(377 days)
Embozene™ Microspheres are indicated for the embolization of hypervascular tumors and arteriovenous malformations. Embozene™ Microspheres may be used for vasculturion of blood vessels within the neurovascular system.
Celonova BioSciences, Inc. Embozene™ Microspheres are spherical embolic hydrogels. They are artificial embolization devices used to obstruct or reduce blood flow to hypervascularized tumors or artenovenous mall ormations via selective microcatheter delivery.
The embolization particles are available in seven (7) size ranges of 40, 100, 250, 400, 500, 700 and 900 um diameters to enable appropriate size selection for the turnor or malformation to be treated. Embozene™ Microspheres are designed for use under fluoroscopic guidance through compatible delivery catheters. The product is provided as a sterile, non pyrogenic, single use device. It is an uncolored or color-coded particle that is opaque under fluoroscopy. The product and its delivery container are steam sterlized.
The provided text is a 510(k) summary for the Embozene™ Microspheres. It states "Clinical Data: None required." and does not contain information about acceptance criteria or a study proving the device meets said criteria. Therefore, most of the requested information cannot be extracted from the given text.
However, I can provide what little information is available:
1. A table of acceptance criteria and the reported device performance
Not provided. The submission states, "Clinical Data: None required."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable, as no clinical data was required or provided.
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)
Not applicable, as no clinical data was required or provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical data was required or provided.
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
Not applicable, as no clinical data was required or provided, and this is not an AI/imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI/algorithm device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable, as no clinical data was required or provided. The device relies on substantial equivalence to predicate devices.
8. The sample size for the training set
Not applicable, as no clinical data was required or provided, and this is not an AI/algorithm device.
9. How the ground truth for the training set was established
Not applicable, as no clinical data was required or provided, and this is not an AI/algorithm device.
§ 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).