(51 days)
The Lysus" Infusion System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
The Lysus® 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.
This is a 510(k) premarket notification for a medical device (Lysus Infusion System), not a clinical study report. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for clinical performance evaluations, is not present in the provided document.
A 510(k) submission primarily demonstrates substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a clinical study. The performance section in a 510(k) summary typically references preclinical (bench and animal) studies to demonstrate design specification adherence, safety, and effectiveness.
Here's a breakdown of what can be extracted from the provided text, and what cannot:
Information Extracted from the Provided Document:
- Device Name: Lysus® Infusion System
- Intended Use: "The Lysus® Infusion System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature."
- Device Description: "The Lysus® 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."
- Type of Studies Mentioned: "EKOS has conducted preclinical bench and animal studies with the Lysus® Infusion System. These studies demonstrate that the performance of the Lysus® Infusion System meets its design specifications and is safe and effective for its intended use."
Information NOT available in the provided document (and why):
- A table of acceptance criteria and the reported device performance: This document is a summary of the 510(k) submission, not the full submission itself, nor a clinical study report. It states that the device "meets its design specifications," but doesn't list those specifications or the performance against them.
- Sample sizes used for the test set and the data provenance: The document mentions "preclinical bench and animal studies" but does not provide details of sample sizes, control groups, or whether the data was retrospective or prospective. It certainly doesn't mention human test sets, as this is a 510(k) premarket notification.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Preclinical studies typically don't involve expert ground truth establishment in the same way clinical studies do.
- Adjudication method for the test set: Not applicable for preclinical studies as described.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an infusion system, not an AI diagnostic tool, and the document describes preclinical testing, not comparative clinical effectiveness.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not explicitly stated for the preclinical studies. In bench studies, "ground truth" would be engineering measurements and physical standards. In animal studies, it would be physiological and histological observations.
- The sample size for the training set: Not applicable. This is not an AI device that undergoes a "training set" process.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a regulatory notice for a 510(k) clearance, which relies on demonstrating substantial equivalence to a predicate device via preclinical data, not on a detailed clinical study proving specific acceptance criteria in humans.
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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: the symbol of the Department of Health & Human Services on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The FDA text is in blue, with "FDA" in a larger, bolder font than the rest of the text.
January 7, 2022
EKOS Corporation Jocelyn Kersten Regulatory Affairs Manager 22030 20th Avenue SE, Suite 101 Bothell, Washington 98021
Re: K041629
Trade/Device Name: Lysus 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 6, 2004. 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 13:31:33 -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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/1/Picture/2 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the edge. In the center of the seal is an emblem of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.
AUG - 6 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
EKOS Corporation c/o Ms. Jocelyn Kersten Director, Regulatory Affairs 22030 20th Avenue, Suite 101 Bothell. WA 98021
Re: K041629 Lysus Infusion System Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II (two) Product Code: KRA Dated: June 15, 2004 Received: June 16, 2004
Dear Ms. Kersten:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rovewed your be determined 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 encreases of 76, the enactment date of the Medical Device Amendments, or to conninered pror to ridy 2011 de necs that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I va may, afere, misions 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 If your device is exassinon 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 Please be advised that I DA s issuazed or our device complies with other requirements of the Act that IDA has made a determination administered by other Federal agencies. You must of ally reactal statutes and regulations and limited to: registration and listing (21 comply with an the Act stequirements, morealing, and manufacturing practice requirements as set CFR in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality bytellio (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro risions (sveting your device as described in your Section 510(k) This letter will anow you to begin mailing of substantial equivalence of your device to a legally premarket notification: The PDF interessification 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 If you desire specific acries ion 902 as 1) 594-4648. Also, please note the regulation entitled, Contact the Oriece of Course 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 general mionnation on your Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
(2017445 0977 6da.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Duana R. Vachner
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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Indications for Use
510(k) Number (if known):___K041629
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use: The Lysus" Infusion System is intended for the controlled and
ers and the success of the securities including thrombolytics, into the Indications Por Ose. The Eysus Infaction Oyclower
selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/03
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)
una R. Lichner
(Division Sign-Off) (Division Sign-Oli)
Division of Cardiovascular Devices
-o(k) Number K041624
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K041629
510(k) Notification
9 510(k) Summary
| Applicant Name: | EKOS Corporation |
|---|---|
| Address: | 22030 20th Ave. SE, Suite 101Bothell, WA 98021 |
| Contact Person: | Jocelyn KerstenDirector, Regulatory Affairs |
| Telephone: | (425) 482-1108 X 287 |
| Fax: | (425) 482-1109 |
| Device: | Lysus® Infusion System |
| Classification: | CFR 870.1210 - Continuous Flush Catheter |
| Panel: | Cardiovascular |
| Product Code: | KRA |
| Intended Use: | The Lysus® Infusion System is intended for the controlled andselective infusion of physician-specified fluids, includingthrombolytics, into the peripheral vasculature. |
| Device Description: | The Lysus® Infusion System is an infusion catheter system designedto deliver fluids via a multi sidehole catheter. The fluid is dispersedvia multiple ultrasound transducers distributed linearly along thelength 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 Lysus® Infusion System is substantially equivalent to otherlegally marketed devices. These devices include• EKOS Corporation: EKOS Peripheral Infusion System(K030367, K033214)• Merit Medical: Fountain Infusion Catheter (K974067, K991619,K992231)• Micro Therapeutics: Cragg/McNamara Infusion Catheter(K964868)• Angiodynamics: SpeedLyser Infusion Catheter Kit (K033443) |
| Performance: | EKOS has conducted preclinical bench and animal studies with theLysus® Infusion System. These studies demonstrate that theperformance of the Lysus® Infusion System meets its designspecifications and is safe and effective for its intended use. |
:
§ 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).