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The Ion™ Endoluminal System (Model IF1000) assists the user in navigating a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree for diagnostic and therapeutic procedures. The Ion™ Endoluminal System enables fiducial marker placement. It does not make a diagnosis and is not for pediatric use.

The Flexision™ Biopsy Needle is used with the Ion™ Endoluminal System to biopsy tissue from a target area in the lung.

The PlanPoint™ Software uses patient CT scans to create a 3D plan of the lung and navigation pathways for use with the Ion™ Endoluminal System.

The Ion™ Endoluminal System (Model IF1000) is a software-controlled, electromechanical system designed to assist qualified physicians to navigate a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree for diagnostic and therapeutic procedures. It consists of a Planning Laptop with PlanPoint™ Software, a System Cart with System Software, a Controller, Instruments, and Accessories. The Model IF 1000 Instruments include the Ion™ Fully Articulating Catheter, the Ion™ Peripheral Vision Probe, and the Flexision™ Biopsy Needles. Accessories such as the Catheter Guide, Vision Probe Adapter, Suction Adapter, and Swivel Connector facilitate use of the Model IF1000 Instruments.

This document (K201146) is a 510(k) premarket notification for a medical device (Ion Endoluminal System) and primarily addresses updates to reprocessing instructions, not the initial performance or efficacy of the device itself. Therefore, many standard elements of AI/ML device performance studies (like MRMC studies, training set details, or standalone algorithm performance) are not applicable to this submission.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer specifically to the reprocessing validation studies.

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria for Reprocessing Validation

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document provides a high-level summary that "All testing passed the predetermined acceptance criteria." Specific quantitative metrics for soil/bioburden reduction or microbial inactivation are not detailed in this public summary, but would have been part of the full submission.

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

• Sample Size: Not explicitly stated for each test in the provided summary. Reprocessing validation studies typically involve a set number of device cycles (e.g., typically 50 or 100 cycles) to demonstrate cleaning and disinfection efficacy over the expected lifespan or number of uses.
• Data Provenance: The studies were laboratory-based reprocessing validation tests. No patient data or clinical data is relevant to this specific submission.

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

• Not Applicable. For reprocessing validation, "ground truth" is established by laboratory standards and established test methods (e.g., AAMI TIR12:2010, AAMI TIR30:2011/(R)2016) which define acceptable levels of residuals or microbial inactivation, not by expert consensus on clinical data. The tests are objective measurements.

4. Adjudication Method for the Test Set

• Not Applicable. As per point 3, this is laboratory testing against objective standards, not a subjective assessment requiring adjudication.

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

• No. An MRMC study is relevant for evaluating the impact of an AI system on human reader performance (e.g., radiologists interpreting images). This submission is about reprocessing instructions for a physical device, not an AI/ML algorithm.

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

• No. This is not an AI/ML algorithm submission.

7. The Type of Ground Truth Used

• For cleaning: Quantitative measurement of residual protein, hemoglobin, carbohydrates, or other organic matter (simulated soil) after cleaning.
• For disinfection: Quantitative measurement of microbial inactivation (log reduction) after the disinfection process using specified test microorganisms.
• The "ground truth" is the established scientific and regulatory thresholds for effective cleaning and disinfection, as outlined in the AAMI standards.

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" in the context of reprocessing validation as this is not an AI/ML model.

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

• Not Applicable. See point 8.

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