(44 days)
The Bard® Snare Retrieval Kit is intended for use to percutaneously remove all Bard optional vena cava filters with a retrieval hook.
The Bard® Snare Retrieval Kit is intended to percutaneously remove Bard filters from the vena cava.
The Bard® Snare Retrieval Kit consists of a Nitinol Snare with 6 French Snare Catheter Assembly and a 11 French O.D Retrieval Sheath with 9 French Dilator Assembly.
The nitinol snare has a 20 mm diameter (fully expanded) radiopaque loop and comes preloaded in the snare catheter. The snare catheter, retrieval sheath, and access sheath have radiopaque marker bands at the distal ends for enhanced fluoroscopic visualization.
This document is a 510(k) summary for the Bard® Snare Retrieval Kit, a medical device intended for percutaneous removal of Bard optional vena cava filters with a retrieval hook. It is a submission to the FDA seeking clearance for market.
The document does not describe an acceptance criteria and study proving a device meets said criteria in the context of an AI/ML algorithm or software. Instead, it describes the process of establishing substantial equivalence for a physical medical device (the Bard® Snare Retrieval Kit) to a legally marketed predicate device (Günther™ Tulip™ Vena Cava Filter Retrieval Set).
Therefore none of the requested information regarding AI/ML performance acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details can be extracted from this document.
The "Functional and Safety Testing" section states: "To verify that device design meets functional and performance requirements, representative samples of the device underwent bench testing in accordance with applicable standards and guidance. These data provide an acceptable assurance of the safety and effectiveness of the Bard® Snare Retrieval Kit and demonstrate the device is equivalent to the predicate."
The "Non-Clinical Tests Submitted" section lists the types of tests performed:
- Performance Testing: Catheter Tensile Strength, Catheter Liquid Leakage, Catheter Corrosion Resistance, Snare Assembly Torque Strength, Snare Simulated Use.
- Biocompatibility Testing: Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Irritation - Intracutaneous Reactivity (ISO10993-10), Acute Systemic Toxicity (ISO10993-11), Pyrogenicity (ISO 10993-11), Hemocompatibility Thromboresistance Coagulation (ISO 10993-4).
However, the specific acceptance criteria for each of these tests and their corresponding quantitative performance results are not provided in this summary. The summary only states that these tests were performed to show substantial equivalence to the predicate 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).