(63 days)
The Barricade Coil System is intended for the endovascular embolization of intracranial aneurysm 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 The system consists of an embolization coil implant comprised of vascular anomalies. 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 rather than presenting a standalone study with detailed acceptance criteria and performance metrics for a new or significantly modified device. Therefore, much of the requested information regarding "acceptance criteria" and "study proving the device meets the acceptance criteria" in the context of a new AI or diagnostic device is not applicable here.
This submission is for a modification to an existing neurovascular embolization device (Barricade Embolization Coil System) and aims to show that the modified device is substantially equivalent to the previously cleared predicate devices (K123338 and K131475). The modifications primarily relate to the inclusion of an optional Handheld Detachment Cable.
Here's an analysis based on the available text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implied/Inferred) | Reported Device Performance |
|---|---|---|
| Simulated Use | The modified device performs equivalently to the predicate device (K123338) and the optional Handheld Detachment Cable has no adverse effect on established performance characteristics. | "The modified device achieved the same results as that of the predicate device (K123338)." "The optional Handheld Detachment Cable has no adverse effect on the established performance characteristics of the device." |
| Tensile Test | The modified device demonstrates adequate tensile strength to withstand anticipated forces during use, and the optional Handheld Detachment Cable has no adverse effect. | "The modified device demonstrated adequate tensile strength to withstand anticipated forces during use." "The optional Handheld Detachment Cable has no adverse effect on the established performance characteristics of the device." |
| Packaging Validation | All packaging demonstrates adequate seal strength and intact sterile barrier, and the optional Handheld Detachment Cable has no adverse effect on these characteristics. | "All packaging demonstrated adequate seal strength and intact sterile barrier." "The optional Handheld Detachment Cable has no adverse effect on the established sterile barrier characteristics of the device." |
| Sterility | Sterility Assurance Level 10^-6 is achieved, and the optional Handheld Detachment Cable has no adverse effect. | "Sterility Assurance Level 10^-6." "The optional Handheld Detachment Cable has no adverse effect on the established sterility characteristics of the device." |
Note on Acceptance Criteria: The document does not explicitly state numerical or specific performance acceptance criteria. Instead, the acceptance criteria are implicitly defined by "sameness" or "no adverse effect" compared to the predicate device's established performance, and meeting general standards like "adequate tensile strength" and "Sterility Assurance Level 10^-6". This is typical for 510(k) submissions demonstrating substantial equivalence for minor modifications.
2. Sample Size Used for the Test Set and Data Provenance
The document states, "All testing was performed on test units representative of finished devices." However, it does not specify the exact sample size (N) for each test (Simulated Use, Tensile Test, Packaging Validation, Sterility).
The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective." Given that these are bench and lab tests, the data would originate from the testing facility (most likely in the US, where Blockade Medical is located). These tests are typically conducted prospectively as part of the verification and validation process for the device modification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This type of information is not applicable to this 510(k) submission. "Ground truth" and "experts" in this context typically refer to clinical or diagnostic evaluation where human interpretation is involved (e.g., radiologists reading images). This submission pertains to the physical and functional performance of a medical device, evaluated through engineering and laboratory tests.
4. Adjudication Method for the Test Set
This is not applicable as there is no clinical test set requiring adjudication of findings (e.g., image interpretations). The tests performed are objective, quantitative measurements in a laboratory setting.
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
This is not applicable. The device is a physical embolization coil system, not an AI or diagnostic software. Therefore, no MRMC study or AI assistance evaluation was performed.
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 medical device, not an algorithm or software.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests (e.g., tensile strength, sterility) is based on objective engineering and laboratory measurements against established standards and internal specifications, and comparison to the predicate device's known performance. It is not based on expert consensus, pathology, or outcomes data in a clinical sense.
8. The Sample Size for the Training Set
This is not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
This is not applicable for the same reasons as above.
§ 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).