HYDROCOIL(R) EMBOLIC SYSTEM (HES)

• K Number: K112181
• Device Name: HYDROCOIL(R) EMBOLIC SYSTEM (HES)
• Manufacturer: MICROVENTION, INC.
• Date Cleared: 2011-12-01 ( 126 days)
• Product Code: HCG , KRD
• Regulation Number: 882.5950
• Type: Special
• Panel: NE
• Reference & Predicate Devices: K100454
• Predicate For: N/A

Intended Use

The HydroCoil® Embolic System (HES) is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The HES is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.

Device Description

The MicroVention HydroCol® Embolic System (HES) consists of an implantable coil attached to a delivery system called a V-Trak® delivery pusher. The HES coils are platinum coils augmented with a hydrophilic polymer. The V-Trak delivery pusher is powered by a V-Grip® detachment controller, which is provided separately.

The HES is available in several coil types based on the coil primary diameter and configuration. Each coil type must be delivered only through a wire-reinforced microcatheter with the minimum inner diameter specified. Within each coil type is a broad range of coil secondary (loop) diameters and lengths.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The document is a 510(k) summary for the HydroCoil® Embolic System (HES), a neurovascular embolization device.

This document primarily focuses on:

• Device Description: What the HydroCoil Embolic System is.
• Indications for Use: The medical conditions and procedures for which the device is intended.
• Substantial Equivalence: A claim that the updated device (with modified product labeling) is substantially equivalent to a previously cleared predicate device, based on a clinical trial.

Crucially, this document is not a study report and does not contain the specific information requested in your prompt regarding acceptance criteria, device performance metrics, sample sizes, ground truth establishment, or human-in-the-loop studies for AI algorithms.

The text mentions the "HydroCoil Endovascular Aneurysm Occlusion and Packing Study (HELPS) trial" as the basis for updating the labeling and demonstrating substantial equivalence. However, it does not provide any details about the design, results, or specific acceptance criteria met by the device in that trial. It only states that the purpose of the submission is to "update the labeling with the additional device experience from the HELPS trial."

Therefore, I cannot fulfill your request for the detailed information as it is not present in the provided text.

Regulation Number and Section

§ 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).