(26 days)
No
The summary does not mention AI, ML, or any related concepts in the device description, intended use, or performance studies.
Yes
The device is intended for the infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature, which is a therapeutic intervention.
No
The device is an "Infusion System" explicitly designed for "controlled and selective infusion of physician-specified fluids," which is a therapeutic function, not a diagnostic one.
No
The device description explicitly mentions hardware components: a disposable infusion catheter with a removable ultrasound core and an instrument that generates and controls energy delivery.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the controlled and selective infusion of fluids into the peripheral vasculature. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a system for delivering fluids and ultrasound energy within the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health. This device does not involve the analysis of such specimens.
Therefore, the Lysus® Infusion System is a therapeutic device, not an in vitro diagnostic device.
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 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.
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
The software was validated prior to release of the upgraded version.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 7, 2022
EKOS Corporation Jocelyn Kersten Director, Regulatory Affairs 22030 20th Avenue SE, Suite 101 Bothell, Washington 98021
Re: K051319
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 June 15, 2005. 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,
Gregory W. Digitally signed by Gregory W. O'connell -S O'connell -S Date: 2022.01.07
13:35:45-05-05-05:00'
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 shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized wing shapes.
JUN 1 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
EKOS Corporation c/o Ms. Jocelyn Kersten Director, Regulatory Affairs 22030 20th Avenue, S.E., Suite 101 Bothell, WA 98021
Re: K051319 Lysus Infusion System Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II (two) Product Code: KRA Dated: May 18, 2005 Received: May 20, 2005
Dear Ms. Kersten:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your became in (d 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 encrease, 1976, the enactment date of the Medical Device Amendments, or to conimered processified in accordance with the provisions of the Federal Food, Drug, de Moos mat nave ocen i deat 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 I va may, diereleve, mains of the Act include requirements for annual registration, listing of general controls provisions 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.
2
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Drina R. Vachner
- A. Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
SPECIAL 510(k) Notification Lysus® Infusion System
Indications for Use
510(k) Number (if known): ≤ (25 1 319
Device Name: Lysus® Infusion System
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.
X Prescription Use (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)
Danna R. Vachner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_Kost319
Page 1 of
4
JUN 1 5 2005
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510(k) Summary Section 4.
General Provisions
| Submitter's Name and Address: | EKOS Corporation
22030 20th Ave. SE
Suite 101
Bothell, WA 98021 |
|-------------------------------|--------------------------------------------------------------------------------|
| Contact Person: | Jocelyn Kersten
425-482-1108
425-482-1109 (fax)
jkersten@EKOSCORP.com |
| Classification Name: | Catheter, Continuous Flush (KRA) |
| Common or Usual Name: | Continuous Flush Catheter |
| Proprietary Name: | Lysus® Infusion System |
| Name of Predicate Device: | Lysus® Infusion System |
| 510(k) Reference No.: | K042456 |
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.
Intended Use
The Lysus® 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 software upgrade and revisions to the Instructions for Use described in this notification do not affect the technological characteristics for the Lysus Infusion System.
Test Summary
The software was validated prior to release of the upgraded version.
5
Kosisla 1.20f2
Section 5. General Information
Trade and Common Names
Trade Name: Lysus Infusion System Common Name: Continuous Flush Catheter
Establishment Registration
3001627457
Manufacturing Facility
EKOS Corporation 22030 20th Ave. SE Suite 101 Bothell, WA 98021
Device Classification
Continuous flush catheters have been classified by the FDA Cardiovascular Panel as Class II (KRA).
Purpose of Notification
The purpose of this SPECIAL 510(k) notification is to seek clearance of a software upgrade and associated revisions to the PT-3 Control Unit Instructions for Use. The software upgrade by itself would not have met the criteria for requiring a new 510(k). However, because revisions to the IFU are also required, this SPECIAL 510(k) is being submitted.
Predicate Device
The Lysus Infusion System is identical in design, composition, function and intended use to the previously cleared Lysus Infusion System (K042456).
Performance Standards
Performance standards have not been promulgated for continuous flush catheters.