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The Apeel CS Plus Catheter Delivery System is intended to provide vascular access including the coronary sinus and serve as a conduit for the delivery and support of other devices where minimizing blood loss is essential.

The Apeel™ CS Plus Catheter Delivery System includes a Peelable Introducer Sheath, Dilator, Cannulator, Detachable Hemostasis Valve with Side Port with 3-way Stopcock, Guidewire, Syringe, Needle, and 2 Valve Bypass Tools. The introducer kits are provided sterile, and are intended for single-use only.

The provided document, K051096, is a Special 510(k) for a device modification of the Apeel™ CS Plus Catheter Delivery System. This type of submission is for device modifications, not for validating new AI algorithms or diagnostic tools. As such, the document does not contain any information related to acceptance criteria, study performance, sample sizes, ground truth establishment, or expert involvement as would be relevant for an AI/diagnostic device.

The submission focuses on establishing substantial equivalence to a predicate device (Apeel CS Catheter Delivery System) and a reference device (Spyglass Angiographic Catheter) for a modified medical device. The "support of the substantial equivalence" section explicitly states: "St. Jude Medical considers the Apeel CS Plus Catheter Delivery System to be substantially equivalent to the predicate and referenced devices."

Therefore, I cannot provide the requested information for an AI/diagnostic device based on this document. The sections you asked for are not applicable to the content of this 510(k) submission.

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The St. Jude Medical (SJM) Agilis™ Steerable Catheter Introducer is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

The Agilis™ Steerable Catheter Introducer set consists of a dilator, guidewire, and steerable sheath, which is designed to provide flexible catheter positioning in the cardiac anatomy. The steerable introducer is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling and pressure monitoring. The steerable introducer features distal vent holes to facilitate aspiration and minimize cavitation, and a radiopaque tip marker to improve fluoroscopic visualization. The device is provided sterile and is intended for single-use only.

The provided text is a 510(k) Summary for the Agilis™ Steerable Catheter Introducer. It includes information about the device, its intended use, and a comparison to predicate devices, but it does not contain any details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or clinical study methodologies.

The document explicitly states: "Where dimensional and material differences exist between the proposed device and the predicate devices, mechanical and biocompatibility testing demonstrated that these differences do not adversely affect safety and effectiveness." This indicates that mechanical and biocompatibility testing were performed, but the details of these tests (e.g., acceptance criteria, specific results, sample sizes) are not provided in this summary.

Therefore, I cannot provide the requested information. The 510(k) Summary focuses on establishing substantial equivalence to a predicate device based on technological characteristics and general safety and effectiveness considerations, rather than detailing specific performance studies with acceptance criteria as typically found in clinical validation reports or more comprehensive technical documentation.

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