(70 days)
Product code NRY:
The CEREGLIDE 71 Catheter System, with the Cerenovus Aspiration Tubing Set and a compatible aspiration pump, is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment.
The Cerenovus Aspiration Tubing Set is intended to connect the Cerenovus Large Bore Catheter or the CEREGLIDE 71, 57, or 42 Intermediate Catheter to the canister of a compatible aspiration pump and to allow the user to control the fluid flow.
Product code QJP:
The CEREGLIDE 71 Catheter System is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the neurovascular system. The CEREGLIDE 71 Catheter System is also indicated for use as a conduit for retrieval devices.
The CEREGLIDE™ 71 Catheter System consists of the CEREGLIDE™ 71 Intermediate Catheter and associated accessories including the INNERGLIDE™ 7 Delivery Aid, Rotating Hemostasis Valve, and Slit Introducers.
The CEREGLIDE™ 71 Intermediate Catheter is a single lumen, variable stiffness catheter designed to be introduced over a steerable guidewire along with a microcatheter and/or compatible support device into the neuro vasculature. The catheter consists of a lubricious PTFE inner lumen liner to facilitate movement of the guidewires and other devices, variable pitch stainless steel and tungsten braid, and various durometer polymer jackets.
These jackets provide distal flexibility and gradually transition to a stiffer proximal shaft to facilitate the advancement of the catheter in the anatomy. The outer surface of the catheter is hydrophilic coated in order to reduce friction during manipulation in the vessel. A radiopaque marker at the distal end of the catheter provides fluoroscopic visualization of the catheter tip. The proximal end of the catheter incorporates a standard Luer adapter to facilitate the attachment of accessories, a hub, and an ID band.
The CEREGLIDE™ 71 Catheter System is packaged with an INNERGLIDE™ 7 Delivery Aid, a Rotating Hemostasis Valve (RHV) with a side port and two Slit Introducer accessories. The INNERGLIDE™ 7 Delivery Aid is a compatible support device comprising of a single lumen catheter with a tapered tip, hydrophilic coating for increased lubricity, radiopaque tip for fluoroscopic visualization, and a proximal luer hub that is designed to be used as part of the CEREGLIDE™ 71 Catheter System to facilitate delivery of the CEREGLIDE™ 71 Intermediate Catheter to select blood vessels in the neurovasculature. The RHV with side port is used for flushing and insertion of catheters. The Slit Introducers are designed to introduce the CEREGLIDE™ 71 Intermediate Catheter into the base catheter and protect the distal tip of the CEREGLIDE™ 71 Intermediate Catheter during insertion into the hemostasis valve of the base catheter.
Product code NRY: The CEREGLIDE™ 71 Intermediate Catheter can be connected to a compatible aspiration pump using the Cerenovus Aspiration Tubing Set.
This document is a 510(k) clearance letter for a medical device (CEREGLIDE 71 Catheter System), and does not contain the information requested about acceptance criteria and a study proving a device meets these criteria for an AI/software medical device.
The 510(k) summary explicitly states:
- "No animal studies were required as appropriate verification and validation of the subject device design were achieved based on the similarities of the proposed device and the predicate devices, and from results of bench testing."
- "Clinical studies were not required as appropriate verification and validation of the subject device design were achieved based on the similarities of the proposed device and the predicate devices, and from results of bench testing."
The document details the device's technical specifications, indications for use, and a comparison to predicate devices, along with non-clinical (bench) performance testing. These bench tests are primarily focused on the physical characteristics and performance of the catheter system, such as dimensions, material properties, durability, and a simple in vitro usability study.
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, ground truth, or MRMC studies, as these aspects are not present in the provided document. The device in question is a physical medical catheter system, not an AI/software medical device that would typically involve such studies for regulatory submission.
§ 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).