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 is a 510(k) premarket notification letter and summary for the EKOS Lysus Infusion System. It details an administrative change related to a product code update and references a previous substantial equivalence determination. However, it does not contain the specific information requested in the prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC study results for device performance.

The document primarily focuses on the regulatory aspects of the device, its intended use, and a general statement about previous safety and durability testing.

Therefore, I cannot provide the requested information from the given text.

Specifically, the following information is missing:

Table of acceptance criteria and reported device performance: Not present.
Sample size used for the test set and data provenance: Not present. The text only mentions "Testing previously performed" and "New testing demonstrated the USC has sufficient durability."
Number of experts used to establish the ground truth for the test set and their qualifications: Not present.
Adjudication method for the test set: Not present.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned.
Standalone (algorithm only) performance: Not applicable as this is a medical device (infusion system), not an AI algorithm.
Type of ground truth used: Not present.
Sample size for the training set: Not applicable/not present.
How the ground truth for the training set was established: Not applicable/not present.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is the Department of Health & Human Services logo, which features a stylized human figure. To the right of this is the FDA logo, with the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

January 7, 2022

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

Re: K052071

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 August 1 6, 2005. 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,

Gregory W - Digitally signed by Gregory W. O'connell -S O'connell -S Pate: 2022.01.07
13:36:48-05'00'

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

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" arranged around the perimeter. Inside the circle is a stylized symbol resembling a caduceus, which is a traditional symbol of medicine, with a staff and intertwined snakes.

AUG 1 6 2005

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: K052071 Trade/Device Name: EKOS Lysus Infusion System Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Infusion Catheter Regulatory Class: II (two) Product Code: KRA Dated: July 29, 2005 · Received: August 1, 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 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours,

Bhomman for

Bram D. Zuckerman, MD 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)

. .

: 上一篇:

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)

Blumunno

(Division Sign-Off Division of Cardlovascular Devices 510(k) Number

Page 1 of __ 1__

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AUG 1 6 2005

052071

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 .:	K051319

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).