(90 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 coils 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™ 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 (sold separately). The implant segment detaches upon activation of the Detachment Controller.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study details as requested:
Device: MicroPlex Coil System - Cosmos 18 (Neurovascular Embolization Device)
1. Table of Acceptance Criteria and Reported Device Performance
For this specific device submission (K102365), the acceptance criteria and reported performance are based on equivalence to the predicate device (MicroPlex Coil System - Cosmos 18, K093358, K090891). The study conducted was primarily a bench test comparison rather than a clinical study with performance metrics in terms of accuracy or clinical outcomes.
| Acceptance Criteria (Bench Test Category) | Reported Device Performance (as compared to predicate) |
|---|---|
| Visual Inspection | Met same specifications as predicate |
| Dimensional Measurement | Met same specifications as predicate |
| Simulated Use: |
- Introduction, Tracking, Deployment
- Frame tumbling
- Microcatheter movement
- Microcatheter manipulation
- Compartmentalization
- Periphery fill
- Basket formation
- Shape retention
- Overall performance | Met same specifications as predicate |
| Detachment Zone Tensile | Met same specifications as predicate |
| Advancement/Retraction Force | Met same specifications as predicate |
| Coil to Coupler Weld Tensile | Met same specifications as predicate |
| Spring Constant | Met same specifications as predicate |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The bench tests are typically conducted on a set number of devices to demonstrate consistency and adherence to specifications. However, the exact quantity of coils tested is not provided in this summary.
- Data Provenance: The data is presumed to be from prospective bench testing conducted by MicroVention, Inc. at their facility in Tustin, California, U.S.A. It is not patient or clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- This information is not applicable as the study was a bench test comparison to a predicate device, not a study requiring expert clinical ground truth on patient data. The "ground truth" here is adherence to engineering specifications.
4. Adjudication Method for the Test Set
- This information is not applicable as the study was a bench test, not a clinical study involving human assessment that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This submission is for a device modification (larger coil sizes) demonstrated through bench testing and comparison to an existing predicate device, not for an AI-assisted diagnostic tool or a therapy where human reader performance improvements would be measured.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
- No, a standalone performance study was not done. This device is a physical medical implant (a coil system), not an algorithm or AI system.
7. Type of Ground Truth Used
- The "ground truth" used for this submission is based on engineering specifications and performance characteristics of the predicate device. The new device's performance was compared to meet the same specifications as the predicate.
8. Sample Size for the Training Set
- This information is not applicable. The 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
- This information is not applicable as there is no training set for this type of device.
Summary of the Study:
The submission for the MicroPlex Coil System - Cosmos 18 (K102365) primarily relies on bench testing to demonstrate substantial equivalence to its predicate device (K093358, K090891). The new device introduces larger coil outer diameters and lengths but maintains the same design attributes, materials, and operating principles as the predicate. The "study" consisted of a series of standard engineering performance tests (e.g., visual inspection, dimensional measurement, simulated use, tensile strength, spring constant) where the subject device was shown to meet the same specifications as the predicate device. This approach is common for 510(k) submissions of modified devices where material or fundamental operating principles have not significantly changed, and clinical performance is assumed to be equivalent to the predicate.
§ 870.3300 Vascular embolization device.
(a)
Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.(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 § 870.1(e).