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The Heli-FX EndoAnchor System is intended to provide fixation and sealing between endovascular aortic grafts and the native artery. The Heli-FX System is indicated for use in patients whose endovascular grafts have exhibited migration or endoleak, or are at risk of such complications, in whom augmented radial fixation and/or sealing is required to regain or maintain adequate aneurysm exclusion. The EndoAnchor may be implanted at the time of the initial endograft placement, or during a secondary (i.e., repair) procedure.

The Aptus® Heli-FX™ and Heli-FX Thoracic EndoAnchor Systems are each comprised of the respective Heli-FX™ Applier with EndoAnchor Cassette (containing ten EndoAnchors™), the respective Heli-FX™ Guides, and the Ancillary EndoAnchor Cassette (containing five EndoAnchors).

The Heli-FX EndoAnchor System comprises the EndoAnchor implant (an intravascularly-applied suture, supplied with the Heli-FX Applier in a Cassette containing 10 EndoAnchors or separately in an Ancillary Cassette containing 5 EndoAnchors), the Heli-FX Applier (a catheter-based device for placement of the EndoAnchor), and the Heli-FX Guide (a deflectable sheath to position the Applier).

The Aptus EndoAnchor is an endovascularly-placed suture designed to attach aortic endografts to the native vessel wall. The EndoAnchor is manufactured from medical-grade nickel-cobalt wire and is wound in a helical shape. The leading end is sharpened to a conical point to act as an integral needle facilitating atraumatic deployment through the graft material and vessel wall. The proximal end of the EndoAnchor includes a diagonal crossbar, which functions as a suture anchor designed to prevent over penetration of the EndoAnchor. Ten (10) EndoAnchors are pre-packaged into a cassette, which is supplied with the Heli-FX Applier. The cassette is designed to facilitate easy and accurate loading of the EndoAnchor into the Applier catheter. An EndoAnchors are also supplied separately in an Ancillary Cassette containing five (5) additional EndoAnchors.

The Heli-FX Applier is designed to implant the Aptus EndoAnchor. The Applier implants one EndoAnchor at a time, and can be used to implant multiple EndoAnchors in a single patient. The Applier is designed for use with the Heli-FX Guide. The Applier is a 12Fr (OD) catheter with an integrated control handle. Two Applier lengths are available for anchoring in different regions of the aorta.

The Heli-FX Guide is a sterile, single use, disposable device designed to direct the Heli-FX Applier to the desired location for EndoAnchor implantation. The device is compatible with a 0.035" guide wire. The Heli-FX Guide consists of a 12 Fr-compatible (inner diameter) guide sheath with integrated control handle, and a matching 12 Fr OD obturator. Deflection of the distal tip of the catheter is accomplished by rotating the Control Knob located on the control handle. The Guide is available in both 62cm (16Fr OD) and 90cm (18Fr OD) working lengths. Multiple deflectable tip lengths are available to accommodate a range of aortic diameters. The Obturator is used during vessel access and is designed to follow the guide wire and provide access through tortuous vasculature.

Here's a summary of the acceptance criteria and study information for the Aptus Heli-FX Ancillary EndoAnchor Cassette based on the provided text:

This submission is for an Ancillary EndoAnchor Cassette, which is essentially additional EndoAnchors packaged separately. The core device (Heli-FX EndoAnchor System) has been previously cleared. Therefore, the testing focuses on demonstrating that the new packaging and configuration of the Ancillary Cassette are substantially equivalent to the existing device.

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of numerical acceptance criteria (e.g., specific tensile strength values, leakage rates, etc.) and corresponding performance data. Instead, it describes overarching performance categories evaluated for substantial equivalence. The acceptance criterion is implied as "no new risks" and "substantially equivalent" to the predicate devices.

Study Details

• 1. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

  • Test Set Sample Size: Not explicitly stated as a numerical value (e.g., N=X units). The text mentions "samples that underwent exposure to transportation simulation." This suggests a sufficient number of units were tested to support the claims.
  • Data Provenance: The testing was "bench top testing." The country of origin of the data is not specified, but the manufacturer is based in Sunnyvale, CA, USA. The testing is prospective as it was conducted specifically for this submission to evaluate the new configuration.

• 2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

  • Not applicable. This was bench testing of packaging and device functionality, not a clinical study requiring expert ground truth for diagnostic or clinical outcomes.

• 3. Adjudication method (e.g. 2+1, 3+1, none) for the test set

  • Not applicable. This was bench testing, not a clinical study requiring adjudication of expert interpretations.

• 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. This submission is for a medical device (endovascular suturing system component), not an AI/imaging diagnostic device.

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

  • Not applicable. This is a medical device, not an algorithm. However, the bench testing did evaluate the device's performance in a standalone manner (without a human in a clinical setting).

• 6. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

  • The "ground truth" for this bench testing was the established performance and integrity benchmarks for medical device packaging and functionality. These benchmarks are based on industry standards and regulatory requirements.

• 7. The sample size for the training set

  • Not applicable. This is not an AI/machine learning model but a physical medical device.

• 8. How the ground truth for the training set was established

  • Not applicable. This is not an AI/machine learning model.

In summary, the study presented for this 510(k) submission primarily consisted of bench-top testing to demonstrate the substantial equivalence of the new Ancillary EndoAnchor Cassette packaging to existing predicate devices. The focus was on ensuring that the new packaging configuration did not introduce new risks regarding visual integrity, seal strength, and the subsequent functionality of the EndoAnchors after transportation simulation. The assessment relied on comparing the new configuration's performance to the known and cleared performance of the predicate devices.

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