(256 days)
The ClotTriever Thrombectomy System is indicated for:
· The non-surgical removal of 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 including deep vein thrombosis (DVT).
The ClotTriever Thrombectomy System is a single-use, sterile medical device designed for use in the peripheral vasculature. The ClotTriever Thrombectomy System consists of the ClotTriever Sheath and the ClotTriever Catheter. The ClotTriever Sheath is made of a reinforced polymeric sheath equipped with a self-expanding distal mesh funnel, a flush/aspiration port and a proximal hemostatic valve. A dilator is included to aid insertion. Other provided accessories include the funnel loading tool and a large bore 60 cc syringe. The ClotTriever Catheter is made of reinforced polymeric coaxial shafts terminating in an expandable coring element and thrombus collection bag. Two ports terminating in stopcocks are provided for de-airing the catheter shafts. To aid in fluoroscopic visualization, the sheath dilator and ClotTriever Catheter distal tips are radiopaque.
The provided text describes a 510(k) premarket notification for the ClotTriever Thrombectomy System, focusing on a labeling change rather than a study proving new performance claims or AI model acceptance criteria. The document states that the change is to replace "fibrous" and "adherent" with "predominantly fibrous" and "firmly adherent" from the contraindications. It explicitly mentions that Non-Clinical Testing was not required to support the change and that Clinical Testing was originally submitted in a previous 510(k) (K193462, cleared on September 9, 2020). Therefore, the document does NOT contain the information needed to answer the prompt regarding acceptance criteria and performance studies for a device, especially not those related to an AI model.
The prompt specifically asks for details about AI model acceptance criteria and performance studies (e.g., sample size, expert ground truth, MRMC studies, standalone performance), which are not discussed in this FDA 510(k) clearance letter for a thrombectomy system.
Therefore, I must state that the requested information is not available in the provided text.
§ 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).