Search Results

The Boston Scientific/Target Sentry Occlusion Balloon Catheter is intended for temporary intravascular occlusion. This device is not intended for use in coronary arteries. This device is not intended for use in the neurovasculature.

The Sentry Occlusion Balloon Catheter consists of an over-the-wire catheter with a soft compliant balloon attached at the distal end. Radiopaque markers (located at the proximal and distal ends of the balloon) facilitate fluoroscopic visualization. The Sentry Occlusion Balloon Catheter has a single lumen shaft that is used with the 510(k) cleared Boston Scientific/Target Transend-010 guidewire (K964611) hydrophilic 0.010" guidewire) to occlude the distal segment of the central lumen and allow inflation of the balloon. To facilitate sealing of the central lumen for balloon inflation, the guidewire is advanced slightly beyond the distal tip of the catheter where the distal seal is located. There is a slight increase in resistance as the guidewire passes through the distal seal, and at this point the balloon can be inflated. The guidewire can be moved distally or proximally once beyond the distal tip (seal portion) of the catheter and still maintain a positive seal for inflating the balloon. The Sentry Occlusion Balloon Catheter has a HYDROLENE® hydrophilic exterior coating that reduces friction during manipulation. The device is manufactured in two sizes, one with a balloon length of 10 mm (nominal inflation diameter of 3.5 mm) and the other with a balloon length of 15 mm (nominal inflation diameter of 3.5 mm). The catheter portion of the device utilizes the construction of the 510(k) cleared Boston Scientific/Target FasTracker Infusion Catheter (K926243, K925813) and the Boston Scientific/Target Turbo Tracker Infusion Catheter (K960806). This construction provides a flexible and strong catheter shaft which facilitates tracking through tortuous vasculature and accessing the target vessel.

The provided text, K993292, describes a medical device submission for regulatory clearance and does not contain information about an AI/ML powered device or a study proving that the device meets acceptance criteria related to AI/ML performance.

Therefore, I cannot provide the requested table and answers regarding acceptance criteria, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth for a study proving an AI/ML device meets acceptance criteria.

The document discusses:

• The Sentry Occlusion Balloon Catheter, a physical medical device.
• Its intended use for temporary intravascular occlusion.
• Predicate devices for substantial equivalence comparison.
• In vitro functional tests (e.g., visual, dimensional, cyclic fatigue, rupture volume) and biocompatibility studies conducted to demonstrate substantial equivalence to predicate devices, not performance against specific acceptance criteria in the context of an AI/ML algorithm.
• Technological differences from predicate devices and how these differences were addressed through testing to raise no new questions of safety and effectiveness.

There is no mention of an algorithm, AI, machine learning, or any study design that would involve features like test sets, training sets, human readers, or expert adjudication for an AI/ML model's performance.

Ask a specific question about this device