(30 days)
The Heli-FX Aortic Securement 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 Heli-FX.Aortic Securement System comprises the EndoAnchor with EndoAnchor Cassette, the Heli-FX Applier, and the Heli-FX Guide.
The Heli-FX Aortic Securement System comprises the EndoAnchor implant (an intravascularlyapplied suture, supplied in a Cassette containing 10 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 sterile to the user. The cassette is designed to facilitate easy and accurate loading of the EndoAnchor into the Applier catheter.
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.
The provided document (K130677) is a 510(k) summary for modifications to the Aptus Heli-FX Aortic Securement System. This type of submission relies on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a new clinical study with acceptance criteria, ground truth, or multi-reader studies for device performance.
The document states:
- "The various components of the Heli-FX System covered in this submission are substantially equivalent in materials, method of operation, and intended use as the prior Heli-FX Systems cleared via K102333 and K121168. Where specific dimensional and performance differences exist, bench testing has shown that these differences do not present new risks."
- "Data relied upon to demonstrate substantial equivalence of the modified Heli-FX System to the predicates, and to demonstrate conformance to special controls, includes the following: Performance and simulated use testing; Mechanical characterization testing."
Therefore, the submission does not detail a clinical study with acceptance criteria, ground truth establishment, sample sizes for training/test sets, or information about expert readers as would be typical for an AI/CADe device. Instead, it relies on bench testing and simulated use to show that the modified device is still substantially equivalent to its already cleared predecessors.
Based on the provided document, the following information cannot be extracted:
- A table of acceptance criteria and reported device performance (in the context of clinical efficacy; only bench testing and simulated use are mentioned for substantial equivalence).
- Sample sizes for a clinical test set, data provenance (e.g., country of origin, retrospective/prospective).
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for a clinical test set.
- Results of a multi-reader multi-case (MRMC) comparative effectiveness study, including human reader improvement with AI.
- Standalone algorithm performance (as this is a mechanical device, not an algorithm).
- Type of ground truth used (pathology, expert consensus, outcomes data – not applicable to this type of device and submission).
- Sample size for a training set (not applicable for this type of device submission).
- How ground truth for a training set was established (not applicable).
In summary, this 510(k) submission is for a medical device that provides mechanical fixation and sealing, not an AI/CADe device that would typically involve the detailed study information requested in the prompt. The "acceptance criteria" here refer to meeting the requirements for substantial equivalence through bench testing and simulated use, rather than clinical performance metrics for an AI system.
§ 870.3460 Endovascular Suturing System.
(a)
Identification. An endovascular suturing system is a medical device intended to provide fixation and sealing between an endovascular graft and the native artery. The system is comprised of the implant device and an endovascular delivery device used to implant the endovascular suture.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device should be demonstrated to be biocompatible;
(2) Sterility and shelf life testing should demonstrate the sterility of patient-contacting components and the shelf-life of these components;
(3) Non-clinical and clinical performance testing should demonstrate substantial equivalence in safety and effectiveness, including durability, compatibility, migration resistance, corrosion resistance, and delivery and deployment;
(4) Non-clinical testing should evaluate the compatibility of the device in an magnetic resonance (MR) environment;
(5) Appropriate analysis and non-clinical testing should validate electromagnetic compatibility (EMC) and electrical safety;
(6) The sale, distribution, and use of the device are restricted to prescription use in accordance with 21 CFR 801.109 of this chapter; and
(7) Labeling must bear all information required for the safe and effective use of the device as outlined in § 801.109(c) of this chapter, including a detailed summary of the non-clinical and clinical evaluations pertinent to use of the device.