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The FilterWire EZ 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 artery 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 cerebral, carotid and peripheral vasculature or in treating native coronaries, including acute myocardial infarction.

The subject FilterWire EZ Embolic Protection System (2.25 mm - 3.5 mm) consists of the same four main components as the FilterWire EZ Embolic Protection System (2.25 mm - 3.5 mm) cleared under K051984. These components are:

• · A Protection Wire (0.014 in. [0.36 mm] guide wire and integrated filter loop) that incorporates a circular/oval-shaped structure (filter loop assembly), which supports a thin, porous, filter membrane designed to contain and remove embolic material while maintaining blood flow.
• · An EZ Delivery Sheath, a low-profile sheath that constrains the filter on the protection wire for delivery to the site of filter loop placement. It is prepackaged with the protection wire for coaxial delivery and has a slit for easy removal in a peel-away fashion.
• · An EZ Retrieval Sheath is intended to negotiate through the anatomy over the protection wire to retrieve the filter. The sheath is designed to track easily to the filter without catching on obstacles such as stents. The sheath has a radiopaque marker and is silicone coated.
• · A tool kit containing one peel-away introducer, one wire torquer and one hemostasis valve dilator

This is a 510(k) premarket notification for a medical device, the Boston Scientific FilterWire EZ Embolic Protection System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical trials with defined acceptance criteria for a new AI/software device.

Therefore, the requested information about acceptance criteria, study details, sample sizes for test and training sets, expert qualifications, ground truth establishment, MRMC studies, and standalone performance metrics are not applicable to this regulatory document.

The document states that the new device is substantially equivalent to a previously cleared device (K051984) and that "Non-clinical tests conducted for the FilterWire EZ Embolic Protection System (2.25 mm - 3.5 mm) showed the device met its design-input criteria, and is safe and effective for its intended use." However, it does not provide specific acceptance criteria or detailed study results in the format requested for an AI/software device.

Here's an attempt to structure the available information, noting the inapplicability of many requested fields:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the context of this 510(k) submission for a non-software medical device. The submission focuses on demonstrating substantial equivalence to a predicate device and meeting "design-input criteria" through non-clinical testing. Specific quantitative acceptance criteria and performance metrics for the device's function (e.g., filter efficiency, guidewire flexibility) are not detailed in this summary.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable as this is not an AI/software device requiring a test set of data. Non-clinical (in-vitro and in-vivo) testing was performed, but specific sample sizes for these tests are not provided in this summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This device is not an AI/software system that uses ground truth labels established by experts on a test set.

4. Adjudication Method for the Test Set

Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study?

No. This is not an AI/software device, so an MRMC study is not relevant.

6. Standalone (Algorithm Only) Performance Study?

No. This is a physical medical device, not a software algorithm.

7. Type of Ground Truth Used

Not applicable.

8. Sample Size for the Training Set

Not applicable. This device does not involve a training set as it's not an AI/software device.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary of Relevant Information from the Document:

While the specific details requested for an AI/software device are not present, the document provides the following:

• Device: Boston Scientific FilterWire EZ Embolic Protection System (2.25 mm - 3.5 mm)
• Purpose of Submission: To demonstrate substantial equivalence to a predicate device (FilterWire EZ Embolic Protection System (2.25 mm - 3.5 mm) cleared under K051984).
• Performance Evaluation: "Non-clinical tests conducted for the FilterWire EZ Embolic Protection System (2.25 mm - 3.5 mm) showed the device met its design-input criteria, and is safe and effective for its intended use."
• Testing Types Mentioned: In-vitro testing, in-vivo testing, biocompatibility, and packaging.
• Compliance: Where appropriate, testing conformed to the requirements of 21 CFR Part 58, Good Laboratory Practices (GLP).

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