GUGLIELMI DETACHABLE COIL

K962503 · Target Therapeutics · HCG · Sep 20, 1996 · Neurology

Device Facts

• Record ID: K962503
• Device Name: GUGLIELMI DETACHABLE COIL
• Applicant: Target Therapeutics
• Product Code: HCG · Neurology
• Decision Date: Sep 20, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5950
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

GDC system comprises remote power supply, delivery wire, and platinum occlusion coil; used for embolization of intracranial aneurysms, vascular malformations, and peripheral vasculature. Physician (neurosurgeon/interventionalist) navigates coil to target site; electrolytic detachment triggered by remote power supply dissolving wire segment. Coil provides permanent obstruction of blood flow. Device enables treatment of high-risk or inoperable intracranial lesions; provides minimally invasive alternative to traditional surgery.

Technological Characteristics

Platinum wire occlusion coil; stainless steel core delivery wire; Teflon outer jacket; electrolytic detachment mechanism; remote power supply unit. Form factor: primary wound coil, secondary helical or curved shape.

Indications for Use

Indicated for patients with intracranial aneurysms deemed high-risk or inoperable by neurosurgical teams, and patients with neurovascular arteriovenous malformations or fistulae. Also indicated for arterial and venous embolizations in the peripheral vasculature.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• GDC (K951256)
• GDC (K960705)
• Target Platinum Occlusion Coils (.018 and .010)
• Target .035 Platinum Occlusion Coils
• COOK OCCLUSION COILS

Reference Devices

• ARTIFICIAL EMBOLIZATION DEVICE (CFR 21 Section 882.5950)

Submission Summary (Full Text)

{0}

SEP 20 1996
K962503

# 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.

510(k) Notification, Target Therapeutics GDC
June 20, 1996

{1}

# 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.

## Indications for Use Comparison Chart

| GDC with expanded indications | 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. |
| --- | --- |
| GDC (K951256, K960705) | 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. |
| Target Platinum Occlusion Coils (.018 and .010) | to obstruct or reduce the rate of blood flow in the peripheral and neuro vasculature for the interventional management of AVM and AVF when devascularization prior to definitive surgical resection is required |
| Target .035 Platinum Occlusion Coils | for arterial and venous embolizations in the peripheral vasculature. |
| COOK OCCLUSION COILS | .018": for embolization of selective vessel supply to arteriovenous malformations and other vascular lesions of the brain, spinal cord, spine and other small vessel applications.
.035": for arterial and venous embolizations |
| ARTIFICIAL EMBOLIZATION DEVICE (CFR 21 Section 882.5950) | Identification: An artificial embolization device is an object that is placed in a blood vessel to permanently obstruct blood flow to an aneurysm or other vascular malformation. |

510(k) Notification, Target Therapeutics GDC
June 20, 1996