(345 days)
The ArtVentive Medical Group Endoluminal Occlusion System (AVMG EOS) is indicated for the percutaneous occlusion of the peripheral arterial and venous vasculature.
The ArtVentive Medical Group Endoluminal Occlusion System™ (AVMG EOS™) has been developed for arterial and venous embolizations in the peripheral vasculature. The system consists of three major components: a preloaded implant, the implant carrier catheter, and the guide sheath with removable core. The AVMG EOS™ is intended for single use only.
The implant is made of a Nitinol coil scaffold with an ePTFE occlusion membrane and is designed with radial force sufficient to provide stiffness and strength against the vessel wall and minimize post-deployment migration. The delivery system is made up of the implant carrier catheter and the guide sheath with removable core. The implant carrier catheter contains one implant loaded on the distal end and a deployment handle on the proximal end connected by the shaft. The delivery catheter has a low profile and is flexible to allow for trackability and pushability. The implant itself and catheter's distal end are visible under fluoroscopy.
The guide sheath is a braided shaft with a stiff proximal section and a more flexible distal section to enable tracking through tortuous peripheral vasculature. A radiopaque marker on the sheath is visible under fluoroscopy. The tip of the sheath is tapered to fit over the removable core. The removable core fits inside the guide sheath, exiting out through the distal end. The removable core also has a tapered end for ease of advancement into the blood vessel. The guidewire and core are removed from the guide sheath once it is in position for delivery of the implant.
This document, a 510(k) summary for the ArtVentive Medical Group Endoluminal Occlusion System (EOS)™, describes the device's technical characteristics, intended use, and a comparison to predicate devices, along with performance data to demonstrate substantial equivalence.
Here's an analysis to extract the requested information:
1. Table of Acceptance Criteria and the Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative format for specific clinical performance metrics like success rates or complication rates, which are typical for medical device studies that involve human subjects for clinical efficacy. Instead, it focuses on demonstrating substantial equivalence through various bench and animal testing. The "reported device performance" refers to the successful completion and outcomes of these tests.
| Performance Metric / Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Dimensional Design Verification/Validation | Performed as intended, demonstrating compliance. |
| Sterilization Validation | Successfully validated. |
| Transit and Package Integrity Testing | Successfully tested. |
| GLP Chronic Animal Safety Testing | Demonstrated safety (no adverse events reported if passed). |
| MRI Compatibility | Demonstrated compatibility. |
| Corrosion Resistance | Successfully tested. |
| Radial Strength | Performed as intended. |
| Biocompatibility Testing | Demonstrated biocompatibility. |
| Substantial Equivalence to Predicate Devices | Achieved, based on intended use, design, technology, materials, and performance (via the above tests). |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document explicitly mentions "GLP chronic animal safety testing." For such tests, a sample size would typically involve a specific number of animals. However, the exact number is not specified in this document.
- Data Provenance: The animal studies were "GLP chronic animal safety testing," implying a controlled laboratory environment. The country of origin is not specified, but given the FDA filing, it's typically either conducted in the US or in facilities compliant with US GLP standards. The study is prospective in nature, as it involves pre-clinical testing of the device for safety.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Number of Experts: This information is not provided in the document.
- Qualifications of Experts: This information is not provided in the document. For animal studies, ground truth establishment would typically involve veterinary pathologists, toxicologists, and other animal care specialists, but their specific involvement or qualifications are not detailed here.
4. Adjudication Method for the Test Set:
- The document describes "GLP chronic animal safety testing," which adheres to Good Laboratory Practice regulations. Adjudication in such studies typically involves independent pathology reviews and data audits. However, the specific adjudication method (e.g., 2+1, 3+1) is not explicitly stated.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human readers interpreting images, not for an embolization system like the AVMG EOS™, which is a therapeutic device.
- Effect Size of Human Readers Improvement with AI: Not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- No, a standalone algorithm performance study was not done. This device is a physical medical implant, not an AI algorithm.
7. The Type of Ground Truth Used:
- For the animal safety testing, the ground truth would be based on histopathology, clinical observations, and potentially laboratory assays from the animal subjects, evaluated by veterinary pathologists and researchers. This is a form of pathology and observational outcomes data.
- For the other bench tests (dimensional, sterilization, etc.), the ground truth is established by engineering specifications, standardized test methods, and quantitative measurements.
8. The Sample Size for the Training Set:
- Not applicable. This device is a physical medical implant, not an AI/ML algorithm that requires a "training set" in the computational sense. The manufacturing process and quality control would involve testing individual batches of devices and components, but this is distinct from training an algorithm.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As a physical device, there is no "training set" in the context of machine learning. The "ground truth" for its design and manufacturing would be established by engineering specifications, material standards, and validated manufacturing processes.
Summary of Device Performance Study:
The primary study mentioned is GLP chronic animal safety testing, alongside various bench studies (dimensional verification, sterilization, transit/package integrity, MRI compatibility, corrosion, radial strength, and biocompatibility). These studies collectively aim to demonstrate the safety and functional performance of the ArtVentive Medical Group Endoluminal Occlusion System (AVMG EOS™), thereby proving its substantial equivalence to existing predicate devices (AGA Medical/Amplatzer® Vascular Plug II, AGA Medical/Amplatzer® Vascular Plug 4, and Reverse Medical MVP™ Micro Vascular Plug System). The document emphasizes that these tests indicate the device performs as intended and that differences between it and the predicates do not raise any significant safety or effectiveness issues.
§ 870.3300 Vascular embolization device.
(a)
Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 870.1(e).