(64 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.
The provided text describes a 510(k) summary for the Barricade Embolization Coil System, focusing on demonstrating substantial equivalence to a predicate device. It details the technical characteristics and the performance data that was collected.
Here's an analysis of your requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Specified Criteria) | Reported Device Performance |
|---|---|
| Visual inspection performance | "The modified Barricade Coil System met all specified criteria and did not raise new safety or performance questions." |
| Dimensional measurement performance | "The modified Barricade Coil System met all specified criteria and did not raise new safety or performance questions." |
| Simulated Use Performance: | "The modified Barricade Coil System met all specified criteria and did not raise new safety or performance questions." |
| - Introduction | "The modified Barricade Coil System met all specified criteria and did not raise new safety or performance questions." |
| - Tracking | "The modified Barricade Coil System met all specified criteria and did not raise new safety or performance questions." |
| - Reposition/deployment | "The modified Barricade Coil System met all specified criteria and did not raise new safety or performance questions." |
| - Detachment | "The modified Barricade Coil System met all specified criteria and did not raise new safety or performance questions." |
| - Overall Performance | "The modified Barricade Coil System met all specified criteria and did not raise new safety or performance questions." |
| Detachment Zone tensile performance | "The modified Barricade Coil System met all specified criteria and did not raise new safety or performance questions." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states: "All testing was performed on test units representative of finished devices." However, it does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the text. The testing conducted was focused on engineering performance (visual inspection, dimensional measurement, simulated use, detachment zone tensile) rather than clinical evaluation requiring expert ground truth in the context of diagnostic or interpretive tasks.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and therefore not provided in the text. The type of testing described (engineering verification and validation) does not involve adjudication by multiple human experts in the way clinical studies or image-based diagnostic device studies do.
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
No MRMC comparative effectiveness study was done or mentioned. This document pertains to a medical device (embolization coil system) and its physical and functional performance, not an AI-powered diagnostic or interpretive tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical embolization coil system, not an algorithm. Therefore, "standalone" algorithm performance is not a relevant concept here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the engineering performance tests would be the engineering specifications and design requirements for the device. For example, a "visual inspection" would verify that the device meets visual quality standards, a "dimensional measurement" would confirm it meets specified dimensions, and "simulated use" would confirm its functional performance in a simulated environment as designed. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for these tests.
8. The sample size for the training set
This is not applicable. The device is a physical medical implant, not an AI model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable. As mentioned in point 8, there is no training set for this device.
§ 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).