(169 days)
Single-Loop Snare Retrieval Kit and Triple-Loop Snare Retrieval Kit are intended for the percutaneous removal of retrievable inferior vena cava (IVC) filters that are no longer medically required, via jugular approach.
The Single-Loop Snare Retrieval Kit and Triple-Loop Snare Retrieval Kit consist of a 9F inner sheath, 11F outer sheath, 8F dilator, hemostasis valve with sideport, high pressure stop-cock, 20mm single-loop snare (fully expanded) or 30mm triple-loop snare (fully expanded), 7F snare catheter, Tuohy-Borst Y-port adapter, and torque handle. The snares have radiopaque loops and are preloaded in the snare catheter. The snare catheter, inner sheath, and outer sheath have a radiopaque marker band at the distal tip for enhanced fluoroscopic visualization. This product does not contain natural rubber latex. The maximum recommended infusion rate is 15mL/sec for power injection of contrast.
The provided text describes the 510(k) premarket notification for the "Single-Loop Snare Retrieval Kit" and "Triple-Loop Snare Retrieval Kit." This document focuses on demonstrating substantial equivalence to predicate devices for these medical devices, which are physical instruments used for retrieving IVC filters.
The information requested in the prompt (acceptance criteria and study details for an AI/software device) is not present in the provided text. The document details non-clinical performance tests for the physical retrieval kits, such as tensile strength, liquid leakage, and biocompatibility, but it does not describe any AI system, its performance metrics, or clinical studies involving human readers or ground truth establishment relevant to an AI/software product.
Therefore, I cannot provide the requested information based on the given input. The document is about physical medical devices, not AI/software.
§ 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).