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The ANGIOGUARD™ XP Emboli Capture Guidewire is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing carotid artery angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of filter basket placement should be from 3mm to 7.5 mm.

The ANGIOGUARD™ RX Emboli Capture Guidewire is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing carotid artery angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of filter basket placement should be from 3mm to 7.5 mm.

Both subject and predicate ANGIOGUARD XP and RX devices consist of a guidewire with integrated emboli filter basket at the distal end. The devices function as an interventional guidewire and distal protection device during delivery and placement of stents and interventional devices in carotid procedures. The guidewire is delivered via an OTW (over-the-wire) or RX (rapid-exchange) deployment sheath and is captured via an OTW or RX capture sheath. ANGIOGUARD devices have a fitter basket at the distal end that is deployed prior to the stenting procedure. When deployed, the filter basket opens in an umbrella-like fashion, allowing passive hemo-filtration with subsequent emboli capture. At the end of the procedure, the filter is collapsed and retrieved.

The Cordis Corporation ANGIOGUARD XP & RX Emboli Capture Guidewires are embolic protection guidewires used during carotid artery angioplasty and stenting procedures. The device's primary function is to contain and remove embolic material (thrombus/debris). This 510(k) notification is for a special 510(k) due to a change in the adhesive material used to adhere radiopaque markers to the filter basket struts.

Here's an analysis of the acceptance criteria and study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document describes "Design verification activities" rather than a clinical human trial needing a test set with specific sample sizes. The testing involved:

• Deployment and Capture Testing: This would likely involve in vitro or bench testing. No specific sample size is provided.
• Visual Inspections: No specific sample size is provided.
• Bioburden Testing: No specific sample size is provided.
• Endotoxin Testing: No specific sample size is provided.
• EtO Residual Testing: No specific sample size is provided.
• Biocompatibility Testing: Conducted per ISO 10993-1. This is a series of tests, and the "sample size" would relate to the number of test articles and controls used in each specific biological evaluation (e.g., cytotoxicity, sensitization, irritation). No specific detailed numbers are given in this summary.

The data provenance is not explicitly stated as retrospective or prospective in the context of human data. Given the "Special 510(k)" for a material change, the focus is on bench testing and laboratory evaluations to confirm the new adhesive does not alter the device's fundamental performance or safety.

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

Not applicable. This submission is for a material change to an already cleared device, relying on design verification activities (bench testing, lab tests) rather than a clinical test set requiring expert ground truth establishment for a diagnostic or imaging device.

4. Adjudication Method for the Test Set:

Not applicable. Since the evaluation consists of design verification activities (bench and lab testing), there is no "adjudication method" in the sense of expert review for clinical data.

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 device is an embolic protection guidewire, a physical medical device, not an AI software. Therefore, an MRMC study related to AI assistance is irrelevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical medical device, not an algorithm or AI software.

7. The Type of Ground Truth Used:

For the design verification activities:

• Technical Specifications/Device Inputs: The "ground truth" for the tests described (Deployment and Capture Testing, Visual Inspections, Bioburden, Endotoxin, EtO residual testing, biocompatibility testing) is adherence to predefined engineering specifications, performance standards, and regulatory standards (e.g., ISO 10993-1). The summary states "Results demonstrated that design outputs continue to meet device inputs."

8. The Sample Size for the Training Set:

Not applicable. This is a change to a physical medical device, not a machine learning model requiring a training set.

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

Not applicable. No training set was used.

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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

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.

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