(325 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.
Here's a breakdown of the acceptance criteria and the study details for the Boston Scientific FilterWire EZ Embolic Protection System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the FilterWire EZ Embolic Protection System are not explicitly stated as numerical targets in a table. Instead, the document frames the acceptance based on a comparison to a predicate device (FilterWire EX) and favorable clinical outcomes. The primary measure of success and performance is the Major Adverse Cardiac Events (MACE) rate at 30 days.
| Acceptance Criteria (Implied) | Reported Device Performance (FilterWire EZ - BLAZE Study) | Comparator Performance (FilterWire EX - FIRE Study) |
|---|---|---|
| Favorable 30-day MACE rate | 6.7% | 9.9% |
| Substantially equivalent or superior performance compared to predicate device | Achieved a lower 30-day MACE rate (difference of 3.3% [-2.8%, 9.3% CL]) | |
| Meet all applicable product specifications | Verified through non-clinical testing |
2. Sample Size for Test Set and Data Provenance
- Sample Size (Clinical Test Set): 90 registry patients
- Data Provenance: Prospective, multi-center, non-randomized study (BLAZE). Data was pooled from 16 U.S. sites and 6 European sites.
3. Number of Experts and Qualifications for Ground Truth
The document does not specify the number of experts, their qualifications, or their role in establishing ground truth for the clinical study (BLAZE). Clinical outcomes (MACE, TIMI flow, device/clinical success) are typically determined by treating physicians and reviewed by a Clinical Events Committee, but these details are not provided in this summary.
4. Adjudication Method for Test Set
The document does not explicitly state the adjudication method used for clinical events in the BLAZE study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This document describes studies for a medical device (embolic protection system), not an AI algorithm for image interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable.
6. Standalone (Algorithm Only) Performance
Not applicable. This is a medical device, not an AI algorithm.
7. Type of Ground Truth Used
For the clinical study (BLAZE), the "ground truth" was based on:
- Clinical Outcomes Data: Primarily Major Adverse Cardiac Events (MACE) at 30 days post-procedure, as well as secondary endpoints like MACE during index hospitalization, device success, clinical success, and final TIMI flow. These are patient-level clinical events and physiological measurements.
- Angiographic Variables: Baseline and final QCA (Quantitative Coronary Angiography) are mentioned, which provide objective measurements of vessel characteristics.
8. Sample Size for Training Set
Not applicable. This is a medical device, not an AI algorithm that requires a training set. The "training" or development involved non-clinical in-vitro and in-vivo animal model testing to refine the device design.
9. How Ground Truth for Training Set Was Established
Not applicable, as there's no "training set" in the AI sense. For the non-clinical development and testing of the device, the "ground truth" against which the device performance was evaluated would have been based on:
- Engineering Specifications: Dimensional tolerances, tensile strength, torque limits, etc.
- Biocompatibility Standards: Established biological safety requirements.
- Functional Performance Requirements: E.g., filter deployment, capture efficiency (though specific metrics are not detailed in this summary).
- Animal Model Outcomes: Safety and performance in animal models are evaluated against physiological parameters and pathological findings.
§ 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).