(30 days)
The Emboshield NAV6 Embolic Protection System is indicated for use as a guide wire and embolic protection system to contain and remove embolic material (thrombus / debris) while performing angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of the Filtration Element placement should be between 2.5 and 7.0 mm.
The Emboshield NAV Embolic Protection System (EPS) is a temporary percutaneous transluminal filtration system designed to capture embolic material released during angioplasty and stent procedures within carotid arteries. The system consists of the following components: BareWire Filter Delivery Wire, RX Delivery Catheter, Filtration Element, and RX Retrieval Catheter.
The provided text describes a 510(k) summary for the Emboshield NAV® Embolic Protection System. It outlines the device description, its intended use, and states that a modification was made to the adhesive used for a radiopaque marker on the delivery catheter. The document then lists performance tests conducted to demonstrate substantial equivalence to predicate devices.
However, the provided text does not contain the detailed acceptance criteria for specific performance metrics, nor does it present a study that directly proves the device meets those criteria in the typical format of a clinical trial or algorithm performance study.
The "Performance Data" section merely lists the types of tests conducted (biocompatibility and tensile testing for marker band integrity). It does not provide:
- Quantitative acceptance criteria (e.g., "tensile strength must exceed X N with a P-value
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).