EKOS PERIPHERAL INFUSION SYSTEM

K050563 · Ekos Corp. · QEY · Mar 29, 2005 · Cardiovascular

Device Facts

• Record ID: K050563
• Device Name: EKOS PERIPHERAL INFUSION SYSTEM
• Applicant: Ekos Corp.
• Product Code: QEY · Cardiovascular
• Decision Date: Mar 29, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

System consists of disposable infusion/ultrasound catheter and control instrument; instrument generates/controls energy delivery to catheter. Catheter features distal tip ultrasound transducer, thermal sensor, and distal end hole for guide wire placement and fluid infusion. Used in clinical settings for peripheral vasculature infusion. Physician-operated; provides controlled fluid delivery to target site. Benefits include targeted therapeutic administration.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

System includes disposable infusion/ultrasound catheter and energy control instrument. Catheter features distal ultrasound transducer and thermal sensor. Designed for guide wire placement and fluid infusion.

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

• EKOS Peripheral Infusion System (K033214)

Submission Summary (Full Text)

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January 7, 2022

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

Re: K050563

Trade/Device Name: EKOS Peripheral 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 29, 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,

Digitally signed by Gregory W. Gregory W. O'connell -O'connell -S Date: 2022.01.07 13:34:51 -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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Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 9 2005

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

Re: K050563

EKOS Peripheral Infusion System Regulation Number: 21 CFR 870.1210 Regulation Name: Catheter, Continuous Flush Regulatory Class: Class II (Two) Product Code: KRA Dated: March 3, 2005 Received: March 4, 2005

Dear Ms. Kersten:

We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your becamed 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 chelosure) to regard) to regard case of the Medical Device American be of the d. Ford. commerce prof to May 20, 1976, the encordance with the provisions of the Federal Food, Drug, devices mat have been recuired in accessfrou in accessful of a premarket approval application (PMA). and Cosment Act (Act) that do not require subject to the general controls provisions of the Act. The You may, therefore, market the act include requirements for annual registration, listing of general controls provisions of the 110 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 classified (500 a0070) mis. Existing major regulations affecting your device can may be subject to suen additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Code of Pouchal Ingerning 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 r lease oc devised that I Drivision that your device complies with other requirements of the Act that I Dr Has Intact a and regulations administered by other Federal agencies. You must or any i coclar sundles and regaranents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It Fat 8077; laceming (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product faction of to begin marketing your device as described in your Section 510(k) I ms letter with and w Jourse of substantial equivalence of your device to a legally premated notification: The 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 other Echeral International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

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 EKOS Peripheral Infusion System

## Indications for Use

510(k) Number (if known):

Device Name:

EKOS Peripheral Infusion System

Indications for Use:

The EKOS Peripheral Infusion System is intended for the controlled and selective infusion of The DICOD Feripheral nuids, 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)

Dia Malli

Koso563 510(k) Number

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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| General<br>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 | EKOS Peripheral Infusion System |
| Name of<br>Predicate Device | Predicate Device<br>EKOS Peripheral Infusion System | 510(k) Reference Nos.<br>K033214 |
| Device<br>Description | The system consists of a disposable infusion/ultrasound catheter and an<br>instrument that generates and controls the delivery of energy to the<br>catheter. The catheter contains a single ultrasound transducer, located at<br>the distal tip, a thermal sensor and a distal end hole for placement over a<br>guide wire and fluid infusion. | |
| Intended Use | The EKOS Peripheral Infusion System is intended for the controlled and<br>selective infusion of physician-specified fluids, including thrombolytics,<br>into the peripheral vasculature. | |
| Summary of<br>Technological<br>Characteristics | The proposed EKOS Peripheral Infusion System is similar in construction<br>and materials to the previously cleared EKOS Peripheral Infusion System. | |
| Test Summary | The proposed EKOS Peripheral Infusion System is considered to be<br>substantially equivalent to the currently marketed EKOS Peripheral<br>Infusion System based on a comparison of the intended uses and designs<br>and results of the testing and evaluations performed. | |

MAR 2 9 2005

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## Section 4. 510(k) Summary