(63 days)
Sniper Infusion Catheter with Balloon Occlusion is intended for use in the peripheral vasculature where temporary occlusion is desired and offers vessel selective technique of temporary vascular occlusion for selectively stopping or controlling blood flow. The Sniper Infusion Catheter with Balloon Occlusion is also intended to assist in the delivery of diagnostic agents such as contrast media and therapeutic agents into the peripheral vasculature.
The Sniper" Infusion Catheter with Balloon Occlusion is a coaxial dual lumen catheter with an occlusion balloon located at the distal end to provide temporary complete occlusion or limitation of blood flow in peripheral blood vessels as well as provide a delivery conduit for diagnostic agents such as contrast media and therapeutic agents such as embolization particles into the peripheral vasculature. One lumen is dedicated to balloon inflation and deflation, the other lumen is intended to accommodate the guide wire and delivery of fluids and other diagnostic and therapeutic agents. Device placement in the target location is achieved using a guiding catheter that has been placed through an introducer. A guidewire is threaded through the device's lumen for navigating the device to the selected vessel location. Device visualization is provided by two radiopaque bands using fluoroscopy. One radiopaque band is located on the distal tip of the device, and one on the distal end of the balloon, which is 1 cm proximal to the distal tip. Through the guidewire (perfusion) lumen, the clinician can deliver diagnostic or therapeutic agents into the selected blood vessel. After treatment, the balloon is deflated and blood flow resumes.
The proximal hub consists of two ports: one port for use by the guidewire and delivery of fluids and the second port for inflation and deflation of the balloon. The low profile balloon is manufactured of a compliant material that allows ease of insertion and withdrawal from the vasculature and conforms to the vessel wall. The balloon is inflated and deflated with a hand held syringe. The device is supplied sterile by ETO and is intended for single use.
This document is a 510(k) summary for a medical device (Sniper Infusion Catheter with Balloon Occlusion) applying for substantial equivalence to a predicate device. It describes performance data but does not describe an AI/ML device or its acceptance criteria in the manner requested.
The document details performance testing that was performed to ensure the device meets safety and performance standards for its intended use as a medical catheter, but these are general engineering and material performance tests, not AI/ML model performance metrics.
Therefore, I cannot extract the requested information such as a table of acceptance criteria for AI/ML performance, sample sizes for test sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone AI performance, type of ground truth for AI, or training set sample sizes because this document does not pertain to an AI/ML device.
§ 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).