(99 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 MCS devices consist of an implantable coil made of platinum alloy (MCS) or a platinum allot with an inner hydrogel core (HES). The coil is attached to a V-Trak delivery pusher via a polymer filament. The proximal end of the pusher is inserted into a hand held battery powered V-Grip Detachment Controller (sold separately). The implant segment detaches upon activation of the Detachment Controller.
Here's an analysis of the acceptance criteria and supporting study for the MicroPlex Embolic System (MCS) Line Extension, based on the provided document:
Acceptance Criteria and Device Performance
The device, the MicroPlex Coil System (MCS) Line Extension (specifically MCS HyperSoft 3D), was subject to a series of bench tests. The acceptance criteria for these tests were established by demonstrating substantial equivalence to predicate devices (K091641 and K103758). The document explicitly states that the new device "Met the same acceptance criteria as the predicate devices" for all listed tests.
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Visual Inspection | Same as predicate devices (K091641, K103758) | Met the same acceptance criteria as the predicate devices |
| Dimensional Measurement | Same as predicate devices (K091641, K103758) | Met the same acceptance criteria as the predicate devices |
| Simulated Use | Same as predicate devices (K091641, K103758) | Met the same acceptance criteria as the predicate devices |
| Detachment Test | Same as predicate devices (K091641, K103758) | Met the same acceptance criteria as the predicate devices |
| Coil to Coupler Weld Tensile | Same as predicate devices (K091641, K103758) | Met the same acceptance criteria as the predicate devices |
| Spring Constant | Same as predicate devices (K091641, K103758) | Met the same acceptance criteria as the predicate devices |
Study Details for Device Performance
It's important to note that this submission is for a Special 510(k) Line Extension, which primarily focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices through bench testing and technological comparison, rather than extensive clinical studies. Therefore, many of the typical clinical study parameters (like sample size for test sets, expert adjudication, MRMC studies, or standalone algorithm performance) are not applicable or detailed in this type of submission.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the document. The testing described is bench testing of the device itself (coils and delivery system), not a study involving patient data.
- Data Provenance: The testing was likely conducted in a laboratory setting by the manufacturer, MicroVention, Inc. (based in Tustin, California, U.S.A.). The data is prospective in the sense that the new coils were manufactured and then tested according to established protocols.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. For bench testing, "ground truth" is typically defined by engineering specifications, validated test methods, and industry standards, rather than expert consensus on medical images or clinical outcomes.
- Qualifications of Experts: N/A
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Bench tests follow predefined protocols and acceptance criteria based on quantifiable measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. This submission is for a physical medical device (coils) and its delivery system, not an AI or imaging diagnostic device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.
6. Standalone (Algorithm Only) Performance
- Standalone Performance Done: No. This is not an algorithmic or software-only device.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for this submission is based on engineering specifications, established test methods, and the performance characteristics of the legally marketed predicate devices. The new device's performance was compared to these established benchmarks to demonstrate substantial equivalence.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. There is no AI model involved that would require a training set. The "training" for this device's development would be the historical data and performance of previous iterations and predicate devices.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no AI training set. The design and validation of the new device are informed by the known and regulated performance of the predicate devices and general neurovascular device development principles.
§ 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).