(25 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 Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, 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 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 MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and 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.
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. 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).
For the MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, and GALAXY G3 XSFT microcoils: The microcoil is fabricated from a platinum alloy wire. The wire is wound into a primary coil which may contain either a polypropylene suture (SR) or an absorbable polymer suture and then formed into a secondary shape. The secondary shape may be spherical, complex, or helical.
For the GALAXY G3 Mini microcoils: 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.
For all Microcoil Delivery Systems: 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, catalog no. DCB2000500, works with the ENPOWER Control Cable and with the standard connecting cable.
The provided text describes a 510(k) premarket notification for microcoil delivery systems, which are medical devices, not an AI/ML powered device. Therefore, a study proving an AI/ML device meets acceptance criteria is not presented in this document.
The document discusses non-clinical performance data for the microcoil delivery systems, specifically focusing on verification and validation testing of minor design modifications related to the Device Positioning Unit's core wire.
Here's the information regarding the device's acceptance criteria and the study that proves it meets them, based on the provided text, adapted for the context of a medical device rather than an AI/ML system:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria Summary | Reported Device Performance |
|---|---|---|
| Tracking Force (delivery) - Verification | Not explicitly stated, but "established acceptance criteria" implies a threshold. | Pass |
| Simulated Use: Tracking Force (delivery) - Validation | Not explicitly stated, but "established acceptance criteria" implies a threshold. | Pass |
| Simulated Use: Microcatheter Stability - Validation | Not explicitly stated, but "established acceptance criteria" implies a threshold. | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "Samples" in the results, but doesn't quantify the number of units tested for each criterion.
- Data Provenance: The tests were conducted internally as "bench testing." The country of origin is not specified, but the applicant, Medos International SARL, is located in Le Locle, Switzerland. The testing is retrospective, as it's part of a 510(k) submission for an already manufactured device with minor modifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable as the study involved non-clinical bench testing of a physical medical device, not a diagnostic or prognostic system requiring expert interpretation of data or images. The "ground truth" here is determined by the physical properties and performance measured during the tests.
4. Adjudication Method for the Test Set
Not applicable. The tests are objective measurements of physical performance and do not involve human adjudication in the typical sense of reviewing subjective interpretations.
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
Not applicable. This is not an AI/ML device, and no MRMC study was performed. The document explicitly states: "Clinical studies were not required as appropriate verification and validation of the minor design modifications was achieved based on the bench testing."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical testing was defined by objective physical measurements and engineering specifications, which determine whether the device meets its design requirements. For example, "tracking force" would have a specified maximum force for successful delivery, and "microcatheter stability" would have an acceptable range of movement.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device, so there is no training set in the AI/ML context.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, there is no AI/ML training set.
§ 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).