(31 days)
MICRUSFRAME, DELTAFILL, and DELTAXSFT Microcoil Delivery Systems are intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and are also intended for arterial and venous embolizations in the peripheral vasculature.
The GALAXY G3 FILL Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and is also intended for arterial and venous embolizations in the peripheral vasculature.
The GALAXY G3 XSFT Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms.
The MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3 FILL, GALAXY G3 XSFT 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 devices in this submission include minor design changes only to the Device Positioning Unit's introducer sheath (introducer). There are no modifications to components or materials of the micro-coil or the ENPOWER Detachment Control System. Minor dimensional and design modifications to the introducer will help improve deliverability of the micro-coils.
The document describes the MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3 FILL, and GALAXY G3 XSFT Microcoil Delivery Systems. These devices are intended for endovascular embolization of intracranial aneurysms, various neurovascular abnormalities, and arterial and venous embolizations in the peripheral vasculature. The submission is for minor design changes to the introducer sheath component of the delivery system's device positioning unit.
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides a table of verification and validation testing, which includes the tests performed, a summary of the test methods, and the results. The acceptance criterion for all tests was "Pass," meaning the samples met the established criteria.
| Test | Test Method Summary | Reported Device Performance (Results) | Acceptance Criteria (Implied) |
|---|---|---|---|
| Visual Inspection | Visual inspection of the test units to check for cosmetic defects to ensure the units are prepared for verification testing as per established test method. | Pass (All units passed visual inspection) | All units pass visual inspection |
| Tracking Force (delivery) | The purpose of the Track Force test was to evaluate the force it takes to deliver the proposed device through a microcatheter and into a clinically relevant model; utilizing the system Catheter Performance Simulation System (CPSS). Test samples were delivered through a compatible microcatheter to verify track forces per approved test method. | Pass (Samples passed the established acceptance criterion) | Samples pass the established acceptance criterion |
| Re-sheathing Reliability | The purpose of the Re-Sheathing Reliability test was to evaluate the ability to re-insert the proposed device into the split sheath introducer after it has been unzipped after the proposed device has been inserted and withdrawal from a clinically relevant model. The introducer sheath underwent 1 re-sheathing cycle to verify reliability per approved test method. | Pass (Samples passed the established acceptance criterion) | Samples pass the established acceptance criterion |
| Dimensional Inspection | The Introducer underwent dimensional inspection per approved test method. | Pass (Samples passed the established acceptance criterion) | Samples pass the established acceptance criterion |
| Particulate Testing | The full assembly underwent particulate testing per approved test method. Simulated use consisted of pushing forward to the tip of the microcatheter and then pulling back 8" and repeating five times. | Pass (Samples passed the established acceptance criterion) | Samples pass the established acceptance criterion |
| Introducer Fuse Joint Testing | The Introducer underwent tensile strength testing per approved test method. | Pass (Samples passed the established acceptance criterion) | Samples pass the established acceptance criterion |
| Acute In-Vivo Animal Study | An in-vivo model allowed the assessment of the acute performance of the test article to deliver an embolic coil to the target parent vessel in swine. | Demonstrated acceptable overall performance in all attributes evaluated. | Acceptable overall performance in all attributes. |
| Biocompatibility Testing | A limited subset of the recommended biocompatibility tests, including in vitro cytotoxicity and in vitro hemolysis were successfully conducted on the modified introducer. In addition, chemical characterization of extractables of the Introducers manufactured with the current heat shrink polymer and the Introducers manufactured with a new heat shrink polymer were successfully conducted per ISO 10993-18. | Successfully conducted (in vitro cytotoxicity, in vitro hemolysis, chemical characterization of extractables). | Successful completion of required biocompatibility tests. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test Set Sample Size: The document repeatedly states "Samples passédes the established acceptance criterion" but does not specify the numerical sample sizes used for each individual bench test (Visual Inspection, Tracking Force, Re-sheathing Reliability, Dimensional Inspection, Particulate Testing, Introducer Fuse Joint Testing). It mentions "statistical sampling methods" were used for all testing as required by Codman & Shurtleff, Inc. Design Control procedures. For the animal study, it states "an acute in-vivo animal study" was performed in "swine," but the number of animals or tests performed is not specified.
- Data Provenance: The document does not specify the country of origin for the data generated from the verification and validation testing. The studies are described as prospective testing conducted in a laboratory setting for the bench tests, and an acute in-vivo animal study for the performance assessment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This information is not applicable to the type of testing described. The tests are engineering and biological performance evaluations of a medical device, not diagnostic evaluations requiring expert interpretation of images or patient data to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable. The tests performed are objective measurements and evaluations of device performance characteristics, not subjective assessments requiring adjudication by multiple experts.
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:
- No, an MRMC comparative effectiveness study was not done. This device is a microcoil delivery system, not an AI or imaging-related diagnostic tool that would typically involve human readers or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a physical medical instrument, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the bench tests was established through objective engineering specifications and validated test methods. For example, for "Tracking Force," the ground truth is a specific force measurement threshold. For "Biocompatibility," the ground truth is adherence to internationally recognized standards (ISO 10993-1, FDA guidance). For the animal study, the ground truth was "acceptable overall performance" in delivering the embolic coil, implying pre-defined success criteria for deployment and functional integrity within the in-vivo model.
8. The sample size for the training set:
- Not applicable. This device is a physical medical instrument, not a machine learning algorithm that requires a training set. The device itself is "trained" through prior design iterations and predicate device experience, and then validated through non-clinical testing.
9. How the ground truth for the training set was established:
- Not applicable. As stated above, this is not a machine learning algorithm. The "ground truth" for the design and manufacturing of the device stems from established engineering principles, material science, regulatory standards (e.g., ISO, FDA guidance), and the performance history of predicate devices.
§ 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).