(29 days)
GDC Coils (All Versions except GDC 18-Fibered VortX™ Shape): The Guglielmi Detachable Coil is intended for embolization of those 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. The GDC is also intended for embolization of other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.
GDC 18-Fibered VortX Shape: This product is intended for embolization of vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae of the neuro vasculature. GDC-18 Fibered VortX Shape is also intended for arterial and venous embolizations in the peripheral vasculature.
Guglielmi Detachable Coils (GDC®) are used as part of a system indicated for endovascular occlusion in patients with high surgical risk intracranial aneurysms and other neurovascular abnormalities. The GDC system consists of the following items, each of which is sold separately - · GDC Power Supply - · GDC SynerG TM occlusion coil attached to a delivery wire - · set of GDC connecting cables - · patient return electrode - · two 9-volt batteries GDC SynerG coils are available in regular (secondary helical), 2D (secondary helical with distal helix) and 3D (tertiary) shapes, in a range of sizes, and in Standard, Soft and Stretch Resistant versions, all of which are compatible with Boston Scientific Target Infusion Catheters with two tip markers. GDC is also available as an UltraSoft™ Coil, developed to address physicians' requests for a softer Stretch Resistant coil and a wider range of coil sizes to treat intracranial aneurysms. Boston Scientific Target also offers a Fibered GDC device, GDC 18-Fibered VortX Shape, incorporating synthetic fibers through the main coil for a more rigid coil. All of the coils are manufactured from a platinum-tungsten alloy wire which is wound into a primary or main coil. Depending upon the desired final configuration, a coil is either formed into a secondary helical shape (standard and Stretch Resistant GDC), vortex shape (GDC-18 Fibered VortX) or tertiary shape (3D GDC). The distal tip of the coil is welded to form a smooth tip (with the exception of Stretch Resistant GDC). The coils are attached to a delivery wire, which consists of a ground stainless-steel core with a stainless-steel coil welded at the distal end and a Teflon® outer jacket. Using fluoroscopic guidance and a guiding catheter to access the lesion, the physician delivers the GDC coil to the targeted site through an infusion catheter. Upon desired placement in the anatomy, the coil is detached by use of a battery-operated power supply designed specifically for use with the GDC system. The GDC SynerG Power Supply used to initiate and control detachment is a self-contained unit that applies a constant current through the GDC system until detachment is detected. Each time the GDC Power Supply is turned on, the unit defaults to the 1.0 mA current setting. Pressing the "Current" switch one time changes the setting to the 0.5 mA current setting; pressing a second time changes the setting to 0.75 mA; pressing a third time returns the unit to the default 1.0 mA setting. Each time the switch is pressed, the current display flashes the new current setting. After selecting a current setting and initiating detachment, the current flowing through the delivery wire begins to dissolve, by electrolysis, the exposed stainless steel at the junction with the platinum-tungsten coil. Over a period of several minutes, the exposed steel completely dissolves and the platinum-tungsten coil detaches. When coil detachment is detected, the GDC SynerG Power Supply immediately halts current flow, freezes the displays and emits an audible signal that coil detachment has occurred. Using fluoroscopy, the physician then verifies that the delivery wire can be withdrawn without disturbing the newly placed coil, and can resume electrolysis if necessary. Multiple GDC coils may be placed within a single aneurysm, at the discretion of the interventional team, to achieve optimum occlusion of the lesion.
The provided document describes a Special 510(k) modification for Boston Scientific Target's GDC® Stretch Resistant Detachable Coils, specifically the replacement of an "Anchor Twister" with an "Anchor Chain." The submission aims to demonstrate that the modified device is substantially equivalent to predicate devices. The information provided is primarily focused on the physical and performance characteristics of the device and how the modification does not negatively impact these characteristics.
Crucially, this submission is for a medical device (Guglielmi Detachable Coil) which is a physical product, not an AI/ML device. Therefore, the questions related to AI/ML specific criteria (like "human readers improve with AI vs without AI assistance," "standalone performance," "training set size," "ground truth for the training set") are not applicable to this document. The document describes a traditional medical device premarket notification.
Acceptance Criteria and Reported Device Performance
The document does not explicitly present "acceptance criteria" in a quantitative, pass/fail table format with specific numerical thresholds. Instead, it states that the modified device "Meets acceptance criteria" for various performance characteristics, implying that internal quality and performance standards were met.
The table below summarizes the reported device performance, noting that the modification has no effect on some critical parameters, indicating equivalence to the predicate device.
| Test or Point of Comparison | Reported Device Performance |
|---|---|
| Tensile Strength | Meets acceptance criteria. |
| Friction | Meets acceptance criteria. |
| Detachment Time | Modification has no affect upon detachment time. |
| Deployment / Retraction Force | Meets acceptance criteria. |
| Tip Ball Strength | Meets acceptance criteria. |
| Coil Migration | Modification has no affect upon coil migration. |
| Coil Stiffness | Meets acceptance criteria. |
| Inner Coil Weld Strength | Modification has no affect upon inner coil weld strength. |
Study Information (Based on available document)
Since this is a submission for a physical device modification, the studies mentioned are engineering verification tests to ensure the modified device performs comparably to the predicate. It does not involve a "study" in the typical clinical trial sense with patient data, experts establishing ground truth, or adjudication methods for diagnostic accuracy.
- Sample size used for the test set and the data provenance: Not explicitly stated. The document refers to "Verification Test Summary Table: Predicate GDC Devices vs Modified Devices," implying in vitro or bench testing. No human or animal data is mentioned. Data provenance (country of origin, retrospective/prospective) is not applicable for this type of engineering test.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for device performance tests is typically established through standard engineering measurements and specifications, not expert consensus on diagnostic images.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are relevant for subjective assessments, primarily in clinical or image-based studies.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is for a physical medical device, not an AI/ML product.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for a physical medical device, not an AI/ML product.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For engineering verification, the "ground truth" would be established by predefined engineering specifications, material properties, and physical testing standards (e.g., measuring tensile strength against a specified minimum).
- The sample size for the training set: Not applicable. This is not an AI/ML device, so there is no "training set."
- How the ground truth for the training set was established: Not applicable.
§ 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).