(30 days)
The HES is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The HES is 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 HES consists of implantable coil made of platinum alloy with inner hydrogel core. The helical-shaped implantable coil is available in various outer dimensions and lengths. The coil is attached to a V-Trak delivery pusher. The proximal end of the pusher is inserted into a hand held battery powered V-Grip Detachment Controller (sold separately). The implant segment detaches upon activation of the Detachment Controller. The modified HES is substantially equivalent to the cleared predicate devices with regard to intended use, principal of operation, materials, manufacturing processes, packaging configuration, and sterilization method.
The provided text describes a Special 510(k) submission for a modification to the HydroCoil Embolic System (HES), specifically to the HydroFill component. This is a submission demonstrating substantial equivalence to a predicate device, not a de novo clearance or a novel device submission. Therefore, the "acceptance criteria" discussed are primarily related to bench testing demonstrating that the modified device performs similarly to the predicate device, rather than clinical efficacy endpoints. The study described is a series of bench tests.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For this Special 510(k), the "acceptance criteria" are implied by demonstrating that the modified device met the same criteria as the predicate device in a series of bench tests. The reported performance is that all tests met these implied criteria.
| Test | Acceptance Criteria (Implied) | Reported Device Performance (Subject Device) |
|---|---|---|
| Visual Inspection | Match predicate device's visual characteristics | Met same criteria as predicate |
| Dimensional Measurement | Match predicate device's dimensional specifications | Met same criteria as predicate |
| Simulated Use | Perform similarly to predicate in: | Met same criteria as predicate |
| • Introduction | • Introduction | • Introduction |
| • Tracking | • Tracking | • Tracking |
| • Reposition / Deployment | • Reposition / Deployment | • Reposition / Deployment |
| • Detachment | • Detachment | • Detachment |
| • Overall Performance | • Overall Performance | • Overall Performance |
| Spring Constant | Match predicate device's spring constant | Met same criteria as predicate |
| Gel Expansion | Match predicate device's gel expansion properties | Met same criteria as predicate |
| Weld Tensile | Match predicate device's weld tensile strength | Met same criteria as predicate |
| Advancement / Retraction Force | Match predicate device's forces | Met same criteria as predicate |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the exact sample sizes (number of devices or tests performed) for each bench test. It only states that the modified device "Met same criteria as predicate." The data provenance is internal to MicroVention, Inc., and is derived from bench testing (presumably in a laboratory setting). It is not clinical data, so terms like "country of origin" or "retrospective/prospective" are not applicable in a clinical sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. For bench tests demonstrating substantial equivalence, ground truth is established by engineering specifications, material properties, and performance benchmarks against the predicate device, not by expert clinical consensus.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
Not applicable. Adjudication methods are typically used in clinical studies involving interpretation of medical images or outcomes, where human expert consensus is required to establish ground truth or resolve discrepancies. Bench tests rely on objective measurement and predefined engineering criteria.
5. 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
Not applicable. This is a submission for a modification to a medical device (embolic coils), not an AI-powered diagnostic or therapeutic system. An MRMC study is not relevant to this type of device and submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the bench tests effectively consisted of the established performance and material specifications of the predicate device. The goal was to demonstrate that the modified device performed equivalently to these known specifications. This is an engineering/performance-based "ground truth."
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set. The data presented is from verification and validation bench testing of the physical device.
9. How the Ground Truth for the Training Set was Established
Not applicable. As noted above, there is no training set for this type of 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).