(62 days)
The V-Grip Plus is used to detach the MicroVention MicroPlex Coil System and the HydroCoil Embolization System. As an accessory to the coils, the indications for use for the Detachment Controller remain the same as the coils and is as follows:
The MicroPlex Coil System and Hydrocoil Embolization System are intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The MCS and HES are also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct hlood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.
The V-Grip Plus Detachment Controller is a hand held, battery operated device designed specifically to detach the MicroVention MicroPlex and HydroCoil family of coils. When the coil is delivered to the treatment site, the proximal end of the delivery pusher (of coil) is inserted into the Detachment Controller. When the Detachment Controller is activated, coil detachment occurs.
Here's a summary of the acceptance criteria and study information based on the provided text for the V-Grip Plus Detachment Controller:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Electrical output verification | Met established criteria |
| Functional testing | Met established criteria |
| Detachment testing | Met established criteria |
| Software validation | Met established criteria |
| Electrical safety testing | Met established criteria |
| Electromagnetic compatibility testing | Met established criteria |
2. Sample Size Used for the Test Set and Data Provenance:
The provided text does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The study appears to be entirely bench testing.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
The provided text does not mention the use of experts or a ground truth established by experts, as the study involves bench testing of a physical device.
4. Adjudication Method for the Test Set:
Not applicable, as this was not a human-reader study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not conducted. The provided information describes testing of a physical device, not an AI or diagnostic tool that would involve human readers.
6. Standalone (Algorithm Only) Performance:
Not applicable, as this is a physical medical device (detachment controller) and not an algorithm.
7. Type of Ground Truth Used:
The ground truth for this device's testing was based on established engineering specifications and performance standards for electrical output, functionality, detachment, software operation, electrical safety, and electromagnetic compatibility.
8. Sample Size for the Training Set:
Not applicable, as this is a physical medical device and does not involve a training set as understood in AI/machine learning contexts.
9. How Ground Truth for the Training Set Was Established:
Not applicable, as there was no training set.
§ 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).