GUGLIELMI DETACHABLE COIL

K960705 · Target Therapeutics · HCG · May 21, 1996 · Neurology

Device Facts

• Record ID: K960705
• Device Name: GUGLIELMI DETACHABLE COIL
• Applicant: Target Therapeutics
• Product Code: HCG · Neurology
• Decision Date: May 21, 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.

Device Story

GDC system comprises remote power supply, delivery wire, and platinum occlusion coil; used for endovascular embolization of intracranial aneurysms, AVMs, and AVFs. Physician navigates coil to target site; applies electrical current via power supply to electrolytically dissolve detachment zone on delivery wire; coil detaches and remains in vessel to obstruct blood flow. Used in neurosurgical/interventional radiology settings. Provides minimally invasive alternative to traditional open surgery for high-risk or inoperable vascular lesions.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and predicate comparison.

Technological Characteristics

Materials: Platinum wire (coil), stainless steel core wire (delivery), Teflon jacket. Principle: Electrolytic detachment of coil via electrical current. Form factor: Primary wound coil formed into secondary helical/curved shape. Energy source: Remote electrical power supply.

Indications for Use

Indicated for patients with intracranial aneurysms deemed high-risk or inoperable by neurosurgical teams, and patients with arteriovenous malformations or arteriovenous fistulae of the neuro 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)
• COOK OCCLUSION COILS

Reference Devices

• ARTIFICIAL EMBOLIZATION DEVICE (CFR 21 Section 882.5950)

Submission Summary (Full Text)

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MAY 21 1996
K960705

# 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.

510(k) Notification, Target Therapeutics GDC
February 15, 1996
Response
7 Page 20

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# Predicate Devices

Target Therapeutics intends to expand the indications for the Guglielmi Detachable Coils (GDC) to include other vascular lesions such as arteriovenous malformations (AVM) and arteriovenous fistulas (AVF). The GDC is substantially equivalent to coils currently marketed by Target Therapeutics and the Cook company for use in vascular lesions such as arteriovenous malformations and arteriovenous fistulae of the peripheral and neuro vasculature.

## 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. |
| --- | --- |
| GDC (K951256) | 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 |
| COOK OCCLUSION COILS | for embolization of selective vessel supply to arteriovenous malformations and other vascular lesions of the brain, spinal cord, spine and other small vessel applications. |
| 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
February 15, 1996
S
Responsible
Page 21