(22 days)
For Pruitt F3 Carotid Shunts:
The Pruitt F3 carotid shunts are indicated for use in carotid endarterectomy as a temporary conduit to allow for blood flow between the common and internal carotid arteries. The size 8 French Shunt is intended for use on those patients whose vasculature is too small to accommodate a size 9 French Shunt.
For XenoSure Biologic Patch:
The patch is intended for use as a surgical patch material for: cardiac and vascular reconstruction and repair, soft tissue deficiency repair and reinforcing the suture line during general surgical procedures.
The Pruitt Carotid Kit is a convenience kit composed of Pruitt F3 carotid shunt and XenoSure (Peripatch) biologic patch.
The provided text is a 510(k) summary for the Pruitt Carotid Kit, which is a convenience kit composed of a carotid shunt and a biologic patch. This document discusses the substantial equivalence of the device to predicate devices based on its indications for use and fundamental scientific technology.
However, the 510(k) summary does not contain any information about acceptance criteria or a study that proves the device meets those criteria, nor does it include information about performance data, sample sizes, ground truth establishment, or expert involvement. The document explicitly states "Summary of Product Testing: N/A".
Therefore, I cannot fulfill the request to provide the detailed information about acceptance criteria and a proving study, as that information is not present in the provided text.
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).