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510(k) Data Aggregation
(353 days)
MEDTRONIC PERCUSURGE, INC.
The PercuSurge GuardWire Plus 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.
The PercuSurge GuardWire Plus Temporary Occlusion & Aspiration System provides temporary vascular occlusion during diagnostic and interventional procedures in the coronary vasculature, specifically-diseased coronary bypass grafts. It is comprised of four principal components: the GuardWire Temporary Occlusion Catheter, the MicroSeal Adapter, the EZ Flator Inflation Device and the Export Aspiration Catheter. The GuardWire Plus System is a sterile, single-use disposable device.
Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary for the PercuSurge GuardWire Plus Temporary Occlusion and Aspiration System primarily establishes substantial equivalence to a predicate device rather than defining new, specific acceptance criteria for performance metrics in a standalone study. Therefore, the "acceptance criteria" are implicitly met by demonstrating comparable safety and efficacy to the predicate device.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (from SAFER Study (K003992)) |
|---|---|
| Safety and Efficacy in Coronary Saphenous Vein Bypass Grafts (2.5-5.0mm) for: |
- Containment and aspiration of embolic material
- Subselective infusion/delivery of agents | **Reference Vessels Diameter
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(30 days)
MEDTRONIC PERCUSURGE, INC.
The PercuSurge GuardWire Plus 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 . Somain and aspenary 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.
Not Found
The provided text is a 510(k) clearance letter from the FDA for the PercuSurge GuardWire Plus Temporary Occlusion and Aspiration System. This document does not contain information regarding acceptance criteria for a device, nor does it detail a study proving the device meets said criteria.
The letter only states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices for the indicated uses. It outlines the regulatory classification and general controls.
Therefore, I cannot provide the requested information based on the input text. The information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not present in this document.
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