(261 days)
The Guglielmi Detachable Coil (GDC) is intended for embolizing certain intracranial aneurysms that - because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team to be:
a)very high risk for management by traditional operative techniques, or,
b) inoperable,
and for embolizing other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neuro vasculature.
The GDC is also intended for arterial and venous embolizations in the peripheral vasculature.
Fibered GDC is intended for the embolization of vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neuro vasculature. Fibered GDC is also intended for arterial and venous embolizations in the peripheral vasculature.
Boston Scientific/Target's Guglielmi Detachable Coil (GDC) Power Supply is intended for use with all versions of Boston Scientific/Target's Guglielmi Detachable Coils in the embolization of intracranial anewrysms and other vascular malformations of the neuro and peripheral vasculature.
The GDC system consists of
- · GDC power supply
- · GDC occlusion coil attached to a delivery wire
- · set of GDC connecting cables
- · patient return electrode
- · two 9-volt batteries
each of which is sold separately.
The occlusion coil is detached by electrolytically dissolving a small portion of the delivery wire upon desired placement of the coil in the anatomy.
GDC occlusion coils are manufactured from platinum wire which is first wound into a primary coil and then formed into a secondary helical shape. Coils are attached to a delivery wire, which consists of a ground stainlesssteel core wire with a stainless-steel coil welded at the distal end and a Teflon® outer jacket. The delivery wire is the same as that employed for the predicate GDC cleared under K962503.
The GDC Power Supply is a self-contained, battery-operated unit designed to initiate and control detachment of a GDC coil. It has an on/off button, connections for the GDC cables, and the following controls and displays:
· Current setting switch and display - Allows for selection of the different current settings. The selected current (mA) is briefly displayed after which the unit displays the current flowing through the system.
· Voltage diplay and indicator - Displays the DC output voltage.
• Time display - Displays the elapsed time that the current has been flowing through the GDC system.
• Check indicator - Flashes on and off at the beginning of a detachment procedure if there is a poor connection to the patient.
· Detach indicator - Flashes on and off when the power supply has detected detachment. Detachment is accompanied by five beeps.
· Battery indicator - Illuminates when the voltage of the internal 9-volt batteries falls below specification.
This document describes a 510(k) premarket notification for the Guglielmi Detachable Coil (GDC) Power Supply and does not contain acceptance criteria for device performance or a study demonstrating the device meets such criteria.
The information provided outlines:
- Trade Name: Guglielmi Detachable Coil (GDC), Class III
- Common Name: Occlusion Coil
- Classification Name: Artificial Embolization Device (21 CFR Section 882.5950)
- Predicate Devices: K962503, K971395, K914786, K930738
- Intended Use: Embolizing intracranial aneurysms and other vascular malformations of the neuro vasculature, and for arterial and venous embolizations in the peripheral vasculature. Fibered GDC is also intended for embolization of vascular malformations.
- Device Description: The GDC system consists of a power supply, occlusion coil attached to a delivery wire, connecting cables, patient return electrode, and batteries. The occlusion coil is detached by electrolytically dissolving a portion of the delivery wire. The power supply allows for current setting, displays voltage, elapsed time, and has indicators for poor connection, detachment, and battery status.
This document is a regulatory submission for substantial equivalence, focusing on safety and effectiveness based on comparison to predicate devices, rather than a performance study with specific acceptance criteria. Therefore, the requested details about acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, adjudication methods, or comparative effectiveness studies are not present in this text.
§ 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).