(55 days)
The Aventus Thrombectomy System is indicated for:
- The non-surgical removal of emboli and thrombi from blood vessels.
- Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The Aventus Thrombectomy System is intended for use in the peripheral vasculature.
The Aventus Thrombectomy System is a catheter-based manual aspiration system designed for minimally invasive removal of emboli and thrombi from the peripheral vasculature and/or infusing fluids into the peripheral vasculature. The System is comprised of the following major components:
- Aspiration Catheter
- Clot Management System consisting of:
- Aspiration Syringe
- Clot Canister
The System is compatible with a standard 24-French (24F) introducer sheath, 4-French (4F) Support Catheters and is to be used with 0.035" guidewires. The System is provided sterile and is intended for single use only.
The Aspiration Catheter includes an atraumatic radiopaque Distal Tip with angled aspiration orifice for directional aspiration and navigation without a dilator, a dedicated navigation catheter lumen with integrated Navigation Catheter, a dedicated infusion lumen for injection of fluids, and a Handle designed to navigate within the vasculature. The Aspiration Catheter shaft incorporates a metallic reinforcement made of stainless steel, an inner liner and polymeric jacket material with variable stiffness.
The System is provided with a 60-cc dual action manual syringe which allows for directional flow control and directs aspirated blood and clot into the Clot Canister.
The provided text describes a 510(k) premarket notification for the Aventus Thrombectomy System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study proving the device meets those criteria in a clinical or AI performance context.
The document does not contain information related to AI/software performance, human reader studies, or explicit acceptance criteria for such an AI system. It primarily details the physical and functional characteristics of a medical device (a thrombectomy catheter) and its non-clinical performance testing (biocompatibility, sterilization, bench testing, and animal studies).
Therefore, I cannot provide the requested information, which pertains to the performance validation of an AI/software device. The provided text describes the regulatory filing for a physical medical device, not an AI or software product.
Based on the provided text, the device is a physical medical device (Aventus Thrombectomy System), not an AI/software product. Therefore, the requested information (AI acceptance criteria, human reader studies, ground truth establishment for AI, etc.) is not present in the document.
The document details the following performance data, which are typical for physical medical devices seeking 510(k) clearance:
- Biocompatibility Testing: Successful completion per ISO 10993-1:2018 (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Hemocompatibility). This demonstrated no risk of negative interaction with patients.
- Sterilization Testing: Successful completion per ISO 14937:2009, with a demonstrated SAL of 10^-6. Bacterial endotoxins test (BET) also confirmed meeting pyrogen limit specifications.
- Distribution, Packaging and Shelf-Life Testing: Successful completion of distribution testing and accelerated aging simulating a six-month shelf-life, demonstrating integrity of the sterile barrier and preservation of properties.
- Performance Testing - Bench: Design verification testing demonstrated physical and functional requirements were met. Specific tests included: Visual and Dimensional Inspection, Tensile Strength, Pressure/Leak Integrity, Clot Burden Removal Validation, Vacuum Test, Leak Test, Pouch Seal Visual Inspection and Bubble Test, Pouch Seal Strength, Compatibility Testing, Torque Transmission Testing, Kink Testing, Kink and Torque to Failure, Simulated-Use.
- Performance Testing – Non-Clinical (GLP Animal Study): A GLP animal study demonstrated the system could be used safely in a chronic large animal study and met all pre-defined study endpoints.
The document does not describe any acceptance criteria or studies related to AI/software performance, such as sensitivity, specificity, human reader performance, or ground truth derived from expert consensus/pathology. Thus, I cannot populate the table or answer the specific questions about AI/software validation.
§ 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).