(178 days)
The NHancer Rx Dual Lumen Rapid Exchange catheter with hydrophilic coating is intended to support a guide wire during access of coronary and/or peripheral vasculature and allows for exchange of guide wires and provides a conduit for the delivery of diagnostic contrast agents. The catheter is not intended for use in the neurovasculature.
The NHancer™Rx is a dual lumen catheter intended to use in the coronary and/or peripheral vasculature. The NHancer™Rx is a 0.014" Rapid Exchange (Rx) guide wire support catheter. The NHancer™Rx has an over the wire (OTW) lumen that runs the length of the catheter and a rapid exchange (RX) delivery lumen on the distal end. The NHancer™Rx has an effective length of 135 cm and is compatible with 0.014"/0.36mm or smaller guide wires. The NHancer™Rx has two depth markings located at 95 cm and 105 cm from the distal tip. The NHancer™Rx has a radiopaque marker identifying the distal end of the catheter and a second radiopaque marker located 8 mm from the distal tip identifies the distal end of the OTW lumen.
To reduce friction in the guide catheter and vasculature, the distal 15 cm of the shaft is fitted with a hydrophilic coating. To reduce friction of the guide wire in the entire lumens of the NHancer Rx are coated with MDX (silicone) coating.
To ease catheter loading into the hemostasis device and the guiding catheter a removable stylet (9) is placed in the OTW lumen
The provided document is a 510(k) premarket notification for a medical device (NHancer Rx Dual Lumen Rapid Exchange catheter). It details the device's characteristics, intended use, and a comparison to a predicate device, along with a summary of performed studies.
However, this document does not contain information about an AI/ML-based medical device study. Therefore, I am unable to provide a response that directly addresses the specific requirements of your prompt regarding acceptance criteria and a study proving device performance for an AI/ML system.
The "studies" mentioned in the document are performance and biocompatibility tests for a physical medical catheter, not a software algorithm. These tests verify physical properties like flexibility, tensile strength, and material biocompatibility, which are fundamentally different from the performance metrics (e.g., sensitivity, specificity, AUC) and study designs (e.g., MRMC, standalone) associated with demonstrating the effectiveness of an AI/ML device.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance for an AI/ML system.
- Sample sizes, data provenance, or ground truth details for an AI/ML test set.
- Information on experts, adjudication methods, or MRMC studies for AI/ML.
- Details on training set size or ground truth establishment for an AI/ML model.
Therefore, paraphrasing or extracting information from the given text to fit your prompt's structure for an AI/ML device would be misrepresentative.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).