(29 days)
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.
| Acceptance Criteria Category | Specific Tests Performed | Reported Device Performance |
|---|---|---|
| Functional Testing | Main Junction Tensile Strength | Verification testing demonstrated substantial equivalence to the predicate. |
| Delivery Wire Tensile Strength | Verification testing demonstrated substantial equivalence to the predicate. | |
| Coil Detachment Time | Verification testing demonstrated substantial equivalence to the predicate. | |
| MR Compatibility Testing | Magnetically induced displacement (ASTM F2052) | Tested successfully, resulting in revised Directions for Use (DFU) with a comprehensive MR Conditional statement. Verification testing demonstrated substantial equivalence. |
| Magnetically induced torque (ASTM 2213) | Tested successfully, resulting in revised DFU with a comprehensive MR Conditional statement. Verification testing demonstrated substantial equivalence. | |
| Magnetically induced heating effect (in 1.5 T and 3 T MR systems - ASTM F2182) | Tested successfully, resulting in revised DFU with a comprehensive MR Conditional statement. Verification testing demonstrated substantial equivalence. | |
| MR induced image artifact (ASTM F2119) | Tested successfully, resulting in revised DFU with a comprehensive MR Conditional statement. Verification testing demonstrated substantial equivalence. | |
| Pre-clinical Testing | Post-implant MR artifact data | Comparison of modified Target Detachable Coil to control coils in coiled aneurysm models was performed, demonstrating substantial equivalence. |
| Comparison in coiled aneurysm models | Comparison of modified Target Detachable Coil to control coils in coiled aneurysm models was performed, demonstrating substantial equivalence. | |
| Biocompatibility Testing | MEM Elution Cytotoxicity | Confirmatory biocompatibility testing was performed, demonstrating substantial equivalence. |
| Hemolysis, Direct Contact | Confirmatory biocompatibility testing was performed, demonstrating substantial equivalence. | |
| USP Physico-Chemical | Confirmatory biocompatibility testing was performed, demonstrating substantial equivalence. | |
| Toxicology Assessment | Assessment of the new grade stainless-steel | Assessed by Boston Scientific's Corporate Toxicology group, contributing to the determination that modifications raise no new questions of safety or effectiveness and demonstrate substantial equivalence. |
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.
§ 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).