(134 days)
Berenstein Coils are intended for the embolization of vascular malformations of the peripheral and neuro vasculature.
The Berenstein Coil is an occlusion coil designed to be delivered by injection through either Target Therapeutics Infusion Catheters or Balt Magic 1.5F and 1.8F catheters. These coils are radiopaque.
The Berenstein Coil is available in a helical shape, in 0.008 or 0.016 inch primary wind diameter (Berenstein Coil - 10 and Berenstein Coil - 18, respectively), and in a variety of lengths. The Berenstein Coil comes loaded in a sheath-like introducer for easy transfer into a catheter.
An adapter, manufactured by Target Therapeutics, is required when Berenstein Coil - 10 Occlusion Devices are used with Balt Magic catheters. The Adapter may be supplied with the Berenstein Coil or may be available separately.
The provided text is a 510(k) summary for the Berenstein Coil, a medical device. It describes the device, its intended use, and predicate devices. Crucially, it does not contain any information about acceptance criteria, study data, sample sizes, ground truth establishment, or expert involvement for evaluating device performance.
Therefore, I cannot fulfill your request for specific details regarding acceptance criteria and study data as this information is not present in the provided input. This document is a regulatory submission summary, not a detailed clinical study report or performance evaluation.
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- The specific performance metrics and their acceptance thresholds.
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§ 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).