Search Results

The CEREGLIDE™ 71 Intermediate Catheter 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 Intermediate Catheter is also indicated for use as a conduit for retrieval devices.

The CEREGLIDE™ 71 Intermediate Catheter is a variable stiffness, single lumen catheter designed to be introduced over a steerable guide wire or microcatheter into the neuro vasculature. The catheter shaft is composed of a stainless steel 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 end of the catheter hub. 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.

The CEREGLIDE™ 71 Intermediate Catheter is a medical device for facilitating neurovascular interventions. The document provided outlines the non-clinical performance data to demonstrate its substantial equivalence to a legally marketed predicate device, the CERENOVUS Large Bore Catheter (K191237).

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the CEREGLIDE™ 71 Intermediate Catheter are implicitly defined by a series of bench tests and biocompatibility tests, with the reported performance consistently being "PASS" or "Samples met the established acceptance criteria," sometimes exceeding comparator devices.

2. Sample Sizes Used for the Test Set and Data Provenance

The document states: "All testing was conducted using sampling methods as required by internal procedure." Specific sample sizes for each test are not explicitly provided.

The data provenance is non-clinical bench testing and in-vitro testing. There is no mention of human clinical data or patient data. Therefore, there is no country of origin or retrospective/prospective distinction for patient data.

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

Not applicable. This device's evaluation relies on objective engineering and material science tests (bench and in-vitro, and biocompatibility tests), not expert interpretation of diagnostic images or clinical outcomes. Therefore, there is no "ground truth" established by experts in this context.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in clinical or image-based studies where expert consensus is required for ambiguous cases. As the studies described are bench and biocompatibility tests, human adjudication is not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted as this is a device clearance based on substantial equivalence using non-clinical performance data, not an AI or diagnostic imaging device requiring human reader interaction.

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

Not applicable. This pertains to an intermediate catheter, which is a physical medical device, not a software algorithm or AI.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for the non-clinical tests is established by pre-defined engineering specifications, material properties, and regulatory standards (e.g., ISO standards, ASTM methods, USP guidance). The device's performance is compared against these objective criteria. For the biocompatibility tests, the "ground truth" is typically the absence of adverse biological reactions as defined by the specific test (e.g., no cytotoxicity, no sensitization, no irritation).

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not a machine learning or AI-based device.

9. How the Ground Truth for the Training Set Was Established**

Not applicable. As there is no training set, there is no ground truth establishment for it.

Ask a specific question about this device

The CEREGLIDE™ 71 Intermediate Catheter, 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 intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

The Cerenovus Aspiration Tubing Set is intended to connect the Cerenovus Large Bore Catheter of the Nouvag Vacuson 60 Aspiration Pump (or equivalent vacuum pump) and to allow the user to control the fluid flow. The Cerenovus Aspiration Tubing Set is also intended to connect the CEREGLIDE™ 71 Intermediate Catheter to the canister of a compatible aspiration pump and to allow the user to control the fluid flow.

The CEREGLIDE™ 71 Intermediate Catheter is a variable stiffness, single lumen catheter designed to be introduced over a steerable guide wire or microcatheter into the euro vasculature. The catheter shaft is composed of a stainless steel 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 end of the catheter hub which can be used to attach accessories for flushing and aspiration. 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, insertion of catheters, and connection to an external aspiration system. 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. The CEREGLIDE™ 71 Intermediate Catheter can be connected to a compatible aspiration pump using the Cerenovus Aspiration Tubing Set.

The provided text describes the regulatory clearance of a medical device (CEREGLIDE™ 71 Intermediate Catheter and Cerenovus Aspiration Tubing Set) and outlines the non-clinical performance data used to demonstrate its substantial equivalence to a predicate device. It does not contain information about an AI/ML-driven device or study parameters related to AI/ML performance evaluation. Therefore, I cannot extract the requested information based on the input.

However, I can provide a summary of the non-clinical performance data presented in the document, which are described as meeting acceptance criteria, albeit not for an AI/ML device.

Table of Acceptance Criteria and Reported Device Performance (Non-AI/ML)

Since the provided document is a 510(k) clearance letter for a physical medical device (catheter and aspiration tubing set) and does not describe any AI/ML components or studies, I cannot answer the questions related to AI/ML specific evaluations:

2. Sample size used for the test set and the data provenance: Not applicable, as there's no machine learning test set described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the non-clinical tests would be the established engineering and biocompatibility standards and specific design requirements.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device