(28 days)
No
The summary does not mention AI, ML, or related terms, and the device description focuses on hardware components for fluid infusion and ultrasound.
Yes
The device is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature, which implies a therapeutic purpose (e.g., dissolving blood clots).
No
The device is described as an "Infusion System" intended for the controlled and selective infusion of fluids, not for the diagnosis of a condition. Its function is to deliver substances to the body, not to assess or identify medical conditions.
No
The device description explicitly states the system consists of a disposable infusion/ultrasound catheter and an instrument that generates and controls energy, indicating hardware components are integral to the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the controlled and selective infusion of fluids (including thrombolytics and contrast materials) into the peripheral and neurovasculature. This is a therapeutic and diagnostic procedure performed directly on the patient's body, not on a sample of bodily fluid or tissue outside the body.
- Device Description: The description details a catheter and an instrument for delivering energy and fluids into the patient. This aligns with an in-vivo (within the living body) device, not an in-vitro device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to deliver substances into the body for treatment or imaging purposes.
N/A
Intended Use / Indications for Use
The EKOS Micro- Infusion System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
The EKOS Micro- Infusion System is intended for regional infusion of contrast materials into selected vessels in the neurovasculature. The EKOS Micro- Infusion System may be used for controlled, regional infusion into selected vessels and is not intended for use in the coronary vasculature.
Product codes
NUI
Device Description
The system consists of a disposable infusion/ultrasound catheter and an instrument that generates and controls the delivery of energy to the catheter. The catheter contains a single ultrasound transducer, located at the distal tip, a thermal sensor and a distal end hole for placement over a guide wire and fluid infusion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature, neurovasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician-specified fluids
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).
0
053437
Section 4. 510(k) Summary
:
| 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 | Ultrasound, Infusion, System (NUI) |
| | Common or Usual Name | Ultrasound Infusion Catheter |
| | Proprietary Name | EKOS Micro- Infusion System |
| Name of Predicate
Device | Predicate Device
EKOS Peripheral Infusion System
EKOS Micro- Infusion System | 510(k) Reference Nos.
K050563
K051225 |
| Device Description | The system consists of a disposable infusion/ultrasound catheter and an instrument
that generates and controls the delivery of energy to the catheter. The catheter
contains a single ultrasound transducer, located at the distal tip, a thermal sensor
and a distal end hole for placement over a guide wire and fluid infusion. | |
| Intended Use | The EKOS Micro- Infusion System is intended for the controlled and selective
infusion of physician-specified fluids, including thrombolytics, into the peripheral
vasculature.
The EKOS Micro- Infusion System is intended for regional infusion of contrast
materials into selected vessels in the neurovasculature. The EKOS Micro- Infusion
System may be used for controlled, regional infusion into selected vessels and is not
intended for use in the coronary vasculature. | |
| | | |
| Summary of
Technological
Characteristics | The proposed EKOS Micro- Infusion Catheter is similar in construction and
materials to the EKOS Micro-Infusion Catheter previously cleared under K051225
and K050563. | |
| Test Summary | The proposed EKOS Micro- Infusion System is considered to be substantially
equivalent to the currently marketed EKOS Micro- Infusion System based on a
comparison of the intended uses and designs and results of the testing and
evaluations performed. | |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Public Health Service
JAN - 6 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Jocelyn Kersten Director, Regulatory Affairs EKOS Corporation 22030 20th Avenue SE, Suite 101 Bothell, Washington 98021
Re: K053437
Trade Name: EKOS Micro-Infusion Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: II Product Code: NUI Dated: December 6, 2005 Received: December 9, 2005
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 as a box warning, immediately following the indications for use, in the device's labeling:
"The safety and effectiveness of the EKOS Micro-Infusion System for thrombolytic therapy in the neurovasculature have not been established. Further clinical studies are necessary to ensure that use of devices to deliver thrombolytic therapy into the neurovasculature does not result in an increased incidence of adverse events (e.g., intracranial hemorrhage)."
2
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 your device is classified (see above) into either class II (Special Controls) or class III (PMA), it your 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 that I Drilatel statutes and regulations administered by other Federal agencies. You must or any 1 vith 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 Crith in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quarty by of voyisions (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) 276-0115. Also, de roo (21 OF Creat on the do "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the CI K Fat 601.77). You may 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,
Neeatlm
Donna Dee Tillman, Ph.D.
Donna-Bea 7 Iman Ph () Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
大 053437 510(k) Number (if known):
Device Name:
EKOS Micro-Infusion System
Indications for Use:
The EKOS Micro-Infusion System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
The EKOS Micro- Infusion System is intended for regional infusion of contrast materials into selected vessels in the neurovasculature. The EKOS Micro- Infusion System may be used for controlled, regional infusion into selected vessels and is not intended for use in the coronary 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)
Barbara-Buchino for MXM
estorative. and Neu
Page I of
510(k) Number K053437