(341 days)
Bead Block™ microspheres are intended to be used for the embolization of hypervascular tumors, including uterine fibroids and arteriovenous malformations (AVMs).
Bead Block™ is made up of preformed soft, deformable microspheres that occlude arteries for the purpose of blocking the blood flow to a target tissue, such as a fibroid or a cancerous tumor. Bead Block™ compressible microspheres consist of a macromer derived from polyvinyl alcohol (PVA). The fully polymerized microsphere is approximately 90-95% water and is compressible to approximately 30% by diameter. Bead Block™ microspheres are dyed blue to aid in the visualization of the microspheres in the delivery syringe. The microspheres can be delivered through typical microcatheters in the 1.5-5Fr range.
The provided document is a 510(k) summary for the Bead Block™ device, which is a vascular embolization device. The information requested pertains to the acceptance criteria and the study that proves the device meets the acceptance criteria. The document largely focuses on demonstrating substantial equivalence to a predicate device rather than performance against specific numeric acceptance criteria for the new device.
Here's an analysis based on the available information:
1. Table of acceptance criteria and the reported device performance
The document does not present a table of explicit numeric acceptance criteria. Instead, it relies on demonstrating that Bead Block™ is "as safe and effective as the predicate device" and that its performance is "similar to the predicate device". The "performance" is described qualitatively through the results of non-clinical and animal testing.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Material Properties: | |
| Residual starting material | Specifications met (details not provided) |
| Residual solvent material | Specifications met (details not provided) |
| Physical Appearance: | |
| Visual inspection | Visual defects, color, solution clarity evaluated (results not explicitly stated, but implied to be acceptable for substantial equivalence) |
| Delivery & Functionality: | |
| Catheter delivery | Evaluated for catheter clogging, aggregation, ease of injection, and particle shape after injection (results not explicitly stated, but implied to be acceptable for substantial equivalence, and "similar to the predicate device") |
| Particle size range | Confirmation performed (results not explicitly stated, but implied to be within specified range as per product configurations table, e.g., 100-300μm, 300-500μm, etc.) |
| Particle fiber shedding | Evaluated (results not explicitly stated, but implied to be acceptable for substantial equivalence) |
| Biocompatibility: | |
| pH | Evaluated (results not explicitly stated, but implied to be acceptable for substantial equivalence) |
| Endotoxin |
§ 870.3300 Vascular embolization device.
(a)
Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.(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 § 870.1(e).