(126 days)
Intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The MCS and HES 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 embolization in the peripheral vasculature.
The MCS Cosmos 10 consists of an implantable coil made of bare platinum alloy. The HES HydroFrame 10 consists of implantable coil made of platinum alloy with a biologically inert and stable inner hydrogel core. Both the Cosmos 10 and the HydroFrame 10 coils are available in various loop sizes and lengths. The coil is attached to a V-Trak delivery pusher. The proximal end of the delivery pusher is inserted into a hand held battery powered V-Grip Detachment Controller (sold separately). The implantable coil detaches upon activation of the Detachment Controller.
Both the Cosmos 10 and the HydroFrame 10 coil implants have a PET member within the primary coil to provide stretch resistance properties. Both feature a 3-dimensional shape that creates a frame when placed within an aneurysm.
The HydroFrame 10 also has a hydrogel core member that runs parallel with the stretch resistant member within the coil. The expansion properties of the hydrogel allow for improved filling properties of the implanted coil.
The provided text describes a 510(k) submission for MicroPlex Coil System – Cosmos 10 and HydroCoil Embolic System - HydroFrame 10, which are neurovascular embolization devices. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against new, specific acceptance criteria through a clinical study.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets them cannot be fully extracted in the way typically expected for a clinical performance study. The submission primarily relies on bench test comparisons to establish equivalence, implying that if the new devices perform similarly to the predicate devices in these tests, they meet the same implicit acceptance criteria as the legally marketed predicates.
Here's a breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance:
Since this is a 510(k) addressing a line extension, explicit "acceptance criteria" for clinical performance are not stated in the provided documents. Instead, the "performance" is demonstrated by showing equivalence to the predicate devices through bench testing. The acceptance criterion for each test is implicitly "Met same criteria as predicate."
| Test (Implicit Acceptance Criteria: Met same criteria as predicate) | Reported Device Performance (Subject Device) |
|---|---|
| Visual Inspection | Met same criteria as predicate |
| Dimensional Measurement | Met same criteria as predicate |
| Simulated Use: | |
| - Introduction | Met same criteria as predicate |
| - Tracking | Met same criteria as predicate |
| - Deployment | Met same criteria as predicate |
| - Frame tumbling | Met same criteria as predicate |
| - Microcatheter movement | Met same criteria as predicate |
| - Microcatheter manipulation | Met same criteria as predicate |
| - Compartmentalization | Met same criteria as predicate |
| - Periphery fill | Met same criteria as predicate |
| - Basket formation | Met same criteria as predicate |
| - Shape retention | Met same criteria as predicate |
| - Overall performance | Met same criteria as predicate |
| Spring Constant | Met same criteria as predicate |
| Gel Expansion (HES only) | Met same criteria as predicate |
| Weld Tensile | Met same criteria as predicate |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: The document does not specify exact sample sizes for each bench test. These are typically performed on a statistically significant number of units according to internal quality standards, but the specific numbers are not provided in this summary.
- Data Provenance: The data is based on bench testing performed by MicroVention, Inc. (Tustin, California, U.S.A.). It is by nature prospective as it involves testing newly manufactured devices.
3. 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):
This information is not applicable to the provided document. The "tests" described are bench tests of physical and mechanical properties, not clinical evaluations requiring expert interpretation of images or patient outcomes. The "ground truth" for these tests would be established by objective measurements and comparisons against engineering specifications and predicate device performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable. Adjudication methods are typically used in clinical studies for interpreting ambiguous clinical data or images. Bench tests rely on objective measurement and comparison.
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:
This information is not applicable. The device is a physical embolization coil, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted or is relevant to this device.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
This information is not applicable. The device is a physical embolization coil, not an algorithm, and therefore does not have a "standalone" algorithmic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the bench tests, the "ground truth" is derived from:
- Engineering specifications and design parameters.
- Measured physical and mechanical properties that demonstrate equivalence to the predicate devices.
- Pre-established performance characteristics of the predicate devices.
8. The sample size for the training set:
This refers to a training set for an algorithm, which is not applicable in this context. The devices are physical medical devices, not algorithms requiring a training set.
9. How the ground truth for the training set was established:
This question is not applicable as there is no algorithm or "training set" for this physical medical 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).