(309 days)
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.
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.
The provided text describes the acceptance criteria and the studies that demonstrate the Stereotaxis Niobe® Magnetic Navigation System (MNS) with Navigant™ Workstation (NWS) and Cardiodrive® meets these criteria. The information is extracted from a 510(k) premarket notification.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from the "Special Controls" section, and the reported performance is from "How Special Control Has Been Met."
| Acceptance Criteria (Special Control) | Reported Device Performance |
|---|---|
| 1) Non-clinical mechanical performance testing: | |
| i. Mechanical performance of the system (without catheter connected) | Magnetic field performance testing using a THM-7025 Hall Effect tesla meter measured applied field strength and accuracy in cardinal directions at 0.08T and 0.1T (worst-case positions). |
| ii. Mechanical performance of the system with compatible catheters connected to verify no impact on catheter function/performance (side-by-side remote control and manual comparisons, all ranges of motion, worst-case; evaluation of accuracy/function of safety features) | Manual Control Performance Testing: Deflection testing, accuracy testing with target phantom, and anatomical position testing with a plastic heart model were performed for the reference Niobe device. |
| Remote Control Performance Testing: The proposed device demonstrated equivalent mechanical performance to the reference device. | |
| Safety Features: Testing of four primary safety controls (magnet positioner movement, cover movement toward patient, continuous catheter advancement, motion e-stops) was conducted on the proposed device, and "All four safety controls passed the test." | |
| iii. Simulated-use testing in a bench anatomic model or animal model | Four non-GLP animal validation studies were conducted after the reference device was cleared to test software iterations (Navigant 4.4, 5.0.1, 5.0.2, 5.0.3) features like ablation lesion assessment, sheath visualization, zone mapping, NaviLine, targeting, and point/line ablation. |
| 2. Non-clinical electrical testing: | |
| i. Electrical performance of the system with compatible catheters connected (Side-by-side remote control and manual comparisons, worst-case; evaluation of accuracy/function of safety features) | Manual Control Performance Testing: EMC and electrical safety testing confirming conformance with IEC 60601 were performed by TuV for the reference device. |
| Remote Control Performance Testing: EMC testing for the proposed device hardware demonstrating conformance with IEC 60601 was performed by TuV. "All tests passed." | |
| Safety Features: Electrical safety testing on the proposed device demonstrating compliance with IEC 60601 was performed by TuV. "All tests passed." | |
| ii. Electrical safety between the device and ablation catheter system and with other electrical equipment in cath lab/OR | The proposed system has been tested for compatibility with specific x-ray, ablation generators, mapping systems. Electrical isolation and emissions testing have been performed by TuV. "All tests passed." |
| 3. In vivo testing: | |
| i. Manipulation and Positioning: Ability to manipulate compatible catheters to pre-specified cardiac locations and conform proper anatomic placement and tissue contact | The VERSATILE Study (K141530) and in vivo animal testing (K071029 for Cardiodrive) demonstrated the ability to manipulate compatible catheters to pre-specified cardiac locations. |
| ii. Safety: Assess device-related complication rate and major procedural complication rate vs. literature/manual comparison group | Clinical data from 4 Stereotaxis-sponsored studies (ATTRAC, ATTRAC II, HEART, VERSATILE) involving 511 patients using the Niobe System (MNS, Cardiodrive, Magnetic Ablation Catheter, Navigant Software) showed an overall 7-day Major Complication Rate of 3.9% (20/511). Individual study rates ranged from 1.3% to 5.4%. Complications included cardiac tamponade, new focal wall abnormality, change in LVEF, vena cava thrombi, groin complication, prolonged hospitalization, pseudoaneurysm, bleeding, anemia, dementia, pericardial effusion, heart block, pulmonary embolisms, AV fistula, and arrhythmia recurrence. Several events were adjudicated as possibly/probably related to the procedure, with some explicitly stated as non-device related. |
| iii. Efficacy: Assess ablation success vs. literature/manual comparison group | Clinical data from the same 4 Stereotaxis-sponsored studies (ATTRAC, ATTRAC II, HEART, VERSATILE) involving 511 patients showed an overall Acute Success Rate of 95.0% (473/498) and a 90-day Success Rate of 96.5% (278/288). Individual study acute success rates ranged from 89.3% to 99.2%, and 90-day success rates from 94.3% to 98.6%. The VERSATILE study did not report 90-day success. |
| iv. User assessment of device remote controls and safety features | Performance impressions were documented on physician feedback forms during evaluations for Navistar RMT, Celsius RMT, and Helios II, where the Navigant system was used to steer the catheter. |
| 4. Post-market surveillance (PMS) | "A post market surveillance study is not warranted." This is based on: |
- "Overwhelming evidence" from four submitted studies (3.9% major adverse event rate, 95.0% acute success, 96.5% 90-day success).
- More than 8,000 patients reported in literature using MNS with a major complication rate of 0.72% (compared to manual rate of 2.1%).
- Acute and long-term success rates were similar in MNS and manual groups in literature.
Stereotaxis proposes continued monitoring through literature and Post Marketing Surveillance program. |
| 5. Training program for clinical and supporting staff | Representatives from the company train physicians and staff. The Niobe ES User's Manual provides operating instructions. Information is reviewed during simulation sessions and phantom training with the actual system. |
| 6. Performance data for sterility of sterile disposable components | The Niobe System is not sterile and not required to be sterilized. The Cardiodrive includes a single-use disposable (QuikCAS) (sterile component). Sterilization testing for QuikCAS resulted in a PASS. |
| 7. Performance data for shelf life (sterility, package integrity, functionality) | The Niobe System is not sterile and thus shelf life for system components is not applicable. The Cardiodrive includes a single-use disposable (QuikCAS) (sterile component). Shelf-life/packaging and sterilization testing for QuikCAS resulted in a PASS, and each component was validated for a shelf life of 3 years. |
| 8. Labeling requirements (Instructions, warnings, cautions, limitations, training, compatibility, testing summaries, technical parameters, expiration) | The Niobe ES User's Manual includes compatible catheters, indications for use, warnings, and safety controls. It has instructions for procedure room components, system positions, table-side magnet controller, power up, cover force sensor, navigation position assistance, software info, Cardiodrive CAS user interface, and activation codes. It explicitly states the Niobe System doesn't have reusable components requiring reprocessing/disinfection. Cleaning instructions for magnet pods are provided. A list of compatible catheters (Biosense Webster Navistar RMT, Navistar RMT Thermocool, Celsius RMT, Celsius RMT Thermocool; Stereotaxis Helios II) and mechanical performance testing is included. Summaries of in vivo testing, adverse events, procedure-related complications, study outcomes, and endpoints are summarized. Fluoroscopy times are reported. Relevant warnings based on complaints and clinical studies have been included. The system generates a directional 0.08T or 0.1T magnetic field within a 6-inch diameter navigation volume. Not applicable for system expiration date/shelf life; for QuikCAS, it is 3 years. |
2. Sample Size Used for the Test Set and the Data Provenance
- Test Set (Clinical Data):
- Sample Size: A total of 511 patients across 4 clinical studies (ATTRAC, ATTRAC II, HEART Study, VERSATILE).
- Data Provenance: The data comes from Stereotaxis-sponsored clinical studies that were previously submitted to the FDA for other regulatory approvals (P050029, K071029, K140804). The location of these studies (e.g., country of origin) is not explicitly stated in the provided text.
- Retrospective/Prospective: All four studies were prospective in nature.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- The document does not specify the number of experts used to establish ground truth for the clinical outcomes (e.g., major complications, acute success, 90-day success).
- However, it does mention that:
- For the VERSATILE study, the DSM (Data Safety Monitoring) adjudicated these events (referring to cardiac tamponade events). This implies expert review of adverse events, but the number and qualifications of DSM members are not provided.
- Physician feedback forms were used for "User assessment of device remote controls and safety features," suggesting clinical expert input on device usability.
4. Adjudication Method for the Test Set
- For adverse events in the VERSATILE study, the DSM (Data Safety Monitoring) was involved in adjudication. The specific method (e.g., 2+1, 3+1) is not detailed.
- For other clinical endpoints like acute and 90-day success, the adjudication method is not described in detail, though it would typically involve clinical follow-up and determination by clinicians/investigators within the study protocols.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- The provided text describes a medical device (a robotic catheter navigation system), not an AI-powered diagnostic or interpretive tool. Therefore, the concept of a "multi-reader multi-case (MRMC) comparative effectiveness study" focusing on human readers improving with AI assistance is not applicable here. The device assists the physician in physically performing a procedure.
- The document does mention a comparison to "manual rates" for major complications and similar success rates in the literature between the MNS and manual groups, indicating some level of comparative safety and efficacy analysis against conventional methods. However, this is not an MRMC study comparing human reader performance with and without AI assistance for interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This question is not applicable to this device. The Niobe System is an interventional workstation designed to be operated with a human-in-the-loop (a physician) to navigate catheters. It is not an algorithm performing a task independently.
7. The Type of Ground Truth Used
- Clinical Outcomes Data: For the in-vivo efficacy and safety studies, the ground truth was based on:
- Major Complication Rates: Clinically diagnosed complications within 7 days post-procedure.
- Ablation Success: Acute success (immediate outcome of the ablation procedure) and 90-day success (long-term absence of arrhythmia recurrence). These are definitive clinical endpoints.
- Manipulation and Positioning: Demonstrated ability to reach pre-specified cardiac locations and achieve proper anatomical placement.
- Bench Testing Data: For mechanical, electrical, and sterility testing, ground truth was established by:
- Measurements: Using instruments like a Hall Effect tesla meter for magnetic field strength.
- Conformance to Standards: Meeting established engineering and safety standards (e.g., IEC 60601-1, ISO 62304, ISO 14971).
- Pre-determined Requirements: The testing "demonstrated that the Niobe System met pre-determined requirements."
- Animal Model Data: For simulated-use testing, the animal studies likely provided physiological and anatomical ground truth for the performance of the system and software features.
8. The Sample Size for the Training Set
- The document refers to "software verification and validation activities" and "non-GLP animal validation studies" for specific software versions (Navigant 4.4, 5.0.1, 5.0.2, 5.0.3). These can be considered part of the development and testing process, but the document does not specify a distinct "training set" sample size in the context of an AI/machine learning model. The clinical studies (511 patients) would be considered the main validation or test set for clinical performance.
9. How the Ground Truth for the Training Set Was Established
- As mentioned above, the concept of a "training set" in the context of AI/machine learning is not directly applicable here. For the non-clinical and animal studies used in development and validation:
- Non-clinical (bench) testing: Ground truth was established through direct physical measurements, adherence to engineering specifications, and compliance with recognized standards.
- Animal Validation Studies: The ground truth would have been established through controlled experimental conditions, physiological measurements, and post-procedure analysis (e.g., ablation lesion assessment).
In summary, this submission focuses on a mechanical-robotic system, not an AI diagnostic, thus many aspects related to AI performance metrics are not applicable. The core of the evidence relies on thorough non-clinical engineering validation and prospective human clinical trials demonstrating safety and efficacy.
§ 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.