(18 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 System: the Split Tube Introducer, Shieldwire™ Guidewire Plug and Installer, 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 provided text describes the TriActiv FX® Embolic Protection System and its clinical evaluation, but it does not include a table of acceptance criteria or explicitly state acceptance criteria for device performance. It focuses on demonstrating non-inferiority to a predicate device based on clinical outcomes.
However, based on the clinical study results presented, we can infer what the implicit performance goals or "acceptance criteria" likely were, particularly in relation to the predicate device.
Here's an attempt to structure the information based on your request, inferring where explicit details are missing:
1. Table of Acceptance Criteria and Reported Device Performance
Since explicit acceptance criteria are not presented in a table in the submission, the table below infers the performance goals based on the non-inferiority study results compared to the predicate. The "Acceptance Criteria" here are derived from the need to demonstrate non-inferiority to the Active Control Arm of the PRIDE Trial (using Guardwire® Plus System or FilterWire® EX System).
| Performance Metric | Acceptance Criteria (Implied for Non-Inferiority) | Reported Device Performance (ASPIRE Enrollment Phase) | Did the Device Meet Criteria? |
|---|---|---|---|
| Major Adverse Cardiac Events (MACE) to 30 days | Non-inferior to predicate (Active Control Arm MACE rate: 10.1%) | 3.2% (3/93) | Yes (p |
§ 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).