(29 days)
The Micrus Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and are also intended for arterial and venous embolizations in the peripheral vasculature.
The Micrus Microcoil System consists of an embolic coil ("Microcoil") attached to a Device Positioning Unit ("DPU")
This document, K082739, is a 510(k) premarket notification for a medical device called the "Micrus Microcoil Delivery System." It aims to demonstrate substantial equivalence to previously cleared devices rather than prove the device meets specific acceptance criteria through a formal study with statistical endpoints. As such, the provided text does not contain the information required to populate most sections of your request.
Here's a breakdown based on the information available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not present in the provided document. The 510(k) submission focuses on demonstrating substantial equivalence through design, material, function, and intended use comparison, along with non-clinical testing. It does not detail specific performance metrics and acceptance criteria for patient outcomes or diagnostic accuracy that would be found in a clinical study for a new device.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not applicable/not present. No "test set" in the context of a clinical study for performance evaluation is described. The submission relies on "non-clinical testing" which typically refers to bench testing, engineering tests, and biocompatibility, not patient data for performance evaluation in the way you're asking.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable/not present. As there is no clinical test set described, there's no mention of experts establishing ground truth for such a set.
4. Adjudication Method for the Test Set:
This information is not applicable/not present. No clinical test set or adjudication process is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This information is not applicable/not present. The document does not describe any MRMC study. The comparison is to predicate devices through design and function, not through a clinical performance comparison with human readers.
6. Standalone (Algorithm Only) Performance Study:
This information is not applicable/not present. This device is a physical medical device (microcoil delivery system), not an algorithm or AI-based diagnostic tool.
7. Type of Ground Truth Used:
This information is not applicable/not present in the context of a clinical performance study. For the substantial equivalence claim, the "ground truth" or basis of comparison is the safety and effectiveness of the predicate devices as established by their prior FDA clearance. The assessment is then whether the new device is "substantially equivalent" to these already cleared devices, meaning its design, materials, function, and intended use are similar enough that it raises no new questions of safety or effectiveness.
8. Sample Size for the Training Set:
This information is not applicable/not present. This is not a study involving a "training set" for an algorithm or a clinical trial with patient enrollment numbers.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable/not present.
Summary of what the document does state regarding acceptance criteria and "proof":
The document states that the Micrus Microcoil Delivery System with a new "Device Positioning Unit" has shown substantial equivalence to FDA-cleared and marketed Micrus Microcoil Systems.
The "proof" for this substantial equivalence is based on:
- Comparison of intended use, design, material, method of construction, and dimensions to predicate devices.
- The assertion that "The modification has not altered the fundamental technology of the predicate devices."
- Non-clinical testing performed by Micrus Endovascular Corporation. (The specifics of this testing, its acceptance criteria, and results are not detailed in this summary document.)
Conclusion:
This 510(k) summary is designed to demonstrate that the modified device is substantially equivalent to existing, cleared devices. It does not contain the kind of detailed study information (acceptance criteria, sample sizes, expert ground truth, etc.) that would be found for a novel device undergoing a performance study or a clinical trial with predefined endpoints. The "acceptance criteria" here implicitly align with the FDA's requirements for substantial equivalence for a Class II device.
§ 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).