(237 days)
The Penumbra Embolectomy Aspiration System (INDIGO™ Aspiration System) is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems. Not for use in the coronaries or the neurovasculature.
The Penumbra Embolectomy Aspiration System's (INDIGO™ Aspiration System) fundamental mechanism of action is aspiration. Aspiration draws the embolus or thrombus into the Aspiration Catheter to remove the embolus or thrombus from the body. All Separators function to break up the clot inside of the catheter to make it more amenable to removal from the body via aspiration. The Aspiration Catheter and Separator are available in multiple configurations. The devices are provided sterile, non-pyrogenic, and intended for single use only.
The provided text describes the Penumbra Embolectomy Aspiration System (INDIGO™ Aspiration System) and its path to FDA clearance. It summarizes non-clinical data, including biocompatibility, bench-top testing, and an animal study, to demonstrate its safety and effectiveness and substantial equivalence to a predicate device. However, it does not include information about a study based on acceptance criteria for a device performance metrics or any kind of AI/algorithm performance. Specifically, it lacks the details needed to fill in the requested table and answer questions about AI/algorithm performance, ground truth, or expert involvement in such an evaluation.
Therefore, I cannot provide the requested information from the given text. The document focuses on demonstrating substantial equivalence through non-clinical testing for a medical device, not on evaluating an AI system's performance against specific acceptance criteria.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).