LYSUS INFUSION SYSTEM

K051319 · Ekos Corp. · QEY · Jun 15, 2005 · Cardiovascular

Device Facts

• Record ID: K051319
• Device Name: LYSUS INFUSION SYSTEM
• Applicant: Ekos Corp.
• Product Code: QEY · Cardiovascular
• Decision Date: Jun 15, 2005
• Decision: SESE
• Submission Type: Special
• 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 consists of disposable infusion catheter with removable ultrasound core and control unit. Catheter features multiple side holes for fluid delivery; ultrasound core contains up to 30 elements for energy delivery. Thermal sensors monitor transducer temperature. Used in clinical settings by physicians for peripheral vasculature infusion. System delivers physician-specified fluids (e.g., thrombolytics) to treatment site. Ultrasound energy delivery is controlled by the instrument. Benefits include targeted fluid delivery to peripheral vasculature.

Clinical Evidence

No clinical data. Bench testing only; software was validated prior to release of the upgraded version.

Technological Characteristics

Disposable infusion catheter with removable ultrasound core; up to 30 ultrasound elements; thermal sensors for temperature monitoring; control unit for energy delivery; software-controlled.

Indications for Use

Indicated for 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

• Lysus Infusion System (K042456)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 7, 2022

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

Re: K051319

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 June 15, 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, [phone], Gregory.Oconnell(@FDA.HHS.gov.

Sincerely,

Gregory W. Digitally signed by Gregory W. O'connell -S O'connell -S Date: 2022.01.07
13:35:45-05-05-05:00'

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 shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized wing shapes.

JUN 1 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K051319 Lysus Infusion System Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II (two) Product Code: KRA Dated: May 18, 2005 Received: May 20, 2005

Dear Ms. Kersten:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your became in (d 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 encrease, 1976, the enactment date of the Medical Device Amendments, or to conimered processified in accordance with the provisions of the Federal Food, Drug, de Moos mat nave ocen i deat 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 I va may, diereleve, mains of the Act include requirements for annual registration, listing of general controls provisions 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Drina R. Vachner

- A. 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): ≤ (25 1 319

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.

X Prescription Use (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)

Danna R. Vachner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_Kost319

Page 1 of

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# JUN 1 5 2005

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#### 510(k) Summary Section 4.

General Provisions

| Submitter's Name and Address: | EKOS Corporation<br>22030 20th Ave. SE<br>Suite 101<br>Bothell, WA 98021 |
|-------------------------------|--------------------------------------------------------------------------------|
| Contact Person: | Jocelyn Kersten<br>425-482-1108<br>425-482-1109 (fax)<br>[e-mail] |
| 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.: | K042456 |

# 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.

# 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 software upgrade and revisions to the Instructions for Use described in this notification do not affect the technological characteristics for the Lysus Infusion System.

### Test Summary

The software was validated prior to release of the upgraded version.

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#### Section 5. General Information

# Trade and Common Names

Trade Name: Lysus Infusion System Common Name: Continuous Flush Catheter

Establishment Registration

3001627457

# Manufacturing Facility

EKOS Corporation 22030 20th Ave. SE Suite 101 Bothell, WA 98021

# Device Classification

Continuous flush catheters have been classified by the FDA Cardiovascular Panel as Class II (KRA).

# Purpose of Notification

The purpose of this SPECIAL 510(k) notification is to seek clearance of a software upgrade and associated revisions to the PT-3 Control Unit Instructions for Use. The software upgrade by itself would not have met the criteria for requiring a new 510(k). However, because revisions to the IFU are also required, this SPECIAL 510(k) is being submitted.

# Predicate Device

The Lysus Infusion System is identical in design, composition, function and intended use to the previously cleared Lysus Infusion System (K042456).

# Performance Standards

Performance standards have not been promulgated for continuous flush catheters.