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510(k) Data Aggregation
(97 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 0.0170" in a diagnostic intravascular catheter with an in-vivo shapeable tip which deflects under operator control at an angle of ±45° to ±90° from the neutral position. The Micrus® Courier Enzo™ Microcatheter 0.0170"is designed with a feature which allows the clinician to adjust the catheter tip shape in-vivo by turning a knob. No shaping tool is required. This design feature allows the clinician to adjust the catheter tip shape to accommodate variations in patient anatomy without having to remove the catheter from the patient's body in order to re-shape it.
Acceptance Criteria and Device Performance for Micrus® Courier Enzo™ Microcatheter 0.0170"
The provided 510(k) summary for the Micrus® Courier Enzo™ Microcatheter 0.0170" states that the device is substantially equivalent to its predicate device, the Micrus® Courier™ Pre-Shaped Microcatheter (K061963), with regard to intended use, shape of distal tip angle, and function. The acceptance criteria for this device are implicitly tied to demonstrating this substantial equivalence through verification testing.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list specific numerical acceptance criteria (e.g., in terms of tensile strength, torqueability, or flow rates) for the Micrus® Courier Enzo™ Microcatheter 0.0170". Instead, the performance is evaluated against the predicate device to demonstrate "substantial equivalence."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Intended Use | Substantially equivalent to predicate: assist in delivery of diagnostic and therapeutic agents into peripheral, coronary, and neuro vasculature. |
| Shape of Distal Tip Angle | Deflects under operator control at an angle of ±45° to ±90° from neutral. Substantially equivalent to predicate in this aspect. |
| Function | Allows in-vivo adjustment of catheter tip shape without removal, substantially equivalent to predicate. |
| Safety and Effectiveness | Verification testing demonstrates that the device does not raise new questions regarding safety and effectiveness compared to the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
The document states "Verification testing conducted on the Micrus® Courier Enzo™ Microcatheter 0.0170" demonstrates the device is substantially equivalent to the predicate device..." However, it does not specify the sample size used for these tests.
The data provenance is not explicitly mentioned (e.g., country of origin). The testing is described as "in-vitro tests," indicating it was conducted in a laboratory setting, not on human subjects (retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish the ground truth for the test set. The evaluation is based on "verification testing" (in-vitro tests) comparing the device's physical and functional characteristics to a predicate device.
4. Adjudication Method for the Test Set
Since human expert review for ground truth establishment is not mentioned, an adjudication method is not applicable or described in this 510(k) summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document presents a 510(k) submission for a medical device (microcatheter), not an AI/software as a medical device (SaMD). Therefore, an MRMC comparative effectiveness study, which typically evaluates the impact of AI on human reader performance, was not performed or described.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
No. As this is not an AI/SaMD product, a standalone algorithm performance study was not applicable and not performed.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation of this device is established by comparison to a legally marketed predicate device (Micrus® Courier™ Pre-Shaped Microcatheter) and through in-vitro verification testing. The performance of the new device is considered acceptable if it demonstrates "substantial equivalence" to the predicate without raising new questions of safety and effectiveness.
8. The Sample Size for the Training Set
As this is not an AI/SaMD product, there is no concept of a "training set" in the context of this device's regulatory submission.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of medical device.
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