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The Niobe System is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart and coronary vascular and peripheral vasculature by orienting the device tip in a desired direction.

The Cardiodrive Catheter Advancement System (CAS) is intended to automatically advance and retract compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis MNS.

The Cardiodrive system is not intended to advance the EP mapping and ablation catheters through the coronary vasculature or the coronary sinus.

The Cardiodrive system is not intended to advance or retract non-compatible catheters and/or other non-compatible devices into the neurovasculature.

Device Description

The Stereotaxis Niobe Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodrive (a.k.a. the Niobe System) is an interventional workstation for the intravascular navigation of appropriately equipped. magnetically adapted, devices (e.g., catheters or guidewires) through tissue to designated target sites. The Niobe System uses computer-controlled permanent magnets for orientating the tip of a magnetic device and employs magnetic fields only to orient or steer the tip of a magnetic device and remotely advance and retract only compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart. The Niobe System incorporates software that determines the direction the magnetic field should be applied based on physician interaction with the user interface devices.

AI/ML Overview

This FDA 510(k) clearance letter for the Stereotaxis Niobe Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodrive (K192775) primarily references existing data from prior submissions and does not detail a new standalone clinical study. The submission relates to software modifications to an already cleared device, thus "special controls" testing and leveraging existing clinical data were used to demonstrate continued safety and effectiveness.

Here’s a breakdown of the acceptance criteria and the study information as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document frames its "acceptance criteria" through how the device addresses a set of "Special Controls" established by the FDA for this class of device. The response to each control serves as the demonstration of meeting the criteria.

Special Control (Acceptance Criteria)	How Special Control Has Been Met (Reported Device Performance)
1) Non-clinical mechanical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Includes:	Magnetic field performance testing: Uses a THM-7025 Hall Effect tesla meter to measure applied field strength and accuracy in cardinal directions (at 0.08T and 0.1T - worst-case).
Manual Control Performance Testing (leveraged from predicate): Deflection testing, accuracy with target phantom, anatomical position testing with plastic heart model. Results provide mechanical performance for reference device.
Remote Control Performance Testing (proposed device): Demonstrates equivalent mechanical performance between subject and reference device.
Evaluation of accuracy/function of safety features: Testing of four primary safety controls related to physical motion (magnet positioners, cover movement, continuous catheter advancement, e-stops). All passed.
Simulated-use testing: Four non-GLP animal validation studies performed using iterations of software after the reference device was cleared, testing features like sheath visualization, zone mapping, Auto NaviLine, single step NaviLine, targeting, point and line ablation, and integration of Acutus AcQMap system.
2) Non-clinical electrical testing must include validation of electromagnetic compatibility (EMC), electrical safety, thermal safety, and electrical system performance.	EMC and Electrical safety testing: Conformance with IEC 60601 performed by TuV for the reference device and the proposed device. All tests passed.
Electrical safety between device/ablation catheter system and other electrical equipment: Tested for compatibility with specific X-ray, ablation generators, mapping systems. Electrical isolation and emissions testing performed by TuV. All tests passed.
3) In vivo testing must demonstrate that the device performs as intended under anticipated conditions of use, including an assessment of the system impact on the functionality and performance of compatible catheters, and documentation of the adverse event profile associated with clinical use. Includes:	i. Manipulation and Positioning: The VERSATILE Study (K141530) and in vivo animal testing (K071029 for Cardiodrive) demonstrated ability to manipulate compatible catheters to pre-specified cardiac locations.
ii. Safety: Clinical data from four Stereotaxis-sponsored studies (ATTRAC, ATTRAC II, HEART, VERSATILE) totaling 511 patients reviewed. Overall 7-day major complication rate was 20/511 (3.9%). Specific adverse events reported (cardiac tamponade, thrombi, groin complication, etc.).
iii. Efficacy: Data from the same four studies (ATTRAC, ATTRAC II, HEART, VERSATILE) reviewed. Acute success rates: 473/498 (95.0%). 90-day success rates: 278/288 (96.5%).
iv. User assessment of device remote controls and safety features: Performance impressions documented on physician feedback forms during evaluations for Navistar RMT, Celsius RMT, and Helios II. Documentation included in reports.
4) Post-market surveillance (PMS) must be conducted and completed in accordance with FDA agreed upon PMS protocol.	Not warranted due to extensive clinical data. Safety and efficacy monitored through literature and PMS program. Major adverse event rate in submitted studies: 3.9%. Major complication rate in literature (>8,000 patients): 0.72% (vs. 2.1% manual). Acute and long-term success rates similar to manual.
5) A training program must be included with sufficient educational elements for safe use.	Company representatives train physicians and staff. Niobe ES User's Manual provides detailed operating instructions. Information reviewed during simulation and phantom training.
6) Performance data must demonstrate sterility of the sterile disposable components of the system.	Niobe System is not sterile and has no sterile disposable components. Cardiodrive includes a single-use disposable (QuikCAS) which underwent sterilization testing and passed.
7) Performance data must support shelf life by demonstrating continued sterility, package integrity, and device functionality over the requested shelf life.	Niobe System is not sterile, so shelf life for sterility is not applicable. QuikCAS disposable underwent shelf-life/packaging and sterilization testing, passing all with a validated 3-year shelf life.
8) Labeling must include appropriate instructions, warnings, cautions, limitations, and information.	Niobe ES User's Manual includes: Compatible Catheters, Indications for Use, Warnings, Safety Controls. Instructions for assembly (catheter-CAS interface), modes/states, controls/inputs/outputs, safety features. Cleaning instructions for non-reusable magnet pods included. Detailed summaries of mechanical compatibility testing (compatible catheters listed with pass/fail results) and in vivo testing (compatible catheters listed, adverse events, study outcomes, fluoroscopy times).

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

The document does not describe a novel "test set" in the context of typical AI/ML validation studies (i.e., a dedicated, novel set of cases exclusively for the purpose of algorithm validation). Instead, it relies heavily on retrospective clinical data from previously submitted studies and non-clinical engineering tests to demonstrate substantial equivalence for software modifications.

Clinical Data (leveraged from prior submissions):
- Total Patients: 511 patients (across 4 studies: ATTRAC, ATTRAC II, HEART Study, VERSATILE)
- Attrition Data within Studies:
  - ATTRAC: 182 enrolled patients, 175/182 for acute success, 145/147 for 90-day success.
  - ATTRAC II: 80 enrolled patients, 71/75 for acute success, 51/54 for 90-day success.
  - HEART Study: 129 enrolled patients, 108/121 for acute success, 82/87 for 90-day success.
  - VERSATILE: 120 enrolled patients, 119/120 for acute success, "Not reported" for 90-day success.
- Data Provenance: The studies were Stereotaxis-sponsored clinical trials, previously submitted to the FDA for other clearances (P050029, K071029, K140804). The country of origin for these studies is not specified in this document. These are prospective studies given the "enrolled patients" context and "7-day major complication rate".
Non-Clinical Data (specific to this submission):
- Software Verification and Validation: This involved internal testing by Stereotaxis under design controls. No specific "sample size" of software test cases is provided but it implies thorough testing.
- Animal Studies: Four non-GLP animal validation studies were conducted. The number of animals is not specified, but these are prospective studies to validate specific software features and integration.

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

Not applicable in the traditional sense of image-based AI ground truth. The "ground truth" for the clinical efficacy and safety data primarily comes from the patient outcomes and procedural data recorded during the clinical trials themselves, which would be managed by the clinical investigators (physicians) and study staff.

For user assessment of device remote controls and safety features, it mentions "physician feedback forms." This implies physicians were the "experts," but the number and their specific qualifications are not detailed.

4. Adjudication Method for the Test Set

For the clinical studies, adverse events were generally reported and reviewed, and in the VERSATILE Study, it explicitly states that the "DSM adjudicated these events to be possibly and probably related to the procedure, respectively." DSM typically refers to a Data Safety Monitoring Board, which is an independent committee of experts (e.g., clinicians, biostatisticians) that monitors patient safety and treatment efficacy data during clinical trials. This suggests an adjudication method, at least for some adverse events.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI vs. Without AI Assistance

No MRMC study is mentioned. This submission is for a device that assists with navigation, not for an AI that interprets images or diagnoses conditions in a way that would typically involve multiple readers assessing cases. The device itself is the "AI" (automated navigation based on software). Comparative effectiveness is primarily drawn from historical controls or comparisons to manual procedures mentioned in the PMS section (e.g., complication rates vs. manual rates).

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device is a "Steerable Cardiac Ablation Catheter Remote Control System." Its core function is to automate or assist in catheter navigation, inherently requiring a human operator (physician) to interact with the system. Therefore, a standalone (algorithm only) performance study without human-in-the-loop is not directly relevant or performed for the primary function of controlling the catheter. However, the mechanical and electrical performance tests (Special Controls 1 & 2) represent isolated system performance without a human in the loop, validating individual components of the system.

7. The Type of Ground Truth Used

Clinical Studies: Patient outcomes (acute success, 90-day success, complication rates) serve as the ground truth for safety and efficacy. This is primarily outcomes data, determined by clinical follow-up and assessments from physicians.
Non-Clinical Studies: Ground truth for mechanical and electrical performance is established via measurement against engineering specifications and validated standards (e.g., THM-7025 Hall Effect tesla meter, IEC 60601 conformance).
Animal Studies: The success of specific software features in animal models (e.g., successful targeting, ablation) serves as the ground truth. This is a form of experimental outcome data.

8. The Sample Size for the Training Set

This document does not describe the Niobe System as an AI/ML device in the modern sense (e.g., a deep learning model requiring a large training dataset of images or other raw data). The "software modifications" refer to updates to the control system. Therefore, there's no mention of a traditional "training set" size for an AI algorithm. The development of software would involve internal testing and validation, but not "training data" in the AI/ML context.

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

As no specific AI/ML training set is described, this question is not applicable. The traditional software development and verification/validation processes would have established "ground truth" through requirements documentation, test specifications, and expected outputs.

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