(29 days)
The Pruitt F3 Carotid Shunt is indicated for use in carotid endarterectomy as a temporary conduit to allow for blood flow between the common and internal carotid arteries.
The Pruitt F3 Carotid Shunt is used in patients with carotid artery disease in instances where removal of vascular occlusions is the therapeutic objective. The Pruitt F3 Carotid Shunt is employed in Carotid Endarterectomy (CEA), where the shunt is used as a short-term conduit for blood flow between the common carotid and the internal carotid arteries. The Pruitt F3 Shunt is provided sterile for single use, and is provided with two 3 ml syringes used to inflate the balloons (accessory syringes have been previously cleared in K051067).
The Pruitt F3 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.
The Pruitt F3 Shunts are multi-lumen 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 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 provided K182916 document for the Pruitt F3 Carotid Shunt is a 510(k) premarket notification. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials as would be required for a PMA.
Therefore, the document does not contain the information requested regarding acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, or MRMC studies.
The document primarily describes bench test data for engineering parameters, not clinical performance metrics tied to specific acceptance criteria.
Here's what can be extracted, and what is explicitly not available:
1. A table of acceptance criteria and the reported device performance
- Not Available directly in the provided text. The document lists "Bench Test Data" items like "Main Lumen Flow Test," "Inflated Common Balloon Diameter," "Deflation Time," etc. However, it does not provide the specific acceptance criteria (e.g., "Deflation Time shall be
§ 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).