ENDOWAVE INFUSION SYSTEM by EKOS CORP.

The safety and effectiveness of the EKOS EndoWaveTM Infusion system 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.

Device Description

The EndoWaveTM Infusion System is an infusion catheter system designed to deliver fluids via a multi sidehole catheter. The fluid is dispersed via multiple ultrasound transducers distributed linearly along the length of an ultrasound core which is placed into the center lumen of the catheter. This device is intended to deliver physician-specified agents or fluids into the peripheral vasculature.

AI/ML Overview

The provided text is a 510(k) summary for the EKOS EndoWave Infusion System. This document focuses on establishing substantial equivalence to predicate devices and detailing the intended use and limitations of the device. It does not contain information about acceptance criteria, device performance metrics, or study details (like sample size, ground truth, expert qualifications) related to a new performance study.

Therefore, I cannot fulfill your request to describe acceptance criteria and the study that proves the device meets the acceptance criteria, as the necessary information is not present in the provided text.

The closest information available is:

"Performance: EKOS has conducted preclinical bench and animal studies with the EndoWave™ Infusion System. These studies demonstrate that the performance of the EndoWave™ Infusion System meets its design specifications for its intended use."

This statement confirms that studies were done and that the device met its design specifications, but it does not provide any specifics about those specifications (acceptance criteria) or the studies themselves. Without these details, the requested table and accompanying study information cannot be generated.

Summary

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510(k) Summary

Applicant Name:	EKOS Corporation	APR 22 2008
Address:	11911 North Creek Parkway SouthBothell, WA 98011
Contact Person:	Jocelyn KerstenVice President, Quality Assurance, Regulatory and Clinical Affairs
Telephone:	(425) 415-3132
Fax:	(425) 415-3102
Device:	EndoWaveTM Infusion System
Classification:	CFR 870.1210 - Continuous Flush Catheter
Panel:	Cardiovascular
Product Code:	KRA
Intended Use:	The EndoWaveTM Infusion System is intended for the infusion ofsolutions into the pulmonary arteries.
	The safety and effectiveness of the EKOS EndoWaveTM Infusionsystem for thrombolytic therapy administration inpulmonary embolus have not been established. In particular, theultrasound energy delivered by the EndoWave system is notintended to be therapeutic, nor has it been cleared with anindication for thrombolysis in pulmonary emboli.
Device Description:	The EndoWaveTM Infusion System is an infusion catheter systemdesigned to deliver fluids via a multi sidehole catheter. The fluid isdispersed via multiple ultrasound transducers distributed linearly alongthe length of an ultrasound core which is placed into the center lumen ofthe catheter. This device is intended to deliver physician-specifiedagents or fluids into the peripheral vasculature.
Predicate Basis:	The EndoWaveTM Infusion System is substantially equivalent to otherlegally marketed devices. These devices include1. EKOS EndoWave Infusion System ( EKOS Corporation , K071933,K072507)2. EKOS NeuroWave Infusion System ( EKOS Corporation , K062508,K063620)3. Edwards Swan-Ganz Standard Thermodilution Pulmonary ArteryCatheter, ( Edwards Lifesciences , K014054)4. Z-Med 11-X, ( NuMED, Inc. , K003052,K011557, K030589)
Performance:	EKOS has conducted preclinical bench and animal studies with the

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EndoWave™ Infusion System. These studies demonstrate that the
performance of the EndoWave™ Infusion System meets its design
specifications for its intended use.

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Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 2 2008

EKOS Corporation c/o Ms. Jocelyn Kersten 11911 North Creek Parkway South Bothell, WA 98011

Re: K073166

EKOS EndoWave Infusion System Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: II (two) Product Code: KRA Dated: January 18, 2008 Received: January 22, 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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear immediately following the indication for use in the device's labeling:

The safety and effectiveness of the EKOS EndoWave™ Infusion system 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.

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Page 2 - Ms. Jocelyn Kersten

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.

If vour device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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.

If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Donna Rae Tillman, Ph.D., M.B.A.

Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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1.10 Indications for Use Statement

EKOS Corporation 11911 North Creek Parkway South Bothell, WA 98011

Indications for Use Statement

510(k) Number (if known): K073166

EndoWave™ Infusion System Device Name:

Indications for Use:

The EndoWave™ Infusion System is intended for the infusion of solutions into the pulmonary arteries.

Prescription Use X (Per 21 CFR 801.109) OR

Over-The-Counter Use Counter

Concurrence of CDRH, Office of Device Evaluation (ODE)

surver 2 (Division Sign-Off)

Division of Cardiovascular Devices

510(k) Number_Ko73166

Regulation Number and Section

§ 870.1210 Continuous flush catheter.

(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).