(77 days)
No
The summary describes a mechanical and electrical system for fluid infusion with ultrasound elements and thermal sensors. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
The device is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, which are used to treat medical conditions, specifically in the peripheral vasculature. This points to a therapeutic purpose rather than a diagnostic one.
No
Explanation: The device is described as an "Infusion System" intended for the "controlled and selective infusion of physician-specified fluids." There is no mention of it collecting or analyzing data from the patient's body to identify a condition or disease.
No
The device description explicitly states the system consists of a disposable infusion catheter with a removable ultrasound core and an instrument that generates and controls energy delivery, indicating significant hardware components.
Based on the provided information, the EndoWave Infusion System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the "controlled and selective infusion of physician-specified fluids... into the peripheral vasculature." This describes a therapeutic intervention performed directly on a patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a catheter and an instrument that delivers energy to the catheter, both used for direct patient treatment. There is no mention of analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis.
Therefore, the EndoWave Infusion System is a therapeutic device used for direct patient treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The EndoWave Infusion System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
Product codes
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 catheter 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
physician-specified
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing confirmed the revised acoustic protocol remains safe and the ultrasound core will operate as required with the new protocol.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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
K080392 page 1 of 1
SPECIAL 510(k) Notification EndoWave™ Infusion System
510(k) Summary Section 4.
General Provisions
Submitter's Name and Address:
EKOS Corporation 11911 North Creek Parkway South Bothell, WA 98011
Catheter, Continuous Flush (KRA)
Contact Person:
Jocelyn Kersten 425-415-3132 425-415-3102 (fax) jkersten@EKOSCORP.com
Classification Name:
Regulation Number:
21 CFR §870.1210
Continuous Flush Catheter
Proprietary Name:
Name of Predicate Device:
Common or Usual Name:
EndoWave Infusion System
EndoWave Infusion System
K072507, K062508 510(k) Reference No .:
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 catheter temperature.
Intended Use
The EndoWave 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 device modification described in this notification does not affect the technological characteristics for the EndoWave Infusion System.
Test Summary
Testing confirmed the revised acoustic protocol remains safe and the ultrasound core will operate as required with the new protocol.