(77 days)
The FilterWire EZ Embolic Protection System is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/ debris) while performing percutaneous transluminal coronary angioplasty or stenting procedures in coronary saphenous vein bypass grafts with reference vessel diameters of 3.5 to 5.5 mm. The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid or peripheral vasculature.
The Boston Scientific FilterWire EZ Embolic Protection System is a temporary intra-vascular 0.014" guide wire filtration system that is placed distal to the vessel lesion to be treated by interventional procedures. The system consists of a protection wire in 190 and 300 cm lengths, an EZ Delivery Sheath, an EZ Soft Tip Retrieval Sheath and accessories. A separately packaged EZ Bent Tip Retrieval Sheath will also be available as an alternate tool for retrieving the FilterWire EZ protection wire. The 190 cm wire is compatible with the Boston Scientific extension wire (K970376 cleared June 6, 1997) for over-the-wire catheter exchanges. The FilterWire EZ protection wire is delivered through a low profile delivery sheath, which allows free rotational movement of the guide wire component. The tip of the protection wire and the filter loop are radiopaque. The filter is deployed distal to the lesion, and the delivery sheath removed, leaving only the filter and filter loop at the end of a standard 0.014" guide wire. Interventional devices, which are 0.014" guide wire compatible, may then be tracked over the FilterWire guide wire to treat the lesion. After treating the lesion, all interventional devices are removed, and a retrieval sheath is advanced to collapse the filter loop, trapping any emboli caught during the procedure. The retrieval sheath and FilterWire are then removed from the patient simultaneously.
I am sorry, but the provided text does not contain the acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is a 510(k) summary for the Boston Scientific FilterWire EZ Embolic Protection System, primarily describing the device, its intended use, and its substantial equivalence to a predicate device.
It details:
- Device Description: What the FilterWire EZ Embolic Protection System is and how it functions.
- Intended Use: The specific medical procedures and patient populations for which the device is indicated.
- Labeling Changes: Minor updates to contraindications.
- FDA Communication: The FDA's determination of substantial equivalence for market clearance.
However, it does not include:
- A table of acceptance criteria and reported device performance.
- Details about a specific study proving it meets acceptance criteria.
- Information on sample sizes for test sets or training sets.
- Data provenance, expert qualifications, adjudication methods, or MRMC studies.
- Standalone algorithm performance or the type of ground truth used.
Therefore, I cannot provide the requested information based on the text provided.
§ 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).