(237 days)
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.
| Acceptance Criterion | Reported Device Performance (PRIDE Study Cohort 2) |
|---|---|
| Non-inferiority in 30-day MACE rates compared to active control devices (FilterWire® EX Embolic Protection System or GuardWire® Plus Temporary Occlusion and Aspiration System) with a delta of 6%. | - TriActiv® 30-day MACE rate: 11.2% (35/313) |
- 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
§ 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).