(114 days)
The Pruitt F3-S Polyurethane Carotid Shunt is in carotid endarterectomy as a temporary conduit to allow for blood flow between the common and internal carotid arteries.
The Pruitt F3-S Polyurethane Carotid Shunt is designed to serve as an artificial passage connecting two blood vessels allowing blood flow from one vessel to another. This is accomplished by using a clear, plastic, sterile conduit that is held in place by a stabilization technique (balloons) on both ends of the conduit. devices with balloons on both the distal (internal carotid) and proximal (common carotid) ends of the shunt. The balloons, when inflated independently, act as a stabilization mechanism to maintain the position of the shunt when it is placed within the common and internal carotid arteries. The Pruitt F3-S Polyurethane Carotid Shunt has features to aid the user during shunt insertion and balloon inflation. The inflation path of the proximal (common carotid) balloon is color-coded. Sterile saline is injected from the blue stopcock, through the blue lumen and into the blue common carotid balloon. The Pruitt F3-S Polyurethane Carotid Shunt is not made of natural rubber latex.
This document is a 510(k) premarket notification for a medical device (Pruitt F3-S Polyurethane Carotid Shunt) and does not contain information about the performance of an AI/ML device. Therefore, the requested information regarding acceptance criteria and study details for an AI-powered device cannot be extracted.
The document focuses on demonstrating substantial equivalence to a predicate device, as required for 510(k) submissions. This involves comparing the new device's technological characteristics, indications for use, and performance data (e.g., sterilization, biocompatibility, functional testing) to those of the predicate device. The functional testing described is for the physical device itself (shunts and balloons), not an AI algorithm.
§ 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).