(112 days)
The Guglielmi Detachable Coil (GDC) is intended for embolizing certain intracranial aneurysms that - because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team to be:
a)very high risk for management by traditional operative techniques, or,
b) inoperable,
and for embolizing other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature.
The GDC is also intended for arterial and venous embolizations in the peripheral vasculature.
The indications for use for Stretch Resistant GDC are identical to those for the predicate GDC device cleared under K962503.
The GDC system consists of:
- · GDC power supply
- · GDC occlusion coil attached to a delivery wire
- · set of GDC connecting cables
- patient return electrode
- · two 9-volt batteries
each of which is sold separately.
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 the same as 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 diplay 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.
This document describes the safety and effectiveness of the Guglielmi Detachable Coil (GDC), a Class III artificial embolization device. The information provided focuses on the "Stretch Resistant GDC" and its comparison to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
The document summarizes a "Verification Test Summary Table: Comparison of Stretch Resistant GDC Devices to the Predicate Device". The acceptance criteria for most tests were established by the predicate device (K962503). For the "Main Coil Stretch Test," acceptance criteria were established for the modified device.
| Test or Point of Comparison | Acceptance Criteria (explicitly stated or inferred from predicate comparison) | Reported Device Performance (Stretch Resistant GDC) |
|---|---|---|
| Friction | Meets acceptance criteria established for predicate device. | Meets acceptance criteria established for predicate device. |
| Tensile Strength, Main Coil Weld | Meets acceptance criteria established for predicate device. | Meets acceptance criteria established for predicate device. |
| Detachment Time | Meets acceptance criteria established for predicate device. | Meets acceptance criteria established for predicate device. |
| Detachment in Saline w/ particulate analysis | No change made that would result in particulate generation. | No change was made which would result in the generation of particulate during detachment. |
| Heating Effect of Electrolysis | No change made that would influence or increase heating effect. | No change made which would influence or increase heating effect. |
| Heating Effect of MRI | No change made that would increase heating effect of MRI. | No change made which would increase heating effect of MRI. |
| Tip Ball Strength | Meets acceptance criteria established for strength of tip ball. | Meets acceptance criteria established for strength of tip ball. |
| Main Coil Stretch Test | Meets acceptance criteria for the modified device. | Meets acceptance criteria for the modified device. |
2. Sample Sizes Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for each specific test mentioned in the "Verification Test Summary Table". It is a descriptive summary of test outcomes rather than a detailed study report with sample sizes.
The data provenance is not specified. However, given that this is a 510(k) submission for a medical device in the US, the testing and data generation would typically follow US regulatory guidelines and standards. It is retrospective in the sense that these tests were conducted to demonstrate substantial equivalence to a previously cleared device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
This document is a technical summary for regulatory submission, focusing on material and functional comparisons of a medical device (GDC coils). It does not involve "ground truth" derived from expert consensus on diagnostic interpretations (like for an AI algorithm). Instead, the performance is assessed against established engineering and safety standards, benchmarks set by the predicate device, or specific acceptance criteria defined for the modified device. Therefore, information about the number or qualifications of experts used to establish "ground truth" in this context is not applicable.
4. Adjudication Method for the Test Set:
Not applicable. The tests described are objective engineering and material performance assessments, not subjective diagnostic interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance:
Not applicable. This document pertains to a physical medical device (embolization coil), not an AI algorithm for diagnostic assistance. Therefore, an MRMC study or the effect size of AI assistance on human readers is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is not an AI algorithm.
7. The Type of Ground Truth Used:
The "ground truth" in this context refers to established engineering specifications, performance benchmarks derived from the predicate device (K962503), or specific design requirements for the new "Stretch Resistant GDC." For example:
- Friction: Measured against a specific frictional force threshold.
- Tensile Strength, Main Coil Weld: Compared against a minimum tensile strength value.
- Detachment Time: Evaluated against a specified temporal range for detachment.
- Particulate Analysis: Absence of particulate generation.
- Heating Effects (Electrolysis, MRI): No increase beyond acceptable thresholds or predicate device performance.
- Tip Ball Strength: Compared against a minimum strength requirement.
- Main Coil Stretch Test: Evaluated against specific criteria established for the elasticity and resistance of the modified device.
These benchmarks and criteria are based on established medical device safety and efficacy standards and the performance history of the predicate device.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
§ 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).