Search Results

Genesis MNS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart and coronary vasculature, neurovascular 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

Stereotaxis Genesis RMN® with Navigant™ Workstation (NWS) and Cardiodrive® System (Genesis MNS) 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 using computer-controlled permanent magnets 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. Genesis MNS incorporates software that determines the direction the magnetic field should be applied based on physician interaction with the user interface devices.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System (Genesis MNS) based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Special Control)	How Special Control Has Been Met (Reported Performance)
Non-clinical mechanical performance testing (without catheter connected):	Magnetic field performance testing (robotic field accuracy survey, reduced field mode angular resolution, isocenter offset) demonstrated that field characteristics (strength, direction, position, accuracy) meet the same requirements as the predicate Niobe, and these tests passed.
Non-clinical mechanical performance testing (with compatible catheters connected):	Deflection testing, accuracy testing with target phantom, and anatomical position testing with a plastic heart model were performed. Subject Genesis system performed at the same level with compatible devices as predicate Niobe System.
(A) Side-by-side remote control and manual comparisons of catheter manipulation:	The subject Genesis system performed at the same level with compatible devices as the predicate Niobe System. The subject device generates the same magnetic fields as the predicate device. Compatible catheter performance testing results identical to Niobe.
(B) Evaluation of accuracy and function of all device control safety features:	Testing of four primary safety controls (physical movement of magnet positioners, movement of covers toward patient, continuous advancement of catheter, motion e-stops) was conducted on the proposed device, and all passed. User testing of safety controls was the same between Niobe and Genesis.
Simulated-use testing in a bench anatomic model or animal model:	Validation testing included use testing of clinical workflows in a bench model. An animal study was performed employing typical clinical workflows (compatibility with mapping system, CardioDrive, fluoroscopy). Clinical workflow testing for Genesis with compatible devices was the same as Niobe, substantiating substantial equivalence.
Non-clinical electrical testing (EMC, electrical safety, thermal safety, electrical system performance):	EMC and Electrical safety testing showing conformance with IEC 60601 were performed by TuV for the reference Niobe device. EMC testing for the proposed device hardware demonstrating conformance with IEC 60601-1-2 was performed by Intertek, and all tests passed. Electrical safety testing on the proposed device demonstrating compliance with IEC 60601, and IEC 60601-1-2 was performed by Intertek.
(A) Electrical performance of system with compatible catheters connected (Side-by-side remote control and manual comparisons of catheter manipulation):	Both predicate and proposed devices tested according to IEC 60601-1-2 standards by Nationally Recognized Testing Labs; all tests passed.
(B) Evaluation of accuracy and function of all device control safety features:	Electrical safety testing on the proposed device demonstrating compliance with IEC 60601, and IEC 60601-1-2 was performed by Intertek.
Electrical safety between device and ablation catheter system and with other electrical equipment:	Proposed system tested for compatibility with specific x-ray, ablation generators, and mapping systems. Electrical isolation and emissions testing performed by Intertek.
In vivo testing (Manipulation and Positioning):	Animal study conducted with compatible devices showed that catheters were directed to predefined targets, and suitable contact was demonstrated. In vivo testing was conducted with the subject device, and all compatible catheters functioned similarly to the predicate device.
In vivo testing (Safety - device-related and major procedural complication rate):	7 Day Major Complication Rate:

ATTRAC: 7/182 (3.8%)
ATTRAC II: 1/80 (1.3%)
HEART Study: 7/129 (5.4%)
VERSATILE: 5/120 (4.2%)
Total: 20/511 (3.9%) |
| In vivo testing (Efficacy - ablation success): | Acute Success RMN:
ATTRAC: 175/182 (96.2%)
ATTRAC II: 71/75 (94.7%)
HEART Study: 108/121 (89.3%)
VERSATILE: 119/120 (99.2%)
Total: 473/498 (95.0%)
90 day success RMN:
ATTRAC: 145/147 (98.6%)
ATTRAC II: 51/54 (94.4%)
HEART Study: 82/87 (94.3%)
VERSATILE: Not reported
Total: 278/288 (96.5%) |
| User assessment of device remote controls and safety features: | Same user assessment testing (device remote controls and safety features) as the predicate device was performed, and all safety features passed. |
| Sterility of sterile disposable components: | Genesis System is not provided in sterile form. CardioDrive includes single-use disposable (QuikCAS) which underwent sterilization testing, resulting in a PASS. |
| Shelf life of sterile disposable components: | Genesis System is not provided in sterile form. CardioDrive's single-use disposable (QuikCAS) underwent shelf-life/packaging and sterilization testing. All testing resulted in a PASS, and each component was validated for a shelf life of 3 years. |

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

The "test set" for clinical performance appears to be a collection of existing clinical studies that used the predicate device (Niobe MNS) and compatible components.

Sample Size: A total of 511 patients were enrolled across 4 studies.
Data Provenance: Clinical data from retrospective analyses of previously submitted studies to the FDA. These studies were sponsored by Stereotaxis. The specific countries of origin are not explicitly stated within the provided text, but these were part of FDA submissions (P050029, K071029, K140804) suggesting they are likely from clinical trials conducted in regions that align with FDA regulatory standards (e.g., US or international sites that adhere to similar clinical trial practices).

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

The document does not specify the number of experts used to establish the ground truth for the clinical outcomes (adverse events, acute success, 90-day success) in these studies, nor their specific qualifications. It mentions that "Clinical data to support the safety of the Magnetic Navigation System... was reviewed" and that "The DSM adjudicated these events to be possibly and probably related to the procedure, respectively" in the VERSATILE study. This suggests that a Data Safety Monitoring board or similar expert body was involved in reviewing adverse events.

4. Adjudication Method for the Test Set

For the VERSATILE study, adverse events were "adjudicated" by the DSM (Data Safety Monitoring board). The specific adjudication method (e.g., 2+1, 3+1) is not detailed, but it indicates an expert review process.

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

No MRMC comparative effectiveness study is mentioned in the document. The comparative effectiveness assessment for the Genesis MNS is primarily against its predicate device (Niobe MNS) and historical clinical data for both the MNS system and manual ablation.

Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable, as this is a robotic navigation system, not an AI-assisted diagnostic or interpretative device that augments human readers. The clinical studies compare outcomes of the magnetic navigation system to historical data or literature on manual ablation. The document states:
- "More than 8,000 patients were reported in the literature using the MNS System with a major complication rate of 0.72% compared to a manual rate of 2.1%." (This implies a lower complication rate for MNS compared to manual.)
- "Acute success rates and long-term success rates were similar in both the MNS and manual groups."

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

The device itself is a "Steerable Cardiac Ablation Catheter Remote Control System" and "Magnetic Navigation System," which is inherently designed for human-in-the-loop operation (a physician interacts with the user interface to control the magnetic field and system). Therefore, a standalone (algorithm only) performance study of the entire system as a diagnostic or interventional tool would not be relevant. The performance data presented focuses on the mechanical and electrical performance of the system and its clinical outcomes when used by an operator.

7. The Type of Ground Truth Used

The ground truth used for the clinical performance assessment consists primarily of:

Clinical Outcomes Data: Major complication rates, acute success rates, and 90-day success rates, as recorded and adjudicated in the patient studies (ATTRAC, ATTRAC II, HEART, VERSATILE). These outcomes intrinsically serve as the "ground truth" for safety and efficacy in a clinical setting.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI. This device is a robotic system, and its development would typically involve engineering design, bench testing, and clinical validation rather than a distinct machine learning training phase. The "data" used for demonstrating its safety and effectiveness are the results from the various tests (mechanical, electrical, animal, and clinical studies of the predicate device).

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

As there is no explicitly defined "training set" in the context of AI/ML, this question doesn't directly apply. The establishment of "ground truth" related to the device's design and operation would have been through engineering specifications, physics principles governing magnetic fields, and established clinical endpoints for cardiac ablation procedures (e.g., successful ablation, absence of major complications).

Ask a Question

Ask a specific question about this device

Page 1 of 1