The Lysus® 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 catheter with removable ultrasound core and an instrument that generates and controls the delivery of energy to the catheter. The infusion catheter contains multiple side holes distributed over the length of the treatment zone. The ultrasound core contains up to 30 ultrasound clements, evenly spaced over the treatment zone. Thermal sensors in the treatment zone monitor transducer temperature.

AI/ML Overview

This document is a 510(k) premarket notification for the EKOS Lysus Infusion System. It is an administrative change notice from the FDA to update the product code of the device, not a re-review of the submission. Therefore, it does not contain the detailed information about acceptance criteria and study results typically found in an initial 510(k) summary that demonstrates a device meets performance criteria.

However, based on the provided text, I can extract what is mentioned about testing:

Key Takeaways from the document:

The initial 510(k) for the EKOS Lysus Infusion System (K060422) was a "Special 510(k) Notification." Special 510(k)s are used for modifications to a manufacturer's own legally marketed device where the modification does not alter the fundamental scientific technology of the device. This implies that the core performance and safety were established in a prior 510(k) (K052071, mentioned as the predicate device reference).
The current submission (K060422) specifically addresses a device modification: an "increase in power."
The "Test Summary" explicitly states: "Testing previously performed and presented to FDA demonstrated safety of the power increase. New testing demonstrated the USC has sufficient durability to be operated with increased power."

Given this, I cannot provide a comprehensive answer to your request regarding acceptance criteria and a detailed study report that proves the device meets those criteria from this specific document. This document is focused on an administrative correction and a previously cleared modification.

Based only on the provided text, the answer to your questions would be as follows:

A table of acceptance criteria and the reported device performance:
- Not available in this document. The document refers to "previously performed testing" and "new testing" for a power increase and durability, but it does not specify the acceptance criteria or reported performance metrics for these tests.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not available in this document.
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 available in this document. The device is an "Embolectomy catheter" / "Continuous Flush Catheter" for DVT/thrombolytic therapy, which typically wouldn't involve expert ground truth establishment in the same way an AI diagnostic device would.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not available in this document.
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:
- Not applicable/Not available in this document. This device is a medical device (catheter system) for infusion, not an AI diagnostic tool that assists human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not available in this document. This is a hardware device for infusion, not an algorithm, so "standalone performance" in the AI sense is not relevant.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not available in this document. The testing mentioned (safety of power increase, durability of USC) would likely rely on engineering/bench testing metrics rather than clinical "ground truth" derived from patient data.
The sample size for the training set:
- Not applicable/Not available in this document. This is a hardware device, not an AI/machine learning algorithm, so there is no "training set."
How the ground truth for the training set was established:
- Not applicable/Not available in this document. (See above, no training set).

Summary

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January 7, 2022

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

Re: K060422

Trade/Device Name: Lysus 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 March 9, 2006. 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 13:48:36 -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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DEPARTMENT OF HEALTH & HUMAN SERVICES

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2006 MAR

2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

EKOS Corporation c/o Ms. Jocelyn Kersten Director, Regulatory Affairs 22030 20th Ave., SE, Suite 101 Bothell, WA 98021

Re: K060422

EKOS Lysus Infusion System Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II (two) Product Code: KRA Dated: February 17, 2006 Received: February 17, 2006

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 (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 (240) 276-0120. 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/industry/support/index.html.

Sincerely yours,

Dmn R. Valner

Image /page/2/Picture/5 description: The image contains a handwritten symbol or signature on the left, which appears to be a stylized letter or mark. To the right of this symbol are the letters 'Br' stacked on top of the letters 'Di'. The text is in a simple, sans-serif font and is positioned closely to the symbol, suggesting they are related, possibly as initials or a name.

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 Lysus® Infusion System

Indications for Use

510(k) Number (if known):

Device Name: Lysus® Infusion System

Indications For Use: The Lysus® Infusion System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dana P. Jackson

Division of Cardiovascular Devices

510(k) Number K060422

Page I of ー

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2006 MAR 9

K060422

Section 4. 510(k) Summary

General Provisions

Submitter's Name and Address:	EKOS Corporation22030 20th Ave. SESuite 101Bothell, WA 98021
Contact Person:	Jocelyn Kersten425-482-1108425-482-1109 (fax)jkersten@EKOSCORP.com
Classification Name:	Catheter, Continuous Flush (KRA)
Common or Usual Name:	Continuous Flush Catheter
Proprietary Name:	Lysus® Infusion System
Name of Predicate Device:	Lysus® Infusion Systèm
510(k) Reference No.:	K052071

Device Description

Intended Use

The Lysus® 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 device modification described in this notification does not affect the technological characteristics for the Lysus Infusion System.

Test Summary

Testing previously performed and presented to FDA demonstrated safety of the power increase. New testing demonstrated the USC has sufficient durability to be operated with increased power.

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).