(25 days)
The TriActiv FX® Embolic Protection System is indicated for use in conjunction with percutaneous coronary intervention (PCI), using a 7F guide catheter (without side holes), of diseased saphenous vein coronary bypass grafts ranging from 3.0mm to 5.0m in diameter. The TriActiv FX® Embolic Protection System is intended to protect 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 established in the cerebral, carotid, or peripheral vasculature; native coronary arteries; or for treatment of patients with acute myocardial infarction.
The TriActiv FX® Embolic Protection 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 components: ShieldWire™ Balloon Guidewire ("balloon guidewire), ShieldWire™ Inflator ("inflator"), FX™ Catheter ("flush catheter"), and AutoStream™ Flow Control ("flow control"). There are also four subcomponents or accessories included in the TriActiv FX® Embolic Protection the Split Tube Introducer, Shieldwire™ Guidewire Plug and Installer, System: TriActiv® Flow Control Power Supply and TriActiv® Tuohy. All TriActiv FX® Embolic Protection System components are supplied sterile and for single use only with exception of the TriActiv® 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 araft (SVG) and positioned just past the target lesion. The balloon is inflated with a medical grade carbon dioxide gas blend, creating a protected space between the quide catheter and the balloon. Once the balloon is inflated and vessel occlusion is confirmed, PTCA and/or stenting can be performed over the balloon guidewire. Immediately after intervention, the flush catheter is loaded on the balloon guidewire and advanced into the graft. With the flush catheter positioned just proximal to the balloon, the flow control delivers saline through the flush catheter to gently wash the vessel and remove any debris generated during the intervention through the guide catheter into a collection bag. The TriActiv FX® Embolic Protection System has been designed to extract at a greater rate than it infuses to prevent aortic embolization. Once the physician is satisfied with the amount of debris removed from the vessel, the protection balloon is deflated and the device is removed.
Here's a breakdown of the acceptance criteria and the study details for the TriActiv FX® Embolic Protection System, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the TriActiv FX® Embolic Protection System were primarily established through a non-inferiority comparison to existing predicate devices (Medtronic Guardwire® or Boston Scientific Filterwire EX™). The key performance metrics are related to Major Adverse Cardiac Events (MACE) and other clinical outcomes.
| Metric (Acceptance Criteria) | Reported Device Performance (TriActiv FX® - ASPIRE Study) | Reference Device Performance (Guardwire® / Filterwire EX™ - PRIDE Study) | Adjusted P-Value | Unadjusted Difference (95% CI) |
|---|---|---|---|---|
| MACE to 30 days (Non-inferiority to predicate) | 3.2% (3/93) | 10.1% (32/318) | 0.013 | -6.8% (-2.7%) |
| Myocardial Infarction (MI) (Lower rate desired) | 2.2% (2/93) | 8.8% (28/318) | 0.021 | -6.7% (-3.1%) |
| Device Success⁴ | 95.7% (89/93) | 94.5% (293/310) | 0.79 | 1.2% (-2.9%) |
| Procedure Success/Patient⁵ (Criteria for successful procedure) | 97.8% (90/92) | 90.5% (286/316) | 0.013 | 7.3% (3.6%) |
| Lesion Success/Lesion⁶ (Criteria for successful lesion treatment) | 100% (103/103) | 99.4% (319/321) | - | 0.6% (-0.1%) |
| Final TIMI Flow 0 | 0% (0/97) | 0.6% (2/306) | 0.98 | - |
| Final TIMI Flow 1 | 0% (0/97) | 0.6% (2/306) | - | - |
| Final TIMI Flow 2 | 4.1% (4/97) | 0.9% (3/306) | - | - |
⁴ Device success is defined as attainment of all of the following: the device was successfully delivered to the target location, the device operated as intended, the device was successfully retrieved.
*⁵ Final stenosis
§ 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).