(30 days)
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 Heli-FX EndoAnchor System comprises the EndoAnchor with EndoAnchor Cassette, the Heli-FX Applier, and the Heli-FX Guide.
The Heli-FX EndoAnchor System comprises the EndoAnchor implant (an intravascularly-applied suture, supplied in a Cassette containing 10 EndoAnchors), the Heli-FX Applier (a catheterbased 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.
This 510(k) summary for the Aptus Heli-FX EndoAnchor System describes modifications to product packaging and confirms substantial equivalence to previously cleared devices. It does not present a new clinical study with acceptance criteria and device performance results as typically requested for AI/software devices.
Instead, the document focuses on demonstrating that the new packaging for the Heli-FX devices meets acceptance criteria for substantial equivalence to the original packaging.
Here's an analysis based on the provided text, addressing your questions where applicable to the packaging modification study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance and Conclusion |
|---|---|---|
| Packaging Integrity | Maintain package integrity after transportation simulation. | Passed. The performance of the modified packaging was assessed via benchtop testing. This testing included visual inspection of the package and product. The results demonstrated that the new packaging is substantially equivalent to the previous packaging. |
| Maintain package integrity after accelerated aging (2 years' equivalent). | Passed. The performance of the modified packaging was assessed via benchtop testing, including bubble emission testing and pouch seal strength on samples following exposure to environmental, transportation, and accelerated aging conditioning. The results demonstrated that the new packaging is substantially equivalent to the previous packaging. | |
| Maintain package integrity after environmental conditioning. | Passed. The performance of the modified packaging was assessed via benchtop testing, including bubble emission testing and pouch seal strength on samples following exposure to environmental, transportation, and accelerated aging conditioning. The results demonstrated that the new packaging is substantially equivalent to the previous packaging. | |
| Product Protection | Prevent damage to the product inside the package during transportation and aging. | Passed. Visual inspection of the product was part of the benchtop testing performed after transportation simulation, and after environmental, transportation, and accelerated aging conditioning. The results demonstrated that the new packaging is substantially equivalent to the previous packaging, implying adequate product protection. |
| Seal Strength | Maintain adequate pouch seal strength after transportation and aging. | Passed. Pouch seal strength was tested on samples that underwent exposure to transportation simulation only, and again following exposure to environmental, transportation, and accelerated aging (two years’ equivalent) conditioning. The results demonstrated that the new packaging is substantially equivalent to the previous packaging. |
| Equivalence | Modified packaging is "substantially equivalent" to previous packaging without new risks. | Concluded. "The data and information presented... support a determination of substantial equivalence of the Heli-FX system with modified packaging as compared to the predicate devices." This implies all relevant performance aspects of the packaging were shown to be equivalent and not introduce new risks to the device itself. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify exact sample sizes for the packaging tests (e.g., how many packages were tested for bubble emission or seal strength). It states "samples that underwent exposure".
- Data Provenance: The data is from benchtop testing, performed by the manufacturer, Aptus Endosystems, Inc. The location is implied to be within the company's testing facilities (e.g., Sunnyvale, CA). This is prospective testing designed to evaluate the new packaging.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- This question is not applicable to this submission. The study is a benchtop engineering test of packaging, not a clinical study requiring expert assessment of medical images or patient outcomes to establish ground truth. "Ground truth" in this context would be the measured physical properties of the packaging (e.g., seal strength, absence of leaks), which are objective.
4. Adjudication Method for the Test Set
- Not applicable. As this is a benchtop test evaluating packaging properties against objective criteria (e.g., quantitative seal strength values, visual inspection for defects), an adjudication method as used in clinical or image-based studies is not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC study was not done. This submission is for packaging modifications of an existing medical device, not a new diagnostic or interventional AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, this is not an algorithm or AI device. Therefore, "standalone performance" in the context of AI is not applicable.
7. The Type of Ground Truth Used
- The ground truth used for this packaging study was objective physical measurements and observations (e.g., seal strength values, presence/absence of bubbles during emission testing, visual integrity of package and product) against pre-defined engineering and quality specifications, demonstrating non-inferiority to the previous packaging.
8. The Sample Size for the Training Set
- Not applicable. This study is not performing machine learning or training an algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no training set, this question is irrelevant.
§ 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.