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The Cook Polyvinyl Alcohol Foam Embolization Particles are intended for cmbolization of the blood supply to symptomatic utcrine fibroids.

Cook Incorporated Polyvinyl Alcohol Foam Embolization Particles are small, flexible, particles made of cross-linked polyvinyl alcohol. The particles are packaged dry and are provided sterile in sealed vials. They are intended for delivery to the target site by a catheter under fluoroscopic control.

Embolization particle sizes appropriate for use in symptomatic uterine fibroid treatment are 300-500 microns and 500-710 microns.

There have been no changes in the design, dimensions, or materials of the device.

This document is a 510(k) summary for Cook Incorporated's Polyvinyl Alcohol (PVA) Foam Embolization Particles. It details the device information, predicate devices, and intended use. However, it does not contain the acceptance criteria or a study proving the device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to pre-existing devices.

Therefore, I cannot provide the requested information. The provided text explicitly states:

• "Clinical data was leveraged to support the substantial equivalence of this proposed device to predicate devices."
• "Clinical data from Cook Incorporated's Polyvinyl Alcohol Foam Embolization Particles were obtained from published studies and from data generated by the FIBROID clinical registry."

This indicates that the submission relies on existing clinical data for established devices to argue for substantial equivalence, rather than presenting a new study with specific acceptance criteria for a new device.

If you have a document that describes the acceptance criteria and the results of a new study for this device, please provide that text.

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