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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 TriActiv® System is indicated for use in conjunction with percutaneous coronary intervention (PCI), using a 7F guide catheter (without side holes), of diseased saphenous mice vention (1 U), assign from 3.0mm to 5.0mm in diameter. The TriActiv® vent coronal y of pass grates the distal coronary vasculature by trapping and extracting thrombotic and atheromatous debris liberated during PCI.

The safety and effectiveness of this device as an embolic protection system has not been r the salery and broot. Annus arotid, or peripheral vasculature; native coronary arteries; or for treatment of patients with acute myocardial infarction.

The TriActiv® System is a temporary balloon occlusion embolic protection device used during percutaneous coronary intervention of diseased saphenous vein grafts ranging from 3.0mm to 5.0mm in diameter. The device is comprised of four principal ShieldWire™ Temporary Occlusion Balloon Guidewire ("balloon components: guidewire), Balloon Inflation Syringe, FlushCath™ Catheter ("flush catheter"), and AutoStream™ Flow Control ("flow control"). There are also five subcomponents or accessories included in the TriActiv® System: the split tube introducer, guidewire plug and installer, AutoStream™ Flow Control Power Supply, TriActiv® Tuohy, and flush catheter attachment tool. All TriActiv® System components are supplied sterile and for single use only with exception of the AutoStream™ Flow Control Power Supply which is non-sterile and reusable. The balloon guidewire is advanced through the hospital supplied 7F guide catheter (without sideholes) prior to percutaneous coronary intervention of a saphenous vein graft (SVG) and positioned just past the target lesion.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text, with clarifications for missing information:

Device: TriActiv® System (Distal Occlusion Balloon Catheter)
Predicate Device: PercuSurge GuardWire® Temporary Occlusion and Aspiration System (K013913)

1. Table of Acceptance Criteria and Reported Device Performance

The core acceptance criterion for the TriActiv® System, as stated in this 510(k) summary, is non-inferiority to existing embolic protection devices for preventing Major Adverse Cardiac Events (MACE) during saphenous vein graft PCI.

• Active Control 30-day MACE rate: 10.1% (32/318)
• Difference (TriActiv® - Active Control): 1.1%
• Upper one-sided 95% confidence bound on the difference: 5.15%
• P-value for non-inferiority (relative to 6% delta): 0.023
  Conclusion: The study met its non-inferiority hypothesis. The device would have achieved non-inferiority for a delta as small as 5.2%. |
  | Device Success Rate | TriActiv® Cohort 2: 94.5% (293/311) |
  | Procedure Success/Patient Rate (Final stenosis

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The indication for use for the stand-alone Export Catheter is:

The Export Aspiration Catheter is indicated for use with the GuardWire Temporary Occlusion and Aspiration System in coronary saphenous vein bypass grafts to:

• · Contain and aspirate embolic material (thrombus/debris) while performing percutaneous transluminal coronary angioplasty or stenting procedures.
• · To subselectively infuse/deliver diagnostic or therapeutic agents with or without vessel occlusion.
• · The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid or peripheral vasculature.

When the Export Catheter is packaged with a GuardWire Temporary Occlusion and Aspiration System, the device will be marketed under the indications for use of that system.

When the Export Catheter is included in the GuardWire 2.5-5 Temporary Occlusion and Aspiration System this system will be labeled as shown below:

The PercuSurge GuardWire Temporary Occlusion & Aspiration System is indicated for use in the coronary saphenous vein bypass grafts (2.5-5.0mm) to:

• · Contain and aspirate embolic material (thrombus/debris) while performing percutaneous transluminal coronary angioplasty or stenting procedures.
• To subselectively infuse/deliver diagnostic or therapeutic agents with or without vessel occlusion.
• · 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.

When the Export Catheter is included in the GuardWire 3-6 Temporary Occlusion and Aspiration System the indications for that system will be labeled as shown below:

The PercuSurge GuardWire Temporary Occlusion & Aspiration System is indicated for use in the coronary saphenous vein bypass grafts to:

• · Contain and aspirate embolic material (thrombus/debris) while performing percutaneous transluminal coronary angioplasty or stenting procedures.
• · To subselectively infuse/deliver diagnostic or therapeutic agents with or without vessel occlusion.
• · The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid or peripheral vasculature.

The Export Catheter is a single lumen catheter that has guidewire access holes on the distal end of the catheter that mimic a single operator guidewire rail. This design, called the "Dual-Trak single lumen" is best described as a single lumen catheter that has wire entry and exit holes on the distal segment of the catheter. This allows a single lumen catheter to be advanced over a wire without the need for a separate wire lumen. The result is a single lumen catheter that has a smaller outer diameter compared to a dual lumen catheter yet can be advanced over a wire like a dual lumen catheter. To accomplish this feature the distal segment of the catheter is distorted so that the catheter in this portion is no longer round.

The access holes are carefully formed in the tip section. This allows the GuardWire to be placed in the distal tip and exit the catheter a short distance down the shaft, thus forming a small rail for the catheter to track over. An aspiration syringe is provided, as is an aspiration line. These are attached to the proximal end of the Export to facilitate blood and debris being evacuated from the site into the syringe.

This document describes a 510(k) premarket notification for the "Export Aspiration Catheter." It is a submission for a medical device seeking clearance based on substantial equivalence to existing legally marketed predicate devices, rather than a study demonstrating performance against specific acceptance criteria for a new AI/software-based device.

Therefore, the requested information (acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, MRMC study, standalone performance, etc.) is not applicable to this type of regulatory submission.

This document focuses on:

• Identifying Information: Submitters, contact person, classification, proprietary name.
• Predicate Devices: Listing previously cleared devices to which the current device is compared for substantial equivalence.
• Description: Explaining the mechanical design of the catheter, particularly its "Dual-Trak single lumen" feature.
• Intended Use: Specifying the medical procedures and anatomical locations for which the catheter is indicated, both as a standalone device and as part of the GuardWire Temporary Occlusion and Aspiration System. It also explicitly states limitations (e.g., not established for cerebral, carotid, peripheral vasculature, acute myocardial infarction, or native coronaries).
• Technology: Stating that the device uses similar manufacturing, processes, and materials as predicates and that its intended use has not changed.
• Bench Testing: Mentioning "in vitro bench testing" to determine substantial equivalence but without providing specific criteria or results.

In summary, there is no discussion of acceptance criteria, device performance metrics, or a study design to prove the device meets such criteria in the context of AI or software performance in this document. The document is a standard 510(k) filing asserting equivalence to existing devices for a physical medical catheter.

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