(30 days)
Matrix Detachable Coils are 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 o) inoperable. Matrix Detachable Coils are also intended for embolization of other neuro vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Matrix Detachable Coils are also intended for arterial and venous ambolizations in the perioheral vasculature.
Matrix Stretch Resistant Detachable Coils are comprised of a platinum-tungsten alloy coil which is coated with a biocompatible absorbable polymer.
Packaging of the device is identical to that of the predicate Matrix Detachable Coils: the finished device is loaded into an introducer sheath and is then placed in a dispenser coil contained within a foil pouch. The foil pouch is then placed into a cardboard display box with a copy of the instructions for use.
Matrix Stretch Resistant Detachable Coils are detached using Boston Scientific's GDC® Power Supply. The system consists of the power supply, powered by two 9 volt batteries, an occlusion coil attached to a delivery wire, a set of connecting cables and a patient return electrode. A positive cable (red) supplies current to the delivery wire while a negative cable (black) completes the circuit by connecting to the patient return electrode (either an adhesive patch attached to the patient's skin or a hypodermic needle inserted subcutaneously through the patient's skin). After placement of the coil in the anatomy, detachment occurs through the clectrolytic dissolving of a small portion of the delivery wire.
Here's a breakdown of the acceptance criteria and study information based on the provided text for the Matrix™ Stretch Resistant Detachable Coils:
1. Table of Acceptance Criteria and Reported Device Performance
| Test or Point of Comparison | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Friction | Meets acceptance criteria | Meets acceptance criteria. |
| Deployment / Retraction | Meets acceptance criteria | Meets acceptance criteria. |
| Catheter Coil Compatibility | Meets acceptance criteria | Meets acceptance criteria. |
| Coil Bond Integrity | Meets acceptance criteria | Meets acceptance criteria. |
| Suture-to-Coil Bond Integrity | Meets acceptance criteria | Meets acceptance criteria. |
| Main Coil Conductivity | Meets acceptance criteria | Meets acceptance criteria. |
| Tensile Strength: main coil-to-pusher wire | Meets acceptance criteria | Meets acceptance criteria. |
| Tensile Strength: stretch resistant suture | Meets acceptance criteria | Meets acceptance criteria. |
| Tensile Strength: distal tip ball | Meets acceptance criteria | Meets acceptance criteria. |
| Proximal Coil Stiffness | Meets acceptance criteria | Meets acceptance criteria. |
| Acute Particulate | Meets acceptance criteria | Meets acceptance criteria. |
| Dynamic Particulate | Meets acceptance criteria | Meets acceptance criteria. |
| Suture Degradation | Meets acceptance criteria | Meets acceptance criteria. |
| Coil Stiffness | Meets acceptance criteria | Meets acceptance criteria. |
| Secondary Coil OD Shape Retention | Meets acceptance criteria | Meets acceptance criteria. |
| Detachment Time | No adverse effect expected | Modification has no affect upon detachment time |
| Inner Coil Weld Strength | No adverse effect expected | Modification has no affect upon inner coil weld strength |
| Coil Migration | No adverse effect expected | Modification has no affect upon coil migration |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test or the data provenance (e.g., country of origin, retrospective/prospective). The studies appear to be bench-top verification tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The tests described are engineering/performance-based, not clinical studies requiring expert ground truth for interpretation of outcomes.
4. Adjudication Method for the Test Set
This information is not applicable and is not provided. The tests described are objective measurements against predefined engineering specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document focuses on technical verification tests to demonstrate substantial equivalence to predicate devices, not clinical effectiveness studies with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies described are standalone performance tests of the device itself, without human-in-the-loop performance considerations. These are material and mechanical property tests.
7. The Type of Ground Truth Used
The "ground truth" for these tests would be objective, pre-defined engineering specifications and measurable physical properties of the device components and its function, primarily mechanical and material characteristics. This isn't a clinical "ground truth" based on pathology or outcomes data.
8. The Sample Size for the Training Set
This document does not describe a "training set" as it would be used in the context of an AI/ML algorithm. The studies are traditional device verification tests.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of this device's verification. The "ground truth" for these engineering tests would have been established through a combination of industry standards, internal design specifications, and performance characteristics of the predicate devices.
§ 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).