(152 days)
MicroPlex Coil System and HydroCoil Embolic System:
The MicroPlex Coil System and HydroCoil Embolic System are intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The MicroPlex Coil System and HydroCoil Embolic System are also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.
AZUR Peripheral Coil System:
The AZUR Peripheral Coil System is intended to reduce or block the rate of blood flow in vessels of the peripheral vasculature. It is intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms, and other lesions of the peripheral vasculature.
The V-Grip Detachment Controller is an accessory for use with the MicroVention MicroPlex Coil System (MCS) and HydroCoil Embolic System (HES). The AZUR Detachment Controller is for use with the MicroVention AZUR Peripheral Coil System (AZUR).
The MCS and AZUR devices consist of an implantable coil made of a platinum alloy (Platinum/Tunqsten). The HES and AZUR metal/gel devices consist of an implantable coil made of the same platinum alloy with a hydrogel inner core.
The implantable coil is attached to a delivery pusher via a polyolefin elastomer material. The proximal end of the delivery pusher is inserted into a hand held, battery powered Detachment Controller. When the Detachment Controller is activated, the flow of electrical current heats the polyolefin elastomer filament, resulting in detachment of the implantable coil. The Detachment Controller is packaged and sold separately.
The primary purpose of the subject submission is a modification to the V-Grip/AZUR Detachment Controller to facilitate battery removal and disposal after use of the device.
This document is a 510(k) premarket notification for MicroVention, Inc.'s MicroPlex Coil System, HydroCoil Embolic System, and AZUR Peripheral Coil System, specifically focusing on modifications to the V-Grip Detachment Controller and the AZUR Detachment Controller. The acceptance criteria and supporting study are related to the performance of these detachment controllers.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria and performance are presented in the "Bench Test Summary" table. All tests resulted in "PASS," indicating the device met the specified criteria.
| Test | Acceptance Criteria Summary (based on Test Method Summary) | Reported Device Performance |
|---|---|---|
| Output Voltage and Time | All 22+ samples (minimum) before and after sterilization shall have a measurement rating of $9.0 \pm 0.5V$ and $0.75 \pm 0.10$ seconds for a minimum of 20 cycles, to meet 90% confidence of 90% reliability for the voltage, time, and number of cycles. | PASS |
| Detachment | All 22+ samples (minimum) before and after sterilization shall detach the implants at the 11th and 20th cycles in under three detachment attempts. | PASS |
| Battery Voltage Measurement | All 22+ samples (minimum) before and after sterilization shall meet the acceptance criteria of > 7V. | PASS |
| LED and Buzzer Sequence | All 22+ samples (minimum) before and after sterilization shall pass the conditional LED and buzzer sequence tests for standard operation, detachment testing, and functional testing beyond 20 cycles. | PASS |
| EMC Compatibility | Test samples were subjected to five EMC tests in accordance with IEC 60601-1-2:2014. | PASS |
| Software Validation | Software validation testing was performed to demonstrate that the modified V-Grip/Azur Detachment Controller met the requirements of Design Specifications and the Software Requirements Specification. | PASS |
| Electrical Safety | The modified V-Grip/AZUR Detachment Controller was evaluated in accordance with IEC 60601-1:2012 Edition 3.1 and other related standards, including risk management file review and safety testing. | PASS |
| Shelf Life, Accelerated Aging 1 year | Shelf life testing was performed on 22 samples subjected to the equivalent of 1-year accelerated aging, sterilization, and simulated shipping hazard. Visual inspection and output performance were tested. | PASS |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: For "Output Voltage and Time," "Detachment," "Battery Voltage Measurement," "LED and Buzzer Sequence," and "Shelf Life, Accelerated Aging 1 year" tests, the sample size used was 22 samples (minimum), both before and after sterilization.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given it's a premarket notification for a medical device modification, the testing described (bench tests, software validation, electrical safety, etc.) is typically prospective and conducted by the manufacturer or accredited labs (e.g., TUV America for EMC and Electrical Safety) to demonstrate compliance with standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document describes a premarket notification for a modification to an accessory for neurovascular embolization devices. The studies conducted are bench tests and engineering validations, not clinical studies involving patient data or expert interpretation of diagnostic images. Therefore, the concept of "ground truth established by experts" (like radiologists for imaging studies) does not apply in this context. The "ground truth" here is determined by engineering specifications, physical measurements, and compliance with recognized standards.
4. Adjudication Method for the Test Set
As this involves bench testing and engineering validation, there is no "adjudication method" in the sense of multiple human readers or experts resolving discrepancies. The results are based on objective measurements against predefined engineering specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This submission focuses on the safety and performance of a device modification (detachment controller) through bench testing and engineering validation, not on the diagnostic accuracy or effectiveness of an AI system with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Again, this is not an AI/algorithm-based diagnostic device. The device itself performs a function (detachment of coils). The tests described are standalone performance tests of the modified mechanical and electrical properties of the detachment controller.
7. The Type of Ground Truth Used
The ground truth for these tests is based on engineering specifications and recognized industry standards. For example:
- Output Voltage and Time: Ground truth is the specified voltage, time, and number of cycles.
- Detachment: Ground truth is successful detachment within a specified number of attempts.
- Battery Voltage Measurement: Ground truth is the specified minimum voltage.
- EMC Compatibility: Ground truth is compliance with IEC 60601-1-2:2014.
- Software Validation: Ground truth is meeting Design Specifications and Software Requirements Specification.
- Electrical Safety: Ground truth is compliance with IEC 60601-1:2012 Edition 3.1 and related standards.
8. The Sample Size for the Training Set
This submission does not discuss a "training set" in the context of machine learning or AI. The tests are for design verification and validation of a physical medical device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML model in this submission. The "ground truth" for the device's design (e.g., target output voltage, detachment time) is established during the device's design and development phase based on performance requirements for its intended use.
§ 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).