FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

This document is a 510(k) summary for the Micrus Cashmere-14 Microcoil System. It is a premarket notification to the FDA to demonstrate substantial equivalence to legally marketed predicate devices, not a study of device performance against acceptance criteria in the typical sense of a clinical trial for an AI/ML device.

Therefore, many of the requested categories are not applicable to this type of regulatory submission for a medical device that is not an AI/ML product.

Here's a breakdown of the information that is available or applicable from the provided text, and an explanation of why other requested information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

This type of table is not present because this is a 510(k) submission focused on substantial equivalence to existing predicate devices, rather than meeting novel performance acceptance criteria through a standalone study. The "performance" described is the device's design, material, function, and manufacturing being equivalent to predicate devices.

Acceptance Criteria (Implied by Substantial Equivalence to Predicates)	Reported Device Performance (as per submission)
Intended Use equivalent to predicate devices	Equivalent: Intended for endovascular embolization of intracranial aneurysms.
Design equivalent to predicate devices	Equivalent: Shares design characteristics.
Material of construction equivalent to predicate devices	Equivalent: Uses same method and material of construction as predicate (Micrus SR Helical-18 Microcoil System). Equivalent to Boston Scientific GDC 360 and Cordis Orbit microcoil predicates.
Implant dimensions (wire diameter, primary wind diameter, pitch, coil stiffness, coil diameter, coil length) equivalent to predicate devices	Equivalent: Same dimensions as predicate (Micrus SR Helical-18 Microcoil System). Equivalent to Boston Scientific GDC 360 and Cordis Orbit microcoil predicates.
Manufacturing method equivalent to predicate devices	Equivalent: Uses same method as predicate (Micrus SR Helical-18 Microcoil System).
Packaging equivalent to predicate devices	Equivalent: Uses same packaging as predicate (Micrus SR Helical-18 Microcoil System).
Sterilization method equivalent to predicate devices	Equivalent: Uses same sterilization method as predicate (Micrus SR Helical-18 Microcoil System).
No alteration to fundamental technology of predicate device	Confirmed: "The modification has not altered the fundamental technology of the sponsor's predicate device."
Safety and Effectiveness substantially equivalent to predicate devices	Concluded: "It is concluded that the Micrus Cashmere-14 Microcoil System is substantially equivalent to the predicate devices in safety and effectiveness."

2. Sample size used for the test set and the data provenance

Not Applicable: This document does not describe a clinical study or a "test set" of patient data in the context of an AI/ML device or novel performance criteria. The evaluation is based on non-clinical testing (likely bench testing, material testing, and design comparisons) and comparison to predicate devices, not data from a test set of patient cases.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable: There is no "test set" of patient cases for which ground truth would be established by experts. The evaluation focuses on engineering and material equivalence.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not Applicable: No clinical test set.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable: This device is a physical medical implant (a microcoil), not an AI/ML diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is irrelevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not Applicable: This device is a physical medical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not Applicable: For a 510(k) submission showing substantial equivalence of a physical device, the "ground truth" is typically the established safety and effectiveness of the predicate device(s) and demonstrable equivalence in design, materials, and function through engineering tests and analyses, rather than clinical outcomes or pathology data for a new device.

8. The sample size for the training set

Not Applicable: This is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established

Not Applicable: This is not an AI/ML device requiring a training set.

Summary of the document's content:

The document is a 510(k) Premarket Notification for the Micrus Cashmere-14 Microcoil System. It asserts that the device is substantially equivalent to several predicate devices (Micrus SR Helical-18 Microcoil System, Boston Scientific GDC 360, Cordis Trufill DCS Orbit Detachable Coil) in terms of:

Intended Use: Endovascular embolization of intracranial aneurysms.
Design: Including implant dimensions (wire diameter, primary wind diameter, pitch, coil stiffness, coil diameter, coil length).
Material of Construction: Same method and material.
Manufacturing Method.
Packaging.
Sterilization Method.

The conclusion is based on design, materials, function, intended use, and non-clinical testing performed by Micrus Endovascular Corporation, leading to the determination of substantial equivalence in safety and effectiveness. The FDA concurred with this determination, allowing the device to be marketed.

Summary

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).