(23 days)
The Micrus MicroCoil Delivery System is intended for endovascular embolization of intracranial aneurysms.
The Micrus Modified Microcoil System, "Cerecyte-18" is intended for endovascular embolization of intracranial aneurysms.
The Micrus Modified MicroCoil 18-System (Cerecyte) consists of an embolic coil ("MicroCoil") attached to a Device Positioning Unit (DPU) (single use, sterile). The Cerecyte 18-System is compatible with commercially available 2-tip marker microcatheters which have internal lumen diameters between 0.017" and 0.021." The coils are available in helical and spherical shapes and are available in various diameters/lengths: Coil lengths range from 4 to 30 centimeters. Coil diameters range from 2 to 20 millimeters. Micrus Cerecyte MicroCoils are fabricated from a platinum alloy wire, which is first wound into a primary coil (containing an absorbable polymer suture inside the wind) and then formed into a secondary helical or spherical shape. The only difference between the Cerecyte 18 System and 10 System is size. Both contain PGA suture as their stretch resistant member. Both contain exactly the same PGA strand, i.e., the amount of PGA suture material is identical. Micrus does not insert a larger strand of suture in the 18 system coils. The 18 System Cerecyte MicroCoils maintain the same design features as all the current MicroCoil Systems. Compared with the current design, size 18 Cerecyte MicroCoil Systems have: The same intended use. Connect to the same connecting cables Detach using the same Detachment Control Box.
Here's an analysis of the acceptance criteria and study information provided for the Cerecyte-18 MicroCoil System:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria / Characteristic | Reported Device Performance / Test Data | Substantial Equivalence Status |
|---|---|---|
| Coil Stiffness/Softness for Cerecyte-18 MicroCoils | The Cerecyte-18 MicroCoils met the stiffness specifications. | Substantially equivalent |
| Friction in the Microcatheter (Delivery Force) | The Modified MicroCoil had average push forces that are comparable to those of the predicate. | Substantially equivalent |
| Tensile Strength | Tensile strength meets desired strength criteria. (Specifically, pre-detachment tensile strength of the suture ball tip and MicroCoil to DPU must be substantially equivalent to the stretch resistant Cerecyte-10 predicate) | Substantially equivalent to the stretch resistant predicate |
| Durability (Reliability after Fatigue) | No knotting, no breakage, no stretching occurred (after withstanding deployment and retraction 6 times in a tortuous anatomy). Durability meets desired durability criteria. | Substantially equivalent |
| Sterilization Validation | Cerecyte-10 was validated under V0394 with a minimum Sterility Assurance Level of 10-6. Due to significant similarities (materials, manufacturing, product weight/density, packaging) between 10 & 18 Systems, V0394 serves as validation for the 18-system. | Substantially equivalent |
| MRI Compatibility of Implant | No change was made which would impact MRI compatibility. | Substantially equivalent |
| Package Integrity | No change was made to packaging. Reference Cerecyte 10 test result V0399. (Characteristic: Demonstrate package integrity per ISO 11607) | Substantially equivalent |
| Ship/Transit | Does successfully withstand domestic and international distribution environment. No change was made to packaging or product materials. Reference Cerecyte 10 test result V0400. (Characteristic: Successfully withstand domestic and international distribution environment) | Substantially equivalent |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the specific numerical sample sizes used for each test (e.g., how many coils were tested for stiffness, or how many deployments for durability). Instead, it describes the characteristics that were tested and the results.
- Data Provenance: The tests were performed by "Micrus Endovascular Corporation" (the manufacturer). The testing is implied to be prospective, laboratory-based functional testing on the device itself. No information is provided regarding the country of origin of the data beyond being generated by the company. The document does reference previous predicate device testing results (e.g., Cerecyte 10 System) to demonstrate substantial equivalence for some characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the document describes physical and functional testing of a medical device, not a diagnostic or prognostic AI/ML algorithm that requires expert-established ground truth. The acceptance criteria relate to engineering performance, sterility, and physical properties.
4. Adjudication method for the test set:
This information is not applicable for the same reason as above. The testing involves measurable physical and performance characteristics, not subjective interpretations requiring adjudication.
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:
This information is not applicable. The device (Cerecyte-18 MicroCoil System) is a physical medical implant used for embolization of intracranial aneurysms. It is not an AI/ML diagnostic tool or software-as-a-medical-device (SaMD) that would be used by human readers (e.g., radiologists) for interpretation assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable as the device is not an algorithm.
7. The type of ground truth used:
- For the physical and functional tests (stiffness, friction, tensile strength, durability, package integrity, ship/transit): The ground truth is based on engineering specifications and established functional criteria that align with safety and efficacy requirements for medical devices of this type. This is determined internally by the manufacturer and often aligns with industry standards or regulatory guidance.
- For sterilization: The ground truth is based on achieving a Sterility Assurance Level (SAL) of 10^-6, which is a recognized regulatory standard for sterile medical devices.
- For MRI compatibility: The ground truth is based on the absence of changes that would impact MRI compatibility, which implies adherence to standards or previous testing for the predicate device.
8. The sample size for the training set:
This information is not applicable as the device is a physical medical implant, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable as the device is a physical medical implant, not an AI/ML model.
§ 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).