(356 days)
The Vado Steerable Sheath is indicated for introducing various catheters into the vasculature and into the chambers of the heart including the left side of the heart through the interatrial septum.
The Vado Steerable Sheath consists of an 8.8F (ID) sheath and dilator, which is designed to provide flexible catheter positioning in the cardiac anatomy. The steerable introducer includes a hemostasis valve to minimize blood loss during catheter exchange. A sideport with three-way stopcock is provided for aspiration, fluid infusion, blood sampling and pressure monitoring. A handle equipped with a deflection knob, deflects the sheath tip. The steerable introducer features distal vent holes for aspiration and radiopaque markers to facilitate visualization under fluoroscopy.
The provided text describes the regulatory clearance of a medical device, the "Vado Steerable Sheath," and details the non-clinical testing performed to demonstrate its substantial equivalence to a predicate device. It does not describe an AI/ML powered device, nor does it contain information about acceptance criteria or supporting studies that are typically associated with performance metrics of AI/ML models (e.g., sensitivity, specificity, AUC).
Therefore, I cannot provide the information requested in the prompt, as the document does not contain:
- A table of acceptance criteria and reported device performance in the context of AI/ML metrics.
- Sample size used for the test set or data provenance for an AI/ML model.
- Number of experts or their qualifications for establishing ground truth for AI/ML validation.
- Adjudication method for AI/ML ground truth establishment.
- Information on a multi-reader, multi-case (MRMC) comparative effectiveness study for AI assistance.
- Standalone performance (algorithm only) for an AI/ML model.
- Type of ground truth used (expert consensus, pathology, outcomes data) for AI/ML validation.
- Sample size for the training set of an AI/ML model.
- How the ground truth for the training set was established for an AI/ML model.
The document focuses on the mechanical and material performance of a medical device (a catheter introducer), including:
- Biocompatibility tests: To ensure the device is safe for human contact.
- Bench performance tests: To assess physical characteristics like dimensions, leakage resistance, deflection, aspiration, and strength.
- Packaging integrity tests: To ensure sterility and product protection.
These tests are standard for a traditional medical device and are aimed at demonstrating that the device meets its functional and performance characteristics and is equivalent to the predicate device in terms of safety and effectiveness, not that it performs an interpretive or diagnostic function with AI/ML.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).