(59 days)
The Crux® Snare Filter Retrieval Set is an endovascular medical device indicated for the retrieval of the Crux® Vena Cava Filter (VCF) percutaneously via the jugular vein or femoral vein approach.
The Crux® Snare Filter Retrieval Set consists of a 0.035" PTFE-coated guidewire, 18 gauge introducer needle, 8.2 F inner sheath with dilator, 10 F outer sheath, Crux Snare, introducer and torque tool. The components are designed to be used percutaneously to retrieve the Crux Vena Cava filter via either the jugular or femoral vein approach.
The provided text describes a 510(k) premarket notification for the Crux® Snare Filter Retrieval Set. It details the device, its intended use, and a comparison to predicate and reference devices. However, the document does not contain the specific information requested about acceptance criteria and a study that proves the device meets those criteria.
The document primarily focuses on:
- Device identification and classification: Trade name, common name, product code, classification, and predicate/reference devices.
- Device description: Components and how it's used.
- Intended use: Retrieval of the Crux® Vena Cava Filter.
- Performance data (Non-clinical): This section briefly mentions bench testing and biocompatibility testing.
- Bench Testing: Evaluated Visual, Dimensional, Hemostasis/Flushing/Compatibility, Radiopacity, Ability to access, and Bond Tensile against "known standards, product specification, or against the predicate device."
- Biocompatibility Testing: Successfully completed Cytotoxicity, Hemocompatibility (Hemolysis, PTT, Complement Activation, Platelet and Leukocyte Count, Thrombogenicity), Sensitization, Irritation, Systemic Toxicity, and Material Mediated Pyrogenicity.
- Conclusion: The device is substantially equivalent to the predicate and reference device based on these tests.
Therefore, I cannot provide the requested information, including the table of acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details, as these details are not present in the provided text.
The document states that bench testing was conducted against "known standards, product specification, or against the predicate device," but it does not elaborate on what those specific standards or specifications were, nor does it provide quantitative performance data against them.
§ 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).