(90 days)
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No
The provided text describes a mechanical device (coils and delivery system) for embolization and makes no mention of AI or ML technology in its intended use, device description, or performance studies.
Yes
The device is intended for embolizing intracranial aneurysms and other vascular malformations, which involves intervening in a medical condition to restore health or alleviate symptoms.
No
Explanation: The device is intended for embolizing aneurysms and vascular malformations, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines physical components like a remote power supply, occlusion coil, delivery wire, and platinum wire, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used within the body (in vivo) for embolizing vascular structures. IVDs are used to examine specimens from the body (in vitro) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a physical implantable device (coil) and its delivery system, not reagents, instruments, or software used for testing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information based on laboratory results.
The device is an artificial embolization device as indicated by the predicate device information (CFR 21 Section 882.5950).
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 arteriovencus fistulae of the neuro vasculature.
Product codes
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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
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
MAY 21
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 arteriovencus fistulae of the neuro vasculature.
1
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.
| 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 |