Search Results

The Vesalio Peripheral Catheter is intended for use in the peripheral arterial vasculature for:

• the removal of fresh, soft emboli and thrombi
• infusion of diagnostic agents, such as contrast media

The Vesalio Peripheral System consists of 1) Peripheral Catheter, 2) Peel away Introducer Sheath and 3) an Aspiration Tubing Set.

The Peripheral Catheter is a single-lumen, coil-reinforced, flexible, variable stiffness composite catheter that facilitates the removal of thrombus from the peripheral arterial vasculature when connected to a compatible aspiration pump and the Aspiration Tubing Set.

The catheter is a hollow cylindrical tube constructed using a combination of medical-grade polymers with metal reinforcement, a lubricous inner liner made from PTFE and the outer jacket consisting of thermoplastics made of polyurethane, polyether block amide, and nylon 12. The distal end of the catheter has a hydrophilic coating aimed to reduce friction and aid tracking through the vasculature. The catheter employs radiopaque characteristics for angiographic visualization.

On the proximal end, the catheter incorporates a flexible strain relief, which provides kink resistance, and a translucent, polycarbonate female luer hub to allow attachment of ancillary devices for navigation, infusion of fluids, and aspiration through the catheter.

A peel-away introducer sheath is provided in the package to facilitate the insertion of the Peripheral Catheter's distal tip into an appropriate vascular sheath.

The Aspiration Tubing Set is provided in a separate package and is made of common medical grade polymers. It comprises of a hollow cylindrical tube that is bonded to a standard male rotator fitting on one end. The male rotator allows the tubing to connect to an RHV or the female luer hub of the catheter. The other end of the tubing consists of a hose fitting to enable connection with a vacuum pump. A flow switch is connected in line to provide vacuum control. The Peripheral System is provided sterile, non-pyrogenic, and is intended for single use only.

N/A

Ask a specific question about this device

The NeVa™ PV Thrombectomy Device is indicated for:

• The non-surgical removal of emboli and thrombi from peripheral blood vessels.
• Temporary use in peripheral vessel occlusion.
• Use with aspiration and with the injection or infusion of contrast media and other fluids.

The NeVa™ PV Thrombectomy Device is a sterile, single-use thrombectomy device designed to for use in the peripheral vasculature to restore blood flow via non-surgical removal of emboli and thrombi from peripheral vessels in the vasculature. The NeVa™ PV device consists of a self-expanding nitinol basket attached to a core pusher wire that can be delivered through a micro catheter, deployed across a clot, and then removed with the clot to enable revascularization of the occluded vessel. To aid in fluoroscopic visualization, radiopaque markers are positioned at the distal end, proximal end, and along the nitinol basket of the NeVa™ PV device. A flexible atraumatic soft tip attached to the distal end of the nitinol basket is radiopaque for enhanced fluoroscopic visualization.

The NeVaTM PV device is provided sterile and is intended for single patient use. The device is not intended to be re-sterilized or re-used. No accessories are provided with the NeVaTM PV device. The device is intended to be used in conjunction with the appropriately sized microcatheter as indicated in the proposed Instructions for Use.

The provided text describes the regulatory clearance of a medical device, the NeVa™ PV Thrombectomy Device, based on its substantial equivalence to a predicate device. It details the device's characteristics, indications for use, and a summary of nonclinical testing performed to demonstrate its performance. However, the document does not contain information about acceptance criteria for a study, nor does it detail a study that proves the device meets specific acceptance criteria in the context of an algorithm or AI performance.

The document is for a medical device clearance (510(k)) that relies on substantial equivalence to a predicate device (ReVive™ PV Thrombectomy Device), not on meeting specific quantitative performance metrics as one might see for an AI/algorithm-based medical device.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving device performance in the context of AI/algorithm evaluation. The document focuses on the physical and functional performance of a mechanical thrombectomy device.

To directly address your request given the provided text, I must state that the information is not present in the provided regulatory submission.

Ask a specific question about this device