(67 days)
The Safe-Cross® .035" Support Catheter is indicated for use with a guide wire in order to access discreet regions of the vasculature. Once the region has been accessed, an exchange of one guide wire for another can occur. The Catheter may also be used to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
The ILT Safe-Cross® .035" Support Catheter is a single-lumen intravascular catheter coated with a Biocoat Hydak® hydrophilic coating intended for percutaneous use. It is designed to be used in conjunction with steerable wires to gain access to locations within the cardiovascular system that are remote from the site of insertion. Once accessed, guide wires may be exchanged within the catheter. The Safe-Cross® .035" Support Catheter may also be used to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
The effective length of the ILT Safe-Cross® .035" Support Catheter is a nominal 135 cm. The nominal maximum outside diameter is 4.4 French (0.057"). The I.D. at the tip of the ILT Safe-Cross® .035" Support Catheter is a nominal 0.041" and the inside diameter will accommodate commercially available 0.035" quide wires.
The ILT Safe-Cross® .035" Support Catheter is packaged in a Tyvek® covered tray that is heat-sealed to form a sterile barrier. The packaged units are sterilized with ethylene oxide gas. The device is provided "STERILE", "Non-Pyrogenic" and is intended for single use only.
The provided text describes the 510(k) Premarket Notification for the ILT Safe-Cross® .035" Support Catheter. This document is for a medical device and therefore does not contain information about an AI/ML device or its associated studies. As a result, many of the requested sections regarding AI/ML device performance and study methodology cannot be answered from the provided text.
Specifically, there is no information about:
- Acceptance criteria and reported device performance for an AI/ML device.
- Sample size used for a test set, data provenance, or ground truth for AI/ML validation.
- Number/qualifications of experts or adjudication methods for AI/ML ground truth.
- MRMC comparative effectiveness studies or effect sizes for AI assistance.
- Standalone performance of an AI algorithm.
- Sample size for a training set or how ground truth for a training set was established.
This document focuses on the mechanical and biocompatibility performance of a physical medical device (a support catheter) and its substantial equivalence to predicate devices. The studies mentioned are "Biocompatibility testing and in vivo bench studies" to evaluate biological and performance characteristics. The conclusions state that "device materials are biocompatible" and "device satisfies functional performance requirements when used as indicated." These are qualitative summaries, not quantitative performance metrics as would be expected for an AI/ML device.
Therefore, I cannot provide the requested table and study details as they pertain to AI/ML devices, as this document is not about an AI/ML medical device.
§ 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).