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The Interlock-35 Fibered IDC Occlusion System is indicated for obstructing or reducing blood flow in the peripheral vasculature during embolization procedures. This device is not intended for neurovascular use.

The Interlock-35 Fibered IDC Occlusion System includes a coil manufactured from a platinum-tungsten alloy that is mechanically attached to a coil delivery wire. This assembly is contained within an introducer sheath. The platinum coil contains synthetic fibers for greater thrombogenicity. The Interlock-35 Fibered IDC Occlusion System is designed to be delivered under fluoroscopy through a 5F (1.70 mm) (0.035 in [0.89 mm] or 0.038 in [0.97 mm] inner lumen) Imager™ II Selective Diagnostic. The interlocking delivery wire design allows the coil to be advanced and retracted before final placement in the vessel, thus aiding in more controlled delivery including the ability to withdraw the coil prior to deployment.

Acceptance Criteria and Study Analysis for Interlock™-35 Fibered IDCT™ Occlusion System (K113651)

This submission (K113651) is a 510(k) premarket notification seeking clearance for a revision to the Directions for Use (DFU) for the Interlock™-35 Fibered IDCT™ Occlusion System, not for a new device or significant modification to the existing device itself. Therefore, the information provided primarily addresses the regulatory implications of this labeling change rather than a study proving new device performance.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this submission is for a DFU revision and explicitly states "Non-clinical performance data was not required since there were no changes made to the device," there are no specific acceptance criteria for device performance or reported device performance metrics in this document. The "acceptance criteria" here relate to the regulatory acceptance of the DFU changes.

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

Not applicable. As this submission is for a DFU revision, there was no "test set" of device performance data used. The modifications were purely textual to the labeling.

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

Not applicable. No ground truth for a test set was established for device performance in this submission. The "ground truth" for the DFU changes would be regulatory compliance and clarity, which would have been assessed internally by Boston Scientific's regulatory team and subsequently by the FDA.

4. Adjudication Method for the Test Set

Not applicable. There was no test set or adjudication process for device performance in this submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices to assess human reader performance with and without AI assistance. This submission pertains to a physical embolization device and a labeling revision.

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

No. This device is a physical medical device, not an algorithm. Therefore, a standalone algorithm performance study is not applicable.

7. The Type of Ground Truth Used

Not applicable for device performance. The "ground truth" for the DFU revision was the clarity, accuracy, and regulatory compliance of the instructional language presented in the DFU, ensuring it accurately reflects the device and its intended use without introducing new risks or unclear information.

8. The Sample Size for the Training Set

Not applicable. There was no training set for an algorithm or device performance study in this submission.

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

Not applicable. There was no training set or associated ground truth establishment for this regulatory submission.

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