(28 days)
The ViewFlex™ X ICE Catheter Sensor Enabled™ is indicated for use in adult and adolescent pediatric patients for intra-cardiac and intra-luminal visualization of cardiac and great vessels anatomy and physiology, as well as visualization of other devices in the heart. When used with a compatible three-dimensional mapping system, the catheter provides location information.
The ViewFlex™ X ICE Catheter Sensor Enabled™ (SE) is a sterile, single use, temporary, radiopaque, intracardiac ultrasound catheter. The catheter shaft is a 9 French (F) catheter constructed with flexible tubing with a useable length of 90 cm. The shaft is compatible with a 10 French or larger introducer for insertion into the femoral or jugular veins. The catheter tip is a 64‑element linear phased array transducer. The distal portion of the shaft is deflectable utilizing two handle mechanisms which create four deflection directions including left, right, anterior and posterior. The distal tip contains an ultrasound transducer and 3-D location sensor providing 2-D imaging and 3-D location and orientation information when used with a compatible ultrasound system and the EnSite X Cardiac Mapping System.
This document is a 510(k) clearance letter for the ViewFlex™ X ICE Catheter, Sensor Enabled™. The provided text does not contain any information regarding acceptance criteria or the study that proves the device meets those criteria, especially in the context of an AI/ML-enabled device as implied by the prompt's request for information about human readers, AI assistance, ground truth, and training sets.
The device described is an intracardiac ultrasound catheter that provides 2-D imaging and 3-D location/orientation information. The mention of "Sensor Enabled™" and "3-D location sensor" suggests a technological upgrade, but there is no indication that this involves the use of artificial intelligence or machine learning for diagnostic interpretation.
Therefore, I cannot provide the requested information based on the provided text. The prompt's questions (acceptance criteria, study details, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types, training set details) are all relevant to the evaluation of AI/ML-enabled medical devices, which is not what this 510(k) summary describes.
In summary, the provided document explains the ViewFlex™ X ICE Catheter, Sensor Enabled™ as a traditional medical device (an intravascular ultrasound catheter) with an added 3-D location sensor for mapping systems. It details the substantial equivalence to a predicate device based on non-clinical testing (bench design verification, biocompatibility, mechanical integrity, etc.). It does not mention any AI or ML components, nor does it describe studies with human readers, AI assistance, or data sets for machine learning model evaluation.
§ 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).