(106 days)
The HydroCoil Embolic System (HES) are intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The HES are also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.
The HydroFrame coils in the HydroCoil Embolic System (HES) consist of implant coil made of platinum alloy with inner hydrogel core. The coils are designed in 3D spherical structure in various loop sizes and lengths. The coil is attached to V-Trak™ or V-Trak™ Advanced Delivery Pusher via polyolefin elastomer filament. The Delivery Pusher is a variable stiffness stainless steel hypotube with platinum and stainless steel coils at the distal end. The proximal end of the Delivery Pusher is inserted into a hand held battery powered V-Grip™ Detachment Controller. When the Detachment Controller is activated, the flow of electrical current heats the polyolefin elastomer filament, resulting in detachment of the implant segment.
This document describes the HydroCoil Embolic System (HES), specifically the HydroFrame® 10 for neurovascular and peripheral vascular embolization.
Here's an analysis of the acceptance criteria and the study performed, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the nature of the "Result" column, which uniformly states "All test samples passed testing", "Non-toxic", "No sensitizer response", "Non-irritant", "Non-hemolytic", "No adverse effect on coagulation time", "Non-pyrogenic", and "Negative response for mutagenicity". The specific quantitative thresholds for "passing" are not explicitly stated in this summary but would be detailed in the full test reports (e.g., PDH-HFRM-ATP for visual inspection).
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Bench Testing | Meets established performance requirements for the test | All test samples passed testing |
| Visual Inspection | Coils inspect per device drawing (PDH-HFRM-ATP) | All test samples passed testing |
| Dimensional Measurement | Coil's secondary wire diameter inspectable using a microscope | All test samples passed testing |
| Simulated Use | Performs as expected in an in-vitro cerebrovascular benchtop model | All test samples passed testing |
| Reposition Time | Gel performs as expected when device is repositioned | All test samples passed testing |
| Advancement/Retraction Force | Maximum force for advancement/retraction meets specifications | All test samples passed testing |
| Expanded Gel Diameter | Expanded diameter of hydrogel (post hydration) meets specifications | All test samples passed testing |
| Spring Constant | Spring constant force (maximum force to break monofilament) meets specifications | All test samples passed testing |
| Weld Tensile | Coil/coupler weld tensile strength meets specifications | All test samples passed testing |
| Biocompatibility (HydroFrame 10 Implant & Delivery Pusher) | ||
| Cytotoxicity (MEM Elution Test) | Non-toxic | Non-toxic |
| Cytotoxicity (ISO Cell Culture Agar Overlay) | Non-toxic | Non-toxic |
| Sensitization (Guinea Pig Max.) | No sensitizer response | No sensitizer response |
| Irritation (Intracutaneous React.) | Non-irritant | Non-irritant |
| Hemocompatibility (Hemolysis) | Non-hemolytic | Non-hemolytic |
| Hemocompatibility (Prothrombin Time) | No adverse effect on coagulation time | No adverse effect on coagulation time |
| Systemic Toxicity (IV injection) | Non-toxic | Non-toxic |
| Systemic Toxicity (Rabbit Pyrogen Test) | Non-pyrogenic | Non-pyrogenic |
| Genetic Toxicology (Ames Test) | Negative response for mutagenicity | Negative response for mutagenicity |
| Implantation (7-day muscle) | Non-irritant | Non-irritant |
| Implantation (13-week intramuscular) | Non-irritant | Non-irritant |
| Implantation (26-week intramuscular) | Non-irritant | Non-irritant |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document repeatedly states "All test samples passed testing" but does not specify the precise number of samples used for each test. This information would typically be found in the detailed test protocols or reports referenced (e.g., PDH-HFRM-ATP).
- Data Provenance: The tests performed are pre-clinical bench and biocompatibility laboratory tests. The country of origin of the data is not explicitly stated, but the company, MicroVention, Inc., is based in Tustin, California, USA, suggesting the testing was likely conducted in the USA or by labs compliant with US regulatory standards. Since these are in-vitro and animal tests, they are inherently prospective as they are specifically conducted for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This document describes technical and biological tests, not studies requiring expert human interpretation of medical images or conditions to establish ground truth. Therefore, the concept of "experts used to establish ground truth" in the clinical sense (e.g., radiologists, pathologists) does not apply here. The "ground truth" for these tests is established by the predefined pass/fail criteria and objective quantitative measurements of the device's physical and biological performance against established standards (e.g., ISO 10993 series for biocompatibility).
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 refer to consensus processes among multiple human reviewers for clinical endpoints or image interpretation. The tests described are objective performance and biocompatibility assays with predefined pass/fail criteria.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned or performed. The document focuses on demonstrating substantial equivalence through technical and biocompatibility performance data, not through human reader performance with or without AI assistance.
6. Standalone (i.e. algorithm only without human-in-the-loop performance) Study
Not applicable. The HydroCoil Embolic System is a physical medical device (coils for embolization), not an algorithm or AI software. Therefore, an "algorithm only" performance study is not relevant. The performance evaluated is the device's physical and biological function.
7. Type of Ground Truth Used
The "ground truth" for the tests described is based on:
- Quantitative Bench Test Specifications: Predefined engineering and performance specifications for physical characteristics like dimensions, forces, and material properties.
- Biocompatibility Standards: Established international standards (e.g., ISO 10993 series) for evaluating the biological response to medical devices. These standards define the acceptable biological reactions (e.g., non-toxic, non-irritant).
8. Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set. The device is a physical medical device.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of medical device.
§ 882.5950 Neurovascular embolization device.
(a)
Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.(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 § 882.1(e).