(79 days)
Micrus Courier Microcatheters are intended to aid in the delivery of diagnostic agents, such as contrast media, as well as therapeutic agents, such as occlusion coils, into the peripheral, coronary and neurovasculature.
Micrus Courier Microcatheters are variable stiffness, single lumen catheters designed to aid the physician in accessing small, tortuous vasculature when used with a guiding catheter and steerable guide wire. Multiple levels of stiffness ranging from a highly flexible tip to a semi-rigid proximal section along the length of the catheter are designed to aid the physician in tracking over guide wires without displacement of the wire. The microcatheters have an outer hydrophilic coating that reduces friction during manipulation in the vessel. The lubricious PTFE-coated inner lumen is designed to facilitate movement of guide wires and other devices. A shaft marker, located 90 cm from the distal tip, is provided to expedite microcatheter insertion to the depth of standard guide catheters (90 cm long). Two marker bands, one at the catheter tip and another 3 cm proximal to the tip, are radiopaque to facilitate fluoroscopic visualization. A luer fitting located on the end of the catheter hub can be used to attach accessories. All microcatheters are packaged with a steam shaping mandrel accessory.
The provided text is a 510(k) Summary for the Micrus Courier 270 Microcatheter. This document primarily focuses on demonstrating substantial equivalence to a predicate device for regulatory approval. It does not contain information about specific "acceptance criteria" based on device performance metrics (e.g., sensitivity, specificity, accuracy) or a study proving that the device meets such criteria in terms of clinical or diagnostic effectiveness.
Medical devices like microcatheters are typically evaluated for performance in terms of mechanical properties, biocompatibility, and functional aspects (e.g.,
delivery of agents, trackability). The document states that the "Micrus Courier 270 Microcatheter is substantially equivalent to other Micrus Courier Microcatheters in terms of intended use, design, specifications, and materials," and that "The Micrus Courier 270 Microcatheter uses the same methods and materials in construction, packaging, and sterilization as its predicate." This implies that the 'acceptance criteria' for this 510(k) submission are met by demonstrating equivalence to a legally marketed predicate device, rather than through a de novo clinical trial demonstrating specific performance metrics against a predefined threshold.
Therefore, most of the requested information cannot be extracted from the provided text, as it pertains to clinical performance study details (e.g., sample size, ground truth, expert adjudication, MRMC studies, standalone performance) typically found in documents for AI/ML-driven devices or devices requiring clinical performance data beyond substantial equivalence.
Information that can be inferred or is directly stated:
- Intended Use/Indications for Use: Micrus Courier Microcatheters are intended to aid in the delivery of diagnostic agents, such as contrast media, as well as therapeutic agents, such as occlusion coils, into the peripheral, coronary and neurovasculature.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied by 510(k) process) | Reported Device Performance (Summary of Equivalence) |
|---|---|
| Substantial Equivalence to Predicate Device | The device is substantially equivalent to predicate devices in terms of intended use, design, specifications, and materials. |
| Uses the same methods and materials in construction, packaging, and sterilization as its predicate. | |
| Modification to the device has not altered the fundamental technology of the predicate devices. |
Note: The document does not provide specific quantitative performance metrics (e.g., in a clinical setting) against which acceptance criteria would typically be set for AI/ML or novel diagnostic devices. The acceptance criteria here are implicitly met by demonstrating substantial equivalence to a predicate device, as required for 510(k) clearance.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
No information available. This type of study data is not typically part of a 510(k) summary for a substantial equivalence claim for a microcatheter.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
No information available. Ground truth establishment with experts is not detailed as there isn't a performance study described in this document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
No information available. Adjudication methods are not applicable to the type of information presented in this 510(k) summary.
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
No information available. This is not an AI/ML device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No information available. This is not an AI/ML device, and no standalone algorithm performance study is mentioned.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
No information available. Ground truth for performance metrics is not discussed, as the document focuses on substantial equivalence of design and function. The 'ground truth' for the regulatory submission is essentially the predicate device's established safety and effectiveness.
8. The sample size for the training set
No information available. This is not an AI/ML device, and no training set is relevant.
9. How the ground truth for the training set was established
No information available. Not applicable.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).