(57 days)
The MicroPlex Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The MCS 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 MCS VFC consists of an implantable coil made of bare platinum alloy. The MCS VFC implantable coils has a 3D shape in various loop sizes and lengths. The coil is attached to a V-Trak delivery pusher. The proximal end 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 MicroPlex Coil System (MCS), VFC is a neurovascular embolization device. The study performed to demonstrate its compliance with acceptance criteria was a bench test summary. This involved various physical and functional tests to ensure the device's safety and effectiveness and its equivalence to a predicate device.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for each test are implicitly stated as "PASS, acceptance criteria met," indicating that the device must successfully perform the specified function or meet the measurement standard.
| Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Visual/Dimensional Inspection (Perform visual inspection and measurements using device drawing) | Device meets specified visual and dimensional standards | PASS, acceptance criteria met |
| Simulate Use (Introduction, Tracking, Deployment, Compartmentalizing, Frame Movement, Microcatheter movement, Detachment, Overall Performance) | Device performs successfully across all simulated use parameters | PASS, acceptance criteria met |
| Detachment Test (Confirm successful detachment according using V-Grip Detachment Controller during simulated use testing) | Successful detachment achieved with the V-Grip Controller | PASS, acceptance criteria met |
| Coil-to-Coupler Weld Test (Test the tensile strength of the coil/coupler weld) | The coil/coupler weld exhibits sufficient tensile strength | PASS, acceptance criteria met |
| Spring Constant (Measure the spring constant force of the coil) | The coil's spring constant force meets specifications | PASS, acceptance criteria met |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the specific number of units tested for each benchmark test. It only provides a summary of results.
- Data Provenance: The tests are described as "Bench Test Summary," implying they were conducted in a laboratory setting. There is no mention of country of origin for the data or whether it was retrospective or prospective, as these are not clinical studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this type of bench testing. "Ground truth" in the context of expert consensus, pathology, or outcomes data typically refers to clinical or image-based studies. For physical device testing, the "ground truth" is established by engineering specifications and objective measurement methods.
4. Adjudication Method for the Test Set
This information is not applicable to this type of bench testing. Adjudication methods like 2+1 or 3+1 are used for human interpretation of data, typically in clinical trials or image reads. For bench tests, the pass/fail criteria are objective and determined by measurement against established engineering specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The MicroPlex Coil System, VFC is a physical neurovascular embolization device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone "algorithm only" study was not done. This device is a physical medical device, not a software algorithm. Its performance is evaluated through physical and functional bench tests, not algorithmic output against human interpretation.
7. Type of Ground Truth Used
The "ground truth" for this device's performance validation is based on engineering specifications and objective physical measurements. For example, dimensions are compared to device drawings, and tensile strength is measured against a required specification.
8. Sample Size for the Training Set
This information is not applicable. The device is a physical product, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As in point 8, there is no training set for a physical 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).