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510(k) Data Aggregation
(148 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 the 510(k) summary for the Barricade Embolization Coil System, a neurovascular embolization device. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a new AI/software device. Therefore, much of the requested information regarding AI/software device studies is not available in this document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of acceptance criteria with specific quantitative targets for device performance in the way an AI/software device would. Instead, it lists various verification and validation tests and their results, primarily focusing on proving safety and substantial equivalence to predicate devices. The "acceptance criteria" are implied by the successful completion of these tests and their favorable outcomes, indicating non-toxicity, appropriate mechanical properties, and similar performance to predicate devices.
| Test Category | Implied Acceptance Criterion (from results) | Reported Device Performance (from results) |
|---|---|---|
| Biocompatibility (Implant) | Non-cytotoxic, non-sensitizing, non-irritant, non-hemolytic, non-toxic, non-pyrogenic, non-mutagenic, non-reactive. | 97% cell viability (Non-cytotoxic), No reaction (Non-sensitizing), No significant greater biological reaction than controls (Non-irritant), < 2% hemolysis (Non-hemolytic), Normal range PT (No adverse effect), No increase in complement activation (Doesn't induce), No significantly greater reaction than controls (Non-toxic), No individual temperature increase ≥ 0.5°C (Non-pyrogenic), No significant increase in revertant colonies (Not mutagenic), No significant increase in mutant frequency (Non-mutagenic), No statistical increase in micronucleated erythrocytes (Non-mutagenic), Bioreactivity rating 3.6 (Non-reactive), No local or systemic signs of toxicity (Non-toxic). |
| Biocompatibility (Delivery System) | Non-cytotoxic, non-sensitizing, non-irritant, non-toxic, non-hemolytic, non-pyrogenic. | < Grade 2 (Non-cytotoxic), Stimulation Indices < 3.0 (Not sensitizing), Mean score difference from control ≤ 1.0 (Non irritant), No mortality or systemic toxicity (Non-toxic), Mean hemolytic index 0% (Non-hemolytic), No individual temperature increase ≥ 0.5°C (Non-pyrogenic). |
| Mechanical/Functional Tests | Device performs as intended and is substantially equivalent to predicate devices. | Successful completion of: Visual inspection, Dimensional measurement, Simulated Use (Introduction, Tracking, Reposition/deployment, Detachment, Overall Performance), Detachment Zone tensile, Stretch Resistance tensile, Corrosion resistance, MR compatibility. |
| Acute Animal Studies | Achieves angiographic occlusion. | BCS product provided angiographic occlusion immediately following treatment. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The text mentions "test units representative of finished devices" for various tests but doesn't specify the sample size for individual tests or the provenance of any data beyond the internal testing performed by Blockade Medical.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided. This device is a medical implant (embolization coil system), not an AI/software device that requires expert review for "ground truth" establishment in a clinical performance study. The "ground truth" for this type of device typically relates to its physical and biological performance as measured through objective tests (e.g., tensile strength, biocompatibility assays, observed occlusion in animal models), not expert consensus on image interpretation.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. As explained above, the tests are primarily objective measurements of physical and biological properties. Adjudication methods like 2+1 or 3+1 are relevant for studies involving human interpretation (e.g., medical imaging reads) and are not used here.
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
This information is not applicable and not provided. The Barricade Embolization Coil System is a physical medical device, not an AI/software product designed to assist human readers. Therefore, an MRMC study related to AI assistance is not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable and not provided. The device is not an algorithm or software. It is a physical embolization coil system.
7. The Type of Ground Truth Used
For the biocompatibility and mechanical tests, the "ground truth" is established by:
- Objective laboratory measurements: Assays for cytotoxicity, hemolysis, tensile strength, corrosion, etc., against predefined scientific standards or benchmarks.
- Observation in animal models: Direct observation of angiographic occlusion in acute animal studies.
- Comparison to predicate devices: The overall performance is benchmarked against established characteristics of legally marketed predicate devices.
8. The Sample Size for the Training Set
This information is not applicable and not provided. This is not an AI/machine learning device, so there is no concept of a "training set" in the context of its development and validation.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided as there is no training set for this type of device.
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