(95 days)
The GALAXY G3 Mini Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations fistulae, and is also intended for arterial and venous embolizations in the peripheral vasculature.
The GALAXY G3 Mini Microcoil Delivery Systems consist of three components, a Microcoil System, a connecting cable, and a Detachment Control Box (DCB). Each component is sold separately. As shown in Figure 1, the Microcoil System consists of a microcoil attached to a Device Positioning Unit (DPU). The Microcoil System is packaged in an introducer sheath designed to protect the coil in the packaging dispenser and to provide support for introducing the coil into the microcatheter catheter. The microcoil is the implantable segment of the device, and is detached from the Device Positioning Unit (DPU) using the Detachment Control System (Detachment Control Box and connecting cable). The microcoil is fabricated from a platinum alloy wire. The wire is wound into a primary coil which contains a polypropylene suture (SR) and then formed into a secondary shape. The secondary shape is complex. The DPU is a variable stiffness wire and has a radiopaque marker band located three (3) cm from its distal end. The Device Positioning Unit includes five (5) fluoro saver markers on the proximal section of the shaft. The markers are intended to indicate when the tip of the microcoil is approaching the tip of the microcatheter. When the distal-most marker reaches the proximal end of the Rotating Hemostatic Valve (RHV) on the microcatheter, the tip of the coil is approaching the tip of the microcatheter and fluoroscopy should be used to guide further coil insertion. The introducer sheath has three main components: an introducer tip, a translucent introducer body, and a re-sheathing tool. The EnPOWER Detachment Control Box (DCB) provides the energy necessary to allow for a thermo-mechanical detachment of the microcoil from the DPU. The connecting cable delivers the energy necessary to detach the embolic coil from the Microcoil System's detachment zone. The connecting cable is connected between the Microcoil System's hub connector on the DPU and the output connector on the DCB. The connecting cables may be one of two types: one with a remote detach button (the EnPower Control Cable) catalog no. ECB000182-00, or one without a detach button (standard connecting cable) catalog no. CCB00157-00. The EnPower Detachment Control Box works with the EnPower Control Cable and with the standard connecting cable.
The provided document describes the development and testing of the GALAXY G3 Mini Microcoil Delivery System. Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document reports several performance tests, and for each, the result is "PASS: Samples passed the established acceptance criterion." The specific numerical acceptance criteria are generally not explicitly stated, but the passing result indicates they were met.
| Test | Test Method Summary | Reported Device Performance |
|---|---|---|
| Spring Constant | Measures the softness of the coil by recording the spring constant of the primary wind. | PASS: Samples passed the established acceptance criterion |
| Complex Shape | Visually inspects the complex shape of the G3 Mini Microcoils. | PASS: Samples passed the established acceptance criterion |
| Particulate | Measures particulate count during simulated use per USP788. | PASS: Samples passed the established acceptance criterion |
| Atraumatic Bead | Visually verifies that the bead end of the coil meets the final assembly specification. | PASS: Samples passed the established acceptance criterion |
| DPU 3 System Outer Diameter | Verifies the OD is within specification to ensure microcatheter compatibility. | PASS: Samples passed the established acceptance criterion |
| Microcatheter Tip Deflection Force | Measures the deflection and/or stability of the microcatheter by recording the force generated at the distal tip as the DPU device is advanced to the tip. | PASS: Samples passed the established acceptance criterion |
| Detachment Zone Tensile Strength | Evaluates the attachment strength of the detachment fiber to prevent unintentional coil detachments. | PASS: Samples passed the established acceptance criterion |
| Stretch Resistance Fiber Tensile Strength | Verifies that the coil provides sufficient stretch resistance under tensile loading to ensure the coil can be retracted and repositioned without stretching. | PASS: Samples passed the established acceptance criterion |
| Track Force (Delivery) | Evaluates the force it takes to deliver the device through a microcatheter and into a clinically relevant model; utilizing the system Catheter Performance Simulation System (CPSS). | PASS: Samples passed the established acceptance criterion |
| Dimensional Inspection of FDL Diameter and Coil Length | Verifies the FDL diameter and the coil length meets the specification. | PASS: Samples passed the established acceptance criterion |
| Coil OD Verification on Final Assembly | Verifies the OD is within specification. | PASS: Samples passed the established acceptance criterion |
| Dimensional Inspection of the Distal Fluro-saver markers | Verifies that the Fluoro Saver Markers are in the correct proximal position to give a visual indication that the microcoil is approaching the distal tip of the microcatheter. | PASS: Samples passed the established acceptance criterion |
| Coil Durability | Evaluates the coil's ability to stay attached to the device during simulated use of six insertions and withdrawals cycled into and out of a clinically relevant aneurysm model. | PASS: Samples passed the established acceptance criterion |
| Detachment, Coil Durability & Reliability | Evaluates the reliability of the detachment mechanism after being cycled into and then out of a clinically relevant anatomical model six times. | PASS: Samples passed the established acceptance criterion |
| Resheathing Reliability | Evaluates the ability to re-insert the device into the split sheath introducer after it has been unzipped after the device has been inserted and withdrawn from a clinically relevant model. | PASS: Samples passed the established acceptance criterion |
| Fluro saver Marker Durability | Evaluates the ability of the Fluoro Saver Markers to stay affixed and in the correct position on the shaft after being cycled into and then out of a clinically relevant anatomical model six times. | PASS: Samples passed the established acceptance criterion |
| Distal Outer Sheath Durability | Evaluates the durability of the distal outer sheath during the simulated use of six insertions and withdrawals of the device into and out of a clinically relevant aneurysm model. | PASS: Samples passed the established acceptance criterion |
| Dimensional Inspection of the Introducer | Introducer underwent dimensional inspection per approved test method. | PASS: Samples passed the established acceptance criterion |
| Introducer Bond Strength | Verifies that the bond strength of the introducer fuse joint. | PASS: Samples passed the established acceptance criterion |
| Coil Transfer to Microcatheter | Evaluates the introducer sheath for allowing for insertion of the embolic coil into the microcatheter through the RHV. | PASS: Samples passed the established acceptance criterion |
| Introducer Flushing | Visually inspects to confirm flushing. | PASS: Samples passed the established acceptance criterion |
| Radiopacity | Verifies the ability to visualize the coil under fluoroscopy for physician to determine the location of the coil during use. | PASS: Samples passed the established acceptance criterion |
| Overall Coil Performance | Evaluates physician's satisfaction rating on performance compared to a predicate device. | PASS: Samples passed the established acceptance criterion |
| MRI Testing | Demonstrates that GALAXY G3 MINI Microcoil to be "MR-conditional" according to the specific conditions used for the assessment. | PASS: Samples passed the established acceptance criterion |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the exact sample sizes used for each individual performance test (test sets). It generally refers to "samples" being tested.
The data provenance is bench testing, which implies the data was collected within a laboratory setting, likely in the US, given the submission to the FDA. It is retrospective in the sense that it's testing a finished device against predetermined criteria.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
No individual experts or their qualifications are mentioned for establishing ground truth for the bench tests. The "ground truth" for these tests is based on established engineering specifications, industry standards (e.g., USP788, ISO standards), and clinical relevance/simulated use scenarios. For the "Overall Coil Performance" test, "physician's satisfaction rating" was evaluated, implying input from medical professionals, but the number and qualifications are not specified.
4. Adjudication Method for the Test Set
Not applicable for the reported tests. The tests are primarily objective measurements against established criteria, or visual inspections by qualified personnel (not specified as "experts" in the context of adjudication).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "A clinical study was not required as appropriate verification and validation of the GALAXY G3 Mini Microcoil Delivery System was achieved based on the similarities of the proposed device to the predicate device, and from results of bench testing."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device (microcoil delivery system), not an algorithm or AI software. Therefore, the concept of "standalone algorithm performance" does not apply. The performance tests are for the physical device itself.
7. The Type of Ground Truth Used
The ground truth for the bench tests is based on:
- Engineering specifications and design requirements: For dimensional checks, material properties, and functional performance (e.g., spring constant, detachment force, tensile strength).
- Industry standards: Such as USP788 for particulate matter, ISO 11607 for packaging, ISO 10993-1 for biocompatibility, and ISO 11135-1 for sterilization.
- Simulated use in clinically relevant models: For tests like track force, coil durability, detachment durability, resheathing reliability, fluoro saver marker durability, and distal outer sheath durability.
- Physician satisfaction rating: For "Overall Coil Performance" compared to a predicate device, which implies a subjective expert assessment.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI or machine learning model that requires a "training set." The listed studies are verification and validation tests for the device itself.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this 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).