(147 days)
The ViewFlex™ Xtra Reprocessed ICE Catheter is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures, blood flow and other devices within the heart.
The ViewFlex™ Xtra Reprocessed ICE Catheter is a temporary intracardiac ultrasound catheter intended for use in patients to accurately visualize cardiac structures, blood flow and other devices within the heart when connected to a compatible intracardiac ultrasound console via the compatible ViewFlex™ Catheter Interface Module. Examples of the types of other devices that can be visualized include, and are not limited to, intracardiac catheters, septal occluders, delivery wires, delivery sheaths, sizing balloons and transseptal needles. The use of these images is limited to visualization with no direct or indirect diagnostic use. The ViewFlex™ Xtra Reprocessed ICE Catheter has a useable length of 90 cm, with a 9 French (F) shaft with an ultrasound transducer. A 10F introducer is recommended for use with this catheter for insertion into the femoral or jugular veins. The catheter tip has four-directional deflection allowing for Left-Right and Posterior-Anterior deflection, with an angle of at least 120 degrees in each direction. The ViewFlex™ Xtra Reprocessed ICE Catheter is compatible with the ViewMate™ Z, ViewMate™ and Philips CX50 ultrasound consoles. The ViewFlex™ Xtra Reprocessed Reprocess Catheter has been reprocessed by Abbott one (1) time. Each catheter includes marking on the proximal handle and connector that identify the catheter status. Device is taken out of service after reaching the maximum number of reprocessing cycles. Abbott restricts its reprocessing to exclude devices previously reprocessed by other reprocessors.
Please specify which information from the document is necessary to fulfill the request. The document is about the FDA 510(k) clearance for a reprocessed medical device, the "ViewFlex™ Xtra Reprocessed ICE Catheter." It describes the device, its intended use, and the testing performed to demonstrate substantial equivalence to a predicate device.
However, the document does not contain the kind of information typically associated with complex AI/ML device studies that require:
- A table of acceptance criteria and reported device performance for an AI/ML algorithm.
- Sample sizes for test sets, data provenance, ground truth establishment by experts, or adjudication methods for AI/ML performance.
- Details on multi-reader multi-case (MRMC) studies or effect sizes of human reader improvement with AI assistance.
- Stand-alone (algorithm-only) performance metrics.
- Training set details for AI/ML models.
The study described in this document focuses on the reprocessing of a medical device and its continued safety and effectiveness after being reprocessed once. The "functional and safety testing" mentioned refers to engineering and manufacturing performance verification (e.g., cleaning validation, biocompatibility, sterilization, design validation/verification, packaging verification) to ensure the reprocessed device performs comparably to the new device and meets established specifications. It's not a study about an AI/ML algorithm's performance in a diagnostic context.
Therefore, I cannot provide the requested information (1-9) as it pertains to an AI/ML device study, because the provided document does not describe such a study.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).