(120 days)
The Cora Microcatheters are intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and peripheral vasculature. They may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for the delivery of saline solutions of diagnostic contrast.
The CoraFlex and CoraForce Microcatheters (Cora Microcatheters) are single lumen catheters designed to access the peripheral and coronary vasculature. Each configuration has a hydrophilic coated coiled catheter with a braided support matrix, radiopaque distal tip, proximal luer, and "spin-friendly" strain relief. The Cora Microcatheters will also allow for the exchange of guidewires and provide a conduit for delivery diagnostic or therapeutic agents.
This document is a 510(k) clearance letter for medical microcatheters, not an AI/ML device. Therefore, the requested information about acceptance criteria, study data, ground truth, and expert involvement for AI device performance is not applicable to this submission.
The FDA clearance is based on non-clinical (bench) testing demonstrating substantial equivalence to a predicate device, as indicated by the following sections:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in a table format. The document states:
"The Cora Microcatheters met all specified criteria and did not raise new questions regarding safety and effectiveness compared to the predicate."
And
"Based on the performance testing, the Cora Microcatheters were found to be substantially equivalent to the predicate."
The specific criteria and direct performance metrics are not detailed in this summary, but the types of tests performed indicate the areas of performance evaluated:
- Simulated Use
- Dimensional Verification
- Radiopacity
- Leak Testing
- Kink Resistance
- Corrosion Resistance
- Component Integrity
- Bond Integrity
- Particulate Testing
- Torque Testing
- Burst Testing
- Lubricity and Coating Integrity Testing
- Design Validation/Usability
- Sterility Testing
- Biocompatibility Assessment
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not explicitly stated in the provided document. The study was non-clinical (bench testing).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as this is a non-clinical device clearance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable, as this is a non-clinical device clearance.
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, as this is a non-clinical device clearance and does not involve AI or human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is a non-clinical device clearance and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. The "ground truth" for this device would be established by engineering specifications and industry standards for medical device performance, as evaluated through bench testing.
8. The sample size for the training set:
Not applicable, as this is a non-clinical device and does not involve a training set as in AI/ML.
9. How the ground truth for the training set was established:
Not applicable, as this is a non-clinical device and does not involve a training set as in AI/ML.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).