(89 days)
The AMPLATZER Vascular Plug is indicated for arterial and venous embolizations in the peripheral vasculature.
The AMPLATZER Vascular Plug is provided sterile and is intended for one-time use. The AMPLATZER Vascular Plug is a self-expandable, cylindrical device made from a Nitinol wire mesh. The device is secured on both ends with platinum marker bands. The delivery system is comprised of a 135 cm long, stainless steel delivery cable and a PTFE loader. The AMPLATZER Vascular Plug is preloaded in a loader and delivered through currently available standard 5 or 6 French guiding catheters.
Here's an analysis of the provided text regarding acceptance criteria and the supporting study for the AMPLATZER® Vascular Plug:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes various tests performed on the AMPLATZER Vascular Plug and its delivery system, primarily focusing on mechanical performance, biocompatibility, and comparing its embolization efficacy to existing coil devices in an animal model. Unlike typical AI/software device submissions, this document focuses on a physical medical device. Therefore, the "acceptance criteria" are more about demonstrating safety and functional equivalence to predicate devices, rather than specific performance metrics like sensitivity, specificity, or AUC as seen in AI/ML applications.
| Acceptance Criterion Category | Specific Criterion / Test Performed | Reported Device Performance (Results) |
|---|---|---|
| Efficacy (Animal Study) | Shorter occlusion time compared to standard coils | Occlusion time: 5.0 ± 3.5 minutes (AMPLATZER) vs. 10.2 ± 9.8 minutes (Cook coils), P |
§ 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).