(47 days)
Easi-Vue® embolic microspheres System is intended for embolization of arteriovenous malformations and hypervasular tumors.
Easi-Vue embolic microspheres are biocompatible, radiopaque, non-compressible, non-resorbable glass microspheres. The Easi-Vue embolic microspheres are included with the Easi-Vue embolic microspheres System which is comprised of Easi-Vue embolic microspheres Delivery Device and the Easi-Vue embolic microspheres Refill Syringe. The Delivery Device provides for controlled and targeted delivery of imageable radiopaque microspheres contained in the Refill Syringe. The Easi-Vue® embolic microspheres System is offered in three sizes: 50um, 100μm, and 150μm to occlude various size arteries for the purpose of blocking blood flow to a target tissue (as summarized in Table 1).
The Easi-Vue embolic microsphere System is sterile, single use, and available only for prescription use. The device is compatible with a catheter with minimum inner diameter of 0.021" and a length between 110-150 cm (as appropriate for the diameter of the intended treatment vessel).
The provided document does not describe acceptance criteria for a study proving device performance in the context of an AI/ML medical device.
The document is a 510(k) premarket notification letter from the FDA for a medical device called "Easi-Vue® embolic microspheres System." This device is a vascular embolization device, not an AI/ML-driven device.
Therefore, the specific information requested in the prompt, which is tailored to the evaluation of AI/ML device performance (e.g., sample size for test sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance, training set details), is not present in the provided text.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Easi-Vue™ embolic microspheres System, K220567), primarily through:
- Indications for Use Comparison: Stating that the indications for use are equivalent.
- Technological Comparison (Table 2): Highlighting similarities in mechanism of action, principle of operation, material composition of the microspheres, size range, physical characteristics, performance, pyrogenicity, MR safety, sterility, and packaging. It notes differences in the material composition and design of the "Delivery Device" but concludes these differences "raise no new safety concerns."
- Non-Clinical Performance Summary: Briefly mentioning that bench testing (including simulated use and performance verification) and biocompatibility studies were conducted and that the system "met all the acceptance criteria and performed as intended." However, the document does not elaborate on what those acceptance criteria were or provide detailed results from these studies.
In summary, none of the requested information regarding acceptance criteria and studies for an AI/ML device is available in this document. The document pertains to a traditional medical device demonstrating substantial equivalence via non-clinical (bench and biocompatibility) testing, not AI/ML performance evaluation.
§ 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).