(30 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.
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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October 30, 2019
Stereotaxis, Inc. Kenneth Lock Sr. Director of Clinical Affairs 4320 Forest Park Avenue, Suite 100 St. Louis, Missouri 63108
Re: K192775
Trade/Device Name: Niobe@ Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodrive Regulation Number: 21 CFR 870.5700 Regulation Name: Steerable Cardiac Ablation Catheter Remote Control System Regulatory Class: Class II Product Code: PJB, NDO Dated: September 27, 2019 Received: September 30, 2019
Dear Kenneth Lock:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Nicole Gillette Acting Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192775
Device Name
Niobe® Magnetic Navigation System (MNS) with Navigation Workstation (NWS) and Cardiodrive
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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SUBMITTER
| Date Prepared: | October 30, 2019 |
|---|---|
| Submitter: | Stereotaxis, Inc.4320 Forest Park AvenueSt. Louis, MO 63108 USA |
| Contact Person: | Kenneth H. LockSr. Director, Clinical AffairsPhone: (314) 678-6123Fax: (763) 493-7849 |
DEVICE
Name of Device: Niobe® Magnetic Navigation System (MNS) with Navigant™ Workstation (NWS) and Cardiodrive® Common or Usual Name: Steerable cardiac ablation catheter remote control system. Classification Name: Catheter remote control system Regulatory Class: Class II Regulation Number: 21 CFR 870.5700 Product Code: PJB FDA Panel: Cardiology PREDICATE DEVICE
| Predicate | 510(k) | Regulation | Device Name | Manufacturer |
|---|---|---|---|---|
| Primary | K183027 | 870.5700 | Niobe® Magnetic NavigationSystem (MNS) with Navigant™Workstation (NWS) andCardiodrive® | Stereotaxis, Inc. |
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.
INDICATIONS FOR USE
The Niobe System 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.
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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 noncompatible devices into the neurovasculature.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
The Niobe System has the same primary technological characteristics as the predicate device, including, but not limited to the following:
Primary Predicate Device:
-
Remotely controlling PMA class III ablation catheter ●
Additional Reference Devices -
Primary Design Elements (magnets, positioners, software) ●
-
. Principle of Operation (magnetic navigation)
-
Performance Parameters (field modes and positions)
-
User Interface Devices (controllers, keyboard, display monitors) ●
-
. Companion Devices and Systems (digital fluoroscopy systems, mapping systems)
CHANGES MADE TO THE PROPOSED DEVICE
Software modifications in the proposed device with respect to the predicate device:
- Onen Mapping Application Programming Interface (Open API) that allows physicians to use their . preferred mapping system with the Niobe MNS. AcQMap® Mapping System from Acutus Medical is now compatible with the Niobe System
- . Companion digital fluoroscopy system from Omega Imaging LLC was added to the list of compatible fluoroscopy systems
- . User interface changes
- Improved some informational messages O
- Better sizing of registration image O
- Optimize window layout for quad screen O
- O Provide import of pre-procedure surface images
- Added an ablation history informational graph O
Any minor differences in technological characteristics between the proposed and reference Niobe System have demonstrated continued performance and do not raise new issues of safety or effectiveness.
NON-CLINICAL STUDIES
The Niobe System underwent verification and validation activities to ensure that the device continues to meet established performance criteria. Evaluations included:
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-
. Biocompatibility Testing
The Niobe System does not contain patient-contacting components. Biocompatibility testing was not required to support of this submission. -
Electromagnetic Compatibility (EMC) ●
Since the changes in the subject device are to software only, Electromagnetic compatibility testing (EMC) was not completed. -
Software Verification and Validation ●
Stereotaxis performed software verification and validation activities under design controls in accordance with ISO 62304 and ISO 14971 for software utilized by the Niobe System device to ensure that the software is safe and appropriate risk control measures are effective.
Performance Testing
For the changes for the subject device, system verification testing were conducted to assess the performance of the device following software modifications. The testing demonstrated that the Niobe System met pre-determined requirements and continued to perform as intended.
Special Controls Testing Summary
The following updates the additional testing that was conducted to meet the special controls requirements. Special Controls testing was leveraged from the predicate device since the software modifications had no effect on the performance of the Niobe System. In Special Control 1) iii, in the table below, animal testing was conducted to test the integration of the AcQMap system with the Niobe System.
| Special Controls | How Special Control Has Been Met | |
|---|---|---|
| 1) Non-clinical mechanical performancetesting must demonstrate that the deviceperforms as intended under anticipatedconditions of use. The followingperformance testing must be performed:i. Mechanical performance of the system(without catheter connected); | Using the proposed device, Magnetic field performance testingwithout the catheter connected uses a THM-7025 Hall Effect teslameter to measure the applied field strength and accuracy in thecardinal direction and at 0.08T and 0.1T (which represent worstcase positions). | |
| ii. Mechanical performance of the systemwith compatible catheters connected toverify that the system does not impactcatheter function or performance.Assessments must include thefollowing:(A) Side-by-side remote control andmanual comparisons of cathetermanipulation (including all rangesof motion of catheter deflection andtip curl) for all compatiblecatheters; must include testing forworst-case conditions, and | Manual Control Performance TestingPerformance testing data for the reference Niobe device includeddeflection testing, accuracy testing with target phantom andanatomical position testing with a plastic heart model. The resultsof this testing provide mechanical performance data for thereference device.Remote Control Performance TestingThe current version (proposed device) of the Niobe MNSSubstantial Equivalence Application Testing demonstratesequivalent mechanical performance between the subject deviceand reference device. | |
| Special Controls | How Special Control Has Been Met | |
| (B) Evaluation of the accuracy andfunction of all device control safetyfeatures; and | Testing of the four primary safety controls related to the physicalmotion of the system was conducted on the proposed device.These concern physical movement of the magnet positioners,movement of the covers toward the patient, continuousadvancement of the catheter, and motion e-stops. All four safetycontrols passed the test. | |
| iii.Simulated-use testing in a benchanatomic model or animal model. | Four non-GLP animal validation studies were conducted andtested the following using iterations of software after thereference device was cleared:Navigant 4.4 features and ablation lesion assessment• Sheath visualization• Zone mappingNavigant 5.0.1 Validation Study• Auto NaviLine ./ single step NaviLineNavigant 5.0.2 Validation Study• NaviLine• Targeting• Point and line ablationNavigant 5.0.3 Validation Study• Targeting / Electrode Targeting• NaviLine• Point and Line AblationNavigant 5.0.5• Integration of the Acutus AcQMap system with the NiobeSystem• Acutus Workflow integration | |
| Special Controls | How Special Control Has Been Met | |
| 2.Non-clinical electrical testing mustinclude validation of electromagneticcompatibility (EMC), electrical safety,thermal safety, and electrical systemperformance. The following performancetesting must be performed:i. | Manual Control Performance TestingEMC and Electrical safety testing showing conformance with IEC60601 were performed by TuV for the reference device. | |
| i.Electrical performance of the systemwith compatible catheters connectedto verify that the system does notimpact catheter function orperformance. Assessments mustinclude the following:A. Side-by-side remote control andmanual comparisons of cathetermanipulation (including allranges of motion of catheterdeflection and tip curl) for allcompatible catheters; mustinclude testing for worst-caseconditions, and | Remote Control Performance TestingEMC testing for the proposed device hardware demonstratingconformance with IEC 60601 was performed by TuV. | |
| All tests passed. | ||
| B. Evaluation of the accuracy andfunction of all device controlsafety features; and | Electrical safety testing on the proposed device demonstratingcompliance with IEC 60601, was performed by TuV. | |
| ii.Electrical safety between the deviceand ablation catheter system and withother electrical equipment expected inthe catheter lab or operating room. | The proposed system has been tested for compatibility withspecific x-ray, ablation generators, mapping systems. In addition,electrical isolation and emissions testing have been performed byTuV.All tests passed. | |
| 3.In vivo testing must demonstrate that thedevice performs as intended underanticipated conditions of use, including anassessment of the system impact on thefunctionality and performance ofcompatible catheters, and documentationof the adverse event profile associatedwith clinical use. Evidence must besubmitted to address the following:i.Manipulation and Positioning:Ability to manipulate compatiblecatheters to pre-specified cardiaclocations and conform properanatomic placement and tissuecontact, in accordance with thesystem indications for use andcompatible catheter indications foruse. | The VERSATILE Study used to support K141530 as well as invivo animal testing provided in K071029 for the Cardiodrivesystem, demonstrated the ability to manipulate compatiblecatheters to pre-specified cardiac locations. | |
| Special Controls | How Special Control Has Been Met | |
| ii. Safety: Assess device-related complication rate and major procedural complication rate (regardless of device relatedness) in comparison to literature and/or manual comparison group for compatible ablation catheters to support the indications for use; | Clinical data to support the safety of the Niobe Magnetic Navigation System, which includes Niobe, Navigant Software, the Cardiodrive catheter advancement system and a compatible ablation catheter, was reviewed.The following is a summary of data from clinical studies sponsored by Stereotaxis that have been submitted to the FDA in three separate submissions:• P050029 Helios II ablation catheter (ATTRAC, ATTRAC II and HEART)• K071029 Cardiodrive with Ablation Catheter (ATTRAC II)• K140804 V-CAS (VERSATILE)A total of 511patients from 4 studies were enrolled using the Niobe Magnetic Navigation System, which included the Niobe MNS, Cardiodrive, a Magnetic Ablation Catheter, and the Navigant Software.The following table describes the major complication rates reported in these trials. | |
| Study | RMN Patients | |
| ATTRAC | 182 | |
| ATTRAC II | 80 | |
| HEART Study | 129 | |
| VERSATILE | 120 | |
| Total | 511 |
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| Special Controls | How Special Control Has Been Met | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Data to support the ablation success of the Niobe Magnetic Navigation System which includes Niobe, Navigant Software, the Cardiodrive catheter advancement system and a compatible ablation catheter was reviewed.The following is a summary of data from clinical studies sponsored by Stereotaxis that have been submitted to the FDA in three separate submissions:P050029 Helios II ablation catheter (ATTRAC ,ATTRAC II and HEART study) K071029 Cardiodrive with Ablation Catheter (ATTRAC) K140804 V-CAS (VERSATILE) A total of 511 patients from 4 studies were enrolled using the Niobe Magnetic Navigation System, which included the Niobe MNS, Cardiodrive, a Magnetic Ablation Catheter, and the Navigant software. The ATTRAC study series and the HEART Study used the Helios ablation catheter, and the Versatile study used the BWI RMT Thermocool catheter. The following table describes the acute and 90-day success rates reported in these trials.Study RMN Patients Acute Success RMN 90 day success RMN ATTRAC 182 175/182 (96.2%) 145/147 (98.6%) ATTRAC II 80 71/75 (94.7%) 51/54 (94.4%) HEART Study 129 108/121 (89.3) 82/87 (94.3%) VERSATILE 120 119/120 (99.2%) Not reported Total 511 473/498 (95.0%) 278/288 (96.5%) | ||||||||||||||||||||||||
| iv. User assessment of device remote controls and safety features. | The Navigant system was used to steer the catheter during the evaluations performed for Navistar RMT, Celsius RMT and Helios II. Performance impressions were documented on physician feedback forms which are included in the reports. | ||||||||||||||||||||||||
| 4. Post-market surveillance (PMS) must be conducted and completed in accordance with FDA agreed upon PMS protocol. | Given the amount of clinical data from submitted studies and peer reviewed publications, a post market surveillance study is not warranted.The following summarizes the overwhelming evidence available to support the safety and efficacy of the MNS system: Four studies submitted to the FDA demonstrated a major adverse event rate of 3.9%. Data from these four studies supported 510(k) clearances for K071029, and K140804 and PMA approval in P050029. Acute success and 90 success rates were 95.0% and |
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| Special Controls | How Special Control Has Been Met |
|---|---|
| 96.5% respectively in those studies 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% Acute success rates and long-term success rates were similar in both the MNS and manual groups Stereotaxis proposes to continue monitoring the safety and efficacy of the Niobe System through the literature and Post Marketing Surveillance program. | |
| 5. A training program must be included with sufficient educational elements that, upon completion of the training program, the clinical and supporting staff can:i. Identify the safe environments for device use,ii. Use all safety features of the device, andiii. Operate the device in simulated or actual use environments representative of indicated environments and use for the indication of compatible catheters. | Representatives from the company train the physician and staff in the use of the Niobe Magnetic Navigation system.The Niobe ES User's Manual provides detailed operating instructions on the system and the navigation software.This information is reviewed with the physician and staff during simulation sessions and phantom training with the actual system |
| 6. Performance data must demonstrate the sterility of the sterile disposable components of the system | The Niobe System is not provided in sterile form nor is it required to be sterilized prior to use, therefore, sterilization information is not applicable. The Niobe System does not include sterile disposable components as part of the system.Cardiodrive includes a single-use disposable (QuikCAS) to interface with the compatible ablation catheter. The sterile components underwent sterilization testing. All sterilization testing resulted in a PASS. |
| 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. | The Niobe System is not provided in sterile form nor is it required to be sterilized prior to use, therefore, shelf life information, including package integrity and function of the device over the stated shelf life are not applicable.Cardiodrive includes a single-use disposable (QuikCAS) to interface with the compatible ablation catheter. The sterile components underwent shelf-life /packaging and sterilization testing. All sterilization and packaging testing resulted in a PASS, and each component was validated for a shelf life of 3 years. |
| Special Controls | How Special Control Has Been Met |
| 8. Labeling must include:i. Appropriate instructions, warnings, cautions, limitations, and information related to the intended patient population, compatible ablation catheters, and the device safeguards for the device;ii. Specific instructions and clinical training needed for the safe use of the device, which includes: | Niobe ES User's Manual includes:• Compatible Catheters• Indications for Use• Warnings• Safety ControlsThe Niobe System does not require assembly of the device prior to use. The Niobe System is considered permanent equipment installed in a Stereotaxis Magnetic Navigation Lab. Stereotaxis performs all installation activities for each Niobe System; therefore, assembly and installation instructions to the physician user are not required. |
| A. Instructions on assembling the device in all available configurations, including installation and removal of compatible catheters; | With regard to use of magnetically-compatible devices with the Niobe System, assembly and installation of these devices to/with the Niobe System is not required. Magnetically-compatible catheters interface with the Cardiodrive CAS device which advances and retracts the device and instructions related to the catheter-CAS interface are provided in the Cardiodrive instructions for use. The Niobe System only applies a magnetic field to orient the distal tip of a magnetically-compatible device; therefore, the manipulation of the distal end of the device is by indirect (non-physical) means for which assembly or installation of other devices is not required. |
| B. Instructions on all available modes or states of the devices;C. Instructions and explanation of all controls, inputs, and outputsD. Instructions on all safety features of the device andE. Validated methods and instructions for reprocessing/disinfecting any reusable components | The Niobe System User Guide includes an explanation and instructions for the following, controls, modes, and states of the device:• Procedure room components• System positions• Tableside Magnet Controller• System power up• Cover Force Sensor• Navigation Position Assistance• Software Basic Information• Cardiodrive CAS user interface• Activation codesThe Niobe System is a medical device that does not have any reusable components that reprocessing or disinfection prior to use. The magnet pods are covered by drapes during the procedure and may be wiped clean using hospital-grade EPA-registered germicide solutions following each procedure. Cleaning instructions are provided in the "Cleaning the Niobe System" section of the Niobe System User Guide). |
| Special Controls | How Special Control Has Been Met |
| iii.A detailed summary of themechanical compatibility testingincluding:A. A table with a complete list ofcompatible catheters tested(manufacturer trade name andmodel number), and | - Biosense Webster Navistar RMT- Biosense Webster Navistar RMT Thermocool- Biosense Webster Celsius RMT- Biosense Webster Celsius RMT Thermocool- Stereotaxis Helios II |
| B. A table with detailed test results,including type of test, acceptancecriteria, and test results (i.e., passfor meeting acceptance criteria); | Mechanical performance testing of compatible catheter isincluded in the Niobe Users Guide. |
| iv.A detailed summary of the in vivotesting including:A. A table with a complete list ofcompatible catheters used duringtesting (manufacturer trade nameand model number); | - Biosense Webster Navistar RMT- Biosense Webster Navistar RMT Thermocool- Biosense Webster Celsius RMT- Biosense Webster Celsius RMT Thermocool- Stereotaxis Helios II |
| B. Adverse events encounteredpertinent to use of the deviceunder use conditions; | Data from four clinical studies involving 511 patients whounderwent catheter ablation using the Stereotaxis MagneticNavigation System (MNS) are summarized. Collectively, the datain these studies demonstrates the safety and effectiveness of theMagnetic Navigation System for catheter ablation.Study Design:All four studies were prospective in nature and included safetyendpoints. Data from all four studies were used to supportregulatory approvals. Evaluation of 7 day major adverse eventsfor safety is reported.Study Results:Adverse Events:The overall 7 day major complication rate for all four studies was20/511 (3.9%) Major adverse events that occurred within 7 dayspost procedure included:- 1 cardiac tamponade related to right sidedcatheter- 1 cardiac tamponade related to the transseptalpuncture |
| Special Controls | How Special Control Has Been Met |
| 1 new focal wall abnormality 1 change in LVEF (60% to 45-50%) 2 vena cava thrombi 1 groin complication 1 chest soreness 1 prolonged hospitalization for grogginess 1 pseudoaneurysm 1 bleeding 1 anemia 1 dementia 1 pericardial effusion 1 heart block requiring pacemaker 2 pulmonary embolisms 1 AV fistula 2 arrhythmia recurrence (per protocol requirement) | |
| ConclusionThe data in this summary support the reasonable assurance of safety and effectiveness of the Stereotaxis Magnetic Navigation System for cardiac ablation procedures.These data have been summarized in the Niobe ES User's Guide. | |
| C. A detailed summary of device-and procedure-relatedcomplications; and | The following listing of the procedure related complications have been reported in clinical trials submitted to the agency:Two (2) patients out of 177 (1.1%) had an acute major adverse event and 5/182 (2.7%) had a major adverse event within 7 days of ablation in the ATTRAC Study. There was 1 death reported in the study secondary to respiratory failure, unrelated to the device. No cardiac tamponades or perforations were reported. One patient experienced a groin complication, two patients experienced vena cava thrombi, one experienced chest soreness, and one had a prolonged hospitalization due to being groggy. There were no device related adverse events.In the ATTRAC II Study, 1/80 (1.3%) patient had a major adverse event which was a cardiac tamponade due to a right sided non-study catheter. There were no deaths reported in this study. There were no device related adverse events.In the HEART study, the overall acute major adverse event rate was 5.4% for the magnetic arm. No deaths or cardiac tamponades were reported. There was 1 pericardial effusion, 1 heart block requiring pacemaker, 2 pulmonary embolisms, 1 AV fistula, and 2 arrhythmia recurrences (considered a major adverse event per the protocol) in the magnetic arm of the study. |
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| Special Controls | How Special Control Has Been Met | ||||
|---|---|---|---|---|---|
| All were reported as device or procedure related adverse events. | |||||
| The overall major adverse event rate in the VERSATILE Studywas 5/120 (4.2%) in this study. There was one cardiactamponade, one pseudo aneurysm, one bleeding, one patientpresented with anemia and dementia. The cardiac tamponadeevent started as a pericardial effusion and progressed intocardiac tamponade due to the transseptal puncture. The DSMadjudicated these events to be possibly and probably related tothe procedure, respectively. There were no device relatedadverse events. | |||||
| A summary of study outcomesD.and endpoints. Informationpertinent to the fluoroscopytimes/exposure for the procedure,patient, and operatorfluoroscopic exposure; | The following table summarizes the acute and long term successrates as well as fluoroscopy times reported in the clinical trials. | ||||
| Study | RMNPatients | AcuteSuccessRMN | 90 day successRMN | MeanFluoroscopytimeMean +/-S.D[range] | |
| ATTRAC | 182 | 175/182(96.2%) | 145/147(98.6%) | 15.89+/-13.15[1.05, 66.5] | |
| ATTRAC II | 80 | 71/75(94.7%) | 51/54 (94.4%) | 10.64 +/-9.78[0.63,61.0] | |
| HEARTStudy | 129 | 108/121(89.3) | 82/87 (94.3%) | 16.91 +/- 9.92[3.13,44.18] | |
| VERSATILE | 120 | 119/120(99.2%) | Not reported | 11.0 +/-10.5[0.03,55.2] | |
| Total | 511 | 473/498(95.0%) | 278/288(96.5%) | ||
| Other labeling items:V. | These data have been summarized in Niobe ES User's Guide.EMC: The Niobe System User Manual includes a summary of | ||||
| A. A detailed summary of pertinentnon-clinical testing information:EMC, mechanical, electrical, andsterilization of device andcomponents; | Electromagnetic Compatibility (EMC) testing under the sectiontitled "Electromagnetic Compatibility Information”.Electrical: In EMC section - Immunity (include ESD, etc.)Mechanical: Non-clinical performance testing of compatiblecatheters is included and summarized in the Niobe ES User'sGuideSterilization: The Niobe System is not provided in sterile formnor is it required to be sterilized prior to use, therefore,sterilization information is not applicable. | ||||
| A detailed summary of theB.device technical parameters; and | The Niobe system generates a directional 0.08T or 0.1T magneticfield within the patient's heart. The navigation volume is 6 inchesin diameter centered at X-ray isocenter. | ||||
| C.An expiration date/shelf life andstorage conditions for the sterileaccessories; and | The Niobe System is not provided in sterile form nor is it requiredto be sterilized prior to use, therefore, expiration date, shelf life,and storage conditions are not applicable. |
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| Special Controls | How Special Control Has Been Met |
|---|---|
| vi.When available, and according tothe timeframe included in the PMSprotocol agreed upon with FDA,provide a detailed summary of thePMS data including:A. Updates to the labeling toaccurately reflect outcomes ornecessary modifications basedupon data collected during thePMS experience, andB. Inclusion of results and adverseevents associated with utilizationof the device during the PMS. | Relevant warnings based on complaints and clinical studies havebeen included in The Niobe User's Guide. |
Stereotaxis believes objective evidence to support Special Controls for the predicate device are sufficient to confirm substantial equivalency for the proposed device. The additional animal testing performed raised no new issues of safety or efficacy for the proposed device.
ANIMAL STUDIES
Animal studies were not required to support the modifications to the Niobe System however; non-GLP animal studies for validation of specific versions of software features are included in the special controls.
CLINICAL STUDIES
Clinical studies were not required to support the modifications to the Niobe System however; human clinical data from other regulatory submissions are included in the special controls.
CONCLUSION
Based on the information presented in this Premarket Notification, Stereotaxis concludes that the Niobe System is substantially equivalent to the predicate and reference devices based on the same intended use and same primary technological characteristics. Any minor differences in technological characteristics between the proposed and reference Niobe System have demonstrated continued performance and do not raise new issues of safety or effectiveness.
§ 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.