LYSUS INFUSION SYSTEM

K041629 · Ekos Corp. · QEY · Aug 6, 2004 · Cardiovascular

Device Facts

• Record ID: K041629
• Device Name: LYSUS INFUSION SYSTEM
• Applicant: Ekos Corp.
• Product Code: QEY · Cardiovascular
• Decision Date: Aug 6, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Lysus Infusion System is an infusion catheter system for peripheral vasculature. Device consists of a multi-sidehole catheter and an internal ultrasound core containing linearly distributed ultrasound transducers. System delivers physician-specified fluids or thrombolytic agents. Ultrasound energy is used to facilitate infusion. Operated by physicians in clinical settings. Output is the controlled delivery of therapeutic agents to target peripheral sites. Benefits include targeted, selective fluid administration for vascular conditions.

Clinical Evidence

Preclinical bench and animal studies were conducted. Results demonstrate that the device meets design specifications and is safe and effective for its intended use. No human clinical trial data provided.

Technological Characteristics

Multi-sidehole infusion catheter with an internal ultrasound core. Ultrasound transducers are distributed linearly along the core to disperse fluids. Class II device (21 CFR 870.1210).

Indications for Use

Indicated for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

Regulatory Classification

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.

Predicate Devices

• EKOS Peripheral Infusion System (K030367, K033214)
• Merit Medical Fountain Infusion Catheter (K974067, K991619, K992231)
• Micro Therapeutics Cragg/McNamara Infusion Catheter (K964868)
• Angiodynamics SpeedLyser Infusion Catheter Kit (K033443)

Submission Summary (Full Text)

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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: the symbol of the Department of Health & Human Services on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The FDA text is in blue, with "FDA" in a larger, bolder font than the rest of the text.

January 7, 2022

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

Re: K041629

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 6, 2004. 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, [phone], Gregory.Oconnell(@FDA.HHS.gov.

Sincerely,

Digitally signed by Gregory W. Gregory W. O'connell -S O'connell -S Date: 2022.01.07 13:31:33 -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

Public Health Service

Image /page/1/Picture/2 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the edge. In the center of the seal is an emblem of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.

AUG - 6 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K041629 Lysus Infusion System Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II (two) Product Code: KRA Dated: June 15, 2004 Received: June 16, 2004

Dear Ms. Kersten:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rovewed your be determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreases of 76, the enactment date of the Medical Device Amendments, or to conninered pror to ridy 2011 de necs that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I va may, afere, misions 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 If your device is exassinon 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 Please be advised that I DA s issuazed or our device complies with other requirements of the Act that IDA has made a determination administered by other Federal agencies. You must of ally reactal statutes and regulations and limited to: registration and listing (21 comply with an the Act stequirements, morealing, and manufacturing practice requirements as set CFR in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality bytellio (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro risions (sveting your device as described in your Section 510(k) This letter will anow you to begin mailing of substantial equivalence of your device to a legally premarket notification: The PDF interessification 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 If you desire specific acries ion 902 as 1) 594-4648. Also, please note the regulation entitled, Contact the Oriece of Course to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mionnation on your Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

(2017445 0977 6da.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Duana R. Vachner

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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## Indications for Use

510(k) Number (if known):___K041629

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use: The Lysus" Infusion System is intended for the controlled and
ers and the success of the securities including thrombolytics, into the Indications Por Ose. The Eysus Infaction Oyclower
selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/03

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)

una R. Lichner

(Division Sign-Off) (Division Sign-Oli)
Division of Cardiovascular Devices

-o(k) **Number** k041624

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K041629
510(k) Notification

## 9 510(k) Summary

| Applicant Name: | EKOS Corporation |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 22030 20th Ave. SE, Suite 101<br>Bothell, WA 98021 |
| Contact Person: | Jocelyn Kersten<br>Director, Regulatory Affairs |
| Telephone: | [phone] X 287 |
| Fax: | [phone] |
| Device: | Lysus® Infusion System |
| Classification: | CFR 870.1210 - Continuous Flush Catheter |
| Panel: | Cardiovascular |
| Product Code: | KRA |
| Intended Use: | The Lysus® Infusion System is intended for the controlled and<br>selective infusion of physician-specified fluids, including<br>thrombolytics, into the peripheral vasculature. |
| Device Description: | The Lysus® Infusion System is an infusion catheter system designed<br>to deliver fluids via a multi sidehole catheter. The fluid is dispersed<br>via multiple ultrasound transducers distributed linearly along the<br>length of an ultrasound core which is placed into the center lumen of<br>the catheter. This device is intended to deliver physician-specified<br>agents or fluids into the peripheral vasculature. |
| Predicate Basis: | The Lysus® Infusion System is substantially equivalent to other<br>legally marketed devices. These devices include<br>• EKOS Corporation: EKOS Peripheral Infusion System<br>(K030367, K033214)<br>• Merit Medical: Fountain Infusion Catheter (K974067, K991619,<br>K992231)<br>• Micro Therapeutics: Cragg/McNamara Infusion Catheter<br>(K964868)<br>• Angiodynamics: SpeedLyser Infusion Catheter Kit (K033443) |
| Performance: | EKOS has conducted preclinical bench and animal studies with the<br>Lysus® Infusion System. These studies demonstrate that the<br>performance of the Lysus® Infusion System meets its design<br>specifications and is safe and effective for its intended use. |

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