(28 days)
The DIVER C.E. Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.
The DIVER C.E. Catheters are aspiration catheters indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system. The catheters fresh, son emoved an lumen running through the full length of the catheter. A luer lock type hub in the proximal end allows the connection of a stopcock and a syringe for blood aspiration and clot removal (not provided). The DIVER C.E. Syringe for blood aspiration lumen and a soft, atraumatic tip. The smooth, soft, atraumatic tip has a radiopaque marker band located at 1mm from its distal end. The DIVER C.E. Catheters are available in two configurations, with and with ut sideholes. The catheters are a rapid exchange design, with the guide wire lumen running from the distal tip to 22.7 cm proximally in the catheter body, where the exit port is located. The catheters are compatible with guide wires with a maximum diameter of 0.014".
This document is a 510(k) summary for the DIVER™ C.E. Catheter, a medical device. It does not contain the detailed information typically found in a clinical study report or a validation study. As such, I cannot extract specific quantitative acceptance criteria or detailed study results that would allow me to fill in all the requested sections of your query.
However, I can extract the information provided regarding the testing and equivalence.
Here's what I can provide based on the given document:
1. Table of acceptance criteria and the reported device performance:
The document mentions "Comparison bench tests regarding performance characteristics were performed on the DIVER C.E. Catheter (with sideholes), DIVER C.E. Catheter (without sideholes), and the predicate devices to demonstrate equivalency."
However, it does not explicitly state the acceptance criteria (e.g., specific thresholds for performance metrics) nor does it provide quantitative reported device performance values from these bench tests. It only states that the tests demonstrated equivalency.
| Acceptance Criteria (e.g., Specific thresholds for performance metrics) | Reported Device Performance (e.g., Achieved values) |
|---|---|
| Not specified in the document. | Not specified in the document. |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified. The document only mentions "Comparison bench tests" without detailing the number of catheters or test scenarios used.
- Data provenance: Not specified. It's bench test data, so it's not patient-derived from a specific country, and it's not explicitly stated as retrospective or prospective in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The document describes bench testing for "performance characteristics" and "biocompatibility," not a clinical study involving human expert assessment of a test set to establish ground truth.
4. Adjudication method for the test set:
- Not applicable. (See #3)
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, an MRMC comparative effectiveness study was not done. The document describes bench testing for device performance and biocompatibility for a catheter, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device (catheter), not an algorithm.
7. The type of ground truth used:
- For Biocompatibility: In vitro and/or in vivo tests were likely conducted according to ISO 10993 and FDA Memorandum #G95-1. The "ground truth" here would be established by the biological responses observed in these standardized tests (e.g., no cytotoxicity, no irritation).
- For Performance Data: The "ground truth" would be the measured physical and mechanical properties of the catheters and their ability to perform their intended function (e.g., aspiration efficacy, catheter navigability, flow rates) in a controlled bench test environment. These would be compared against the predicate devices.
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. (See #8)
Summary of available information:
The document concerns the regulatory submission for a physical medical device (catheter). The "study" referenced is a summary of bench testing to demonstrate performance characteristics and biocompatibility testing to show material safety. The purpose of these tests was to demonstrate substantial equivalence to predicate devices, not to establish specific performance against a defined numerical acceptance criterion in a clinical setting or to evaluate an AI algorithm. Therefore, many of the requested fields are not applicable or the information is simply not present in this regulatory summary.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).