(24 days)
The AZUR PURE is intended to reduce or block the rate of blood flow in vessels of the peripheral vasculature. It is intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms, and other lesions of the peripheral vasculature.
The AZUR PURE Peripheral Coil System, Pushable 18, consists of an implantable coil housed in an introducer. A stainless steel stylet is used to deploy the coil from the introducer into a delivery catheter. The coil is delivered to the treatment site through the delivery catheter using a standard guidewire.
The subject of this Special 510(k) is the addition of a platinum overcoil to the AZUR PURE Pushable 18 device. The purpose is to improve tracking performance of the coil implant during delivery.
With the exception of the modification to add the platinum overcoil, the modified devices are identical to the cleared predicate devices with regard to intended use, principal of operation, materials, manufacturing processes, packaging configuration, and sterilization method.
Here's an analysis of the provided text regarding the acceptance criteria and study for the AZUR PURE Peripheral Coil System, Pushable 18:
1. Table of Acceptance Criteria and Reported Device Performance
| Test / Test Description | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Simulate Use (Introduction, Tracking, Deployment, Compartmentalizing, Frame Movement, Microcatheter movement, Detachment, Overall Performance) | All performance ratings shall be ≥ 3 | PASS, acceptance criteria met |
| Advancement Force (Measure the force required to advance the coil into the microcatheter) |
§ 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).