(207 days)
BRITE TIP RADIANZ™ Guiding Sheath is intravascular introduction of interventional and/or diagnostic devices into the peripheral vasculature through the radial artery.
Each BRITE TIP RADIANZ™ device consists of a 6F compatible guiding sheath, a vessel dilator (0.035" guidewire compatible) and a removable hemostasis valve. The guiding sheath has a lubricious hydrophilic coating to enhance entry and withdrawal during vessel access, and a low-profile outer diameter with a smooth transition to the vessel dilator to minimize or prevent radial vasculature trauma and spasm of the radial artery. The sheath is available in two lengths, 110 cm and 135 cm. The sheath hub is an over-molded hub with a luer and is compatible with the removable hemostasis valve provided (described below) and with other hemostasis valves or common vascular accessories of the user's choice. The vessel dilator is compatible with 0.035" guidewires (not included) and is tapered such that it creates a smooth transition between the guiding sheath tip and the guidewire. The vessel dilator hub is over molded and includes a locking feature located in the distal end of the hub to facilitate locking the vessel dilator to the sheath cannula proximal hemostasis valve. The system contains a removable hemostasis valve to facilitate entry and withdrawal of intravascular devices through the guiding sheath and minimize the backflow of blood. It also has a side-port arm with attached 3-way stopcock for flushing or aspiration. The preassembled hub connector is removable, such that it can be exchanged for a hemostasis valve or other common vascular accessory of the user's preference.
The provided FDA 510(k) summary for the BRITE TIP RADIANZ™ Guiding Sheath does not contain information about acceptance criteria or a study proving that the device meets those criteria in the context of an AI/ML device. This document describes a traditional medical device (a catheter introducer) and its substantial equivalence to a predicate device based on bench testing and biocompatibility, not AI/ML performance.
Therefore, many of the requested categories related to AI/ML device evaluations (such as sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance) are not applicable to this document.
However, I can extract information related to the device's performance testing and the general conclusion of substantial equivalence.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present "acceptance criteria" in a quantitative format for specific performance metrics in the way an AI/ML study would. Instead, it states that various tests were "successfully performed" or "passed" according to relevant ISO standards and internal test methods, indicating that the device met the requirements of those standards.
Acceptance Criteria & Reported Device Performance (as implied by successful testing against standards):
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Meets requirements of ISO 10993-1 and specific tests. | Biocompatible for intended use based on successful testing. |
| Sterilization | Achieves a sterility assurance level (SAL) of 10^-6. | Validated per ISO 11135:2014+A1:2018 (SAL of 10^-6 achieved). |
| Residuals (EO, ECH) | Meets requirements for limited exposure devices ( |
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).