(29 days)
The Barricade Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Barricade Coil System is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.
The Barricade Embolization Coil System (BCS) is a series specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant comprised of platinum/tungsten, affixed to a delivery pusher with an introducer sheath to facilitate insertion into the hub of a microcatheter. The system is available in various shapes, lengths and sizes. The devices are to be placed into aneurysms to create blood stasis, reducing flow into the aneurysm and thrombosing the aneurysm. Upon positioning coils into the aneurysm, the coils are electrolytically detached from the delivery pusher in serial manner until the aneurysm is occluded.
Here's an analysis of the provided text regarding the Barricade Embolization Coil System's acceptance criteria and study information:
This document is a 510(k) summary for a medical device (Barricade Embolization Coil System), which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone clinical trial with detailed acceptance criteria for a novel AI algorithm. Therefore, many of the requested points related to AI performance, ground truth, and expert adjudication are not applicable to this type of submission.
The "study" in this context refers to the non-clinical performance testing conducted to show the device functions as intended and is comparable to previously cleared devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Visual inspection | Met all specified criteria |
| Dimensional measurement | Met all specified criteria |
| Simulated Use (Introduction, Tracking, Reposition/deployment, Detachment) | Met all specified criteria; demonstrated substantial equivalence to predicate devices |
| SR tensile | Met all specified criteria |
2. Sample size used for the test set and the data provenance
- Sample size: Not explicitly stated. The document mentions "test units representative of finished devices," but does not provide specific numbers for each test.
- Data provenance: Not explicitly stated. The testing was performed internally by the manufacturer, Blockade Medical. Given it's a 510(k) summary, the tests are typically conducted in a laboratory setting. No information on country of origin of data (likely USA, where Blockade Medical is located) or retrospective/prospective nature is provided, as these are non-clinical engineering tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This device is a physical medical implant, not an AI algorithm requiring expert ground truth for image or data analysis. The "ground truth" here is adherence to engineering specifications and functional performance.
4. Adjudication method for the test set
- Not applicable. See point 3. Testing involved standard engineering measurements and visual inspections against predefined specifications.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is not an AI diagnostic, prognostic, or assistive device. It is a physical embolization coil system. Therefore, no MRMC study or AI-assisted human reader improvement analysis was performed or is relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. See point 5.
7. The type of ground truth used
- Engineering Specifications and Functional Performance Benchmarks: The "ground truth" for this device's performance is adherence to established engineering specifications (e.g., dimensions, material properties, detachment mechanism) and functional performance observed during simulated use testing that demonstrates its intended operation and comparability to predicate devices.
8. The sample size for the training set
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI. Performance is based on physical device testing, not data training.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
§ 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).