(201 days)
The intended use of these devices is to provide a temporary bypass during carotid endarterectomy.
The Pruitt-Inahara Carotid Shunt (Model 400-40-8F) and the Inahara-Pruitt Carotid Shunt (Model 500-50-8F) are dual lumen balloon shunts which channel and divert blood in the carotid artery during endarterectomy. The 8 French shunts are for use in arteries too small to accommodate a 9 French shunt. Both the 400-40-8F and 500-50-8F have a T Port to confirm patency and allow back-bleeding after insertion. There is an external safety balloon on the inflation port for the balloon which lies in the internal carotid artery. The safety balloon is designed to inflate when the internal carotid balloon reaches 17 psi; this reduces the possibility of balloon overinflation and resultant vessel damage. All the materials are identical to those used in other models of Ideas for Medicine's shunts. These materials have been used for years and were certified to meet the requirements of the USP Class VI testing for biocompatibiltiy. Every lot is supplied sterile and non-pvrogenic.
This document is a 510(k) summary for a medical device (Pruitt-Inahara Carotid Shunt and Inahara-Pruitt Carotid Shunt). It describes the device, its intended use, and its substantial equivalence to other devices. However, this document does not contain any information about acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, or expert involvement that would be relevant to evaluating AI/ML-based device performance.
Therefore, I cannot provide the requested information. The provided text is a regulatory submission for a physical medical device, not for a software-as-a-medical-device (SaMD) or an AI-powered diagnostic tool.
§ 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).