(51 days)
Not Found
No
The summary describes a mechanical and ultrasound-based infusion system without mentioning any AI or ML components or functionalities.
Yes.
The device is intended for the "controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature," which directly implies a therapeutic intervention.
No
The device is described as an "Infusion System" and "infusion catheter system" intended for "controlled and selective infusion of physician-specified fluids". Its function is to deliver fluids, not to diagnose conditions.
No
The device description explicitly details hardware components like a catheter, ultrasound transducers, and an ultrasound core, indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Lysus® Infusion System is designed to deliver fluids directly into the patient's peripheral vasculature. It is an infusion system, not a diagnostic test performed on a sample outside the body.
- Intended Use: The intended use clearly states "controlled and selective infusion of physician-specified fluids... into the peripheral vasculature." This is a therapeutic or procedural function, not a diagnostic one.
The device's purpose is to administer substances to the patient, not to analyze a sample from the patient to gain diagnostic information.
N/A
Intended Use / Indications for Use
The Lysus" Infusion System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
Product codes
QEY, KRA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
K030367, K033214, K974067, K991619, K992231, K964868, K033443
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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.
2
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
3
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
4
K041629
510(k) Notification
9 510(k) Summary
| Applicant Name: | EKOS Corporation |
|---|---|
| Address: | 22030 20th Ave. SE, Suite 101 |
| Bothell, WA 98021 | |
| Contact Person: | Jocelyn Kersten |
| Director, 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 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. | |
| Predicate Basis: | The Lysus® Infusion System is substantially equivalent to other |
| legally 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 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. |
: