(111 days)
Numen™ Coil Embolization System is intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Numen™ Coil Embolization System is indicated for endovascular embolization of:
-Intracranial aneurysms
-Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae -Arterial and venous embolizations in the peripheral vasculature
NumenFR™ Detachment System is intended for use with MicroPort NeuroTech Numen™ Coil Embolization System in the embolization of intracranial aneurysms and other vascular abnormalities of the neuro and peripheral vasculature.
MicroPort NeuroTech has developed the Numen™ Coil Embolization System and NumenFR™ Detachment System. The Numen™ Coil Embolization System is designed to be used in conjunction with the NumenFRTM Detachment System (sold separately) for endovascular embolization of vascular abnormalities described in the intended use.
The Numen™ Coil Embolization System is composed of two parts as described below:
- . An introducer sheath: The function of the introducer sheath is to facilitate introduction of the coil into the microcatheter.
- . The coil system: The coil system is composed of a pusher and coil implant. The coil is a permanent implant intended to occlude blood flow in vascular abnormalities. The pusher is used to deliver the coil implant to the target lesion.
The MicroPort NeuroTech NumenFRTM Detachment System is a sterile, handheld, single-patient use device designed for use with the MicroPort NeuroTech Numen™ Coil Embolization System. The device is operated by two pre-loaded batteries.
The provided text describes a 510(k) premarket notification for a medical device, the Numen™ Coil Embolization System and NumenFR™ Detachment System. The document details the device, its intended use, comparison to a predicate device, and performance testing. However, it does not describe acceptance criteria for a study proving the device meets those criteria in the context of an Artificial Intelligence/Machine Learning (AI/ML) powered medical device.
The "Performance Testing" section (page 6) outlines bench testing conducted to evaluate device changes and demonstrate substantial equivalence to a predicate device. This is typical for traditional (non-AI/ML) medical devices, focusing on physical and functional properties, rather than AI performance metrics like sensitivity, specificity, or reader agreement.
Therefore, I cannot fulfill your request to describe acceptance criteria and a study demonstrating an AI/ML device's performance based on the provided text, as the text pertains to a different type of medical device assessment.
If you can provide a document that discusses the evaluation of an AI/ML medical device, I would be happy to analyze it according to your requested criteria.
§ 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).