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GDC® 360° Detachable Coils are intended for the endovascular embolization of:

• Intracranial aneurysms
• Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae
• Arterial and venous embolizations in the peripheral vasculature .

Boston Scientific's GDC® 360° Detachable Coil is a device which facilitates endovascular embolization of intracranial aneurysms and other vascular abnormalities. The GDC® 360° Detachable Coil is a platinum/tungsten alloy coil attached to a stainless steel delivery wire. The GDC® 360° Detachable Coil is detached (using the Boston Scientific Detachable Coil Power Supply or InZone Detachment System) by electrolytically dissolving a small portion of the delivery wire upon its desired placement within an aneurysm or other vascular site via a microcatheter. Multiple coils can be delivered into an aneurysm or other vascular site through the same microcatheter until the aneurysm or other vascular site is densely packed.

The GDC® 360° coil is first wound into a primary or main coil and then into a secondary shape using a secondary shaping (winding) mandrel. The distal end of the main coil is formed such that there is a smaller distal loop at the end of the main coil, the diameter of which is 75% that of the main coil to facilitate placement of the coil into an aneurysm.

The GDC 360° Detachable Coil is a line extension to the GDC® family of devices and include the following coil subtypes:

• . GDC®-10 360° Coil
• GDC -10 360° Soft Coil, and .
• GDC®-18 360° Coil .

The primary differences between the GDC® and the GDC® 360° Coil include the following:

• a slightly modified shape relative to the predicate GDC® coils (accomplished . through use of a new secondary coil winding mandrel)
• an expanded range of coil sizes (i.e., in terms of coil outside, or secondary, . diameter and coil length) and,
• minor additional changes related to these two changes noted above. .

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The submission focuses on expanding the indications for use of the GDC® 360° Detachable Coils, rather than on proving the initial safety and effectiveness of the device itself. Therefore, the "acceptance criteria" are primarily related to demonstrating that the expanded indications (for ruptured intracranial aneurysms) do not introduce new safety or effectiveness concerns compared to the existing indications and predicate devices.

The established acceptance criteria for the GDC® 360° Detachable Coils were likely set during the clearance of K042539 (original GDC 360° coils) and K031049 (ISAT indication for all GDC devices). The current submission leverages these previous clearances.

Table of Acceptance Criteria and Reported Device Performance:

Study Details for Clinical Performance (Expanded Indications)

The primary evidence for the expanded indications comes from the International Subarachnoid Aneurysm Trial (ISAT).

1. Sample Size used for the test set and the data provenance:

   • Sample Size: The original ISAT trial included 2143 patients with ruptured intracranial aneurysms (as stated in reference 1). The follow-up studies mentioned cover these patients for longer durations (e.g., risk of death at five years, mean of 9 years follow-up, range 6-14 years).
   • Data Provenance: The trial was an international, prospective, randomized controlled trial. While the specific countries are not enumerated in this summary, the name "International Subarachnoid Aneurysm Trial" strongly suggests data from multiple countries. It is prospective as it involved randomizing patients to treatment arms and following them forward.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document does not specify the "number of experts" used to establish ground truth for the test set in the way one might for an AI study (e.g., independent review of images).
   • Instead, ISAT was a clinical trial comparing two treatment approaches (endovascular coiling vs. surgical clipping) for ruptured intracranial aneurysms. The "ground truth" for the outcomes (e.g., death, dependency, rebleeding) was established through direct patient follow-up, clinical assessments, and medical records by the clinical teams involved in the trial. The qualifications would be neurosurgeons, interventional neuroradiologists, neurologists, and other medical professionals responsible for patient care and data collection in a large-scale international clinical trial.

3. Adjudication method for the test set:

   • The document does not explicitly state an "adjudication method" in the context of independent expert review of a dataset (like 2+1 or 3+1 for image interpretation).
   • For clinical trials like ISAT, outcomes (dependency, death, rebleeding events) are typically defined by strict protocols and often assessed by independent committees or masked assessors to minimize bias. The summary mentions "risk of dependency or death" and "risk of recurrent subarachnoid haemorrhage, death, or dependence," implying clearly defined clinical endpoints collected and analyzed according to trial methodology.

4. 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:

   • No, a MRMC comparative effectiveness study was not done. This submission is for a medical device (coils for aneurysm embolization) and not an AI-assisted diagnostic or treatment planning system that would involve human "readers" or AI assistance in that specific context. The ISAT trial compared two human-performed interventions.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • No, a standalone algorithm performance study was not done. As above, this is a medical device, not an AI algorithm.

6. The type of ground truth used:

   • The ground truth for the ISAT study was patient clinical outcomes data, including:
     • Mortality (death)
     • Functional neurological outcomes (dependency)
     • Rebleeding events
     • These outcomes were determined directly from patient follow-up and medical records generated during the clinical trial.

7. The sample size for the training set:

   • There is no training set in the typical machine learning sense for this submission. The ISAT study was a clinical trial evaluating a treatment.

8. How the ground truth for the training set was established:

   • Since there was no training set in this context, this question is not applicable. The ISAT trial established its outcomes (ground truth) through direct patient follow-up and clinical assessment.

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Target Detachable Coils are intended for use in the treatment of intracranial aneurysms and other neuro and peripheral vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.

Target Coils are indicated for endovascular embolization of:

• Intracranial aneurysms
• Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae
• Arterial and venous embolizations in the peripheral vasculature

Boston Scientific Corporation's Target Detachable Coils are comprised of four coil types: Target Coil 360 STANDARD, Target Coil 360 SOFT, Target Coil 360 ULTRA and Target Coil HELICAL ULTRA. All Target Coils are stretch resistant coils. Target Coils incorporate a length of multi-strand material through the center of the coil designed to help resist stretching. Target Coils are designed for use with Boston Scientific's InZone Detachment System (sold separately).

Each Target Coil type consists of a platinum-tungsten alloy coil attached to a stainless steel delivery wire. For Target Coil 360 STANDARD, Target Coil 360 SOFT and Target Coil 360 ULTRA coils the distal end of the main coil is formed such that there is a smaller distal loop at the end of the main coil to facilitate placement of the coil. The diameter of the distal loop is 75% that of the rest of the main coil loops.

Boston Scientific's InZone Detachment System is intended for use with all Boston Scientific Detachable Coils in the embolization of intracranial aneurysms and other vascular malformations of the neuro and peripheral vasculature.

On September 15, 2010 Boston Scientific submitted a Special 510(k) for modification of the grade of stainless-steel for two components of the finished device: 1) the stainless-steel wire sub-assembly and 2) the etched link component.

The stainless-steel wire sub-assembly is a component of the delivery wire to which the main coil is attached. During assembly, the wire is placed coaxially through the lumen of a coil-hypotube assembly. The etched link component joins the delivery wire to the main coil.

The modification was made to minimize magnetic resonance imaging (MRI) artifact during follow-up MRI.

The provided document describes the predicate devices and modifications made to the Target Detachable Coils, which are used for embolization of intracranial aneurysms and other vascular abnormalities. The document focuses on demonstrating substantial equivalence to predicate devices through various verification tests rather than presenting a study with specific acceptance criteria and detailed device performance results in a comparative format.

Therefore, many of the requested sections (e.g., sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance) are not applicable or cannot be extracted from this type of regulatory submission. The information provided is primarily related to product modifications, safety and effectiveness testing, and regulatory clearance.

Here's a breakdown of what can be extracted based on the provided text, and what cannot:

1. A table of acceptance criteria and the reported device performance

The document does not present a formal table of acceptance criteria with corresponding performance statistics. Instead, it lists the types of verification testing performed to demonstrate substantial equivalence to the predicate device after a modification to the stainless steel grade in two components. The "performance" is generally stated as the tests demonstrating substantial equivalence or successful completion.

2. Sample size used for the test set and the data provenance

The document does not explicitly state the sample sizes for the test sets in the verification testing. The tests conducted are primarily engineering/performance tests (e.g., tensile strength, detachment time, MR compatibility) and biocompatibility tests, rather than clinical studies with human patient data.

• Sample Size: Not specified for any of the verification tests.
• Data Provenance: Not specified, but likely from laboratory testing (functional, MR compatibility, biocompatibility) and pre-clinical animal models (for post-implant MR artifact data and aneurysm models). It is not human clinical data, and thus country of origin or retrospective/prospective nature is not applicable in the context of this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided because the tests performed are primarily laboratory and pre-clinical evaluations, not assessments requiring expert "ground truth" establishment in a diagnostic or clinical interpretation context.

4. Adjudication method for the test set

Not applicable, as the tests performed are objective measurements (e.g., tensile strength values, detachment times, MR signal characteristics) rather than subjective assessments requiring adjudication.

5. 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 submission concerns a physical medical device (detachable coils for embolization) and modifications to its material, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable, as this is not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the functional and MR compatibility tests, the "ground truth" would be the established engineering specifications and test standards (e.g., ASTM standards). For biocompatibility, it would be the biological response criteria. For pre-clinical aneurysm models, it would be direct observation or imaging of the embolization outcomes in the animal model. This is not derived from expert consensus, pathology, or human outcomes data in the context of this submission.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

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