(113 days)
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.
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.
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).
§ 870.5700 Steerable cardiac ablation catheter remote control system.
(a)
Identification. A steerable cardiac ablation catheter remote control system is a prescription device that is external to the body and interacts with the manual handle of a steerable cardiac ablation catheter to remotely control the advancement, retraction, rotation, and deflection of a compatible, steerable ablation catheter used for the treatment of cardiac arrhythmias in the right side of the heart. The device allows reversion to manual control of the steerable cardiac ablation catheter without withdrawal of the catheter and interruption of the procedure.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Non-clinical mechanical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance testing must be performed:
(i) Mechanical performance of the system (without catheter connected);
(ii) Mechanical performance of the system with compatible catheters connected to verify that the system does not impact catheter function or performance. Assessments must include the following:
(A) Side-by-side remote control and manual comparisons of catheter manipulation (including all ranges of motion of catheter deflection and tip curl) for all compatible catheters; must include testing for worst-case conditions, and
(B) Evaluation of the accuracy and function of all device control safety features; and
(iii) Simulated-use testing in a bench anatomic model or animal model.
(2) Non-clinical electrical testing must include validation of electromagnetic compatibility (EMC), electrical safety, thermal safety, and electrical system performance. The following performance testing must be performed:
(i) Electrical performance of the system with compatible catheters connected to verify that the system does not impact catheter function or performance. Assessments must include the following:
(A) Side-by-side remote control and manual comparisons of catheter manipulation (including all ranges of motion of catheter deflection and tip curl) for all compatible catheters; must include testing for worst-case conditions, and
(B) Evaluation of the accuracy and function of all device control safety features; and
(ii) Electrical safety between the device and ablation catheter system and with other electrical equipment expected in the catheter lab or operating room.
(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. Evidence must be submitted to address the following:
(i) Manipulation and Positioning: Ability to manipulate compatible catheters to pre-specified cardiac locations and confirm proper anatomic placement and tissue contact, in accordance with the system indications for use and the compatible catheter indications for use;
(ii) Safety: Assess device-related complication rate and major procedural complication rate (regardless of device relatedness) in comparison to literature and/or a manual comparison group for compatible ablation catheters to support the indications for use;
(iii) Efficacy: Assess ablation success in comparison to literature and/or a manual comparison group for compatible ablation catheters to support the indications for use; and
(iv) User assessment of device remote controls and safety features.
(4) Post-market surveillance (PMS) must be conducted and completed in accordance with FDA agreed upon PMS protocol.
(5) A training program must be included with sufficient educational elements that, upon completion of the training program, the clinician and supporting staff can:
(i) Identify the safe environments for device use,
(ii) Use all safety features of device, and
(iii) Operate the device in simulated or actual use environments representative of indicated environments and use for the indication of compatible catheters.
(6) Performance data must demonstrate the sterility of the sterile disposable components of the system.
(7) Performance data must support shelf life by demonstrating continued sterility of the device (of the sterile disposable components), package integrity, and device functionality over the requested shelf life.
(8) Labeling must include the following:
(i) Appropriate instructions, warnings, cautions, limitations, and information related to the intended patient population, compatible ablation catheters, and the device safeguards for the safe use of the device;
(ii) Specific instructions and the clinical training needed for the safe use of the device, which includes:
(A) Instructions on assembling the device in all available configurations, including installation and removal of compatible catheters;
(B) Instructions and explanation of all controls, inputs, and outputs;
(C) Instructions on all available modes or states of the device;
(D) Instructions on all safety features of the device; and
(E) Validated methods and instructions for reprocessing/disinfecting any reusable components;
(iii) A detailed summary of the mechanical compatibility testing including:
(A) A table with a complete list of compatible catheters tested (manufacturer trade name and model number), and
(B) A table with detailed test results, including type of test, acceptance criteria, and test results (
i.e., pass for meeting acceptance criteria);(iv) A detailed summary of the in vivo testing including:
(A) A table with a complete list of compatible catheters used during testing (manufacturer trade name and model number);
(B) Adverse events encountered pertinent to use of the device under use conditions;
(C) A detailed summary of the device- and procedure-related complications; and
(D) A summary of study outcomes and endpoints. Information pertinent to the fluoroscopy times/exposure for the procedure, patient, and operator fluoroscopic exposure;
(v) Other labeling items:
(A) A detailed summary of pertinent non-clinical testing information: EMC, mechanical, electrical, and sterilization of device and components;
(B) A detailed summary of the device technical parameters; and
(C) An expiration date/shelf life and storage conditions for the sterile accessories; and
(vi) When available, and according to the timeframe included in the PMS protocol agreed upon with FDA, provide a detailed summary of the PMS data including:
(A) Updates to the labeling to accurately reflect outcomes or necessary modifications based upon data collected during the PMS experience, and
(B) Inclusion of results and adverse events associated with utilization of the device during the PMS.