(185 days)
The LBI Embolectomy System is indicated for use in removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature.
The system consists of a 0.014" guidewire compatible aspiration catheter with attachable stopcock assembly (Xtract catheter, K071529) and a fiber element on a 0.014" guide wire with attachable actuator tool. System accessories included in the package consist of two 30 ml syringes, a peel-away introducer, an actuation template, and a 40um cell strainer cup.
The provided text is a 510(k) premarket notification summary for the LBI Embolectomy System. It does not describe an AI/ML medical device, nor does it contain information about clinical studies with acceptance criteria, sample sizes, expert involvement, or comparative effectiveness with human readers.
Therefore, I cannot fulfill your request for this specific document.
The document discusses the substantial equivalence of the LBI Embolectomy System to legally marketed predicate devices, focusing on:
- Intended Use: Removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature.
- Device Description: A 0.014" guidewire compatible aspiration catheter with attachable stopcock assembly and a fiber element on a 0.014" guidewire with an attachable actuator tool, along with accessories.
- Safety & Performance: Demonstrated through comparison to predicate devices, biocompatibility testing, in vitro testing, and animal testing.
No information about a study proving the device meets specific acceptance criteria in the context of AI/ML performance metrics (e.g., sensitivity, specificity, AUC) is present.
§ 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).