(29 days)
The APRO 55 Intermediate Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The APRO 55 Intermediate Catheter is also indicated for use as a conduit for retrieval devices.
The APRO 55 Intermediate Catheter is a single-lumen, braid and coil reinforced catheter. The catheter is designed to facilitate the insertion and guidance of interventional devices into peripheral and neuro vasculature. Using standard catheterization techniques under fluoroscopic guidance, the APRO 55 Intermediate Catheter is introduced through a guide catheter or guide sheath and over a guidewire into the target vasculature. The distal segment of the catheter shaft has a hydrophilic coating to aid navigation through the vasculature. A radiopaque marker is located at the distal tip of the catheter for visualization under fluoroscopy. The catheter is provided with an Introducer Sheath.
The FDA 510(k) clearance letter for the APRO 55 Intermediate Catheter (K250962) indicates that this is a catheter device, not an AI/Software as a Medical Device (SaMD).
Therefore, the requested information regarding acceptance criteria, study design, expert consensus, ground truth, and training data, which are typical for SaMD or AI-based medical devices, are not applicable to this submission.
The clearance is based on the device being substantially equivalent to a predicate device (APRO® 55 Catheter, K234115) with the only difference being in the packaging configuration. The substantial equivalence is supported by non-clinical testing, specifically bench testing for sterility and shelf-life, and a justification for not requiring new biocompatibility testing (due to material and processing similarity to previously cleared devices).
In summary, there is no AI component or related clinical performance study described in this document that would necessitate the details requested in your prompt.
§ 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).