(215 days)
The FilterWire EX 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 EX™ Embolic Protection System is a temporary intra-vascular 0.014" guidewire 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 EX Delivery Sheath, an EX Soft Tip Retrieval Sheath and accessories. A separately packaged EX Bent Tip Retrieval Sheath will also be available as an alternate tool for retrieving the FilterWire protection wire. When deployed, the protection wire's filter bag is designed to capture and recover emboli that may be produced during the angioplasty/stenting procedure while allowing blood flow to continue. Once deployed, the protection wire is used as a standard 0.014" steerable guidewire.
This 510(k) summary describes a medical device, not an AI/ML device, so many of the requested criteria regarding AI-specific studies (training/test sets, ground truth establishment, MRMC studies, standalone performance) are not applicable. However, I can extract the information relevant to the device's acceptance criteria and the studies performed.
Here's the analysis based on the provided text for the Boston Scientific FilterWire EX™ Embolic Protection System:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from Predicate Device Equivalence) | Reported Device Performance (FilterWire EX) |
|---|---|
| Similar Intended Use: Embolic protection during percutaneous transluminal coronary angioplasty or stenting in coronary saphenous vein bypass grafts. | Indicated for the same use in coronary saphenous vein bypass grafts with reference vessel diameters of 3.5 to 5.5 mm. |
| Non-Inferiority in 30-day MACE rates compared to no protection: (Implicitly, the predicate likely demonstrated superiority over no protection, setting a bar for the new device to achieve similar outcomes). | 30-day MACE rate of 7.3% (vs. 7.8% for no protection). Not statistically significant, suggesting non-inferiority or similar performance. |
| Non-Inferiority in 30-day MACE rates compared to predicate device (Medtronic® AVE PercuSurge GuardWire Plus®): (The primary clinical comparison for substantial equivalence). | 30-day MACE rate of 9.9% (FilterWire EX) vs. 11.6% (GuardWire Plus). Concluded significantly equivalent with a delta of 5.5% (p=0.0016) and upper 95% CI of the difference at 3.1%. |
| Functional and Safety Specifications: (Met through non-clinical testing). | Met all applicable product specifications through in-vitro dimensional, tensile/torque, and functional testing; biocompatibility, packaging, shelf life testing; and functional testing in animal models. |
| Technological Characteristics: Similar 0.014-inch guidewire platform, distal embolic protection. | Incorporates a filter membrane on a Nitinol loop, 0.014-inch diameter guidewire, distal embolic protection. |
2. Sample Size Used for the Test Set and Data Provenance
- FilterWire EX vs. No Protection Cohort:
- Test set (FilterWire EX): 110 patients
- Control (No Protection): 103 patients
- FilterWire EX vs. Predicate Device Cohort:
- Test set (FilterWire EX): 332 patients
- Control (Medtronic® AVE PercuSurge GuardWire Plus®): 319 patients
- Total Clinical Study Participants: 864 saphenous vein graft subjects.
- Data Provenance: The study was a randomized clinical trial, indicating it was prospective. The country of origin is not explicitly stated, but given the submission is to the US FDA by a US-based company, it's highly likely to include US data, possibly with international sites.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable to this type of device submission. The "ground truth" for clinical outcomes (MACE, death, MI, revascularization) is established through medical records and clinical assessment by treating physicians and study investigators, not by a separate panel of experts creating a labeled dataset in the way it's done for AI/ML algorithms.
4. Adjudication Method for the Test Set
The document does not explicitly state the adjudication method for clinical events (like MACE). In randomized clinical trials, clinical events are typically adjudicated by an independent Clinical Events Committee (CEC) composed of medical professionals (e.g., cardiologists, neurologists) to ensure consistent and unbiased endpoint reporting. However, this specific detail is not provided in the summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a medical device (embolic protection system), not an AI/ML diagnostic or assistive tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI/ML algorithm.
7. The Type of Ground Truth Used
For the clinical studies, the "ground truth" was clinical outcomes data (e.g., 30-day rates of major adverse cardiac events (MACE) including death, myocardial infarction, emergent coronary artery bypass grafting, or repeat target vessel revascularization). This data is derived from direct patient observation and medical records, not from expert consensus on images or pathology.
8. The Sample Size for the Training Set
Not applicable. This is a hardware medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no AI/ML training set.
§ 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).