(29 days)
The Penumbra Smart Coil System is indicated for the embolization of:
- · Intracranial aneurysms
- · Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae
- · Arterial and venous embolizations in the peripheral vasculature
The Smart Coil functions to selectively embolize targeted segments of the vasculature by packing a sufficient quantity of bare platinum coils to achieve occlusion. The Smart Coil System consists of three components: a Coil Implant attached to a Detachment Pusher and a Detachment Handle.
The provided text is a 510(k) premarket notification for the Penumbra Smart Coil. This document is a regulatory submission to the FDA aiming to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device.
Crucially, this document is NOT a study that proves the device meets acceptance criteria. Instead, it's a justification for market clearance based on a comparison to an already approved device. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, device performance metrics, sample sizes for test or training sets, expert qualifications, or adjudication methods for a new study.
The document explicitly states:
- "A literature review was conducted to substantiate the safe and effective performance of the Smart Coil and Smart Coil Detachment Handle, as well as its substantial equivalence to the predicate device." This indicates that no new primary clinical study was performed for this specific 510(k) submission to establish performance against acceptance criteria.
- "Review concluded that revised labeling is appropriate." The core of this 510(k)'s purpose is to update the Instructions for Use (IFU), specifically revising a precaution and updating the manufacturer's address. It's not about proving new performance.
- "The Penumbra Smart Coil was found to have a safety and effectiveness profile that is similar to the predicate device." The "study" here is a comparison to a predicate device that was already cleared for market (K143218, cleared March 18, 2015).
Therefore, I cannot populate the requested table and answer the questions because the provided text describes a regulatory submission based on demonstrating substantial equivalence to a predicate device, not a new clinical or performance study with defined acceptance criteria and results.
§ 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).