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 EKOS Peripheral Infusion System is an infusion catheter system designed to deliver ultrasound energy through a transducer element at the distal catheter tip. This device is intended to deliver physician-specified agents or fluids into the peripheral vasculature.

AI/ML Overview

The provided document is a 510(k) premarket notification for the EKOS Peripheral Infusion System. This type of FDA submission is not a clinical trial report but rather a demonstration of substantial equivalence to a legally marketed predicate device. Therefore, it does not contain detailed information regarding acceptance criteria, a specific study proving the device meets those criteria, or the methodology typically associated with clinical performance studies (like sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance).

The information provided primarily focuses on the device's intended use and a general statement about preclinical performance.

Here's an analysis based on the provided text, highlighting what is not present:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated within this document. For a 510(k), the primary acceptance criterion is "substantial equivalence" to a predicate device. This is assessed by comparing technological characteristics and intended use, and ensuring any differences do not raise new questions of safety or effectiveness.
Reported Device Performance:
- Qualitative Statement: "These studies demonstrate that the performance of the Peripheral Infusion System meets its design specifications and is safe and effective for its intended use."
- Specific Metrics/Numerical Results: No specific performance metrics (e.g., sensitivity, specificity, accuracy, or clinical outcome measures) or numerical results are provided in this summary.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size: Not provided. The document mentions "preclinical bench and animal studies," but no sample sizes for these studies are given.
Data Provenance: Not provided. The document doesn't specify if the studies were retrospective or prospective, or the country of origin of the data (though the applicant and predicate devices are generally US-based).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable/Not provided. Since this is a 510(k) submission primarily relying on preclinical (bench and animal) testing and substantial equivalence, the concept of "ground truth established by experts" in the context of diagnostic or interpretive performance does not apply or is not detailed.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable/Not provided. This relates to the evaluation of expert consensus for ground truth, which is not detailed in this document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC study was not done. The device described is an "infusion catheter system" that delivers ultrasound energy and fluids. It is a medical device for intervention, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI-related performance metrics are irrelevant to this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable/Not provided. This device is not an algorithm, but a physical infusion system. Its performance is evaluated through its mechanical, material, and functional properties in preclinical studies, not as a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the preclinical bench studies, "ground truth" would likely relate to objective measurements of the device's physical properties, fluid delivery rates, ultrasound energy output, material integrity, and functionality against design specifications (e.g., flow rate accuracy, catheter integrity under pressure, ultrasound intensity measurements).
For the animal studies, "ground truth" would relate to physiological responses, tissue effects, and safety outcomes in an in-vivo model (e.g., patency of vessels, absence of adverse tissue damage, successful delivery of fluids to target areas).
The document does not elaborate on the specific types of ground truth for these preclinical studies.

8. The sample size for the training set

Not applicable/Not provided. This document describes a physical medical device, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable/Not provided. As above, this is not an AI device with a training set.

Summary of Study Information (as provided):

The document states that EKOS Corporation conducted "preclinical bench and animal studies" to demonstrate that the EKOS Peripheral Infusion System meets its design specifications and is safe and effective for its intended use. However, no specific details about these studies (like sample sizes, specific protocols, or quantitative results) are provided in this 510(k) summary. The primary basis for FDA clearance in this case is the device's substantial equivalence to several legally marketed predicate devices, as listed in the "Predicate Basis" section.

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: 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, (301) 796-6075, 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

Image /page/1/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract design featuring three stylized lines that resemble an eagle or a bird in flight, with a wavy line underneath.

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 (301) 594-4646. 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 (800) 638-2041 or (301) 443-6597 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 101Bothell, WA 98021
Contact Person:	Jocelyn KerstenRegulatory Affairs Manager
Telephone:	(425) 482-1108 X 287
Fax:	(425) 482-1109
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 andselective infusion of physician-specified fluids, includingthrombolytics, into the peripheral vasculature.
Device Description:	The EKOS Peripheral Infusion System is an infusion cathetersystem designed to deliver ultrasound energy through a transducerelement at the distal catheter tip. This device is intended to deliverphysician-specified agents or fluids into the peripheral vasculature.
Predicate Basis:	The EKOS Peripheral Infusion System is substantially equivalentto other legally marketed devices. These devices includeBoston 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.

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).