(26 days)
The ClotTriever Thrombectomy System consists of the ClotTriever Catheter and ClotTriever Thrombectomy System is indicated for:
- · The non-surgical removal of soft thrombi and emboli from blood vessels.
- · Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature.
The ClotTriever Thrombectomy System is a single-use, sterile medical device system designed for use in the peripheral vasculature. The ClotTriever Thrombectomy System consists of the ClotTriever Sheath and the ClotTriever Catheter. The ClotTriever Sheath consists of a polymeric sheath equipped with a self-expanding distal mesh funnel, a flush/aspiration port with tubing clamp, and a proximal hemostatic valve. A dilator is provided to aid insertion. Other provided accessories include a clot reservoir, a flush port adapter, an aspiration insert, funnel loading tool, and a 60 cc syringe. The ClotTriever Catheter consists of four pre- assembled polymeric coaxial catheters terminating in an expandable coring element and thrombus collection bag. At the proximal end of the catheter is a handle used to enable tensioning of the coring element. Two ports terminating in stopcocks are provided for de-airing the catheter shafts. To aid in fluoroscopic visualization, the dilator and ClotTriever Catheter distal tips are radiopaque, and radiopaque marker bands are located on the coring element shaft at the proximal end of the expandable coring element, and at the distal ends of the ClotTriever Sheath and ClotTriever Catheter outer shaft.
The prompt asks to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided text. However, the provided text does not contain details about specific acceptance criteria (e.g., numerical thresholds for performance metrics) or a study with detailed results that explicitly "prove" the device meets these criteria. Instead, it describes non-clinical testing performed to establish substantial equivalence to a predicate device.
Therefore, many of the requested details cannot be extracted directly from the provided document. I will answer based on what is available, and explicitly state when information is missing.
Here's the breakdown of what can be inferred/extracted:
1. A table of acceptance criteria and the reported device performance
The document lists various non-clinical tests conducted but does not provide a table with specific acceptance criteria (e.g., "Deployment Force
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).