(147 days)
The Captus Vascular Retrieval System is intended for use in the cardiovascular system to retrieve foreign objects, including, but not limited to guide wires, coils, balloons, catheters, and filters.
The Captus Vascular Retrieval System consists of a flexible polyetheretherketone (PEEK) and Pebax shaft with a nitinol Braided Loop Snare (BLS) on the distal end. The device is designed to capture and retrieve foreign objects from the cardiovascular system. The lumen of the 120 cm long flexible snare shaft contains an inner rod that is secured to the BLS using an ultra-high molecular weight polyethylene (UHMWPE) braided suture. The external torquer is attached to the proximal end of the shaft and supports BLS manipulation. During the procedure, once the distal end has been positioned near the foreign object, the torquer can be turned clockwise (in relation to the shaft) in order to cinch the BLS. This feature allows the foreign object to be more firmly secured before its retrieval.
The provided text describes the 510(k) premarket notification for the Captus Vascular Retrieval System. However, it does not contain information about a study proving the device meets specific acceptance criteria in the context of AI/ML performance, human-in-the-loop studies, multi-reader multi-case (MRMC) studies, or detailed ground truth establishment as would be expected for an AI/ML medical device.
The document primarily focuses on demonstrating the substantial equivalence of the Captus Vascular Retrieval System to predicate devices according to FDA's 510(k) process. This involves non-clinical testing to demonstrate safety and performance based on industry standards for medical devices, rather than an AI/ML algorithm.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them with respect to AI/ML performance, as this information is not present in the provided text.
Specifically, the document states:
- "No FDA performance standards have been established for the Captus System." This indicates that the type of quantitative performance metrics (like sensitivity, specificity, or AUC) typically seen with AI/ML devices and their associated acceptance criteria are not relevant to this submission.
- The tests performed are biocompatibility, design verification and performance tests (e.g., total length, tensile strength, leak), corrosion resistance, and simulated use testing. These are traditional engineering and material science tests for a physical medical device.
- "A feasibility study documenting the retrieval of various foreign bodies from the vascular system was performed to demonstrate that the device is appropriate with the stated indications." This is a functional test, likely in a lab or animal model, not an AI/ML performance study.
In summary, the provided text does not contain the information required to answer your prompt because the Captus Vascular Retrieval System is a physical medical device, not an AI/ML algorithm, and its approval process does not involve the types of studies you've outlined for AI/ML performance claims.
§ 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).