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 elements, evenly spaced over the treatment zone. Thermal sensors in the treatment zone monitor transducer temperature.

AI/ML Overview

The provided text describes a 510(k) submission for the Lysus® Infusion System, a medical device. This type of submission is for demonstrating substantial equivalence to a predicate device, not for establishing novel performance acceptance criteria or conducting extensive clinical efficacy studies typically found in PMA submissions.

Therefore, many of the requested data points (like sample sizes for test/training sets, expert qualifications, MRMC studies, specific ground truth types) are not applicable to the information provided because a 510(k) summary focuses on demonstrating equivalence through design and limited testing, rather than proving new clinical performance.

Here's a breakdown of the available information based on your request:

Acceptance Criteria and Study Details

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Substantial Equivalence to Predicate Device (Lysus® Infusion System K041629 and K042456)	The proposed Lysus® Infusion System is considered substantially equivalent to the currently marketed Lysus® Infusion System based on a comparison of intended uses, designs, and results of testing and evaluations.
Similar in Construction	The modified system includes a lubricious coating on the inside of the Drug Delivery Catheter, yet it is still considered similar in construction.
Maintained Intended Use	The intended use remains the same: "The Lysus® Infusion System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature."

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

Not explicitly stated. The 510(k) summary mentions "results of the testing and evaluations performed," but does not provide specific sample sizes for any test sets. The focus is on demonstrating equivalence through design and functionality, rather than detailed clinical trial data.
Data Provenance: Not specified, but likely internal engineering and bench testing data given the nature of a 510(k) for a minor modification.

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

Not applicable/Not stated. In a 510(k) for a device like this, "ground truth" as it relates to expert review of output for clinical performance is not typically established or reported. The evaluation is focused on engineering and design equivalence.

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

Not applicable/Not stated. This concept is generally relevant for clinical performance studies involving interpretation of data (e.g., medical images), which is not the primary focus of this 510(k) submission.

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. This is a medical device, not an AI/imaging diagnostic device. MRMC studies are not relevant to this submission.

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

No. This device is an infusion system, not an algorithm.

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

Not applicable/Not explicitly stated. For this type of device, "ground truth" would likely refer to engineering specifications and performance benchmarks (e.g., flow rates, material compatibility, structural integrity) rather than clinical diagnostic outcomes. The summary merely states "results of the testing and evaluations performed."

8. The sample size for the training set:

Not applicable/Not stated. This submission is for 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 stated. As above, no training set for an algorithm is involved.

Summary

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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 System
510(k) Reference No.:	K041629 and K042456

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 proposed Lysus Infusion System is similar in construction to the previously cleared Lysus Infusion System. The modified system includes a lubricious coating on the inside of the Drug Delivery Catheter.

Test Summary

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a bird-like figure with three curved lines representing wings or streams.

MAR 1 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Rc: K050472

Lysus® Infusion System Regulation Number: 21 CFR 870.1210 Regulation Name: Continous Flush Catheter Regulatory Class: Class II (two) Product Code: DRA Dated: February 24, 2005 Received: February 25, 2005

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 for abornerou ar 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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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- . 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.

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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): K050472

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)

Duana R. Kirchner

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number_K 050 47 2

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Regulation Number and Section

§ 870.1280 Steerable catheter.

(a)
Identification. A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.(b)
Classification. Class II (performance standards).