(342 days)
The Aptus EndoStapling System is intended to provide fixation and sealing between endovascular aortic grafts and the native artery. The Aptus EndoStapling 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 Aptus EndoStapling System is comprised of an endovascular suture (the EndoStaple) and implantation means (the EndoStaple Applier) as well as a steerable guide sheath (the EndoGuide) for access and delivery within the vasculature. The system is intended to provide fixation and sealing between endovascular aortic grafts and the native artery. This is accomplished via selective catheter placement of discrete helical sutures (EndoStaples) through the endograft and into the tissue of the native vessel (aorta) around the circumference of the endograft. Access to the intended implantation site is gained through the use of the Steerable Endoguide, a deflectable guide sheath. The EndoStaples are implanted, one at a time, by the EndoStaple Applier, a battery-powered, software-controlled, catheter-based device.
Here's a breakdown of the acceptance criteria and the studies conducted to demonstrate the device meets these criteria, based on the provided document:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| I. Biocompatibility | All patient-contacting devices (Steerable EndoGuide, EndoStaple Applier, and EndoStaple implant) shown to be biocompatible per ISO 10993-1:2003 with respect to their intended uses. |
| II. Sterility and Shelf Life | - Sterilization process validation and routing monitoring comply with ISO 11135:2007. |
- Shelf life of one year established through accelerated and real-time aging, meeting visual inspection, simulated use, mechanical integrity, bubble, and peel testing. |
| III. Non-Clinical and Clinical Performance for Durability, Compatibility, Migration Resistance, Corrosion Resistance, Delivery, and Deployment | Durability: - 10-year simulated loading (≥ 380 million cycles) on EndoStaple/endograft interface showed no migration, fracture, or endograft damage.
Compatibility: - Simulated use testing in an anatomical model demonstrated successful performance per IFU.
Migration Resistance (Bench & Animal): - Cadaver study demonstrated improved migration resistance with EndoStaples.
- Animal study (calves) showed safe deployment and fixation, with acceptable biological reaction and no migration.
Corrosion Resistance: - Cyclic potentiodynamic polarization testing showed breakdown potential Eb at least [Redacted as (b)(4)] greater than resting potential Er (Eb-Er ≥ 600mV).
Delivery and Deployment (Clinical): - Animal study showed reasonable safety of deployment and fixation.
- Clinical study (154 subjects) reported average implantation time of 16.8 min, 0.65% Type I endoleak (one subject, core lab), and one intervention for Type I endoleak.
- 15 device malfunctions reported, none leading to clinical events or adverse patient sequelae. |
| IV. MR Compatibility | - Satisfactory MR compatibility of the implant demonstrated for RF heating, MR force, MR torque, and image artifact testing per ASTM standards. - EndoStaples determined to be MR Conditional. |
| V. Electromagnetic Compatibility (EMC) and Electrical Safety | - Aptus EndoStaple Applier deemed compliant to relevant electrical and electromagnetic safety requirements per IEC 60601-1 and IEC 60601-1-2 through successful completion of testing. |
| VI. Software Validation | - Independent verification and validation of the firmware/hardware combination successfully completed and deemed acceptable. - Software provides power-on self-test, cycle counter (limits to 15 deployments), staple deployment monitoring, and error detection/mitigation. |
| VII. Effectiveness (Clinical) | - Clinical study: Through one-year follow-up, no endograft migration experienced, one subject (of 154) had a Type I endoleak identified, and one subject required intervention for a Type I endoleak. - No EndoStaple fractures observed through one-year follow-up.
- System demonstrated to be safe and effective as a proximal fixation tool. |
Additional Information on Studies:
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Sample size used for the test set and the data provenance:
- Clinical Study: 155 subjects enrolled (145 male, average age 73 years). 154 subjects received EndoStaple implantation. The study was a prospective, multi-center, single-arm clinical study conducted at 25 centers in the United States.
- Animal Study: 14 calves.
- Cadaver Study: One investigational endovascular graft and seven commercially-available endovascular grafts implanted in non-preserved human cadaveric aortas.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number or qualifications of experts used to establish ground truth for the clinical core lab (e.g., for endoleak identification or EndoStaple fracture). It only states "identified by the core lab."
- For the animal and cadaver studies, the document does not specify expert involvement in establishing ground truth beyond the study design and evaluation methods.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not specify an adjudication method for the clinical core lab findings or other study outcomes.
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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:
- No, an MRMC comparative effectiveness study involving human readers and AI assistance was not done. This device is a surgical stapling system, not an AI-powered diagnostic imaging device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a form of standalone performance was assessed for the software (firmware) within the EndoStaple Applier. Independent verification and validation of the firmware/hardware combination was successfully completed, confirming the algorithm's control over the motor, self-tests, cycle counting, and error detection functions. This is a standalone assessment of the device's internal software operations, not an AI diagnostic algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Clinical Study: Ground truth was primarily based on clinical outcomes data (e.g., endograft migration, Type I endoleak identified by core lab, need for intervention, device malfunctions, absence of EndoStaple fractures) and direct observation/measurements from follow-up scans.
- Animal Study: Ground truth was based on radiological, gross postmortem, morphometric, and histological findings at 30, 60, and 150-day sacrifices.
- Cadaver Study: Ground truth was based on mechanical testing results (migration resistance) following modified ISO standards.
- Bench Testing: Ground truth was based on pre-defined specifications and acceptance criteria for mechanical integrity, functional performance, corrosion resistance, and durability, measured using specialized equipment and simulated conditions.
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The sample size for the training set:
- The document does not describe a "training set" in the context of an AI/machine learning model. The clinical study was a single-arm evaluation study, and bench/animal studies were for device validation.
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How the ground truth for the training set was established:
- Not applicable, as no described training set for an AI model. For the device's software (firmware), ground truth for its internal functioning would have been established through software requirements specifications and verified through testing against these requirements.
§ 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.