(85 days)
No
The device description and intended use focus on a mechanical embolization coil system and do not mention any AI or ML components or functionalities. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is intended for "embolizing certain intracranial aneurysms" and "other vascular malformations," which are medical conditions, and thus seeks to treat or mitigate diseases, making it a therapeutic device.
No
The device, Guglielmi Detachable Coil (GDC), is described as an embolizing device used for treating intracranial aneurysms and vascular malformations by occluding them. Its purpose is therapeutic, not diagnostic.
No
The device description clearly outlines physical hardware components including a remote power supply, occlusion coil, delivery wire, platinum wire, and stainless steel components.
Based on the provided information, the Guglielmi Detachable Coil (GDC) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the GDC is for embolizing (blocking blood flow) certain intracranial aneurysms and other vascular malformations. This is a therapeutic intervention performed directly on the patient's anatomy.
- Device Description: The device description details a physical coil and delivery system designed to be placed within blood vessels.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The GDC does not perform any such analysis of specimens.
The GDC is a therapeutic medical device used for interventional procedures within the body. The reference to "ARTIFICIAL EMBOLIZATION DEVICE (CFR 21 Section 882.5950)" further supports its classification as a device used for embolization, which is a therapeutic procedure.
N/A
Intended Use / Indications for 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.
Product codes
Not Found
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intracranial (aneurysms, neuro vasculature), peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
treating neurosurgical team
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
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.
| 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 tha
is placed in a blood vessel to permanently obstruct blood flow
to an aneurysm or other vascular malformation |