MICRO-INFUSION SYSTEM

K062507 · Ekos Corp. · QEY · Nov 22, 2006 · Cardiovascular

Device Facts

• Record ID: K062507
• Device Name: MICRO-INFUSION SYSTEM
• Applicant: Ekos Corp.
• Product Code: QEY · Cardiovascular
• Decision Date: Nov 22, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EKOS Micro-Infusion System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature. The EKOS Micro-Infusion System is intended for regional infusion of contrast materials into selected vessels in the neurovasculature. The EKOS Micro-Infusion System may be used for controlled, regional infusion into selected vessels and is not intended for use in the coronary vasculature.

Device Story

System comprises disposable infusion/ultrasound catheter and control unit (PT-2B). Catheter features distal ultrasound transducer, thermal sensor, and distal end hole for guidewire placement and fluid infusion. Device used in clinical settings for controlled, regional delivery of fluids or contrast agents. Physician operates system to manage infusion parameters. Ultrasound energy delivery facilitates infusion process. System provides controlled, selective fluid delivery to target vessels, aiding in therapeutic or diagnostic procedures.

Clinical Evidence

Bench testing only. Electrical safety and system testing confirmed the PT-2B control unit operates as intended with the Micro-Infusion Catheters.

Technological Characteristics

System includes disposable infusion/ultrasound catheter and PT-2B control unit. Catheter features distal ultrasound transducer and thermal sensor. Energy source: ultrasound. Connectivity: system-integrated control unit. Sterilization: not specified. Software: embedded control unit firmware.

Indications for Use

Indicated for controlled, selective infusion of physician-specified fluids (including thrombolytics) into peripheral vasculature and regional infusion of contrast materials into neurovasculature. Not intended for coronary 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

• Micro-Infusion System (K060084)
• Micro-Infusion System (K053437)
• Micro-Infusion System (K053432)

Submission Summary (Full Text)

{0}------------------------------------------------

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 seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, with the letters "FDA" in a blue square. Next to the blue square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 7, 2022

EKOS Corporation Jocelyn Kersten Vice-President of Regulatory Affairs 11911 North Creek Pkwy. South Bothell, Washington 98011

Re: K062507

Trade/Device Name: Micro-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 November 22, 2006. 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 13:50:17 -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

{1}------------------------------------------------

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 consists of a stylized eagle with three overlapping wing segments, facing right. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 2 2006

Jocelyn Kersten Vice-President of Regulatory Affairs EKOS Corporation 11911 North Creek Pkwy South Bothell, WA 98011

Re: K062507

Trade Name: EKOS Micro-Infusion System-Peripheral Indication Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous flush catheter Regulatory Class: Class II Product Code: KRA Dated: November 2, 2006 Received: November 6, 2006

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.

{2}------------------------------------------------

### Page 2 - Ms. 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Dinah R. Lochnes

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

# Indications for Use

510(k) Number (if known): 1<06 2 50 7

Device Name: Micro-Infusion System

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

The EKOS Micro-Infusion System is intended for regional infusion of contrast materials into selected vessels in the neurovasculature. The EKOS Micro-Infusion System may be used for controlled, regional infusion into selected vessels and is not intended for use in the coronary 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)

Donna E. Barnes

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K067507

Page 1 of 1

{4}------------------------------------------------

K062507

SPECIAL 510(k) Notification Micro-Infusion System

## NOV 2 2 2006

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

General Provisions

| Submitter's Name and Address: | EKOS Corporation<br>11911 North Creek Pkwy South<br>Bothell, WA 98011 |
|-------------------------------|--------------------------------------------------------------------------------|
| Contact Person: | Jocelyn Kersten<br>425-415-3132<br>425-415-3101 (fax)<br>[e-mail] |
| Classification Name: | Catheter, Continuous Flush (KRA) |
| Common or Usual Name: | Continuous Flush Catheter |
| Proprietary Name: | Micro-Infusion System |
| Name of Predicate Device: | Micro-Infusion System |
| 510(k) Reference No.: | K060084<br>K053437<br>K053432 |

### Device Description

The system consists of a disposable infusion/ultrasound catheter and an instrument that generates and controls the delivery of energy to the catheter. The catheter contains a single ultrasound transducer, located at the distal tip, a thermal sensor and a distal end hole for placement over a guide wire and fluid infusion.

### Intended Use

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

The EKOS Micro- Infusion System is intended for regional infusion of contrast materials into selected vessels in the neurovasculature. The EKOS Micro- Infusion System may be used for controlled, regional infusion into selected vessels and is not intended for use in the coronary vasculature.

### Summary of Technological Characteristics

The device modifications described in this notification do not affect the technological characteristics for the Micro-Infusion System.

### Test Summary

Electrical safety and system testing confirmed the PT-2B operates as intended with the Micro-Infusion Catheters.

{5}------------------------------------------------

#### Section 5. General Information

## Trade and Common Names

Trade Name: Micro-Infusion System Common Name: Continuous Flush Catheter

# Establishment Registration

3001627457

## Manufacturing Facility

EKOS Corporation 11911 North Creck Pkwy South Bothell, WA 98011

## 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 for a device modification that will implement a 2nd generation of the PT-2 Control Unit, the PT-2B.

## Predicate Device

The Micro-Infusion System is similar in design and composition and identical in function and intended use to the previously cleared Micro-Infusion System (K053437, K053432 and K060084).

## Performance Standards

Performance standards have not been promulgated for continuous flush catheters.