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The Pulse*Spray System, PRO Infusion Catheter, and its related components, are intended for the administration of fluids, including thrombolytic agents and contrast media, into the peripheral vasculature.

The Uni*Fuse Infusion System is intended for the administration of fluids, including thrombolytic agents and contrast media, into the peripheral vasculature.

The PulseSpray Catheter is packaged in a kit configuration. The following components are sold in the PulseSpray Infusion Catheter Kits:

·PRO (Pressure Responsive Outlet) Infusion Catheter with longitudinal slits at the distal end. Slits are located at 90° intervals around the catheter. Radiopaque markers on the catheter shaft indicate the active infusion pattern.

· Occluding Guidewire or Occluding Ball Wire which occludes the distal end of the PRO Infusion Catheter. The Occluding Guidewires or Occluding Ball Wires have proximal markers for occlusion position verification.

·1 mL Syringe and finger flange

• •10 mL Syringe
• ·20 mL Syringe
• · Y-Connector with Tuohy-Borst adapter
• ·Dual Check Valve

The Uni*Fuse Catheters are sold in only one configuration, with an occluding guidewire.

The provided document is a 510(k) premarket notification approval letter for AngioDynamics' PulseSpray and UniFuse Infusion Systems. It primarily details the regulatory approval process and demonstrates the substantial equivalence of the modified device to a previously marketed predicate device.

Crucially, this document does not contain any information regarding clinical studies, AI/algorithm performance, or the establishment of ground truth by expert readers (radiologists, etc.). The listed "Performance Data" in section F and G explicitly refers to non-clinical bench testing only.

Therefore, I cannot extract the requested information regarding acceptance criteria, sample sizes for test/training sets, expert involvement, adjudication methods, or MRMC studies, as these types of studies were not conducted or reported in this document.

The document indicates that the device's modification was a change in catheter shaft and hub material, and the approval was based on demonstrating the device's substantial equivalence through non-clinical bench testing, not clinical performance or AI/algorithm evaluation.

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The Pulse*Spray ® System, PRO™ Infusion Catheter, and its related components, are intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics and contrast media, into the peripheral vasculature.

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This document is a 510(k) clearance letter from the FDA for a medical device called the "Pulse*Spray Infusion System." It does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter primarily addresses the regulatory classification and clearance of the device based on its substantial equivalence to previously marketed devices.

Therefore, I cannot provide the requested information.

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