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Boston Scientific Target's Guglielmi Detachable Coil (GDC) Power Supply is intended for use with all versions of Boston Scientific Target's Guglielmi Detachable Coils in the embolization of intracranial aneurysms and other vascular malformations of the neuro and peripheral vasculature.

The GDC system consists of the following items, 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 GDC is detached by electrolytically dissolving a small portion of the delivery wire upon desired placement of the coil in the anatomy.

GDC coils are manufactured from a platinum / tungsten alloy wire which is wound into a primary or main coil. Depending upon the desired final configuration, the coil is either formed into a secondary helical shape (standard and Stretch Resistant GDC), vortex shape (GDC-18 Fibered VortX) or tertiary shape (3D GDC).

GDC coils are attached to a delivery wire, which consists of a ground stainless-steel core with a stainless-steel coil welded at the distal end a Teflon® outer jacket. The delivery wire is similar to that employed for the predicate GDC cleared under K991139.

GDC coils are available in a range of sizes for use with either Boston Scientific Target's -10 or -18 Infusion Catheters with two tip markers.

The GDC Power Supply is a battery-operated, self-contained unit designed to initiate and control the electrolytic detachment of a GDC coil inside an aneurysm.

Each time the GDC Power Supply is turned on, the unit defaults to the 1.0 mA current setting. Pressing the "Current" switch one time changes the setting to the 0.5 mA current setting; pressing a second time changes the setting to 0.75 mA; pressing a third time returns the unit to the default 1.0 mA setting. Each time the switch is pressed, the current display flashes the new current setting.

The GDC Power Supply is designed to apply a constant current through the GDC System and to detect when coil detachment has occurred. It maintains a constant current by:

• 1. sensing the amount of resistance to current flow through the GDC System, and
• 2. adjusting the voltage needed to maintain the desired current setting. It is also designed to identify subtle changes in the way current is flowing through the GDC System and to recognize those changes which indicate detachment.

Once those patterns are identified, the GDC Power Supply signals detachment and stops the flow of current through the GDC System.

This document describes a Special 510(k) submission for a modification to the Boston Scientific Target's GDC™ Power Supply. A Special 510(k) is typically used for device modifications that do not significantly alter the device's fundamental technology or intended use, meaning extensive new clinical studies are often not required. The information provided focuses on demonstrating that the modified device remains substantially equivalent to its predicate.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a "table of acceptance criteria and reported device performance" in the way one might expect for a new device requiring rigorous performance evaluation. Instead, it details changes made to the GDC Power Supply and asserts that for most attributes, no change was made, and it remains the same as the predicate device. For the one functional change—the current settings—it's presented as a modification rather than a performance target with a specific metric.

The implicit acceptance criterion for most parameters is "no change from the predicate." For the current settings, the acceptance criterion is that the device now offers the specific new settings.

2. Sample Size Used for the Test Set and Data Provenance

The document does not mention any clinical test set, sample size, or data provenance (country of origin, retrospective/prospective). This is typical for a Special 510(k) for a device modification, where the focus is on engineering verification and validation that the changes do not negatively impact safety or effectiveness, rather than a new clinical performance study. The "Verification Test Summary Table" lists various engineering/technical tests (e.g., EMC, Operating System Test), but not clinical trials.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. No clinical test set requiring expert ground truth establishment is described in this submission.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. No MRMC study or any comparative effectiveness study with human readers is mentioned or implied. The device (GDC Power Supply) is an accessory used by a neurosurgical team, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable in the context of AI/algorithms. The GDC Power Supply is a hardware device that controls the detachment of coils. Its function is to apply current and detect detachment. The "Operating System Test (Assembly Source Code)" mentioned in the verification table hints at internal software verification, but this is a standard engineering test for embedded systems, not an AI algorithm performance test.

7. The Type of Ground Truth Used

For the design verification that was performed, the "ground truth" would be established engineering specifications and performance standards for electrical devices, EMC, and software functionality. For example, for current settings, the ground truth is simply whether the device outputs the specified 0.5 mA, 0.75 mA, or 1.0 mA when selected, and whether it correctly detects coil detachment as designed. This is assessed through bench testing and functional verification, not clinical expert consensus or pathology.

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning or AI, so there is no "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. This device does not involve machine learning or AI.

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