(87 days)
GelSpheres™/Bead Block™ Compressible Microspheres are indicated for Embolization of hypervascular tumors and arteriovenous malformations (AVM's).
GelSpheres™ and Bead Block™ Compressible Microspheres are preformed soft, deformable microspheres that occlude arteries for the purpose of blocking the blood flow to a target tissue, such as a hypervascular tumor or arteriovenous malformations (AVM's). GelSpheres™ and Bead Block ™ Compressible Microspheres consist of a macromer derived from polyvinyl alcohol (PVA). The fully polymerized microsphere is approximately 90% water and is compressible to approximately 20-30% by diameter. Bead Block™ Compressible Microspheres is dyed blue (GelSpheres™ are available in natural color) to aid in the visualization of the microspheres in the delivery syringe. The microspheres can be delivered through typical microcatheters in the 1.8-5Fr range.
GelSpheres ™ Microspheres is supplied sterile and packaged in sealed glass vials. Bead Block™ Compressible Microspheres is supplied sterile and packaged in a polycarbonate syringe. Two quantities will be available in a vial: (1) 1.0 mL GelSpheres™ /Bead Block™ Compressible Microspheres in sterile physiologic buffered saline (PBS) to a volume of 8 mL, and (2) 2.0mL GelSpheres™/Bead Block™ Compressible Microspheres in sterile PBS to a volume of 8 mL.
GelSpheres™ and Bead Block Compressible Microspheres are supplied in several unit sizes covering the range from 100μm to 1200um diameter. At the time of use, GelSpheres"™/Bead Block™ Compressible Microspheres is mixed with a nonionic contrast agent, e.g. Omnipaque, to make a 30-50% by weight solution. The bolus of contrast agent elutes from the vascular bed to leave a radiolucent, embolized vessel.
The provided FDA 510(k) Pre-Market Notification for GelSpheres™ Microspheres and Bead Block™ Compressible Microspheres does not describe a study that uses acceptance criteria related to device performance metrics, nor does it report on such performance metrics for the device itself.
Instead, this submission focuses on demonstrating substantial equivalence to previously cleared predicate devices (K023089 and K033761). The core of the submission is that the current device (K042231) is identical in design, intended use, warnings, contraindications, product, manufacturing, and primary packaging to the predicates. The only reported change is the final packager from BioCure, Inc. to Biocompatibles UK Ltd.
Therefore, the information requested in your prompt regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not present in this document.
The document lists Performance Standards that the device meets, but these are generic regulatory and biological evaluation standards, not specific performance metrics (e.g., accuracy, sensitivity, specificity) for evaluating its efficacy in embolization. These standards ensure the device meets safety and manufacturing requirements, but not a clinical performance standard regarding, for example, the success rate of embolization or reduction in tumor size.
Specifically:
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A table of acceptance criteria and the reported device performance: Not applicable. No performance metrics (e.g., embolization success rate, AVM reduction) or associated acceptance criteria are stated or evaluated in this document. The "acceptance criteria" here are implied to be meeting the listed performance standards (e.g., ISO, AAMI for biocompatibility, sterility, packaging), and the "device performance" is deemed equivalent to the predicate devices.
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Sample sizes used for the test set and the data provenance: Not applicable. No clinical or performance test set data is presented.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth for performance evaluation is established or discussed.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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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: Not applicable. This device is a medical implant (microspheres for embolization), not an AI-powered diagnostic or assistive tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
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The sample size for the training set: Not applicable.
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How the ground truth for the training set was established: Not applicable.
In summary, this 510(k) submission primarily relies on demonstrating substantial equivalence based on design and intended use rather than presenting new clinical or performance data against pre-defined acceptance criteria for efficacy. The "study that proves the device meets the acceptance criteria" refers to the entire 510(k) submission process, which asserts equivalence and compliance with general safety and performance standards rather than specific performance metrics directly related to its therapeutic effect.
§ 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).