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Indicated for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.

The superDimension i·Logic inReach System is a device that guides a bronchoscope and endoscopic tools to a target in or adjacent to the bronchial tree on a path identified by CT scan. The superDimension i·Logic inReach System also allows visualization of the target and the interior of the bronchial tree; placement of catheters in the bronchial tree; and placement of radiosurgical and dye markers into soft lung tissue to guide radiosurgery and thoracic surgery. superDimension is introducing the Edge Catheter System for use with the superDimension i·Logic inReach System. The i·Logic inReach System accomodates both the Edge Catheter and the currently available inReach Catheter System.

This 510(k) submission (K102604) for the superDimension® i·Logic™ inReach® System with Edge™ Catheter is a Special 510(k), which indicates a modification to an already cleared device. For such submissions, the FDA typically relies on design control processes, risk management, and verification/validation activities rather than new clinical trials to demonstrate substantial equivalence, especially when the fundamental scientific technology and intended use remain the same.

Therefore, the provided document explicitly states: "Clinical tests were not required to validate the changes to the superDimension inReach System."

This means that the submission does not include a detailed study proving the device meets specific acceptance criteria through a clinical trial or performance study comparing it against predefined metrics. Instead, the justification for meeting acceptance criteria is based on:

• Design Control Process: The Edge Catheter System, i·Logic inReach Software, and Instructions for Use were subjected to the superDimension design control process.
• Risk Management: Risk management was performed to analyze potential hazards associated with the changes.
• Design Verification and Validation: Appropriate design verification and validations were performed to assure the superDimension i Logic inReach System continues to be safe and effective for its intended use.

Since no clinical study data is provided in the document, I cannot fill in the table or answer questions related to sample size, data provenance, expert panels, adjudication, MRMC studies, standalone performance, or training set details. The acceptance criteria themselves are implicitly met through the "safe and effective for its intended use" statement, supported by the design control process rather than quantitative performance metrics from a new clinical study in this specific 510(k).

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