(74 days)
The MicroPlex® Coil System (MCS) and 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 MCS and HES are also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other neurovascular abnormality, and for arterial and venous embolizations in the peripheral vasculature.
The MicroPlex® Coil System (MCS) and HydroCoil® Embolic System (HES) consist of an implantable coil attached to a delivery system called a Delivery Pusher. The Delivery Pusher is powered by a hand-held, battery-powered Detachment Controller designed specifically for the MCS and HES. The Detachment Controller is provided separately.
The coil is delivered to treatment site on the Delivery Pusher through standard neurointerventional micro-catheters. A removable introducer sheath on the outside of the Delivery Pusher assists in the placement of the MCS and HES into the micro-catheter. During deployment, the proximal end of the Delivery Pusher is connected to the Detachment Controller. When the controller is turned on, the coil detaches.
The provided documentation describes a 510(k) premarket notification for the MicroPlex® Coil System (MCS) and HydroCoil® Embolic System (HES). This type of submission relies on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing acceptance criteria and conducting a primary study to prove that the device meets those criteria.
Therefore, much of the requested information regarding specific acceptance criteria, detailed study designs, and performance metrics in the typical sense of a de novo or PMA submission is not explicitly available in this document. The document emphasizes equivalence through design, materials, and existing performance.
Here's an analysis based on the information provided, highlighting what is and isn't available:
There are no specific acceptance criteria for performance metrics (such as sensitivity, specificity, accuracy) provided in this document as it is a 510(k) for substantial equivalence. The "performance data" referred to is primarily comparative testing against predicate devices to demonstrate equivalent performance, rather than a standalone study establishing new performance benchmarks.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as quantifiable metrics. The implicit acceptance criterion is demonstration of substantial equivalence to predicate devices. | "Performance testing has demonstrated that the MicroPlex® Coil System (MCS) and HydroCoil® Embolic System (HES) with a modified detachment system are equivalent in performance to the predicate devices." |
Study Information (Based on Substantial Equivalence Approach)
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Sample size used for the test set and the data provenance:
- Not Applicable (N/A) / Not provided in this document. No "test set" in the sense of a clinical or analytical performance study is detailed. The performance data mentioned relates to comparative testing for substantial equivalence, likely bench or animal testing, not a clinical trial with a defined test set of patients or medical images.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A / Not provided. Ground truth establishment by experts is typically done for diagnostic or prognostic devices, often involving human interpretation of medical data. This document describes a medical device for embolization, where performance is assessed through engineering and possibly animal studies, not expert ground truth on a test set.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A / Not provided. As no clinical "test set" requiring expert interpretation and adjudication is described, this information is not relevant to this submission type.
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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:
- No, an MRMC study was not done. This device is an embolization coil system, not an AI-assisted diagnostic or imaging system. Therefore, MRMC studies are not applicable.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- N/A / Not applicable. This is a physical medical device, not a software algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A / Not explicitly stated for performance testing. For a mechanical device, ground truth often relates to engineering specifications, material properties, detachment mechanisms, and possibly animal studies demonstrating successful embolization. The document only vaguely mentions "performance testing."
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The sample size for the training set:
- N/A / Not applicable. There is no "training set" in the context of an AI/ML algorithm or a device that learns from data.
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How the ground truth for the training set was established:
- N/A / Not applicable. As there is no training set, this information is not relevant.
In summary: The provided document is a 510(k) submission for substantial equivalence. It does not detail specific acceptance criteria or a comprehensive study with the types of metrics and methodologies commonly found in submissions for AI/ML devices or novel diagnostic tools. The "performance data" mentioned refers to comparative testing that established equivalence to predicate devices in design, materials, manufacturing, and intended use.
§ 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).