(85 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.
The GDC system consists of a remote power supply and an occlusion coil attached to a delivery wire. The occlusion coil is detached by electrolytically dissolving a small portion of the delivery wire upon desired placement of the coil in the anatomy. The occlusion coils are manufactured from a platinum wire which is wound into a primary coil, and formed into a secondary helical or curved shape. The delivery wire consists of a stainless steel core wire with a stainless steel coil soldered on at the distal end and a Teflon outer jacket proximal to the detachment zone.
This document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The provided text describes a medical device (Guglielmi Detachable Coil - GDC) and its intended use, as well as compares its indications for use with predicate devices. It is a summary of safety and effectiveness, likely from a regulatory submission, but it lacks the specific details requested regarding performance studies.
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SEP 20 1996
Section 2 - Summary of Safety and Effectiveness and Class III Certification and Summary
a. Summary Of Safety And Effectiveness
Contact Person Laraine Pangelina Manager, Regulatory Affairs Target Therapeutics 47201 Lakeview Blvd. Fremont, CA. 94538
Device Name Guglielmi Detachable Coil (GDC), Class III.
Device Description
The GDC system consists of a remote power supply and an occlusion coil attached to a delivery wire. The occlusion coil is detached by electrolytically dissolving a small portion of the delivery wire upon desired placement of the coil in the anatomy. The occlusion coils are manufactured from a platinum wire which is wound into a primary coil, and formed into a secondary helical or curved shape. The delivery wire consists of a stainless steel core wire with a stainless steel coil soldered on at the distal end and a Teflon outer jacket proximal to the detachment zone.
Intended Use
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.
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Predicate Devices
Target Therapeutics intends to expand the indications for use for the GDC Guglielmi Detachable Coil. The GDC is currently cleared for use in intracranial aneurysms and other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neuro vasculature (K951256, K960705). The purpose of this submission is to expand the indications to include peripheral indications.
| GDC with expandedindications | for embolizing certain intracranial aneurysms that - because oftheir morphology, their location, or the patient's generalmedical condition - are considered by the treatingneurosurgical team to be a)very high risk for management bytraditional operative techniques, or b) inoperable, and forembolizing other vascular malformations such asarteriovenous malformations and arteriovenous fistulae of theneuro vasculature. The GDC is also intended for arterial andvenous embolizations in the peripheral vasculature. |
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| GDC (K951256, K960705) | for embolizing certain intracranial aneurysms that - because oftheir morphology, their location, or the patient's generalmedical condition - are considered by the treatingneurosurgical team to be a)very high risk for management bytraditional operative techniques, or b) inoperable , and forembolizing other vascular malformations such asarteriovenous malformations and arteriovenous fistulae of theneuro vasculature. |
| Target Platinum OcclusionCoils (.018 and .010) | to obstruct or reduce the rate of blood flow in the peripheraland neuro vasculature for the interventional management ofAVM and AVF when devascularization prior to definitivesurgical resection is required |
| Target .035 PlatinumOcclusion Coils | for arterial and venous embolizations in the peripheralvasculature. |
| COOK OCCLUSION COILS | .018": for embolization of selective vessel supply toarteriovenous malformations and other vascular lesions of thebrain, spinal cord, spine and other small vessel applications..035": for arterial and venous embolizations |
| ARTIFICIALEMBOLIZATION DEVICE(CFR 21 Section 882.5950) | Identification: An artificial embolization device is an object thais placed in a blood vessel to permanently obstruct blood flowto an aneurysm or other vascular malformation |
Indications for Use Comparison Chart
§ 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).