(26 days)
The Lysus® Infusion System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
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.
I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets them as requested. The document is an FDA 510(k) clearance letter and a 510(k) summary for the Lysus Infusion System.
While it mentions a "Test Summary" stating that "Testing confirmed the safety and effectiveness of the Lysus Infusion System is not affected by revising the Instructions for Use," it does not provide any specific details about:
- Acceptance criteria (e.g., performance metrics, thresholds)
- Reported device performance against those criteria
- Sample sizes for test sets or training sets
- Data provenance
- Number or qualifications of experts
- Adjudication methods
- Multi Reader Multi Case (MRMC) comparative effectiveness study results
- Standalone algorithm performance
- Type of ground truth used
- How ground truth for training data was established
The document primarily focuses on the regulatory clearance of a device and an administrative change related to its product code, not on the detailed technical study results.
§ 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).