Search Results

The CEREGLIDE 42 Intermediate Catheter and the CEREGLIDE 57 Intermediate Catheter are 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 57 Intermediate Catheter is also indicated for use as a conduit for retrieval devices.

Both the CEREGLIDE™ 42 Intermediate Catheter and CEREGLIDE™ 57 Intermediate Catheter (hereafter referred to as the CEREGLIDE™ 42 and CEREGLIDE™ 57 Intermediate Catheters) are variable stiffness, single lumen catheters designed to be introduced over a steerable guide wire or microcatheter into the neuro vasculature. The catheter shaft is composed of a stainlesssteel variable pitch braid with a PTFE inner liner to facilitate movement of guide wires and other devices. The exterior of the catheter shaft is covered with polymer materials, which encapsulate the stainless-steel braid construction. The catheter has a stiff proximal shaft which transitions into the flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The distal end of the catheter has a radiopaque marker band to facilitate fluoroscopic visualization and has a hydrophilic coating to provide lubricity to reduce friction during navigation in the vasculature. The proximal end of the catheter has a luer fitting located on the catheter hub which can be used to attach accessories for flushing. An ID band is placed at the distal end of the hub over a strain relief. The catheter is packaged with a Tuohy Borst Rotating Hemostasis Valve (RHV) with a side port and two slit introducers as accessories. The RHV with side port is used for flushing and insertion of catheters. The slit introducers are designed to introduce the catheter into the base catheter and protect the distal tip of the catheter during insertion into the RHV of the base catheter.

This document describes the premarket notification (510(k)) for the CEREGLIDE™ 42 and CEREGLIDE™ 57 Intermediate Catheters, asserting their substantial equivalence to a predicate device based on non-clinical performance data.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document states: "All testing was conducted using sampling methods as required by internal procedure." However, specific sample sizes for each test are not provided. The data provenance is from bench testing and in-vitro usability studies conducted by the manufacturer, Cerenovus, Inc. The document does not specify a country of origin for the data beyond the manufacturer's location (Miami, FL, United States). These studies are considered prospective as they were conducted specifically for the purpose of this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not applicable as the document describes performance testing for medical devices based on engineering specifications and benchmark comparisons, not diagnostic or interpretive tasks requiring expert ground truth establishment in a clinical context.

4. Adjudication Method for the Test Set:

This information is not applicable for the type of device performance testing described. Adjudication methods are typically used in clinical studies where multiple human readers or systems interpret data, and discrepancies need to be resolved. The tests here involve objective measurements against predefined acceptance criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance:

This information is not applicable. The device is an intermediate catheter, not an AI-powered diagnostic tool. Therefore, no MRMC study involving human readers and AI assistance was conducted or mentioned.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:

This information is not applicable. The device is a physical medical instrument, not a software algorithm. Standalone performance refers to the assessment of AI algorithms without human intervention, which is not relevant here.

7. The Type of Ground Truth Used:

The "ground truth" for the performance tests outlined is based on pre-defined engineering specifications, industry standards (e.g., ISO 10555-1), and comparative performance against a legally marketed predicate device. For example, "Catheter ID" uses internal diameter requirements as its ground truth, and "Peak Tensile Strength" uses ISO 10555-1 Section 4.5.

8. The Sample Size for the Training Set:

This information is not applicable. There is no mention of a "training set" as this device is a physical product and not an AI/machine learning algorithm that requires training data.

9. How the Ground Truth for the Training Set was Established:
This information is not applicable for the same reasons as above.

Ask a specific question about this device