliver substances directly into the patient's blood vessels.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

QEY, KRA

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

peripheral vasculature

Indicated Patient Age Range

Not Found

Intended User / Care Setting

physician

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The proposed EKOS Peripheral Infusion System is considered to be substantially equivalent to the currently marketed EKOS Peripheral Infusion System based on a comparison of the intended uses and designs and results of the testing and evaluations performed.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K030637

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 870.5150 Embolectomy catheter.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

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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

1

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

4

K033214

1

OCT 1 4 2003

Section 4. 510(k) Summary

| General
Provisions | Submitter's Name and Address | EKOS Corporation
22030 20th Ave. SE
Suite 101
Bothell, WA 98021 |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| | Contact Person | Jocelyn Kersten
425-482-1108
425-482-1109 (fax)
[e-mail] |
| | Classification Name | Catheter, Continuous Flush (KRA) |
| | Common or Usual Name | Continuous Flush Catheter |
| | Proprietary Name | EKOS Peripheral Infusion
System |
| Name of
Predicate Device | Predicate Device
EKOS Peripheral Infusion System | 510(k) Reference No.
K030637 |
| 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 Peripheral Infusion System is intended for the controlled and
selective infusion of physician-specified fluids, including thrombolytics,
into the peripheral vasculature. | |
| Summary of
Technological
Characteristics | The proposed EKOS Peripheral Infusion System is similar in construction
and materials to the previously cleared EKOS Peripheral Infusion System. | |
| Test Summary | The proposed EKOS Peripheral Infusion System is considered to be
substantially equivalent to the currently marketed EKOS Peripheral
Infusion System based on a comparison of the intended uses and designs
and results of the testing and evaluations performed. | |