(28 days)
The TRUFILL DCS ORBIT™ Detachable Coil is indicated for embolizing intracranial aneurysms and other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature.
The TRUFILL DCS ORBIT™ Detachable Coil is also intended for arterial and venous embolization in the peripheral vasculature.
The TRUFILL® DCS Syringe is indicated for use with the TRUFILL® family of Detachable Coils.
The TRUFILL® DCS Syringe II is indicated for use with the TRUFILL® family of Detachable Coils.
Not Found
I am sorry, but the provided text is a 510(k) clearance letter from the FDA. It does not contain information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods for a device. Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given text.
The document states that the TRUFILL DCS ORBIT™ Detachable Coil and associated syringes have been found substantially equivalent to legally marketed predicate devices, allowing them to proceed to market. However, it does not provide the specific performance data or the study design used to demonstrate this equivalence.
§ 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).