(112 days)
The Fibered GDC is intended for embolization of vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature. Fibered GDC is also intended for arterial and venous embolizations in the peripheral vasculature.
The GDC system consists of the following components, each of which is sold separately:
- · GDC power supply
- · GDC occlusion coil attached to a delivery wire
- · set of GDC connecting cables
- · patient return electrode
- · two 9-volt batteries
The occlusion coil is detached by electrolytically dissolving a small portion of the delivery wire upon desired placement of the coil in the anatomy.
GDC occlusion coils are manufactured from platinum wire which is first wound into a primary coil and then formed into a secondary helical shape.
Coils are attached to a delivery wire, which consists of a ground stainlesssteel core wire with a stainless-steel coil welded at the distal end and a Teflon® outer jacket. The delivery wire is similar to that employed for the predicate GDC cleared under K962503.
The GDC Power Supply is a self-contained, battery-operated unit designed to initiate and control detachment of a GDC coil. It has an on/off button, connections for the GDC cables, and the following controls and displays: - · Current setting switch and display Allows for selection of the different current settings. The selected current (mA) is briefly displayed after which the unit displays the current flowing through the system.
- · Voltage display and indicator Displays the DC output voltage.
- · Time display Displays the elapsed time that the current has been flowing through the GDC system.
- Check indicator Flashes on and off at the beginning of a detachment procedure if there is a poor connection to the patient.
- · Detach indicator Flashes on and off when the power supply has detected detachment. Detachment is accompanied by five beeps.
- · Battery indicator Illuminates when the voltage of the internal 9-volt batteries falls below specification.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Guglielmi Detachable Coil (GDC), specifically the Fibered GDC-18 VortX Shape Guglielmi Detachable Coil:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the device Fibered GDC-18 VortX Shape Guglielmi Detachable Coil is being compared to its predicate device, the original Guglielmi Detachable Coil (GDC). The acceptance criteria are "established for predicate devices," and the reported device performance indicates that the Fibered GDC "Meets acceptance criteria established for predicate device."
| Acceptance Criteria (Established for Predicate Devices) | Reported Device Performance (Fibered GDC) |
|---|---|
| Friction | Meets acceptance criteria established for predicate devices. |
| Tensile Strength, Main Coil Weld | Meets acceptance criteria established for predicate device. |
| Detachment Time | Meets acceptance criteria established for predicate device. |
| Detachment in Saline w/ particulate analysis | No change was made which would result in the generation of particulate during detachment. |
| Heating Effect of Electrolysis | No change made which would influence heating effect. |
| Heating Effect of MRI | No change made which would increase heating effect of MRI. |
| Main Coil Stretch Test | Meets acceptance criteria established for predicate device. |
| Fiber Retention Strength | Meets acceptance criteria established for predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). The verification tests listed are device-specific mechanical and physical tests, not clinical studies. Therefore, these tests typically involve a relevant number of devices to demonstrate reproducibility and meet statistical significance for product specifications, but the exact number is not provided.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
This information is not applicable and not provided in the document. The "tests" described are engineering/bench tests comparing the new device to its predicate, not studies requiring expert interpretation or ground truth establishment in a clinical context.
4. Adjudication Method for the Test Set
This information is not applicable and not provided in the document. As mentioned above, these are bench tests, not studies requiring adjudication by multiple readers or experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs. without AI assistance
This information is not applicable and not provided in the document. This document describes a medical device (embolic coil), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this device submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided in the document. As stated, this is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the verification tests is based on the acceptance criteria established for the predicate devices. This implies that the performance targets (e.g., specific friction values, tensile strength ranges, detachment times) of the predicate device serve as the benchmark for the new Fibered GDC. The document does not describe "pathology" or "outcomes data" as ground truth for these specific verification tests.
8. The Sample Size for the Training Set
This information is not applicable and not provided in the document. As this is a medical device, there is no "training set" in the context of machine learning or AI. The development of such a device involves design specifications, material testing, and manufacturing process controls rather than data for algorithm training.
9. How the Ground Truth for the Training Set was Established
This information is not applicable and not provided in the document. There is no concept of "training set" or "ground truth for a training set" for this type of medical device submission.
§ 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).