Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System

K193147 · Stereotaxis, Inc. · PJB · Mar 5, 2020 · Cardiovascular

Device Facts

• Record ID: K193147
• Device Name: Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System
• Applicant: Stereotaxis, Inc.
• Product Code: PJB · Cardiovascular
• Decision Date: Mar 5, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Genesis MNS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart and coronary vasculature, neurovascular and peripheral vasculature by orienting the device tip in a desired direction. The Cardiodrive® Catheter Advancement System (CAS) is intended to automatically advance and retract compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis MNS. The Cardiodrive® system is not intended to advance the EP mapping and ablation catheters through the coronary vasculature or the coronary sinus. The Cardiodrive® system is not intended to advance or retract non-compatible catheters and/or other non-compatible devices into the neurovasculature.

Device Story

Genesis MNS is an interventional workstation for intravascular navigation of magnetically-adapted devices (catheters/guidewires). System uses computer-controlled permanent magnets to orient/steer device tips and remotely advance/retract compatible EP mapping and ablation catheters. Used in procedure rooms by physicians. Navigant Workstation (NWS) software processes physician inputs from user interface devices (mouse, keyboard, tableside controller) to determine required magnetic field orientation. System generates 0.08-0.12 Tesla magnetic fields. Output includes visual navigation guidance on monitors and robotic control of catheter tip orientation and advancement. Benefits include robotic precision and safety in complex cardiac/vascular procedures. System integrates with mapping systems (e.g., Carto, AcQmap) and fluoroscopy. Genesis features a center-of-mass magnet design without floor tracks, improving response time compared to predicate.

Clinical Evidence

Evidence includes bench testing, animal studies (porcine model), and clinical data from 511 patients across four studies (ATTRAC, ATTRAC II, HEART, VERSATILE) using the Niobe MNS. Primary endpoints included safety (major adverse events) and efficacy (acute/90-day success). Overall 7-day major complication rate was 3.9% (20/511). Acute success rate was 95.0% (473/498) and 90-day success was 96.5% (278/288). Bench testing confirmed mechanical performance, electrical safety (IEC 60601), and EMC compliance. Animal studies validated clinical workflows and compatibility with mapping/ablation systems.

Technological Characteristics

Permanent magnet system (metal alloy) with 0.08-0.12 Tesla field strength. Center-of-mass design, no floor track. Navigant NWS software (V5.0.6) controls magnetic field orientation. Connectivity includes integration with mapping systems (Carto, AcQmap) and digital fluoroscopy (Omega, Siemens). Components include tableside magnet controller, PC-compatible mouse/keyboard. Sterilization not applicable to system; sterile single-use disposable (QuikCAS) used for catheter interface.

Indications for Use

Indicated for navigation of compatible magnetic devices through tissue to target sites in the right/left heart, coronary vasculature, neurovascular, and peripheral vasculature. Cardiodrive CAS is indicated for automatic advancement/retraction of compatible magnetic EP mapping and ablation catheters in the heart. Contraindicated for advancing EP catheters through coronary vasculature/sinus and for advancing/retracting non-compatible devices into the neurovasculature.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Niobe MNS (K192775)

Reference Devices

• Helios II ablation catheter (P050029)
• CardioDrive with Ablation Catheter (K071029)
• V-CAS (K140804)
• Niobe MNS (K183027)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 5, 2020

Stereotaxis, Inc. Kenneth Lock Vice President, Clinical, Regulatory and Quality 4320 Forest Park Avenue, Suite 100 St. Louis, Missouri 63108

## Re: K193147

Trade/Device Name: Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System (Genesis MNS) Regulation Number: 21 CFR 870.5700 Regulation Name: Steerable Cardiac Ablation Catheter Remote Control System Regulatory Class: Class II Product Code: PJB, NDQ Dated: February 1, 2020 Received: February 3, 2020

## 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 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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Mark Fellman Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices 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) K193147

Device Name

Stereotaxis Genesis RMN® with Navigant™ Workstation (NWS) and Cardiodrive® System (Genesis MNS)

#### Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable):

| <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|---------------------------------------------------------------------------------|
| <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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Image /page/3/Picture/0 description: The image is a logo for Stereotaxis. The logo features an orange graphic on the left, resembling two leaves with a blue dot in the center. To the right of the graphic is the word "STEREOTAXIS" in a bold, sans-serif font. Below the word is the tagline "Improving Life with Robotic Precision and Safety" in a smaller font.

# 510(k) Summary per 21CFR §807.92

| Submitter's information | Stereotaxis, Inc.<br>4320 Forest Park Ave, Suite 100<br>St. Louis, MO 63108<br>Contact: Kenneth Lock, Vice President, Clinical, Regulatory and Quality<br>Telephone: [phone] |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device/classification name | |
| Device Name: | Genesis RMN® with Navigant™ Workstation (NWS) and Cardiodrive® System (Genesis MNS) |
| Classification/Common name: | Steerable cardiac ablation catheter remote control system. |
| Classification Number: | 870.5700 |
| Product Code: | PJB |
| Classification Panel: | Cardiovascular |
| Predicate Devices: | Niobe MNS (K192775) |
| Device description | Stereotaxis Genesis RMN® with Navigant™ Workstation (NWS) and Cardiodrive® System (Genesis MNS) is an interventional workstation for the intravascular navigation of appropriately equipped, magnetically adapted, devices (e.g., catheters or guidewires) through tissue to designated target sites using computer-controlled permanent magnets to orient or steer the tip of a magnetic device and remotely advance and retract only compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart. Genesis MNS incorporates software that determines the direction the magnetic field should be applied based on physician interaction with the user interface devices. |
| Intended use | 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.<br>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.<br>The Cardiodrive® system is not intended to advance the EP mapping and ablation catheters through the coronary vasculature or the coronary sinus.<br>The Cardiodrive® system is not intended to advance or retract non-compatible catheters and/or other non-compatible devices into the neurovasculature. |

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Image /page/4/Picture/0 description: The image shows the logo for Stereotaxis. The logo consists of an orange abstract shape on the left, resembling two leaves with a blue dot in the center. To the right of the shape is the word "STEREOTAXIS" in a bold, sans-serif font. Below the word is the tagline "Improving Life with Robotic Precision and Safety" in a smaller font.

## Technological Characteristics

| | SUBJECT DEVICE<br>Stereotaxis Genesis RMN® with<br>Navigant™ Workstation (NWS)<br>and Cardiodrive® System | PREDICATE DEVICE<br>Stereotaxis Niobe MNS with<br>Navigant<br>NWS, and Cardiodrive<br>K183027, K192775 |
|-----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Magnet System | | |
| Type of Magnets | Permanent, Positioned Mechanically,<br>metal alloy | Permanent, Positioned<br>Mechanically, metal alloy |
| Magnet Position | Permanent, Positioned Mechanically | Permanent, Positioned Mechanically |
| Navigation Volume | 6 inch B field Sphere | 6 inch B field Sphere |
| Magnet System Design | Center of Mass design no floor track | Cantilevered with floor track |
| Magnet Weight and Size | 640 lb | 764 lb |
| Distance from Magnet to Cover | 8.17 mm | 74 mm |
| Response Time | Faster - movement from center less<br>momentum | Slower- larger motion heavier<br>magnet more momentum |
| Articulating Arms | Biceps and forearm shoulder | Track mounted arc and fixed<br>position |
| Base Tilt Sensing | Available with continuous sensing | Not available |
| Control Cabinet | 81.7" (H) X 30.4" (W) X 32.1" (D) | 84.5"(H) X 59.1" (W) X 23.6" (D) |
| Control of Steerable Device Orientation | Remote and Computer Control | Remote and Computer Control |
| Devices Controlled by System | Specially Designed Magnetic<br>Catheters and Guidewires | Specially Designed Magnetic<br>Catheters and Guidewires |
| Adjusts Magnetic Field | Based on information received from<br>Navigant NWS Software | Based on information received from<br>Navigant NWS Software |
| Operating Magnetic Field Strength | 0.08-0.12 Tesla | 0.08-0.12 Tesla |
| Magnet Positioners | | |
| Number, Location | 2, positioned on right and left side of<br>patient | 2, positioned on right and left side of<br>patient |
| Magnet Covers | | |
| Material | Fiberglass | Fiberglass |
| Sensors | Yes, Contact Sensors | Yes, Contact Sensors |
| Magnetic Field Modes and Positions | | |
| Magnetic Field Modes | Applied, Reduced, Stowed | Applied, Reduced, Stowed |
| Magnetic Field Positions | Stowed, Pivoted, Retracted, Navigate<br>AP, Navigate LAO, Navigate RAO | Stowed, Pivoted, Retracted,<br>Navigate AP, Navigate LAO,<br>Navigate RAO |
| NAVIGANT NAVIGATION WORKSTATION | | |
| User Interface Components | | |
| Navigant Software | V5.0.6 | V5.0.6 |
| Tableside Magnet Controller | 1, Located on the patient table<br>accessory rail | 1, Located on the patient table<br>accessory rail |
| Mouse | 1, Standard PC compatible wheel<br>Mouse | 1, Standard PC compatible wheel<br>Mouse |
| Keyboard | 1, Standard PC compatible Keyboard<br>(without integrated keypad functions) | 1, Standard PC compatible Keyboard<br>(without integrated keypad<br>functions) |
| Keypad | 1, Separate component, contains the<br>keys from the predicate keyboard | 1, Separate component, contains the<br>keys from the predicate keyboard |
| Display Monitors, Location | 1+ (User preference) | 1+ (User preference) |
| | SUBJECT DEVICE<br>Stereotaxis Genesis RMN® with<br>Navigant™ Workstation (NWS) | PREDICATE DEVICE<br>Stereotaxis Niobe MNS with<br>Navigant |
| | and Cardiodrive® System | NWS, and Cardiodrive<br>K183027, K192775 |
| | Procedure and Control Rooms | Procedure and Control Rooms |
| Procedure Types | | |
| Electrophysiology (EP) | Yes | Yes |
| Interventional Cardiology (IC) | Yes | Yes |
| Cardiac Resynchronization Therapy<br>(CRT) | Yes | Yes |
| Interventional Radiology (IR) | Yes | Yes |
| Interventional Neuroradiology (INR) | Yes | Yes |
| Control Panels | | |
| Clinical Workflow Manager (CWM) | Optional use feature that acts as a<br>map and allows a physician to work<br>their way through an entire procedure | Optional use feature that acts as a<br>map and allows a physician to work<br>their way through an entire<br>procedure |
| Control Panel - Navigations | • Pre-set navigations<br>• Stored navigations<br>• Rename stored navigations<br>• Delete stored navigations | • Pre-set navigations<br>• Stored navigations<br>• Rename stored navigations<br>• Delete stored navigations |
| Control Panel - Visible Objects | • Delete<br>• Edits geometry<br>• Right-click menu for vessels<br>• Vessel properties<br>• Manual vessel registration<br>• Carto colors and Carto tags | • Delete<br>• Edits geometry<br>• Right-click menu for vessels<br>• Vessel properties<br>• Manual vessel registration<br>• Carto colors and Carto tags |
| Control Panel - Bullseye Targeting | • Bullseye target colors<br>• Altering bullseye targeting<br>• Bullseye targeting automation | • Bullseye target colors<br>• Altering bullseye targeting<br>• Bullseye targeting automation |
| Control Toolbars | | |
| Control Toolbar – Main | Title Bar, Status Bar, Reference<br>Images | Title Bar, Status Bar, Reference<br>Images |
| Control Toolbar - Hardware | Status Indicator | Status Indicator |
| User Views | | |
| Pre-operative Navigation | Included | Included |
| 3D Constellation | Included | Included |
| 3D Anatomic | Included | Included |
| Navigation Fluoroscopy Images | Included | Included |
| Display Graphics on Live Fluoroscopy | | |
| Field Mode Indicator | Included | Included |
| Magnetic Fields | Included | Included |
| Reduced Fields | Included | Included |
| Virtual Catheter | Included | Included |
| Points and Constellations | Included | Included |
| Pre-Op Data | | |
| Load, Register, and Display Pre-<br>operative Data | Included | Included |
| | SUBJECT DEVICE<br>Stereotaxis Genesis RMN® with<br>Navigant™ Workstation (NWS)<br>and Cardiodrive® System | PREDICATE DEVICE<br>Stereotaxis Niobe MNS with<br>Navigant<br>NWS, and Cardiodrive<br>K183027, K192775 |
| Apply and Reduce Magnetic Field | Included | Included |
| Image Transfer | Included | Included |
| 3D Anatomic, 3D Constellation,<br>Naviline Fluoroscopy | Included | Included |
| Click and Go Targeting | Included | Included |
| Naviline | Included | Included |
| Auto-mapping | Included | Included |
| Ablation History Graph Display | Included | Included |
| Ablation History Volume Display | Included | Included |
| Digital Fluoroscopy | Compatible with Omega and<br>Siemens | Compatible with Omega, Siemens<br>and Philips |
| Physician Preference Companion Devices and Systems | | |
| Odyssey Workstation | FDA-cleared, compatible | Included |
| Compatibility with updated firmware<br>for integrated video component | Included | Included |
| Vdrive Robotic Navigation System | FDA-cleared, compatible | Included |
| Cardiodrive Catheter Advancement<br>System (CAS) | FDA-cleared, compatible | Included |
| Cardiodrive Catheter Advancement<br>System (CAS) | Included | Included |
| Mapping Systems | FDA-cleared, compatible system<br>Carto, and AcQmap | Included |
| User Interface | Included | Included |
| Ablation Catheters | FDA-approved, magnetic compatible | Same |

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Image /page/5/Picture/0 description: The image shows the logo for Stereotaxis. The logo features an orange abstract design on the left, followed by the word "STEREOTAXIS" in a bold, sans-serif font. Below the word, there is a tagline that reads "Improving Life with Robotic Precision and Safety".

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Image /page/6/Picture/0 description: The image shows the logo for Stereotaxis. The logo consists of two orange shapes resembling leaves with a blue dot in the center, followed by the word "STEREOTAXIS" in a bold, sans-serif font. Below the word, there is a tagline that reads "Improving Life with Robotic Precision and Safety".

### Performance data

Performance data establish the substantial equivalence of the Genesis MNS including software verification and validation data, bench performance testing and animal testing. Performance testing was conducted for electrical safety, and EMC compatibility.

Animal Testing: Stereotaxis performed an animal study in a porcine model to evaluate the safety and effectiveness of Genesis MNS to perform movements of multiple compatible ablation catheters, safety features, and mechanical performance testing according to the Special Controls. This study demonstrated that the Genesis MNS met its performance requirements.

Based upon the documentation presented in this 510(k) it has been demonstrated that the Genesis MNS device is safe and effective for its intended use.

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Image /page/7/Picture/0 description: The image is a logo for Stereotaxis. The logo features two orange shapes that resemble leaves or flames on the left side, with a blue dot in the center. To the right of the shapes is the word "STEREOTAXIS" in a bold, sans-serif font. Below the word is the tagline "Improving Life with Robotic Precision and Safety" in a smaller font.

# Special Controls

| Special Controls | How Special Control Has Been Met | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| 1) Non-clinical mechanical performance<br>testing must demonstrate that the device<br>performs as intended under anticipatedconditions of use. The following<br>performance testing must be performed:<br>i. Mechanical performance of the<br>system (without catheter connected); | Using the proposed device, Magnetic field performance testing without the<br>catheter connected. Testing included:<br>a robotic field accuracy survey. reduced field mode angular resolution isocenter offset (for heart position) Field characteristics (strength, direction, position and accuracy) meet the<br>same requirements for the predicate Niobe and the subject Genesis. | |
| ii. Mechanical performance of the<br>system with compatible catheters<br>connected to verify that the system<br>does not impact catheter function or<br>performance. Assessments must<br>include the following: | Manual Control Performance Testing<br>Performance testing data for the reference Niobe device included deflection<br>testing, accuracy testing with target phantom and anatomical position testing<br>with a plastic heart model. The results of this testing provide mechanical<br>performance data for the reference device. | |
| (A) Side-by-side remote control and<br>manual comparisons of catheter<br>manipulation (including all<br>ranges of motion of catheter<br>deflection and tip curl) for all<br>compatible catheters; must<br>include testing for worst-case<br>conditions, and | Remote Control Performance Testing<br>The same performance testing of compatible devices was performed with the<br>subject Genesis system that included deflection testing, accuracy testing<br>with target phantom and anatomical position testing with a plastic heart<br>model. The results of this testing provide mechanical performance data for<br>the reference device.<br><br>The subject Genesis system performed at the same level with compatible<br>devices as the predicate Niobe System. The subject device generates the<br>same magnetic fields as the predicate device. The compatible catheter<br>performance testing results were the same for Genesis as it was for Niobe<br>and demonstrates substantial equivalence. | |
| (B) Evaluation of the accuracy and<br>function of all device control<br>safety features; and | Testing of the four primary safety controls related to the physical motion of<br>the system was conducted on the proposed device. These concern physical<br>movement of the magnet positioners, movement of the covers toward the<br>patient, continuous advancement of the catheter, and motion e-stops. All<br>safety controls passed the test.<br><br>Successful user testing of safety controls was the same between Niobe and<br>Genesis. Genesis is substantial equivalent to the predicate device in relation<br>to the accuracy and function of the device control safety features. | |
| iii. Simulated-use testing in a bench<br>anatomic model or animal model. | Validation testing for Genesis includes use testing of clinical workflows in a<br>bench model.<br><br>An animal study was performed that employed typical clinical workflows<br>including compatibility with mapping system, CardioDrive, and<br>fluoroscopy.<br><br>Clinical workflow testing for Genesis with compatible devices was the same | |
| Special Controls | How Special Control Has Been Met | |
| | as Niobe. Animal and simulated use testing provided objective evidence to<br>substantiate that the Genesis MNS is substantially equivalent to the predicate<br>device. | |
| 2. Non-clinical electrical testing must<br>include validation of electromagnetic<br>compatibility (EMC), electrical safety,<br>thermal safety, and electrical system<br>performance. The following<br>performance testing must be<br>performed: | Manual Control Performance Testing<br>EMC and Electrical safety testing showing conformance with IEC 60601<br>were performed by TuV for the reference Niobe device. | |
| | Remote Control Performance Testing<br>EMC testing for the proposed device hardware demonstrating conformance<br>with IEC 60601-1-2 was performed by Intertek. | |
| i. Electrical performance of the<br>system with compatible catheters<br>connected to verify that the<br>system does not impact catheter<br>function or performance.<br>Assessments must include the<br>following:<br>A. Side-by-side remote control<br>and manual comparisons of<br>catheter manipulation<br>(including all ranges of<br>motion of catheter deflection<br>and tip curl) for all<br>compatible catheters; must<br>include testing for worst-case<br>conditions, and | As required, both the predicate device and proposed device were tested<br>according to IEC 60601-1-2 standards by Nationally Recognized Testing<br>Labs. All tests passed. | |
| B. Evaluation of the accuracy<br>and function of all device<br>control safety features; and | Electrical safety testing on the proposed device demonstrating compliance<br>with IEC 60601, and IEC 60601-1-2 was performed by Intertek. | |
| ii. Electrical safety between the<br>device and ablation catheter<br>system and with other electrical<br>equipment expected in the<br>catheter lab or operating room. | The proposed system has been tested for compatibility with specific x-ray,<br>ablation generators, and mapping systems.<br>In addition, electrical isolation and emissions testing have been performed<br>by Intertek. | |
| Special Controls | How Special Control Has Been Met | |
| 3.<br>In vivo testing must demonstrate that<br>the device performs as intended under<br>anticipated conditions of use,<br>including an assessment of the system<br>impact on the functionality and<br>performance of compatible catheters,<br>and documentation of the adverse<br>event profile associated with clinical<br>use. Evidence must be submitted to<br>address the following:<br>i.<br>Manipulation and Positioning:<br>Ability to manipulate<br>compatible catheters to pre-<br>specified cardiac locations and<br>conform proper anatomic<br>placement and tissue contact, in<br>accordance with the system<br>indications for use and<br>compatible catheter indications<br>for use; | Animal study was conducted with compatible devices to demonstrate<br>compatibility. Catheters were directed to predefined targets and evidence of<br>suitable contact was demonstrated.<br>In vivo testing was conducted with the subject device and all compatible<br>devices functioned in a similar manner to the predicate device. This te…