(60 days)
The Micrus Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms.
The Micrus Cashmere-Cerecyte and Cashmere-SR Microcoil Systems each consists of an embolic coil (“Microcoil”) attached to Device Positioning Unit (DPU) (single use, sterile)
This document describes a 510(k) premarket notification for the Micrus Microcoil Delivery System and does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices, which is a different regulatory pathway.
Therefore, I cannot fulfill the request to provide information based on acceptance criteria and a study from the provided text.
Here's why the prompt cannot be answered with the given text:
- Type of Submission: The document is a "Summary of Safety and Effectiveness" for a 510(k) submission. 510(k) submissions typically demonstrate substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific, predefined acceptance criteria through a clinical or performance study.
- Content Focus: The text explicitly states, "Based upon the design, materials, function, intended use, comparison with currently marketed devices and the non-clinical testing performed by Micrus Endovascular Corporation, it is concluded that the Micrus Cashmere-Cerecyte and Cashmere-SR Microcoil Systems are substantially equivalent to the predicate devices in safety and effectiveness." This indicates that the "study" was primarily a comparison to existing devices and non-clinical testing, not a formal study with acceptance criteria being met.
- Missing Information: The document lacks the detailed information requested in the prompt, such as:
- Specific acceptance criteria values.
- Quantitative performance results for the new device against those criteria.
- Sample sizes for test sets, data provenance, ground truth establishment, expert information, adjudication methods, MRMC studies, or standalone algorithm performance.
- Training set details.
In summary, the provided text is a regulatory clearance document for a medical device based on substantial equivalence, not a detailed report of a study designed to meet specific acceptance 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).