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510(k) Data Aggregation
(51 days)
MICROSHEATH XL CATHETERS
The MicroSheath XL is a single lumen catheter intended to create a pathway for other devices in the peripheral vasculature.
The FlowCardia MicroSheath™ XL is a single lumen catheter that is available in four lengths: 53cm, 73cm, 93cm or 123cm, and three different tip configurations: vertebral, internal mammary artery, and multipurpose. All MicroSheath XL catheters have a standard lucr fitting at the proximal end. A radiopaque distal tip aids in fluoroscopic visualization. The distal tip is atraumatic to help facilitate vessel navigation. The MicroSheath XL is also 7F Sheath compatible.
The provided text is a 510(k) summary for the FlowCardia MicroSheath XL Catheters. It details the device's design, intended use, and its substantial equivalence to predicate devices, rather than a study with acceptance criteria and device performance in the context of an AI/algorithm or similar medical device.
Therefore, the requested information elements related to AI/algorithm performance, ground truth establishment, expert adjudication, MRMC studies, standalone performance, and sample sizes for test/training sets are not applicable to this document.
However, I can extract the information that is relevant to the "acceptance criteria" and "study" as presented in this 510(k) summary for a traditional medical device.
Acceptance Criteria and Study for FlowCardia MicroSheath XL Catheters
The FlowCardia MicroSheath XL Catheters demonstrate substantial equivalence to predicate devices through various physical and bench test data, rather than clinical study data with statistical acceptance criteria as would be found for an AI model.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Study Type) | Reported Device Performance |
|---|---|
| Physical Test Data: | |
| Dimensional Verification | Met acceptance criteria |
| Tensile Strength | Met acceptance criteria and performed similarly to predicate devices |
| Tip Flexibility | Met acceptance criteria and performed similarly to predicate devices |
| Access and Navigation Bench Modeling | Met acceptance criteria and performed similarly to predicate devices |
| Critical Bend Testing | Met acceptance criteria and performed similarly to predicate devices |
| Leak and Pressure Testing | Met acceptance criteria and performed similarly to predicate devices |
| Torque Strength | Met acceptance criteria and performed similarly to predicate devices |
| Material Equivalence: | |
| Materials | Equivalent to VP Sheath (predicate) |
| Manufacturing Methods | Equivalent to VP Sheath (predicate) |
| Sterilization | Equivalent to VP Sheath (predicate) |
| Biocompatibility Testing: | Met relevant guidance document requirements |
| Intended Use Comparison: | Substantially equivalent to all three predicate devices |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable for this type of device and submission. The "test set" here refers to physical devices undergoing bench testing. The data provenance is from internal FlowCardia, Inc. testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth for physical tests is established by engineering specifications and direct measurement, not expert review.
4. Adjudication Method for the Test Set
Not applicable. Physical tests follow defined protocols; there is no expert adjudication process.
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. This is not an AI/algorithm-based device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an AI/algorithm-based device.
7. The Type of Ground Truth Used
For physical tests, the "ground truth" is based on:
- Engineering specifications and design requirements.
- Measurements and observations against established standards and predicate device performance.
8. The Sample Size for the Training Set
Not applicable. This device does not use a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device does not use a "training set."
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