(28 days)
The MicroPlex Coil System (MCS) is 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 MicroVention MicroPlex Coil System (MCS) consists of an implantable coil attached to a fluid injection delivery system called a Delivery Pusher. 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 implantable coil into the microcatheter. The MicroPlex Coil System (MCS) is provided in two basic coil configurations, complex and helical. The MCS-CC-2D and MCS-CC-1D are platinum complex coils that 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 complex and helical coils are provided in a number of diameters and lengths. The complex and helical coils are available in 18- and 10-compatible systems. The 18compatible systems may be delivered through 14- and 18-type micro-catheters. The 10compatible systems may be delivered through 10- and 14-type micro-catheters.
The provided document is a 510(k) summary for the MicroPlex™ Coil System (MCS) with the MCS-HC-SX Helical Coil. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study.
Therefore, many of the requested elements for describing specific acceptance criteria and a study proving those criteria are not applicable or extractable from this particular 510(k) submission.
Here's a breakdown of what can be inferred and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicit in document. The document states that performance testing "demonstrated that the MicroPlex Coil System (MCS) with the MCS-HC-SX helical coil has equivalent performance to the predicate device." However, the specific quantitative acceptance criteria (e.g., tensile strength thresholds, detachment force, etc.) for this equivalence are not detailed. | * Tensile Strength: Demonstrated equivalence to predicate device. (Specific values not provided) |
| * Coil Detachment: Demonstrated equivalence to predicate device. (Specific values not provided) | |
| * Simulated Use: Demonstrated equivalence to predicate device. (Specific details not provided) |
2. Sample size used for the test set and the data provenance:
- Not Applicable/Not Provided. This document does not describe a clinical study with a "test set" in the context of typical AI/medical device performance evaluation. The performance data mentioned (tensile strength, coil detachment, simulated use) refers to engineering/bench testing, not a study on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable/Not Provided. This information is not relevant to the type of performance data presented in this 510(k) summary (bench testing for equivalence).
4. Adjudication method for the test set:
- Not Applicable/Not Provided. This information is not relevant to the type of performance data presented in this 510(k) summary.
5. 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 document describes a medical device (embolization coil), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study with human readers and AI assistance would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is an embolization coil, which is a physical implant, not an algorithm.
7. The type of ground truth used:
- Not Applicable in the traditional sense. For the bench testing, the "ground truth" would be established by validated testing methods and specifications for the physical properties of the device (tensile strength, detachment force, etc.).
- For the "substantial equivalence" claim, the ground truth is the performance of the predicate device (MicroPlex Coil System, K012145).
8. The sample size for the training set:
- Not Applicable/Not Provided. There is no "training set" in the context of this device's development or the type of performance data presented.
9. How the ground truth for the training set was established:
- Not Applicable/Not Provided. Similarly, there is no training set mentioned.
Summary of the Study Proving Substantial Equivalence (as described in the document):
The "study" or performance data proving the device meets the acceptance criteria of substantial equivalence (not specific clinical performance criteria) is characterized as follows:
- Type of Study: Bench testing and simulated use.
- Purpose: To demonstrate that the MicroPlex Coil System (MCS) with the MCS-HC-SX helical coil has equivalent performance to its predicate device (MicroPlex Coil System, K012145).
- Tests Performed:
- Tensile Strength
- Coil Detachment
- Simulated Use
- Outcomes: The testing "demonstrated that the MicroPlex Coil System (MCS) with the MCS-HC-SX helical coil has equivalent performance to the predicate device."
- Ground Truth (for equivalence): The performance characteristics of the previously cleared MicroPlex Coil System (K012145). This equivalence approach eliminates the need for separate clinical studies to establish safety and effectiveness for characteristics already demonstrated by the predicate.
In essence, this 510(k) is a declaration that the new coil is functionally identical to an already approved one, based on engineering and performance tests, not clinical trial data against defined "acceptance criteria" for a novel 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).