(262 days)
The FilterWire EZTM 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 coronary saphenous vein bypass grafts. The diameter of the vessel at the site of filter loop placement should be between 2.25 mm and 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 safety and effectiveness of the device as an embolic protection system has not been established in treating patients with acute myocardial infarction.
- The safety and effectiveness of the device as an embolic protection system has not been established in treating native coronaries.
The Boston Scientific FilterWire EZ (2.25 mm - 3.5 mm) 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 (190 cm or 300 cm length), an EZ Delivery Sheath, an EZ Retrieval Sheath and accessories. The 190 cm long wire is compatible with the Boston Scientific Add Wire® Extension Wire (K970376 cleared June 6, 1997) for over-the-wire catheter exchanges. The Filter Wire EZ (2.25 mm - 3.5 mm) Protection Wire is delivered via the EZ Delivery Sheath. Once the Protection Wire is across the lesion, the filter bag is expanded in the artery lumen by removing the EZ Delivery Sheath. After treating the lesion, all interventional devices are removed, and the EZ Retrieval Sheath or EZ Bent Tip Retrieval Sheath is advanced to the proximal end of the filter and the filter loop is retracted into the EZ Retrieval Sheath, trapping any emboli caught during the procedure. The EZ Retrieval Sheath and EZ Protection Wire are then removed from the patient simultaneously.
This document is a 510(k) premarket notification for the Boston Scientific FilterWire EZ™ Embolic Protection System (2.25 mm – 3.5 mm). The study described is not for an AI/ML device, but rather a traditional medical device. Therefore, much of the requested information (e.g., number of experts, adjudication methods, MRMC study, standalone performance, training set details) is not applicable.
However, based on the provided text, here is an analysis of the acceptance criteria and study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Primary Endpoint) | Reported Device Performance (BLAZE II) | Comparator Performance (FIRE Trial subset) | Outcome |
|---|---|---|---|
| 30-day MACE rate of the FilterWire EZ (2.25 mm - 3.5 mm) System, demonstrating non-inferiority to the predicate device (GuardWire Plus). | 3.8% (initial analysis) | 12.4% | FilterWire EZ demonstrates superiority. |
| Revised 30-day MACE rate (imputing 1 additional patient for missing CK-MB data) | 4.6% (6/131)** | 12.4% (21/169) | FilterWire EZ demonstrates superiority and non-inferiority is achieved. |
| Device success | 98.5% | Not explicitly stated for comparator | N/A |
| Clinical success | 94.7% | Not explicitly stated for comparator | N/A |
| Final TIMI 3 flow | 100% | Not explicitly stated for comparator | N/A |
Note: The primary acceptance criterion for the clinical study was likely to demonstrate non-inferiority in the 30-day MACE rate compared to the predicate GuardWire Plus device in the specified vessel diameter range.
2. Sample Size and Data Provenance
- Test Set (Clinical Study):
- FilterWire EZ Group (BLAZE II): 131 registry patients, 8 roll-in patients, 1 compassionate use patient (total 140 enrolled, but performance analysis focuses on "131 registry patients").
- GuardWire Plus Control Group (FIRE Trial subset): 169 patients treated within the 2.25 mm - 3.5 mm vessel diameter range.
- Data Provenance: Prospective, multi-center study (BLAZE II) for the FilterWire EZ device. The comparator data (GuardWire Plus) was from a subset of a previously completed study (FIRE Trial). The countries of origin of the data are not explicitly stated, but it's a multi-center study.
3. Number of Experts and Qualifications
This information is not applicable as the submission describes a traditional medical device with a clinical trial, not an AI/ML device where expert consensus is typically used to establish ground truth for a test set.
4. Adjudication Method
This information is not applicable for a traditional clinical trial measuring clinical outcomes like MACE. MACE (Major Adverse Cardiac Events) are defined clinical endpoints.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not Applicable. This is a study for a traditional medical device (embolic protection system), not an AI/ML diagnostic or assistive device that would involve human readers.
6. Standalone Performance
- Not Applicable. This device is an interventional tool, and its performance is inherently linked to human use during a procedure. "Standalone performance" as often understood for AI algorithms (i.e., algorithm only without human-in-the-loop) is not relevant here. However, the study focuses on the device's technical success, clinical success, and impact on patient outcomes (MACE) when used by clinicians.
7. Type of Ground Truth Used
- Clinical Outcomes Data: The primary ground truth for the clinical study was the occurrence of Major Adverse Cardiac Events (MACE) at 30 days post-procedure, as well as device success, clinical success, and final TIMI 3 flow. MACE is a composite of clinically defined adverse events (e.g., all-cause death, myocardial infarction, target vessel revascularization). The presence of non-Q wave MI was assessed via CK-MB levels.
8. Sample Size for the Training Set
- Not Applicable. This is not an AI/ML device that requires a "training set" in the context of machine learning. The device design and specifications are based on engineering principles and preclinical testing.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. See point 8.
§ 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).