(18 days)
The MicroPlex Coil System (MCS) and HydroCoil Embolic System (HES) with the HydroLink Syringe Kit are intended for embolization of those intracranial aneurysms that - because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team to be very high risk for management by traditional operative techniques or inoperable. The MCS and HES are also intended for embolization of other neuro-vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae and for arterial and venous embolizations in the peripheral vasculature.
The MicroVention 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 coil is delivered on the Delivery Pusher through standard neurointerventional microcatheters. The Delivery Pusher consists of a variable stiffness tube with a retention sleeve that attaches the pusher to the implantable coil. A peel-away introducer sheath assists in the delivery of the coil into the microcatheter. The HydroLink Syringe Kit is packaged separately and includes a 1.0-cc syringe for system de-airing and a 0.25-cc and/or 0.5-cc syringe for coil detachment. An introducer needle is also included for use with the 0.25-cc or 0.5-cc syringe to fill the hub of the Delivery Pusher with contrast agent and eliminate any air.
The MicroPlex Coil System (MCS) is marketed in two basic coil configurations, complex and helical. The MCS-CC-2D and MCS-CC-1D are platinum complex coils that are used to establish the initial framework in the treatment of vascular abnormalities (e.g., intracranial aneurysms). The MCS-HC-R, MCS-HC-S and MCS-HC-SX are platinum helical coils that provide additional filling once the initial framework has been established by one or more complex coils. The MCS-CC-2D, MCS-CC-1D, MCS-HC-R and MCS-HC-S platinum coils were determined to be substantially equivalent on October 29, 2001 (reference K012145). The MCS-HC-SX platinum coils were determined to be substantially equivalent on July 9, 2002 (reference K021914). The complex and helical coils are provided in a number of diameters and lengths to meet the needs of the physician.
The MCS-HCP are platinum helical coils with an outer layer of a hydrophilic, acrylic polymer that also provides additional filling once the initial framework has been established by placement of one or more MCS platinum complex coils. The MCS-HCP coils were determined to be substantially equivalent on July 29, 2002 (reference K020434) and were originally included as part of the MicroPlex Coil System (MCS). In order to differentiate the platinum/polymer coils from the platinum coils, the system trade name has been changed to HydroCoil Embolic System (HES) and the coils are denoted as HES-HC-R.
This document is a 510(k) premarket notification for a medical device, the MicroPlex™ Coil System (MCS) and HydroCoil™ Embolic System (HES) with the HydroLink™ Syringe Kit. This type of submission is a declaration of substantial equivalence to a predicate device, and thus typically does not include extensive clinical studies or acceptance criteria tables as would be found in a PMA (Premarket Approval) application.
Based on the provided text, here's an analysis of the performance data:
The document states:
"Performance testing including tensile strength, coil detachment and simulated use demonstrated that the MicroPlex Coil System (MCS) and HydroCoil Embolic System (HES) with the HydroLink Syringe Kit has equivalent performance to the predicate devices."
This indicates that the device's performance was compared to existing, legally marketed predicate devices rather than against specific, pre-defined acceptance criteria based on clinical outcomes. The study aims to show equivalence of performance, not necessarily superiority or meeting standalone performance thresholds as would be established in a clinical trial designed for efficacy.
1. Table of Acceptance Criteria and Reported Device Performance:
Based on the provided text, specific numerical acceptance criteria (e.g., "tensile strength must be >X N") and detailed reported device performance values are not explicitly stated. The document only provides a high-level summary that "performance testing... demonstrated that the device has equivalent performance to the predicate devices."
| Performance Criterion | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Tensile Strength | Equivalent to predicate devices (K012145, K021914, K020434, K875196) | Demonstrated equivalence to predicate devices |
| Coil Detachment | Equivalent to predicate devices (K012145, K021914, K020434, K875196) | Demonstrated equivalence to predicate devices |
| Simulated Use | Equivalent to predicate devices (K012145, K021914, K020434, K875196) | Demonstrated equivalence to predicate devices |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Performance testing" but does not specify the sample size used for these tests. It also does not indicate the data provenance (e.g., country of origin, retrospective or prospective). Given the nature of a 510(k) and the types of tests described (tensile strength, coil detachment, simulated use), these are typically benchtop or in vitro tests, not human clinical studies. Therefore, concepts like "country of origin" or "retrospective/prospective" data are not applicable in the context of this specific performance data summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable as the performance testing described (tensile strength, coil detachment, simulated use) pertains to the physical and functional characteristics of the device, not to diagnostic image interpretation or clinical outcomes that would require expert-established ground truth. These tests would involve engineering and materials science analyses.
4. Adjudication Method for the Test Set:
This information is not applicable for the same reasons as in point 3. Adjudication methods (like 2+1, 3+1) are relevant for clinical endpoints or expert consensus in diagnostic studies, not for benchtop performance tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The submission explicitly states "Performance testing including tensile strength, coil detachment and simulated use demonstrated that the MicroPlex Coil System (MCS) and HydroCoil Embolic System (HES) with the HydroLink Syringe Kit has equivalent performance to the predicate devices." This is a technical equivalence claim, not a clinical effectiveness study involving human readers or AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This device is an embolization coil system, a physical medical device for treatment, not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" is irrelevant.
7. The Type of Ground Truth Used:
For the performance testing mentioned (tensile strength, coil detachment, simulated use), the "ground truth" would be established by objective physical measurements and engineering standards, not clinical endpoints like expert consensus, pathology, or outcomes data. For example, tensile strength would be measured against ASTM standards, and coil detachment against defined functional specifications.
8. The Sample Size for the Training Set:
Not applicable. This device is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable for the same reason as in point 8.
§ 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).