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The ClosureFast catheter is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.

The ClosureFast™ Radio Frequency Ablation catheter is a sterile, single use, disposable device with an integrated connection cable. The catheter has a 6F profile with a heating element (coil) 8 cm in length and 2.00 mm in diameter. It is available in two working lengths, 60 cm and 100 cm. A single-use limiter feature is added in the Printed Circuit Board Assembly (PCBA) housed inside the handle of the device. It establishes an effective treatment window of 2 hours after the first energy cycle. The catheter's function is to provide thermal energy to the desired treatment site via radiofrequency heating of the catheter heating element. The ClosureFast catheter is designed to be used with the ClosureRFG™ Radiofrequency Generator.

The ClosureFast™ Endovenous Radiofrequency Ablation (RFA) Catheter is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.

Acceptance Criteria and Device Performance:

The provided text details the performance data through design verification and validation testing, and generally states that the device "meets acceptance criteria and performance requirements." However, it does not explicitly list specific numerical acceptance criteria or the reported performance data in a table format for each test. The document provides a list of tests performed, which include:

• Mechanical
• Dimensional
• Mechanical / Tensile Strength
• Electrical
• Environmental
• Simulated Use
• Packaging Verification
• Software Verification and Validation
• Usability
• Benchtop Validation
• Sterilization Validation
• Biocompatibility

The study concluded that: "Test results demonstrate that the proposed ClosureFast catheter meets acceptance criteria and performance requirements and is acceptable for its intended use."

Additional Information (Based on the Provided Text):

1. Sample size used for the test set and the data provenance: Not specified in the provided text.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified in the provided text. The submission focuses on device performance testing rather than clinical study data involving human experts for ground truth establishment.
3. Adjudication method for the test set: Not applicable, as no clinical study or ground truth establishment by experts is described for this device's performance testing.
4. 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. The device is an electro-surgical catheter, not an AI-powered diagnostic or assistive tool for human readers.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The "Software Verification and Validation" was performed, which would be a standalone evaluation of the software components within the device. However, this is not an 'algorithm only' study in the context of diagnostic AI.
6. The type of ground truth used: For the design verification and validation tests, the "ground truth" would be established by engineering specifications, regulatory standards, and established scientific principles for each test (e.g., tensile strength measurement against a specified minimum, electrical resistance within a defined range). This is not a clinical ground truth like pathology or expert consensus.
7. The sample size for the training set: Not applicable, as this is not an AI/ML device that requires a training set in the typical sense.
8. How the ground truth for the training set was established: Not applicable.

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