(101 days)
The CAPERE™ Thrombectomy System is indicated for:
· Non-surgical removal of soft emboli and thrombi from blood vessels.
- · Injection, infusion and/or aspiration of contrast media and other fluids into blood vessel.
The CAPERE™ Thrombectomy System is intended only for use in the peripheral vasculature and is not intended for use in the pulmonary arteries.
The CAPERE™ Thrombectomy System primarily consists of an 8Fr Delivery Catheter and Funnel Catheter. The CAPERE™ Thrombectomy System is delivered percutaneously via transfemoral or jugular venous access. Once delivered, the System's fine mesh nitinol wire basket is used to capture and mechanically remove emboli and thrombi. The CAPERE™ System does not use aspiration to pull out the thrombus but does have a side port in the funnel catheter that allows aspiration or injection of saline or fluids if needed.
The document provided pertains to a 510(k) premarket notification for the CAPERE Thrombectomy System, a physical medical device (embolectomy catheter), not an AI/ML medical device. Therefore, the information typically required for describing the acceptance criteria and the study proving an AI/ML device meets those criteria (such as ground truth, expert consensus, MRMC studies, training/test set details, etc.) is not present in this document.
The document describes performance data for a physical device, which includes:
- Biocompatibility testing: To ensure the materials are safe for patient contact.
- Package integrity and accelerated aging studies: To demonstrate the sterility barrier and shelf-life.
- Functional bench testing: To ensure the device performs as intended, adhering to standards like ISO 10555-1 and ISO 594-1.
- Simulated Use Testing: To show the device can retrieve simulated clots without damage or adverse effects.
- Confirmatory In vivo testing in an animal model: To confirm usability, ease of use, and interaction within the vascular system.
The acceptance criteria for these tests would be related to specific measurements (e.g., tensile strength, burst pressure, clot retrieval efficiency, absence of damage) that are typically defined in engineering specifications and test protocols for physical medical devices.
Based on the provided text, I cannot extract the specific details requested for an AI/ML device's acceptance criteria and study, as the device in question is a physical thrombectomy system.
Therefore, I cannot fill out the requested table or answer the specific questions about AI/ML device validation.
§ 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).