(61 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 vascular malformation 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 fluid injection delivery system called a delivery pusher. The delivery pusher is a variable stiffness stainless steel tube with several outer layers of PET tubing. A luer hub at the proximal end of the pusher is used for system de-airing and coil detachment. The proximal end of the coil incorporates a coupler for attachment to the delivery pusher. PET tubing is heat-shrunk over the coupler/pusher junction in order to attach the coil to the delivery pusher. The coil is delivered to treatment site on the delivery pusher through standard neuro-interventional micro-catheters. An introducer sheath on the outside of the delivery pusher assists in the placement of the MCS and HES into the micro-catheter. A 1.0-cc syringe is used for system de-airing and a 0.25-cc syringe is used for coil detachment.
Here's a breakdown of the acceptance criteria and study information based on the provided text, but it's important to note that the document is a 510(k) summary, not a detailed clinical study report. Therefore, specific details like sample sizes for test/training sets, expert qualifications, and adjudication methods are not present in this type of document.
This summary focuses on showing substantial equivalence to predicate devices, rather than establishing performance against novel criteria through detailed human reader studies.
Acceptance Criteria and Device Performance (Inferred from Substantial Equivalence)
Since this is a 510(k) submission, the "acceptance criteria" are primarily based on demonstrating substantial equivalence to a legally marketed predicate device. The performance data presented in such submissions is typically comparative rather than absolute, aiming to show that the new device performs at least as well as, or equivalently to, the predicate.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Operating Principle | Substantially Equivalent to Predicate: The MicroPlex™ Coil System (MCS) and HydroCoil® Embolic System (HES) with expanded indications for use are substantially equivalent in operating principle to the predicate devices (MicroPlex™ Coil System, K020434, and MicroCoil System, K031578). Both involve an implantable coil delivered via a fluid injection system to embolize neurovascular abnormalities or occlude blood vessels. |
| Method of Application | Substantially Equivalent to Predicate: The device's method of application (delivery on a delivery pusher through standard neuro-interventional micro-catheters for coil delivery and detachment) is substantially equivalent to the predicate devices. |
| Indications for Use | Expanded but Substantially Equivalent in Principle: While the current submission indicates expanded uses (vascular occlusion of blood vessels within the neurovascular system and for arterial and venous embolizations in the peripheral vasculature) beyond the initial intracranial aneurysm/neurovascular abnormality indications, these expanded indications are considered substantially equivalent in their underlying biomedical application and risk profile to the predicate devices' established uses. The previous predicate devices likely covered the core embolization concept. |
| Design | Substantially Equivalent to Predicate: The design, including components like the implantable coil, fluid injection delivery system (delivery pusher with PET tubing and luer hub for de-airing/detachment), and introducer sheath, is substantially equivalent to the predicate devices. |
| Packaging and Sterilization | Substantially Equivalent to Predicate: The device's packaging and sterilization methods are substantially equivalent to the predicate devices. |
| Performance Data (Mechanical/Functional) | Equivalent to Predicate: Performance testing documented in prior 510(k)s (K012145, K021914, and K020434)—including tensile strength, coil detachment, simulated use, and animal testing—demonstrated that the MCS and HES with expanded indications for use are equivalent in performance to the predicate devices. This implies meeting similar mechanical and functional benchmarks as the legally marketed predicate devices. |
Here's a breakdown of the specific questions based on the provided text:
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A table of acceptance criteria and the reported device performance
- See the table above. The "acceptance criteria" for a 510(k) are implicitly tied to demonstrating "substantial equivalence" to a predicate device across various characteristics (operating principle, method of application, indications for use, design, packaging, sterilization, and performance). The reported performance is that the device is substantially equivalent and has equivalent performance in specific tests.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not specified in the provided document. 510(k) summaries typically do not contain this level of detail for performance testing. The "Performance Data Summary" refers to testing documented in previous 510(k)s (K012145, K021914, K020434) and states "tensile strength, coil detachment, simulated use and animal testing." Details about the number of coils tested, the number of animals used, or the origin/nature of that data are not included in this high-level summary.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not specified. This document describes a medical device (embolization coil), not an AI or diagnostic imaging device that would typically rely on expert ground truth for performance evaluation in a clinical setting. The performance testing mentioned (tensile strength, coil detachment, simulated use, animal testing) are engineering and pre-clinical tests, not human-read clinical studies.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. As mentioned above, this type of adjudication is relevant for studies involving human interpretation (e.g., radiology readers) where a consensus ground truth needs to be established. The tests described are objective engineering and animal tests.
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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, this was not done. This is a physical medical device (embolization coil), not an AI algorithm or diagnostic aid that would involve human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For the "performance data" mentioned (tensile strength, coil detachment, simulated use, animal testing), the "ground truth" would be established by objective physical measurements (e.g., force required for detachment, dimensions, material integrity post-simulation) and observation of physiological effects/outcomes in animal models, rather than expert consensus on clinical images or pathology.
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The sample size for the training set
- Not applicable/Not specified. This pertains to machine learning algorithms, which this device is not. The "performance data" refers to validation testing, not training of an algorithm.
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How the ground truth for the training set was established
- Not applicable/Not specified. This pertains to machine learning algorithms.
§ 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).