EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION

K081467 · Ekos Corp. · QEY · Jun 26, 2008 · Cardiovascular

Device Facts

• Record ID: K081467
• Device Name: EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION
• Applicant: Ekos Corp.
• Product Code: QEY · Cardiovascular
• Decision Date: Jun 26, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5150
• Device Class: Class 2

Intended Use

The EkoSonic™ Endovascular System with Rapid Pulse Modulation is intended for the infusion of solutions into the pulmonary arteries. The EkoSonic System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

Device Story

System comprises disposable infusion catheter with removable ultrasound core and control instrument. Catheter features multiple side holes for fluid delivery; ultrasound core contains up to 30 elements for energy delivery. Thermal sensors monitor treatment zone temperature. Used by physicians in clinical settings for controlled, selective infusion of physician-specified fluids (including thrombolytics) into peripheral vasculature or pulmonary arteries. Ultrasound energy is non-therapeutic. Device provides infusion capability; healthcare providers use output to manage fluid delivery. Benefits include targeted, controlled infusion.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including electrical safety, electrical circuit qualification, software validation, and system integration testing.

Technological Characteristics

System includes disposable infusion catheter with removable ultrasound core and control instrument. Features up to 30 ultrasound elements and thermal sensors in the treatment zone. Infusion catheter has multiple side holes. Operates via controlled energy delivery to catheter. Software-controlled system integration.

Indications for Use

Indicated for infusion of solutions into pulmonary arteries and peripheral vasculature. Not indicated for thrombolytic therapy in pulmonary embolus; safety and effectiveness for this use not established.

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

• EndoWave Infusion System (K080392, K073166)

Submission Summary (Full Text)

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November 22, 2021

EKOS Corporation Jocelyn Kersten Vice President 11911 N Creek Parkway South Bothell, Washington 98011

Re: K081467

Trade/Device Name: EkoSonic Endovascular System With Rapid Pulse Modulation 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 26, 2008. 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: 2021.11.22 13:37:13 -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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 6 2008

EKOS Corporation c/o Ms. Jocclyn Kersten Vice President, Quality Assurance, Regulatory and Clinical Affairs 11911 N Creek Pkwy S Bothell, WA 98011

Re: K081467

Trade/Device Name: EkoSonic™ Endovascular System with Rapid Pulse Modulation Regulation Number: 21 CFR 870.1210 Regulation Name: Catheter, Continuous Flush Regulatory Class: Class II (two) Product Code: KRA Dated: May 22, 2008 Received: May 27, 2008

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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

R. Vochner

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 EkoSonic™ Endovascular System

EKOS Corporation 11911 North Creek Parkway South Bothell, WA 98011

## Indications for Use Statement

510(k) Number (if known): k081467

EkoSonic™ Endovascular System with Rapid Pulse Modulation Device Name:

Indications for Use:

The EkoSonic™ Endovascular System with Rapid Pulse Modulation is intended for the infusion of solutions into the pulmonary arteries.

The safety and effectiveness of the EKOS EkoSonic™ Endovascular System with Rapid Pulse Modulation for thrombolytic therapy administration in pulmonary embolus have not been established. In particular, the ultrasound energy delivered by the EndoWave system is not intended to be therapeutic, nor has it been cleared with an indication for thrombolysis in pulmonary emboli.

Prescription Use X (Per 21 CFR 801.109) OR

Over-The-Counter Use

Concurrence of CDRH, Office of Device Evaluation (ODE)

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K081467 page lot 2

SPECIAL 510(k) Notification EkoSonic™ Endovascular System

JUN 2 6 2008

## Section 4. 510(k) Summary

General Provisions

| Submitter's Name and Address: | EKOS Corporation<br>11911 North Creek Parkway South<br>Bothell, WA 98011 |
|-------------------------------|--------------------------------------------------------------------------------|
| Contact Person: | Jocelyn Kersten<br>425-415-3132<br>425-415-3102 (fax)<br>[e-mail] |
| Classification Name: | Catheter, Continuous Flush (KRA) |
| Regulation Number: | 21 CFR §870.1210 |
| Common or Usual Name: | Continuous Flush Catheter |
| Proprietary Name: | EkoSonic™ Endovascular System with Rapid Pulse<br>Modulation |
| Name of Predicate Device: | EndoWave Infusion System |
| 510(k) Reference No.: | K080392, K073166 |

## 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 catheter temperature.

## Intended Use

The EkoSonic System is intended for the controlled and selective infusion of physicianspecified fluids, including thrombolytics, into the peripheral vasculature.

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KCE1167 page 2 of 2

SPECIAL 510(k) Notification EkoSonic™ Endovascular System

The EkoSonic ™ Endovascular System with Rapid Pulse Modulation is intended for the infusion of solutions into the pulmonary arteries.

The safety and effectiveness of the EKOS EkoSonic™ Endovascular System with Rapid Pulse Modulation for thrombolytic therapy administration in pulmonary embolus have not been established. In particular, the ultrasound energy delivered by the EndoWave system is not intended to be therapeutic, nor has it been cleared with an indication for thrombolysis in pulmonary emboli.

Summary of Technological Characteristics

The device modification described in this notification does not affect the technological characteristics for the EkoSonic System.

Test Summary

Electrical safety testing, electrical circuit qualification testing, software validation testing and system integration testing confirmed the modified EkoSonic System is substantially equivalent to the predicate EndoWave System.