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510(k) Data Aggregation
(28 days)
The Micrus Courier microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into peripheral, coronary, and neuro vasculature.
The Micrus® Courier Enzo™ Microcatheter 0.0190" in a diagnostic intravascular catheter with an in-vivo shapeable tip which deflects under operator control at an angle of ±90° from the an m-110 shapedere up was @ Courier Enzo™ Microcatheter 0.0190"is designed with a feature which allows the clinician to adjust the catheter tip shape in-vivo by turning a knob. No shaping while anovired. This design feature allows the clinician to adjust the catheter tip shape to toor to require variations in patient anatomy without having to remove the catheter from the patient's body in order to re-shape it.
The provided text describes a 510(k) submission for the Micrus® Courier Enzo™ Microcatheter 0.0190". This submission aims to demonstrate substantial equivalence to a predicate device, the Micrus® Courier Enzo™ Microcatheter 0.0170".
Here's an analysis of the acceptance criteria and the study as described in the document, based on the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state specific quantifiable acceptance criteria (e.g., tensile strength greater than X, or burst pressure greater than Y). Instead, it relies on demonstrating substantial equivalence to a predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence in intended use, shape, materials, design, and function compared to predicate device (Micrus® Courier Enzo™ Microcatheter 0.0170"). | The Micrus® Courier Enzo™ Microcatheter 0.0190" is stated to be "substantially equivalent to the predicate device with regard to intended use, shape of distal tip angle, materials, design, and function." The intended use is clearly defined as assisting in the delivery of diagnostic and therapeutic agents into peripheral, coronary, and neuro vasculature. The device description highlights its in-vivo shapeable tip, a feature also present in the predicate, allowing adjustment of the catheter tip shape under operator control. The accessories listed are also consistent with those for the predicate device. |
| Verification that the device does not raise new questions regarding safety and effectiveness. | "Verification testing conducted on the Micrus® Courier Enzo™ Microcatheter 0.0190" demonstrates the device is substantially equivalent to the predicate device and does not raise new questions regarding safety and effectiveness with respect to diagnostic intravascular catheters when used in accordance with its Instructions for Use." While specific test results are not detailed, the statement implies that the testing confirmed safety and effectiveness within the defined parameters. |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "in-vitro tests" were conducted.
- Sample Size for Test Set: Not explicitly stated.
- Data Provenance: The document implies the data is from in-vitro testing performed by the manufacturer, Micrus Endovascular Corporation, based in San Jose, California, USA. It is therefore prospective as it was conducted for the purpose of this submission. No human or patient data is mentioned, only laboratory testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a microcatheter, and the evaluation is based on engineering and performance criteria through in-vitro testing, not on interpretation of complex medical images or diagnoses requiring expert consensus for ground truth.
4. Adjudication Method for the Test Set
Not applicable. As described above, the evaluation relies on in-vitro testing against pre-defined performance characteristics, not on subjective interpretations requiring adjudication.
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 done or mentioned. This type of study is relevant for diagnostic imaging AI systems where human reader performance is being evaluated with and without AI assistance. This document describes a medical device (microcatheter), not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a medical device, not an algorithm or AI system. Its performance inherently involves human handling and operation. The "in-vivo shapeable tip which deflects under operator control" explicitly indicates human-in-the-loop operation.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation is based on engineering specifications and functional performance criteria established for medical catheters, primarily against the predicate device. It's not derived from expert consensus, pathology, or outcomes data in the traditional sense for diagnostic or prognostic devices. The substantial equivalence argument relies on demonstrating that its physical and functional characteristics meet or are comparable to those of the predicate device, which is already legally marketed.
8. The Sample Size for the Training Set
Not applicable. This is a medical device (microcatheter), not a machine learning model. Therefore, there is no "training set" in the context of AI or algorithm development.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As mentioned, there is no training set for this type of medical device.
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