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.

The EKOS Micro-Infusion system is intended to deliver physician specified fluids to the coronary vasculature.

WARNING: The safety and effectiveness of the EKOS Micro-Infusion system used for intracoronary thrombolytic therapy administration have not been established. In particular, the ultrasound energy delivered by the EKOS Micro-Infusion system is intended to be therapeutic, and the safety and effectiveness of the EKOS system for coronary thrombolysis or thrombectomy (i.e., clot disruption) have not been established.

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 to deliver physician specified fluids to the coronary vasculature.

Device Description

The EKOS Micro-Infusion System is an infusion catheter system designed to deliver fluids through the catheter end-hole while simultaneously delivering ultrasound energy via a transducer element at the distal catheter tip.

AI/ML Overview

This document is a 510(k) premarket notification for the EKOS Micro-Infusion System. It is an administrative letter from the FDA, not a study report. Therefore, it does not contain the detailed information requested regarding specific acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study designs (MRMC, standalone).

The document states that the EKOS Micro-Infusion System is "substantially equivalent" to legally marketed predicate devices. This means that the FDA determined the new device is as safe and effective as a legally marketed device that is not subject to premarket approval. The basis for this determination is often through bench testing and, in some cases, animal studies to demonstrate that the device meets design specifications and performs as intended.

Here's what can be extracted from the provided text, while also noting what is not present:

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

This information is not provided in the document. The document refers to "preclinical bench and animal studies" that demonstrate the "performance of the Micro-Infusion System meets its design specifications and is safe and effective for its intended use." However, the specific acceptance criteria (e.g., flow rate, infusion accuracy, ultrasound power output, etc.) and the quantitative results of those performance tests are not included.

2. Sample size used for the test set and the data provenance:

This information is not provided in the document. The general statement "preclinical bench and animal studies" does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. Ground truth establishment typically applies to studies involving human interpretation or categorization, which is not described here.

4. Adjudication method for the test set:

This information is not provided in the document. Adjudication methods like 2+1 or 3+1 are used in studies involving expert review of cases, which is not detailed in this premarket notification.

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:

This information is not provided in the document. An MRMC study would be relevant for evaluating AI-assisted diagnostic devices. The EKOS Micro-Infusion System is an infusion catheter system, not an AI diagnostic device.

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

This information is not provided in the document. A standalone performance evaluation would be relevant for an algorithm or AI system. The EKOS Micro-Infusion System is a physical medical device.

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

This information is not explicitly stated in the document beyond the mention of "preclinical bench and animal studies." For a medical device like an infusion system, the "ground truth" would likely involve engineering specifications, physical measurements of fluid delivery, and physiological responses observed in animal models.

8. The sample size for the training set:

This information is not provided in the document. Training sets are relevant for machine learning or AI models, which is not the primary focus of this device's evaluation.

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

This information is not provided in the document, as it pertains to training AI models, which is not applicable here.

Summary of Device Information Available:

Device Name: EKOS Micro-Infusion System
Intended Use:
- Regional infusion of contrast materials into selected vessels in the neurovasculature.
- Controlled, regional infusion into selected vessels.
- Deliver physician-specified fluids to the coronary vasculature.
- Controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
Device Description: An infusion catheter system designed to deliver fluids through the catheter end-hole while simultaneously delivering ultrasound energy via a transducer element at the distal catheter tip.
Predicate Devices: EKOS Micro-Infusion System (K053437, K053432, K062507, K062508), Endeavor Infusion Catheter (K972110), PV 0.018 F/X (K944004), Renegade Hi-Flo Microcatheter (K000177), TurboTracker 18 Infusion Catheter (K960806), FasTracker 10 Infusion Catheter (K926243).
Performance Data Mentioned: "EKOS has conducted preclinical bench and animal studies with the Micro-Infusion System. These studies demonstrate that the performance of the Micro-Infusion System meets its design specifications and is safe and effective for its intended use." Specific details of these studies are not provided.
Labeling Limitation: "The safety and effectiveness of the EKOS Micro-Infusion system used for intracoronary thrombolytic therapy administration have not been established. In particular, the ultrasound energy delivered by the EKOS micro-infusion system is not intended to be therapeutic, and the safety and effectiveness of the EKOS system for coronary thrombolysis or thrombectomy (i.e., clot disruption) have not been established." This indicates a specific disclaimer regarding certain uses, rather than a performance claim.

In conclusion, the provided FDA 510(k) clearance letter confirms the substantial equivalence of the EKOS Micro-Infusion System but does not contain the detailed study results, acceptance criteria, sample sizes, or ground truth information typically found in a comprehensive study report. This type of information would be found in the original 510(k) submission documentation, which is more detailed than the FDA's clearance letter.

Summary

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January 7, 2022

EKOS Corporation Jocelyn Kersten Vice President, Regulatory & Clinical Affairs 11911 N Creek Parkway South Bothell, Washington 98011

Re: K063620

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 August 6, 2007. 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 -O'connell -S Date: 2022.01.07 13:51:23 -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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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human services.

AUG 6 2007

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

EKOS Corporation c/o Ms. Jocelyn Kersten Vice President, Regulatory and Clinical Affairs 11911 North Creek Parkway South Bothell, WA 98011

Re: K063620

Trade/Device Name: EKOS Micro Infusion System Regulation Number: 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: II Product Code: KRA Dated: April 24, 2007 Received: April 25, 2007

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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling:

The safety and effectiveness of the EKOS Micro-Infusion system used for intracoronary thrombolytic therapy administration have not been established. In particular, the ultrasound energy delivered by the EKOS micro-infusion system is not intended to be therapeutic, and the safety and effectiveness of the EKOS system for coronary thrombolysis or thrombectomy (i.e., clot disruption) have not been established.

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Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as prooced in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting (1 Mr.), N. May 6 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 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.

If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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1.10 Indications for Use Statement

EKOS Corporation 11911 North Creek Parkway South Bothell, WA 98011

Indications for Use Statement

510(k) Number (if known): K063620

EKOS Micro-Infusion System Device Name:

Indications for Use:

The EKOS Micro-Infusion system is intended to deliver physician specified fluids to the coronary vasculature.

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Signature

Division Sign-OffCONFIDENTIAL

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K063620

8.0 510(k) Summary

Applicant Name:	EKOS Corporation	AUG - 6 2007
Address:	11911 North Creek Parkway SouthBothell, WA 98011
Contact Person:	Jocelyn KerstenDirector, Regulatory Affairs
Telephone:	(425) 415-3132
Fax:	(425) 415-3102
Device:	EKOS Micro-Infusion System
Classification:	CFR 870.1210 - Continuous Flush Catheter
Panel:	Cardiovascular
Product Code:	KRA
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 to deliver physician specified fluids to the coronary vasculature.

Device Description:	The EKOS Micro-Infusion System is an infusion catheter systemdesigned to deliver fluids through the catheter end-hole whilesimultaneously delivering ultrasound energy via a transducerelement at the distal catheter tip.
Predicate Basis:	The EKOS Micro-Infusion System is substantially equivalent toother legally marketed devices. These devices include:EKOS Micro-Infusion System, (EKOS Corporation, K053437,K053432, K062507, K062508)Endeavor Infusion Catheter, (Cordis Corporation, K972110)

CONFIDENTIAL

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PV 0.018 F/X, (JoMed, K944004)
Renegade Hi-Flo Microcatheter, (Boston ScientificCorporation, K000177)
TurboTracker 18 Infusion Catheter, (Boston ScientificCorporation, K960806)
FasTracker 10 Infusion Catheter, (Boston ScientificCorporation, K926243)
Performance:	EKOS has conducted preclinical bench and animal studies with theMicro-Infusion System. These studies demonstrate that theperformance of the Micro-Infusion System meets its designspecifications 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).