(252 days)
MReye Flipper Detachable Embolization Coils are intended for arterial and venous embolization in the peripheral vasculature.
The MReye® Flipper® Detachable Embolization Coil and Delivery System consists of a fibered detachable embolization coil and a delivery system. The MReye Flipper Detachable Embolization Coils are constructed from coiled Inconel (nickel chromium alloy) wire and synthetic fibers. The wire forms primary coil diameters from 0.035 inch. Upon exiting from the catheter, the embolization coil forms a secondary curl in vasculature, ranging from 3 to 8 mm.
The provided document is a 510(k) premarket notification for the Cook Incorporated MReye Flipper Detachable Embolization Coil and Delivery System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance criteria through extensive clinical studies as might be seen for novel technologies or PMAs.
Therefore, the document does not contain the information requested in points 1-9 regarding specific acceptance criteria, detailed study designs, sample sizes, ground truth establishment, or multi-reader multi-case studies for demonstrating clinical performance.
Instead, the document highlights the following:
1. Comparison to Predicate Device:
The submission asserts that the MReye® Flipper® Detachable Embolization Coil and Delivery System is "substantially equivalent" to its predicate device, the Flipper® Detachable Embolization Coil (K063619). The key argument for equivalence is that the new device is "identical to the predicate device in terms of intended use, principle of operation, materials of construction, and basic technological characteristics." The primary modification mentioned is related to MRI compatibility.
2. Performance Data (Limited):
The only performance testing mentioned is "MRI Testing."
- Acceptance Criteria (Implied): To verify that the implant can be labeled as "MR Conditional."
- Reported Device Performance: The MRI testing verifies that the implant "will be labeled as MR Conditional 0 with the applicable parameters described in the Instructions for Use."
This indicates that the focus of this particular submission was to ensure the device's compatibility with Magnetic Resonance Imaging, rather than re-proving its embolization efficacy, which is inferred to be equivalent to the predicate device.
In summary, none of the specific items requested in points 1-9 can be extracted from this document, as it pertains to a 510(k) submission based on substantial equivalence, with a primary focus on MRI compatibility for the modification.
§ 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).