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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.

The provided text is a 510(k) summary for the Lysus Infusion System, primarily concerning a software upgrade and associated revisions to the Instructions for Use. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

Therefore, I cannot fulfill your request for the detailed table and study information. The document explicitly states:

• "The software was validated prior to release of the upgraded version." This is a general statement about validation but provides no specifics about acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement.
• "Performance standards have not been promulgated for continuous flush catheters." This reinforces that there aren't formal, publicly available performance benchmarks for this device category.
• "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." This indicates that the core functionality and performance characteristics proven in a previous 510(k) (K042456) are considered unchanged by this specific submission.

To answer your questions, one would need access to the original 510(k) submission (K042456) for the Lysus Infusion System, as that would likely contain the performance data and acceptance criteria that established its substantial equivalence. The current document is an administrative update for a software change.

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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.

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