(134 days)
The IDC Coil is a modified interlocking detachable coll indicated to obstruct or reduce rate of blood flow in the peripheral vasculature. This device is not intended for neurovascular use.
The IDC Coil includes a standard or soft coil (manufactured from platinum-tungsten alloy) that is mechanically attached to a coil delivery wire. This assembly is contained within an introducer sheath. The IDC Coil is designed to be delivered under fluoroscopy with a 0.53 mm (0.021 in) inner diameter (I.D.) microcatheter (e.g. Renegade™ Microcatheter) with one radiopaque (RO) tip marker. The interlocking delivery wire design allows the coil to be advanced and retracted before final placement in the vessel, thus aiding in more controlled delivery including the ability to withdraw the coil prior to deployment.
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance studies, or the type of ground truth used.
The document is a 510(k) premarket notification for a medical device (IDC Interlocking Detachable Coils) and primarily focuses on establishing substantial equivalence to a predicate device. It mentions "Performance Data" but only provides details about MRI safety testing and concludes that the modifications do not affect intended use or fundamental technology. It does not contain the kind of detailed study information requested in your prompt regarding device performance metrics against specific acceptance criteria.
§ 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).