(89 days)
The Liberant Thrombectomy System is indicated for the removal of fresh, soft emboli or thrombi from the vessels of the peripheral arterial and venous systems.
The Liberant Thrombectomy System consists of the Liberant Thrombectomy Set (catheter, clotbuster, dilator, aspiration tubing and hemostasis valve), Liberant Blood Conservation Unit (BCU), Riptide Aspiration Pump and Riptide Collection Canister with intermediate tubing. The Liberant Thrombectomy Set is single use and provided sterile.
The Liberant BCU and Riptide Pump are provided separately from the Liberant Thrombectomy Set as non-sterile capital units. The single use, non-sterile Riptide Collection Canister is provided separately to the pump.
The provided FDA 510(k) clearance letter pertains to a thrombectomy system, which is a physical medical device (catheter-based system) used for removing blood clots. It is not an AI/ML device. Therefore, the request for acceptance criteria and study details relevant to AI/ML devices, such as sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, and standalone performance, cannot be answered from the provided text.
The document focuses on the substantial equivalence of the Liberant Thrombectomy System to a predicate device (Penumbra Indigo Aspiration System) based on:
- Indications for Use: Both systems are indicated for the removal of fresh, soft emboli or thrombi from peripheral arterial and venous systems.
- Operating Principle/Technological Design: Both utilize continuous aspiration and fragmentation tools (clotbuster/separator).
- Catheter Specifications: Similar sizes, lengths, and guidewire compatibility.
- Non-Clinical Data: Extensive performance, biocompatibility, shelf-life, sterilization, packaging, software validation (for the pump control), and electrical/EMC testing were performed. This type of "software validation" typically refers to embedded software controlling the pump mechanics, not an AI/ML diagnostic or predictive algorithm.
Therefore, I cannot provide the requested information regarding AI/ML device acceptance criteria and study details because the provided document describes a non-AI medical device.
§ 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).