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The SeQure® NF and SeQure® microcatheters are intended for the infusion of contrast media into all peripheral vessels.

The SeQure® NF and SeQure® microcatheters are also intended for drug infusion in intra-arterial therapy and infusion of embolic materials.

The SeQure® NF and the SeQure® microcatheters should not be used in cerebral vessels.

The SeQure® NF and SeQure® microcatheters are single use microcatheters primarily comprised of a luer lock hub, a strain relief cover and tube, central shaft, and a distal tip with radiopaque markers for visualization. The two models differ only in the design of the distal tip. The SeQure®'s distal end has side holes and two radiopaque markers while the SeQure® NF's distal end has no side holes and one radiopaque marker. These markers allow for the fluoroscopic visualization of the distal tip of the microcatheters.

The inner lumen is made of PTFE (polytetrafluoroethylene), which allows for the smooth passage of fluids, embolic agents and devices such as guide wires. The distal section of the shaft in both models is coated in a hydrophilic polymer layer, which ensures high lubricity when wet with saline or blood.

The SeQure® NF and the SeQure® microcatheters are sterile single lumen devices and are available in several different diameters and lengths.

This document describes the regulatory submission for the SeQure® NF and SeQure® microcatheters, demonstrating their substantial equivalence to a predicate device. As such, the "acceptance criteria" discussed here refer to the performance standards and testing outcomes that were required for FDA clearance, rather than acceptance criteria for a diagnostic AI algorithm. Similarly, the "study that proves the device meets the acceptance criteria" refers to the engineering bench tests, biocompatibility tests, and animal studies conducted to demonstrate the safety and performance of the catheters according to established medical device standards.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this medical device (catheters) are implicitly defined by the successful completion of various performance tests, demonstrating that the device is safe and performs as intended, comparable to the predicate device. The document states that "All tests met the predefined acceptance criteria."

2. Sample size used for the test set and the data provenance

• Test Set (Applicable to Animal Study): The document does not explicitly state the number of animals used in the GLP Animal Study. It refers to the study as "GLP Animal Study" implying a sufficient sample size for regulatory purposes, but the specific number is not provided.
• Data Provenance: The GLP Animal Study was performed at the Asaf Harophe GLP facility in Israel. The document does not specify if it was retrospective or prospective, but GLP (Good Laboratory Practice) studies are typically prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable in the context of this device submission. The device is a physical catheter, not an AI diagnostic algorithm requiring expert annotation for ground truth. The "ground truth" for proving safety and performance comes from objective physical and chemical tests, and pre-clinical animal studies, not human expert consensus on interpreted data.

4. Adjudication method for the test set

Not applicable as this is not an AI diagnostic algorithm study. The animal study involved "different users" for comparison to the predicate device, and the evaluation included gross pathology and histopathology which would be interpreted by qualified personnel, but a specific adjudication method isn't detailed as it would be for reader-based image interpretation.

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 a submission for a physical medical device (catheter), not an AI algorithm, so no MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

The "ground truth" for the device's performance and safety was established through:

• Objective Test Results: Passing results from various bench tests (e.g., burst pressure, trackability, tensile strength) and biocompatibility tests (e.g., cytotoxicity, hemolysis) against predefined, quantitative acceptance criteria.
• Animal Study Observations and Pathology: Direct observation of device performance, absence of adverse events, and histology/pathology findings from the animal study.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. No training set was used for this type of device submission.

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