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

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,

AI/ML Overview

This FDA 510(k) summary for the EndoWave Infusion System (K071933) indicates that the submission is for an administrative correction to an already cleared device, primarily for a product code update (page 0). The original substantial equivalence (SE) determination was made in 2007 (page 1). Because this is an administrative update, the provided information does not describe a new study conducted to establish acceptance criteria for the device's performance in the context of an AI/ML algorithm.

The document discusses the EndoWave Infusion System which is a medical device for controlled and selective infusion of physician-specified fluids (including thrombolytics) into the peripheral vasculature (page 3, 4). The "device" in the context of the question refers to this physical system, not an AI/ML algorithm.

Therefore, the following information cannot be extracted from the provided text:

Acceptance criteria and reported device performance related to AI/ML algorithm.
Sample size used for the test set and data provenance.
Number of experts used to establish ground truth.
Adjudication method.
Multi-reader multi-case (MRMC) comparative effectiveness study information.
Standalone (algorithm only) performance information.
Type of ground truth used for AI/ML.
Sample size for the training set for AI/ML.
How ground truth for the training set was established for AI/ML.

The document briefly mentions a "Test Summary" on page 5, which states: "The proposed EndoWave Infusion System is considered to be substantially equivalent to the currently marketed EndoWave Infusion System based on a comparison of the intended uses and designs and results of the testing and evaluations performed." However, it does not provide details about the specific tests, acceptance criteria, or their results. It instead points to "Substantial Equivalence" as the basis, comparing it to a previously cleared device (K060422). This implies that performance was assessed against the predicate device rather than through a new, full-blown clinical study with specific acceptance criteria that would typically be described for a novel device or AI/ML product.

Summary

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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: on the left, there is the Department of Health & Human Services logo, which features a stylized human figure. To the right of this is the FDA logo, with the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

January 7, 2022

EKOS Corporation Jocelyn Kersten Vice President, Regulatory & Clinical Affairs 11911 N Creek Parkway South Bothell, Washington 98011

Re: K071933

Trade/Device Name: EndoWave 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 10. 2007. 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, (301) 796-6075, Gregory.Oconnell(@FDA.HHS.gov.

Sincerely,

Digitally signed by Gregory W. Gregory W. O'connell -S O'connell -S Date: 2022.01.07 13:52:20 -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 Druq Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 0 2007

EKOS Corporation c/o Ms. Jocelyn Kersten Vice President, Regulatory and Clinical Affairs 11911 North Creek Parkway South Bothell, WA 98011

Re: K071933 EndoWave Infusion System Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: II (Two) Product Code: KRA Dated: July 12, 2007 Received: July 13, 2007

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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Bfmmmorfr

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 EndoWave™ Infusion System

Indications for Use

K071933 510(k) Number (if known):

Device Name: EndoWave® Infusion System

Indications For Use: The EndoWave® Infusion System is intended for the controlled and selective infusion of physician-specified fluids, 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)

B. Bammema

ision Sign-Off) Dision of Cardloyascular Devices 51 J(k) Number_

Page 1 of

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Page 5

AUG 1 0 2007

510(k) Summary Section 4.

General Provisions

Submitter's Name and Address:	EKOS Corporation11911 North Creek Parkway SouthBothell, WA 98011
Contact Person:	Jocelyn Kersten425-415-3132425-415-3102 (fax)jkersten@EKOSCORP.com
Classification Name:	Catheter, Continuous Flush (KRA)
Common or Usual Name:	Continuous Flush Catheter
Proprietary Name:	EndoWave® Infusion System
Name of Predicate Device:	EndoWave® Infusion System
510(k) Reference No.:	K060422

Device Description

Intended Use

The EndoWave® 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 proposed EndoWave Infusion System is similar in construction to the previously cleared EndoWave Infusion System. The modified manifold of the Drug Delivery Catheter performs the same function as the previous manifold with improved manufacturability.

Test Summary

The proposed EndoWave Infusion System is considered to be substantially equivalent to the currently marketed EndoWave Infusion System based on a comparison of the intended uses and designs and results of the testing and evaluations performed.

K071933 p. Lof I

Regulation Number and Section

§ 870.5150 Embolectomy catheter.

(a)
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.(b)
Classification. Class II (performance standards).