(277 days)
The Cleveland Multiport Ventricular Catheter Set is indicated for gaining access to the ventricles of the brain for the removal of cerebrospinal fluid (CSF) or for injecting Cytarabine.
The Cleveland Multiport Ventricular Catheter contains a main or central lumen for the insertion stylet which is surrounded by four minor lumens (equally spaced) that contain the microcatheters. The catheter includes a ribbed distal tip, a housing for locking the insertion stylet, and proximal male Luer fittings at the end of each micro-catheter. The ribbed distal tip of the main catheter allows the micro-catheters to retract into the main catheter, by stretching the catheter when the insertion stylet is fully inserted and locked. This stretched state allows the catheter tip outside diameter to reduce slightly for atraumatic insertion into the ventricles of the brain. Once the insertion stylet is removed the catheter tip returns to its relaxed state (larger outside diameter) and the micro-catheters deploy. The enlarged tip aids in backflow prevention during injection of fluids. The distal Luer fittings allow for connectivity to a standard syringe or infusion pumps for removal of CSF and/or infusion. The biocompatible metal insertion stylet provides temporary rigidity to the distal portion of the device during catheter insertion and is removed after placement. The Cleveland Multiport Ventricular Catheter has no software, power sources, or radiation emitting components.
The provided text describes a 510(k) premarket notification for a medical device called the "Cleveland Multiport Ventricular Catheter Set." This submission is to demonstrate that the new device is substantially equivalent to legally marketed predicate devices. The document refers to various tests performed to support this claim, but it does not describe an AI/ML powered device, an acceptance criteria table with reported device performance in the context of AI/ML, nor does it include information about sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for AI/ML models.
The information provided relates to the physical and functional aspects of a traditional medical device (a catheter) and its comparison to existing catheters. Therefore, most of the requested fields are not applicable to the given text.
Here's an attempt to answer the applicable parts of your request based on the provided text, while explicitly stating when information is not available or not applicable:
1. A table of acceptance criteria and the reported device performance
The document lists various performance tests and their results, indicating that the device "passed" and "results demonstrate the Cleveland Multiport Ventricular Catheter is substantially equivalent to the predicate devices." The specific quantitative acceptance criteria are generally implied rather than explicitly stated as numerical thresholds in this summary, but the results confirm compliance.
| Test | Acceptance Criteria (Implied from "passed") | Reported Device Performance |
|---|---|---|
| Joint and Bond Strength Tests | Withstand minimum pull-off forces; exceed minimum tip loading requirements. | All joints bonds were above the minimum pull-off force requirement. Tip loading exceeded the minimum load requirements. Withstood pull forces based on clinically relevant forces with a safety factor. |
| Viscosity Test | Kinematic viscosity of Cytarabine and saline are comparable (within 2%). | Kinematic viscosity of Cytarabine and saline are similar (within 2%). Bench testing using saline is acceptable. |
| Depth Marking | Depth marks remain legible after swabbing. | Depth gauge marks were not altered. |
| Pressure Testing (Flow Burst, Infusate Pressure, Aspiration Flow Rate) | Withstand pressure spikes; reach specified flow rate within specified time; inject fluid at maximum flow rate; linear pressure profile across all flow rates without leakage or kinking; withstand maximum pressure/spikes; capable of aspirating at clinically acceptable rate. | Reached specified flow rate within specified time; capable of injecting fluid at its maximum flow rate. Reached a linear pressure profile across all flow rates without leakage and no kinking; withstood maximum pressure/spikes. Passed pressure-flow with suture tab attached. Capable of aspirating at its clinically acceptable aspiration rate. |
| Reflux Test | Resists flow in the reverse direction. | Resists flow in the reverse direction. |
| Deployment and Retraction Test | Minimal dimensional changes from deployment/retraction; meet maximum loads for insertion/removal of stylet. | Met specified dimensional and maximum distance insertion and removal forces. |
| Tissue Insertion Test | Withstand insertion and removal from bovine brain tissue. | Passed insertion and removal for bovine tissue. |
| Bend Radius Test | Withstand minimum bend radius without kinking. | Withstands a minimum bend radius without kinking. |
| Dimensional Verification | Manufactured and reproduced to predetermined specifications. | Manufactured and reproduced to predetermined specifications. |
| Micro-Catheter Strength Test | Minimum strength of micro-catheters PTFE material exceeds minimum force requirements. | Micro-catheter material exceeds the minimum force requirements. |
| Syringe Drop Test | Withstand drop without damage to device or operation. | Withstood drop without damage and operation verified. |
| Surface Inspection | Free from voids, cracks, or extraneous matter. | Free from voids, cracks or extraneous matter along the effective length. |
| Particulate Testing | Shedding of particulates below specified limit. | Shedding of particulates are below a specified limit. |
| Leakage under pressure | Free of leaks during infusion and aspiration. | Free of leaks during infusion and aspiration. |
| Cadaver Assessment | Can be placed using conventional techniques and visualized using CT. | Placed using conventional techniques and visualized on axial CT scan with successful infusion of CT dye. |
| Stylet Strength | Withstand excessive loading on stylet handle without fracturing. | Withstood pull forces based on clinically relevant forces with a safety factor. |
| Stylet Corrosion Resistance | Withstand corrosion with extended exposure to sodium chloride. | Withstood corrosion with extended exposure to sodium chloride. |
| Biocompatibility | Compliance with ISO 10993 requirements for tissue contact, limited exposure ( |
§ 882.4100 Ventricular catheter.
(a)
Identification. A ventricular catheter is a device used to gain access to the cavities of the brain for injection of material into, or removal of material from, the brain.(b)
Classification. Class II (performance standards).