(57 days)
The Micrus MicroCoil Delivery System is intended for endovascular embolization of intracranial aneurysms.
The Micrus Modified MicroCoil System consists of an embolic coil ("MicroCoil") attached to a Device Positioning Unit (DPU) (single use, sterile). The Micros Modified MicroCoils are available in a 10-System size, compatible with 10 and 14 sized microcatheters. They are available in helical and spherical shapes and are available in various diameters/lengths: Coil lengths range from 1 to 30 centimeters. Coil diameters range from 2 to 10 millimeters. Micrus Modified 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 difference between the Micros Modified MicroColl and the Micros Stretch Resistant MicroCoil is that the Modified MicroCoil and the MicroCoil contains absorbable polyglycolic acid (PGA) suture whereas the Stretch Resistant MicroCoil contains non-absorbable polypropylene suture. The Modified MicroCoils are available in both stretch resistant and non-stretch resistant configurations with different stiffness characteristics and stretch resistant properties.
Here's a summary of the acceptance criteria and study information for the Micrus Modified MicroCoil System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Acute Animal Testing (V0327-acute outcome) | Aneurysm occlusion and detachment reliability similar to predicate devices. | Coils detached with the first detachment cycle in > 95% of detachments and ≥90% aneurysm occlusion was obtained in all 5 aneurysms. |
| Chronic Animal Testing for Coil Stability & Aneurysm Occlusion (V0327-chronic outcome) | Positional stability and aneurysm occlusion maintained through extended implant duration; no coil compaction. | Positional stability and aneurysm occlusion maintained through 6 months of implant. No coil compaction present at 6-month angio. Histology showed chronic biocompatibility per study V0401. |
| Coil Stiffness/Softness for Wide Pitch Modified MicroCoils (V0396) | Stiffness limits for loosely wound (wide pitch) modified coils must be met. | The loosely wound (wide pitch) Helical and Spherical Modified MicroCoils met the stiffness specifications. |
| Friction in the Microcatheter (Delivery Force) (V0429) | Average push force must be substantially equivalent to predicate devices. | The Modified MicroCoil had average push forces that are comparable to those of the predicate. |
| Biocompatibility of Materials (V0401 & V0435) | Meets the requirements of ISO 10993 for new materials. | The only new material in the Micrus Modified MicroCoil is absorbable suture, which passed ISO 10993 biocompatibility testing. |
| Sterilization Validation (V0394) | Minimum Sterility Assurance Level of 10-6. | Passed minimum sterility assurance level of 10-6. |
| Shelf Life Test (V0397) | No performance degradation after 3 years of shelf life aging. | Minimum tensile strength after 3 year accelerated aging shows no degradation. |
| Tensile Strength: Stretch Resistant Modified MicroCoils (V0427) | Pre-detachment tensile strength of the suture ball tip and MicroCoil to DPU must be substantially equivalent to the stretch resistant predicate. | Tensile strength meets desired strength criteria. |
| Tensile Strength: Non-Stretch Resistant Modified MicroCoils (V0398) | Pre-detachment tensile strength of the MicroCoil to DPU must be substantially equivalent to the non-stretch resistant predicate. | Tensile strength meets desired strength criteria. |
| Tensile Strength: Non-Stretch Resistant (suture ball tip) (V0428) | Pre-detachment tensile strength of the suture ball tip and MicroCoil must be substantially equivalent to the non-stretch resistant predicate. | Tensile strength meets desired strength criteria. |
| Durability (Reliability after Fatigue) (V0405) | Withstand deployment and retraction 6 times in a tortuous anatomy without knotting, breakage, or stretching. | No knotting, no breakage, no stretching occurred. Durability meets desired durability criteria. |
| MRI Compatibility of Implant | No change in MRI compatibility compared to predicate. | No change was made which would impact MRI compatibility (Therefore, it is assumed to be substantially equivalent to the predicates which are MRI compatible). |
| Package Integrity (V0399) | Demonstrate package integrity per ISO 11607. | Meets ISO 11607 criteria. |
| Ship/Transit (V0400) | Successfully withstand domestic and international distribution environment. | Does successfully withstand domestic and international distribution environment. |
2. Sample Size Used for the Test Set and Data Provenance:
- Acute Animal Testing: 5 aneurysms were tested. The study did not specify the type of animal used, but "animal testing" implies a prospective animal study. The country of origin is not specified.
- Chronic Animal Testing: Covers 6 months of implant. The study did not specify the type of animal used, but "animal testing" implies a prospective animal study. The country of origin is not specified.
- Other tests (Coil Stiffness, Friction, Biocompatibility, Sterilization, Shelf Life, Tensile Strength, Durability, Package Integrity, Ship/Transit): The specific sample sizes for these bench and materials tests are not explicitly stated in the provided text. The data provenance is laboratory testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- This document describes pre-market device testing (bench, animal) for substantial equivalence to predicate devices, not studies involving human image analysis or diagnostic performance. Therefore, there is no mention of experts establishing ground truth in the context of image analysis or clinical diagnosis. The "ground truth" for these tests relates to physical measurements and biological responses defined by established scientific and engineering principles.
4. Adjudication Method for the Test Set:
- As explained above, this document does not describe studies requiring expert adjudication of a test set in the typical sense (e.g., medical image interpretation). The evaluation of results from the non-clinical tests would have been based on pre-defined criteria and measurements.
5. If a Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC comparative effectiveness study was not done. This device is an implantable medical device (microcoil), and the studies described are non-clinical (bench and animal) tests to demonstrate safety and effectiveness for a 510(k) submission, not comparative effectiveness studies of human readers with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- This question is not applicable. The device is a physical medical implant, not an AI algorithm. The performance described is the standalone performance of the physical device in laboratory and animal models.
7. The Type of Ground Truth Used:
- The ground truth varied depending on the test:
- Acute/Chronic Animal Testing: Pathological findings, angiographic results (aneurysm occlusion), and observation of device stability and detachment success.
- Biocompatibility: Conformance to ISO 10993 standards.
- Mechanical Tests (Stiffness, Friction, Tensile Strength, Durability): Quantitative physical measurements against established engineering specifications and comparison to predicate device performance.
- Sterilization, Shelf Life, Package Integrity, Ship/Transit: Conformance to relevant ISO standards and industry best practices.
8. The Sample Size for the Training Set:
- Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. (See #8).
§ 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).