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The WavelinQ™ EndoAVF System is indicated for the creation of an arteriovenous fistula (AVF) using concomitant ulnar artery and ulnar vein or concomitant radial artery and radial vein in patients with minimum artery and vein diameters of 2.0 mm at the fistula creation site who have chronic kidney disease and need hemodialysis.

The WavelinQ™ EndoAVF System consists of two single-use disposable magnetic catheters: a venous catheter and an arterial catheter. The venous catheter contains an array of magnets positioned on either side of a radiofrequency (RF) cutting electrode contained within an isolative housing. The arterial catheter contains a matching array of magnets positioned on either side of an electrode "backstop". The backstop serves as a mechanical stop for the cutting electrode to contact following the creation of the AVF. The magnets in the two catheters serve to align and appose the arterial backstop of the arterial catheter with the RF electrode of the venous catheter when positioned in the target AVF location. Radiofrequency energy can then be delivered through the electrode for cutting tissue and AVF creation.

The arterial and venous catheters are both comprised of braid reinforced Pebax catheter shafts. These shafts provide flexibility for device delivery and torquability to aid in rotational alignment and positioning. Both catheters include a soft, radiopaque, rapid exchange style Pebax tip for atraumatic device navigation with radiographic visibility. These tips allow the catheters to track over a standard guide wire 0.014" or smaller. The catheters include a handle/hub to facilitate device delivery, positioning and alignment.

The provided text describes the WavelinQ EndoAVF System and its substantial equivalence to a predicate device (WavelinQ 4F EndoAVF System). However, it does not contain detailed information about specific acceptance criteria for a diagnostic performance study, nor does it describe a study that uses a test set, ground truth, or expert readers/adjudication in the way requested in the prompt.

The document refers to "acceptance criteria" in the context of device design verification and validation, but these appear to be related to engineering, safety, and functionality, rather than a diagnostic performance study comparing device outputs to a ground truth established by experts.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, or details about sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these elements are not present in the provided text.

The closest information related to testing is in the "Performance Data: Non Clinical Performance Data" section, which lists:

• Electrical Safety per IEC 60601
• Electromagnetic Compatibility (EMC) Testing
• Design Validation Cadaver Study
• Magnet Array Force Coaptation Testing
• S-Turn Tortuosity Coaptation and Alignment Comparison Testing

These tests are primarily focused on the physical and functional performance of the device's components and its ability to create the fistula, rather than assessing a diagnostic output against a clinical ground truth.

The document states: "The subject device, WavelinQ™ EndoAVF System, met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs." This is a general statement of compliance but does not provide the specifics requested for a diagnostic performance study.

In summary, the provided text does not contain the information necessary to fulfill the request for acceptance criteria and study details related to diagnostic performance.

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