Predicate Devices

Niobe MNS (K192775)

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description states the software determines the magnetic field direction based on physician interaction, not through AI/ML algorithms. There is no mention of AI, DNN, or ML in the document, nor any description of training or test data sets typically associated with AI/ML development.

Therapeutic

Yes
The device is described as "an interventional workstation for the intravascular navigation of appropriately equipped, magnetically adapted, devices (e.g., catheters or guidewires) through tissue to designated target sites". It is used in conjunction with "electrophysiology (EP) mapping and ablation catheters" and clinical studies show its use in "evaluating the safety and effectiveness of Genesis MNS to perform movements of multiple compatible ablation catheters". Ablation catheters are therapeutic devices used to destroy abnormal tissue. Therefore, the Genesis MNS is part of a system intended to perform a therapeutic function.

Diagnostic

No

Explanation: The device is described as an interventional workstation used for navigation of medical devices, specifically for advancing and retracting catheters for procedures like mapping and ablation. While these procedures may follow a diagnosis, the device itself is not presented as providing diagnostic information.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the Genesis MNS is an "interventional workstation" that includes "computer-controlled permanent magnets" and the "Cardiodrive® System," which is a hardware component for advancing and retracting catheters. While it incorporates software, it is not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly describes a system for navigating and advancing devices within the patient's body (in vivo). It focuses on physical manipulation of catheters and guidewires for therapeutic and diagnostic procedures.
Device Description: The description reinforces this by detailing an "interventional workstation for the intravascular navigation" of devices.
Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (blood, tissue, etc.) outside of the body to provide diagnostic information.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. This device's function is entirely focused on interacting with the patient's anatomy directly.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes (comma separated list FDA assigned to the subject device)

PJB, NDQ

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Fluoroscopy

Anatomical Site

right and left heart and coronary vasculature, neurovascular and peripheral vasculature

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

In vivo testing: Animal study was conducted with compatible devices to demonstrate compatibility. Catheters were directed to predefined targets and evidence of suitable contact was demonstrated. In vivo testing was conducted with the subject device and all compatible devices functioned in a similar manner to the predicate device. This testing is equivalent to the testing performed for the predicate device. This demonstrates that the subject device is substantially equivalent to the predicate device with compatible catheters.

Clinical Studies:
A total of 511 patients from 4 studies (ATTRAC, ATTRAC II, HEART Study, VERSATILE) were enrolled using the Niobe Magnetic Navigation System, which included the Niobe MNS, CardioDrive, a Magnetic Ablation Catheter, and the Navigant Software.

Acute Success Rates:
ATTRAC: 175/182 (96.2%)
ATTRAC II: 71/75 (94.7%)
HEART Study: 108/121 (89.3%)
VERSATILE: 119/120 (99.2%)
Overall: 473/498 (95.0%)

90 day success Rates:
ATTRAC: 145/147 (98.6%)
ATTRAC II: 51/54 (94.4%)
HEART Study: 82/87 (94.3%)
VERSATILE: Not reported
Overall: 278/288 (96.5%)

Mean Fluoroscopy time:
ATTRAC: 15.89+/-13.15 [1.05, 66.5]
ATTRAC II: 10.64 +/-9.78 [0.63, 61.0]
HEART Study: 16.91 +/-9.92 [3.13, 44.18]
VERSATILE: 11.0 +/-10.5 [0.03, 55.2]

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

7 Day Major Complication Rates:
ATTRAC: 7/182 (3.8%)
ATTRAC II: 1/80 (1.3%)
HEART Study: 7/129 (5.4%)
VERSATILE: 5/120 (4.2%)
Total: 20/511 (3.9%)

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Niobe MNS (K192775)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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.

Summary

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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

1

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,

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

2

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):

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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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.
4320 Forest Park Ave, Suite 100
St. Louis, MO 63108
Contact: Kenneth Lock, Vice President, Clinical, Regulatory and Quality
Telephone: 314-678-6123 |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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.
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. |

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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
Stereotaxis Genesis RMN® with
Navigant™ Workstation (NWS)
and Cardiodrive® System | PREDICATE DEVICE
Stereotaxis Niobe MNS with
Navigant
NWS, and Cardiodrive
K183027, K192775 |
|-----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Magnet System | | |
| Type of Magnets | Permanent, Positioned Mechanically,
metal alloy | Permanent, Positioned
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
momentum | Slower- larger motion heavier
magnet more momentum |
| Articulating Arms | Biceps and forearm shoulder | Track mounted arc and fixed
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
Catheters and Guidewires | Specially Designed Magnetic
Catheters and Guidewires |
| Adjusts Magnetic Field | Based on information received from
Navigant NWS Software | Based on information received from
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
patient | 2, positioned on right and left side of
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
AP, Navigate LAO, Navigate RAO | Stowed, Pivoted, Retracted,
Navigate AP, Navigate LAO,
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
accessory rail | 1, Located on the patient table
accessory rail |
| Mouse | 1, Standard PC compatible wheel
Mouse | 1, Standard PC compatible wheel
Mouse |
| Keyboard | 1, Standard PC compatible Keyboard
(without integrated keypad functions) | 1, Standard PC compatible Keyboard
(without integrated keypad
functions) |
| Keypad | 1, Separate component, contains the
keys from the predicate keyboard | 1, Separate component, contains the
keys from the predicate keyboard |
| Display Monitors, Location | 1+ (User preference) | 1+ (User preference) |
| | SUBJECT DEVICE
Stereotaxis Genesis RMN® with
Navigant™ Workstation (NWS) | PREDICATE DEVICE
Stereotaxis Niobe MNS with
Navigant |
| | and Cardiodrive® System | NWS, and Cardiodrive
K183027, K192775 |
| | Procedure and Control Rooms | Procedure and Control Rooms |
| Procedure Types | | |
| Electrophysiology (EP) | Yes | Yes |
| Interventional Cardiology (IC) | Yes | Yes |
| Cardiac Resynchronization Therapy
(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
map and allows a physician to work
their way through an entire procedure | Optional use feature that acts as a
map and allows a physician to work
their way through an entire
procedure |
| Control Panel - Navigations | • Pre-set navigations
• Stored navigations
• Rename stored navigations
• Delete stored navigations | • Pre-set navigations
• Stored navigations
• Rename stored navigations
• Delete stored navigations |
| Control Panel - Visible Objects | • Delete
• Edits geometry
• Right-click menu for vessels
• Vessel properties
• Manual vessel registration
• Carto colors and Carto tags | • Delete
• Edits geometry
• Right-click menu for vessels
• Vessel properties
• Manual vessel registration
• Carto colors and Carto tags |
| Control Panel - Bullseye Targeting | • Bullseye target colors
• Altering bullseye targeting
• Bullseye targeting automation | • Bullseye target colors
• Altering bullseye targeting
• Bullseye targeting automation |
| Control Toolbars | | |
| Control Toolbar – Main | Title Bar, Status Bar, Reference
Images | Title Bar, Status Bar, Reference
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-
operative Data | Included | Included |
| | SUBJECT DEVICE
Stereotaxis Genesis RMN® with
Navigant™ Workstation (NWS)
and Cardiodrive® System | PREDICATE DEVICE
Stereotaxis Niobe MNS with
Navigant
NWS, and Cardiodrive
K183027, K192775 |
| Apply and Reduce Magnetic Field | Included | Included |
| Image Transfer | Included | Included |
| 3D Anatomic, 3D Constellation,
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
Siemens | Compatible with Omega, Siemens
and Philips |
| Physician Preference Companion Devices and Systems | | |
| Odyssey Workstation | FDA-cleared, compatible | Included |
| Compatibility with updated firmware
for integrated video component | Included | Included |
| Vdrive Robotic Navigation System | FDA-cleared, compatible | Included |
| Cardiodrive Catheter Advancement
System (CAS) | FDA-cleared, compatible | Included |
| Cardiodrive Catheter Advancement
System (CAS) | Included | Included |
| Mapping Systems | FDA-cleared, compatible system
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
testing must demonstrate that the device
performs as intended under anticipatedconditions of use. The following
performance testing must be performed:
i. Mechanical performance of the
system (without catheter connected);	Using the proposed device, Magnetic field performance testing without the
catheter connected. Testing included:
a robotic field accuracy survey. reduced field mode angular resolution isocenter offset (for heart position) Field characteristics (strength, direction, position and accuracy) meet the
same requirements for the predicate Niobe and the subject Genesis.
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:	Manual Control Performance Testing
Performance testing data for the reference Niobe device included deflection
testing, accuracy testing with target phantom and anatomical position testing
with a plastic heart model. The results of this testing provide mechanical
performance data for the reference device.
(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	Remote Control Performance Testing
The same performance testing of compatible devices was performed with the
subject Genesis system that included deflection testing, accuracy testing
with target phantom and anatomical position testing with a plastic heart
model. The results of this testing provide mechanical performance data for
the reference device.

The subject Genesis system performed at the same level with compatible
devices as the predicate Niobe System. The subject device generates the
same magnetic fields as the predicate device. The compatible catheter
performance testing results were the same for Genesis as it was for Niobe
and demonstrates substantial equivalence. | |
| (B) Evaluation of the accuracy and
function of all device control
safety features; and | Testing of the four primary safety controls related to the physical motion of
the system was conducted on the proposed device. These concern physical
movement of the magnet positioners, movement of the covers toward the
patient, continuous advancement of the catheter, and motion e-stops. All
safety controls passed the test.

Successful user testing of safety controls was the same between Niobe and
Genesis. Genesis is substantial equivalent to the predicate device in relation
to the accuracy and function of the device control safety features. | |
| iii. Simulated-use testing in a bench
anatomic model or animal model. | Validation testing for Genesis includes use testing of clinical workflows in a
bench model.

An animal study was performed that employed typical clinical workflows
including compatibility with mapping system, CardioDrive, and
fluoroscopy.

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
substantiate that the Genesis MNS is substantially equivalent to the predicate
device. | |
| 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: | Manual Control Performance Testing
EMC and Electrical safety testing showing conformance with IEC 60601
were performed by TuV for the reference Niobe device. | |
| | Remote Control Performance Testing
EMC testing for the proposed device hardware demonstrating conformance
with IEC 60601-1-2 was performed by Intertek. | |
| 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 | As required, both the predicate device and proposed device were tested
according to IEC 60601-1-2 standards by Nationally Recognized Testing
Labs. All tests passed. | |
| B. Evaluation of the accuracy
and function of all device
control safety features; and | Electrical safety testing on the proposed device demonstrating compliance
with IEC 60601, and IEC 60601-1-2 was performed by Intertek. | |
| ii. Electrical safety between the
device and ablation catheter
system and with other electrical
equipment expected in the
catheter lab or operating room. | The proposed system has been tested for compatibility with specific x-ray,
ablation generators, and mapping systems.
In addition, electrical isolation and emissions testing have been performed
by Intertek. | |
| Special Controls | How Special Control Has Been Met | |
| 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
conform proper anatomic
placement and tissue contact, in
accordance with the system
indications for use and
compatible catheter indications
for use; | Animal study was conducted with compatible devices to demonstrate
compatibility. Catheters were directed to predefined targets and evidence of
suitable contact was demonstrated.
In vivo testing was conducted with the subject device and all compatible
devices functioned in a similar manner to the predicate device. This testing
is equivalent to the testing performed for the predicate device. This
demonstrates that the subject device is substantially equivalent to the
predicate device with compatible catheters. | |
| 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; | The subject device generates the same magnetic fields as the predicate
device and works with the same compatible fluoroscopic, mapping and
ablation devices. Existing magnetic navigation clinical data are still relevant.
The following information is sufficient enough to demonstrate substantial
equivalency to the predicate device.
Clinical data to support the safety of the 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 | 7 Day Major
Complication |
| ATTRAC | 182 | 7/182 (3.8%) |
| ATTRAC II | 80 | 1/80 (1.3%) |

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Image /page/8/Picture/0 description: The image is a logo for Stereotaxis. The logo features an orange abstract shape 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/9/Picture/0 description: The image is the logo for Stereotaxis. The logo features an orange graphic on the left, followed by the word "STEREOTAXIS" in a tall, sans-serif font. Below the word is the tagline "Improving Life with Robotic Precision and Safety."

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Image /page/10/Picture/0 description: The image shows the logo for Stereotaxis. The logo features 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, and below that is the tagline "Improving Life with Robotic Precision and Safety".

Special Controls	How Special Control Has Been Met
	HEART Study	129	7/129 (5.4%)
	VERSATILE	120	5/120 (4.2%)
	Total	511	20/511 (3.9%)
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	The subject device generates the same magnetic fields as the predicate
device and works with the same compatible fluoroscopic, mapping and
ablation devices. Existing magnetic navigation clinical data are still relevant.
The following information is sufficient enough to demonstrate substantial
equivalency to the predicate device.

Data to support the ablation success of the 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 | | | |
| | 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 same user assessment testing of the predicate device was performed
with the subject device and all safety features passed testing. This is
sufficient to demonstrate substantial equivalency to the predicate device with
regard to the safety controls. | | | |
| 4.
Post-market surveillance (PMS) must
be conducted and completed in
accordance with FDA agreed upon
PMS protocol. | The subject device generates the same magnetic fields as the predicate
device and works with the same compatible fluoroscopic, mapping and
ablation devices. Existing magnetic navigation clinical data are still relevant.
The following information is sufficient enough to demonstrate substantial
equivalency to the predicate device. | | | |

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Image /page/11/Picture/0 description: The image shows the logo for Stereotaxis. The logo consists of an orange abstract shape on the left, followed by 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	How Special Control Has Been Met
	Given the amount of clinical data from submitted studies and peer reviewed publications for magnetic navigation, 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 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 Genesis 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: Identify the safe environments for device use, Use all safety features of the device, and 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 Genesis Magnetic Navigation system using simulator and phantom testing. The Genesis 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 Genesis System is not provided in sterile form nor is it required to be sterilized prior to use, therefore, sterilization information is not applicable. The Genesis 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.
Special Controls	How Special Control Has Been Met
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 Genesis 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. |
| 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:
A. Instructions on assembling the device in all available configurations, including installation and removal of compatible catheters; | Genesis User's Manual includes:
• Compatible Catheters
• Indications for Use
• Warnings
• Safety Controls

The Genesis System does not require assembly of the device prior to use. The Genesis System is considered permanent equipment installed in a Stereotaxis Magnetic Navigation Lab. Stereotaxis performs all installation activities for each Genesis System; therefore, assembly and installation instructions to the physician user are not required.

With regard to use of magnetically-compatible devices with the Genesis System, assembly and installation of these devices to/with the Genesis 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 Genesis 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. |
| Special Controls | How Special Control Has Been Met |
| B. Instructions on all available
modes or states of the
devices;
C. Instructions and explanation
of all controls, inputs, and
outputs
D. Instructions on all safety
features of the device and
E. Validated methods and
instructions for
reprocessing/disinfecting any
reusable components | The Genesis 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 codes The Genesis 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 Genesis
System" section of the Genesis System User Guide). |
| 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); | Biosense Webster Navistar RMT Biosense Webster Navistar RMT Thermocool Biosense Webster Celsius RMT Biosense Webster Celsius RMT Thermocool Mechanical testing for both the predicate device and the subject device
included accessing pre-defined geometric targets from multiple positions
with each of the compatible catheters. Testing also included anatomical
phantom navigation to pre-defined anatomical targets with each of the
compatible catheters. All tests passed successfully. The subject device
demonstrated substantial equivalence to the predicate device. |
| 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); | Biosense Webster Navistar RMT Biosense Webster Navistar RMT Thermocool Biosense Webster Celsius RMT Biosense Webster Celsius RMT Thermocool In vivo testing was performed with the subject device that included the
listed compatible catheters. In the subject device, all compatible catheters
functioned in a similar manner to the predicate device. The Genesis system |
| Special Controls | How Special Control Has Been Met |
| | system as Niobe. |
| B. Adverse events encountered
pertinent to use of the device
under use conditions; | The Genesis system provides the same magnetic field, works with the same
CardioDrive system and same compatible catheters as Niobe. Performance
data has shown that the catheters respond to the field in the same manner.
Data from four clinical studies involving 511 patients who underwent
catheter ablation using the Stereotaxis Magnetic Navigation System (MNS)
are summarized. Collectively, the data in these studies demonstrates the
safety and effectiveness of the Magnetic Navigation System for catheter
ablation.

Study Design:

All four studies were prospective in nature and included safety endpoints.
Data from all four studies were used to support regulatory approvals.
Evaluation of 7 day major adverse events for safety is reported.

Study Results:

Adverse Events:

The overall 7 day major complication rate for all four studies was 20/511
(3.9%) Major adverse events that occurred within 7 days post procedure
included:
1 cardiac tamponade related to right sided catheter 1 cardiac tamponade related to the transseptal puncture 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 |

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Image /page/12/Picture/0 description: The image shows the logo for Stereotaxis. The logo features an orange abstract shape 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/13/Picture/0 description: The image is a logo for Stereotaxis. The logo features an orange abstract shape 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/14/Picture/0 description: The image shows the logo for Stereotaxis. The logo features 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.

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Image /page/15/Picture/0 description: The image shows the logo for Stereotaxis. The logo features 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".

Special Controls	How Special Control Has Been Met
	Conclusion
The 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 Genesis User's Guide.
C. A detailed summary of
device- and procedure-related
complications; 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. All were reported as device or procedure related adverse events.
	The overall major adverse event rate in the VERSATILE Study was 5/120
(4.2%) in this study. There was one cardiac tamponade, one pseudo
aneurysm, one bleeding, one patient presented with anemia and dementia.
The cardiac tamponade event started as a pericardial effusion and
progressed into cardiac tamponade due to the transseptal puncture. The
DSM adjudicated these events to be possibly and probably related to the
procedure, respectively. There were no device related adverse events.
D. A summary of study
outcomes and endpoints.
Information pertinent to the
fluoroscopy times/exposure
for the procedure, patient, and
operator fluoroscopic
exposure;	The following table summarizes the acute and long term success rates as
well as fluoroscopy times reported in the clinical trials.
Study RMN
Patient
s Acute Success
RMN 90 day success
RMN Mean
Fluoroscopy time
Mean +/-S.D
[range] ATTRAC 182 175/182 (96.2%) 145/147 (98.6%) 15.89+/-13.15
[1.05, 66.5]

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Image /page/16/Picture/0 description: The image shows the logo for Stereotaxis. The logo features 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 company name, "STEREOTAXIS," in a bold, sans-serif font. Below the name is the tagline, "Improving Life with Robotic Precision and Safety," in a smaller font.

Special Controls	How Special Control Has Been Met
	ATTRAC II	80	71/75 (94.7%)	51/54 (94.4%)	10.64 +/-9.78
[0.63,61.0]
	HEART Study	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%)
	These data have been summarized in Genesis User's Guide.
Other labeling items:
v.
A. A detailed summary of
pertinent non-clinical testing
information: EMC,
mechanical, electrical, and
sterilization of device and
components;	EMC: The Genesis System User Manual includes a summary of
Electromagnetic Compatibility (EMC) testing under the section titled
"Electromagnetic Compatibility Information".
Electrical: In EMC section – Immunity (include ESD, etc.)
Mechanical: Non-clinical performance testing of compatible catheters is
included and summarized in the Genesis User's Guide
Sterilization: The Genesis System is not provided in sterile form nor is it
required to be sterilized prior to use, therefore, sterilization information is
not applicable.
B.
A detailed summary of the
device technical parameters;
and	The Genesis system generates a directional 0.08T or 0.1T magnetic field
within the patient's heart. The navigation volume is 6 inches in diameter
centered at X-ray isocenter.
C.
An expiration date/shelf life
and storage conditions for the
sterile accessories; and	The Genesis System is not provided in sterile form nor is it required to be
sterilized prior to use, therefore, expiration date, shelf life, and storage
conditions are not applicable.
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	Relevant warnings based on complaints and clinical studies have been included in The Genesis User's Guide.

Date 510 (k) Summary revised: March 4, 2020