(30 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 Cosmos consist of an implant coil made of platinum alloy. The coils are designed in 3D spherical structure in various loop sizes and lengths. The coil is attached to a V-Trak™ MCS delivery pusher via a polymer filament. The delivery pusher contains radiopaque positioning markers at the distal end. The proximal end is inserted into a hand held battery powered V-Grip™ Detachment Controller. The implant segment detaches upon activation of the Detachment Controller.
The MicroPlex Coil System - Cosmos (K093919) is a neurovascular embolization device. The provided document is a 510(k) summary, which indicates that the device's acceptance criteria and performance are typically evaluated through substantial equivalence to a predicate device, rather than a clinical study with detailed statistical endpoints.
Based on the provided information, here's a breakdown of the acceptance criteria and the "study" (bench testing) that demonstrates the device meets these criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the MicroPlex Coil System - Cosmos are defined by the predicate device's established performance and design specifications. The "reported device performance" in this context refers to the results of bench tests conducted to demonstrate that the new device meets these pre-established criteria. The document states that all listed tests "Met established criteria," implying satisfactory performance against predefined internal specifications or industry standards.
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Visual Inspection | Conformance to visual design specifications | Met established criteria |
| Dimensional Measurement | Conformance to specified dimensions | Met established criteria |
| Simulated Use | Functionality and performance in simulated use conditions | Met established criteria |
| Detachment Test | Reliable and controlled detachment of the coil | Met established criteria |
| Detachment Zone Tensile | Sufficient tensile strength at the detachment zone | Met established criteria |
| Advancement/Retraction Force | Acceptable forces for device manipulation | Met established criteria |
| Coil to Coupler Weld Tensile | Sufficient strength of the weld | Met established criteria |
| Spring Constant | Conformance to specified mechanical properties | Met established criteria |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states that the submission is a "510(k) SUMMARY OF SAFETY AND EFFECTIVENESS" and that the "Cosmos Coils are substantially equivalent to the predicate device with regard to intended use, patient population, device design, materials, processes, and operating principal."
This indicates that the primary "study" proving the device meets acceptance criteria is bench testing to demonstrate performance similar to the predicate device. The document does not specify the sample size used for each of the listed bench tests.
Regarding data provenance:
- Country of Origin: The submitting company, MicroVention, Inc., is based in Tustin, California, U.S.A. Therefore, the bench testing was likely conducted in the USA.
- Retrospective or Prospective: Bench testing, by its nature, is a prospective evaluation where tests are designed and performed to assess the device's characteristics. It is not based on historical patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since this is a 510(k) for a device demonstrated through substantial equivalence and bench testing, there is no mention of experts involved in establishing ground truth for a test set in the clinical sense. Ground truth for bench testing would typically be engineering specifications, established scientific principles, or comparison to the predicate device's known performance. These are not typically established by clinical experts in the same way as, for example, a radiologist establishing ground truth for an imaging AI algorithm.
4. Adjudication Method for the Test Set
As there is no clinical test set or human expert review described for establishing ground truth, there is no adjudication method mentioned. The "acceptance criteria" are likely engineering specifications or performance metrics derived from the predicate device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or mentioned in this 510(k) summary. This type of study is common for evaluating the effectiveness of AI-assisted diagnostic tools, which is not the nature of this device (a physical neurovascular embolization coil).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This device is a physical medical implant, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the acceptance criteria for this device is based on:
- Engineering Specifications: Pre-defined technical requirements for the device's visual, dimensional, and mechanical properties.
- Performance of the Predicate Device: The MicroPlex Coil System (MCS) - Cosmos (K082461 and K090891) serves as the benchmark against which the new device (Cosmos) is compared for substantial equivalence. The predicate device's established safety and effectiveness dictate the expected performance of the new device.
There is no mention of pathology, outcomes data, or expert consensus in a clinical setting establishing "ground truth" for these bench tests.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical implant, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI or data-driven model development.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As stated above, there is no training set for this 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).