(146 days)
The Reprocessed ViewFlex Xtra 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 Reprocessed ViewFlex Xtra ICE 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 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.
I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that the device meets those criteria. The document is an FDA 510(k) clearance letter and summary for a reprocessed medical device (Reprocessed ViewFlex Xtra ICE Diagnostic Ultrasound Catheter).
The document outlines:
- The device's trade name, regulation number, and classification.
- The FDA's decision of substantial equivalence to a predicate device.
- The indications for use for the reprocessed catheter.
- A description of the reprocessed device and its technological characteristics.
- A list of functional and safety testing conducted (e.g., biocompatibility, cleaning validation, functional testing, mechanical characteristics, electrical safety testing, packaging validation).
However, it does not provide:
- A table of specific acceptance criteria (e.g., performance metrics like sensitivity, specificity, accuracy) and reported device performance against those criteria.
- Details about a specific study designed to "prove the device meets acceptance criteria," especially in the context of diagnostic performance involving a test set, ground truth, or expert interpretations. The testing mentioned is for the physical and functional integrity of the reprocessed device to ensure it performs comparably to the original, not to establish diagnostic performance for an AI/algorithm.
- Information regarding sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth types for diagnostic evaluation.
- Sample size for the training set or how ground truth was established for a training set, as this is not an AI/algorithm-based device.
The "studies" mentioned (biocompatibility, cleaning validation, functional testing, etc.) are bench and laboratory tests to demonstrate the safety and effectiveness of the reprocessing process and the reprocessed device's physical/functional integrity, not diagnostic performance.
§ 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).