The Niobe System is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart and coronary vascular and peripheral vasculature by orienting the device tip in a desired direction.

The Cardiodrive Catheter Advancement System (CAS) is intended to automatically advance and retract compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis MNS.

The Cardiodrive system is not intended to advance the EP mapping and ablation catheters through the coronary vasculature or the coronary sinus.

The Cardiodrive system is not intended to advance or retract non-compatible catheters and/or other non-compatible devices into the neurovasculature.

Device Description

The Stereotaxis Niobe Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodrive (a.k.a. the Niobe System) is an interventional workstation for the intravascular navigation of appropriately equipped, magnetically adapted, devices (e.g., catheters or guidewires) through tissue to designated target sites. The Niobe System uses computer-controlled permanent magnets for orientating the tip of a magnetic device and employs magnetic fields only to orient or steer the tip of a magnetic device and remotely advance and retract only compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart. The Niobe System incorporates software that determines the direction the magnetic field should be applied based on physician interaction with the user interface devices.

AI/ML Overview

The provided text describes the acceptance criteria and the studies that demonstrate the Stereotaxis Niobe® Magnetic Navigation System (MNS) with Navigant™ Workstation (NWS) and Cardiodrive® meets these criteria. The information is extracted from a 510(k) premarket notification.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the "Special Controls" section, and the reported performance is from "How Special Control Has Been Met."

Acceptance Criteria (Special Control)	Reported Device Performance
1) Non-clinical mechanical performance testing:
i. Mechanical performance of the system (without catheter connected)	Magnetic field performance testing using a THM-7025 Hall Effect tesla meter measured applied field strength and accuracy in cardinal directions at 0.08T and 0.1T (worst-case positions).
ii. Mechanical performance of the system with compatible catheters connected to verify no impact on catheter function/performance (side-by-side remote control and manual comparisons, all ranges of motion, worst-case; evaluation of accuracy/function of safety features)	Manual Control Performance Testing: Deflection testing, accuracy testing with target phantom, and anatomical position testing with a plastic heart model were performed for the reference Niobe device. Remote Control Performance Testing: The proposed device demonstrated equivalent mechanical performance to the reference device. Safety Features: Testing of four primary safety controls (magnet positioner movement, cover movement toward patient, continuous catheter advancement, motion e-stops) was conducted on the proposed device, and "All four safety controls passed the test."
iii. Simulated-use testing in a bench anatomic model or animal model	Four non-GLP animal validation studies were conducted after the reference device was cleared to test software iterations (Navigant 4.4, 5.0.1, 5.0.2, 5.0.3) features like ablation lesion assessment, sheath visualization, zone mapping, NaviLine, targeting, and point/line ablation.
2. Non-clinical electrical testing:
i. Electrical performance of the system with compatible catheters connected (Side-by-side remote control and manual comparisons, worst-case; evaluation of accuracy/function of safety features)	Manual Control Performance Testing: EMC and electrical safety testing confirming conformance with IEC 60601 were performed by TuV for the reference device. Remote Control Performance Testing: EMC testing for the proposed device hardware demonstrating conformance with IEC 60601 was performed by TuV. "All tests passed." Safety Features: Electrical safety testing on the proposed device demonstrating compliance with IEC 60601 was performed by TuV. "All tests passed."
ii. Electrical safety between the device and ablation catheter system and with other electrical equipment in cath lab/OR	The proposed system has been tested for compatibility with specific x-ray, ablation generators, mapping systems. Electrical isolation and emissions testing have been performed by TuV. "All tests passed."
3. In vivo testing:
i. Manipulation and Positioning: Ability to manipulate compatible catheters to pre-specified cardiac locations and conform proper anatomic placement and tissue contact	The VERSATILE Study (K141530) and in vivo animal testing (K071029 for Cardiodrive) demonstrated the ability to manipulate compatible catheters to pre-specified cardiac locations.
ii. Safety: Assess device-related complication rate and major procedural complication rate vs. literature/manual comparison group	Clinical data from 4 Stereotaxis-sponsored studies (ATTRAC, ATTRAC II, HEART, VERSATILE) involving 511 patients using the Niobe System (MNS, Cardiodrive, Magnetic Ablation Catheter, Navigant Software) showed an overall 7-day Major Complication Rate of 3.9% (20/511). Individual study rates ranged from 1.3% to 5.4%. Complications included cardiac tamponade, new focal wall abnormality, change in LVEF, vena cava thrombi, groin complication, prolonged hospitalization, pseudoaneurysm, bleeding, anemia, dementia, pericardial effusion, heart block, pulmonary embolisms, AV fistula, and arrhythmia recurrence. Several events were adjudicated as possibly/probably related to the procedure, with some explicitly stated as non-device related.
iii. Efficacy: Assess ablation success vs. literature/manual comparison group	Clinical data from the same 4 Stereotaxis-sponsored studies (ATTRAC, ATTRAC II, HEART, VERSATILE) involving 511 patients showed an overall Acute Success Rate of 95.0% (473/498) and a 90-day Success Rate of 96.5% (278/288). Individual study acute success rates ranged from 89.3% to 99.2%, and 90-day success rates from 94.3% to 98.6%. The VERSATILE study did not report 90-day success.
iv. User assessment of device remote controls and safety features	Performance impressions were documented on physician feedback forms during evaluations for Navistar RMT, Celsius RMT, and Helios II, where the Navigant system was used to steer the catheter.
4. Post-market surveillance (PMS)	"A post market surveillance study is not warranted." This is based on: - "Overwhelming evidence" from four submitted studies (3.9% major adverse event rate, 95.0% acute success, 96.5% 90-day success). - More than 8,000 patients reported in literature using MNS with a major complication rate of 0.72% (compared to manual rate of 2.1%). - Acute and long-term success rates were similar in MNS and manual groups in literature. Stereotaxis proposes continued monitoring through literature and Post Marketing Surveillance program.
5. Training program for clinical and supporting staff	Representatives from the company train physicians and staff. The Niobe ES User's Manual provides operating instructions. Information is reviewed during simulation sessions and phantom training with the actual system.
6. Performance data for sterility of sterile disposable components	The Niobe System is not sterile and not required to be sterilized. The Cardiodrive includes a single-use disposable (QuikCAS) (sterile component). Sterilization testing for QuikCAS resulted in a PASS.
7. Performance data for shelf life (sterility, package integrity, functionality)	The Niobe System is not sterile and thus shelf life for system components is not applicable. The Cardiodrive includes a single-use disposable (QuikCAS) (sterile component). Shelf-life/packaging and sterilization testing for QuikCAS resulted in a PASS, and each component was validated for a shelf life of 3 years.
8. Labeling requirements (Instructions, warnings, cautions, limitations, training, compatibility, testing summaries, technical parameters, expiration)	The Niobe ES User's Manual includes compatible catheters, indications for use, warnings, and safety controls. It has instructions for procedure room components, system positions, table-side magnet controller, power up, cover force sensor, navigation position assistance, software info, Cardiodrive CAS user interface, and activation codes. It explicitly states the Niobe System doesn't have reusable components requiring reprocessing/disinfection. Cleaning instructions for magnet pods are provided. A list of compatible catheters (Biosense Webster Navistar RMT, Navistar RMT Thermocool, Celsius RMT, Celsius RMT Thermocool; Stereotaxis Helios II) and mechanical performance testing is included. Summaries of in vivo testing, adverse events, procedure-related complications, study outcomes, and endpoints are summarized. Fluoroscopy times are reported. Relevant warnings based on complaints and clinical studies have been included. The system generates a directional 0.08T or 0.1T magnetic field within a 6-inch diameter navigation volume. Not applicable for system expiration date/shelf life; for QuikCAS, it is 3 years.

2. Sample Size Used for the Test Set and the Data Provenance

Test Set (Clinical Data):
- Sample Size: A total of 511 patients across 4 clinical studies (ATTRAC, ATTRAC II, HEART Study, VERSATILE).
- Data Provenance: The data comes from Stereotaxis-sponsored clinical studies that were previously submitted to the FDA for other regulatory approvals (P050029, K071029, K140804). The location of these studies (e.g., country of origin) is not explicitly stated in the provided text.
- Retrospective/Prospective: All four studies were prospective in nature.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

The document does not specify the number of experts used to establish ground truth for the clinical outcomes (e.g., major complications, acute success, 90-day success).
However, it does mention that:
- For the VERSATILE study, the DSM (Data Safety Monitoring) adjudicated these events (referring to cardiac tamponade events). This implies expert review of adverse events, but the number and qualifications of DSM members are not provided.
- Physician feedback forms were used for "User assessment of device remote controls and safety features," suggesting clinical expert input on device usability.

4. Adjudication Method for the Test Set

For adverse events in the VERSATILE study, the DSM (Data Safety Monitoring) was involved in adjudication. The specific method (e.g., 2+1, 3+1) is not detailed.
For other clinical endpoints like acute and 90-day success, the adjudication method is not described in detail, though it would typically involve clinical follow-up and determination by clinicians/investigators within the study protocols.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

The provided text describes a medical device (a robotic catheter navigation system), not an AI-powered diagnostic or interpretive tool. Therefore, the concept of a "multi-reader multi-case (MRMC) comparative effectiveness study" focusing on human readers improving with AI assistance is not applicable here. The device assists the physician in physically performing a procedure.
The document does mention a comparison to "manual rates" for major complications and similar success rates in the literature between the MNS and manual groups, indicating some level of comparative safety and efficacy analysis against conventional methods. However, this is not an MRMC study comparing human reader performance with and without AI assistance for interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable to this device. The Niobe System is an interventional workstation designed to be operated with a human-in-the-loop (a physician) to navigate catheters. It is not an algorithm performing a task independently.

7. The Type of Ground Truth Used

Clinical Outcomes Data: For the in-vivo efficacy and safety studies, the ground truth was based on:
- Major Complication Rates: Clinically diagnosed complications within 7 days post-procedure.
- Ablation Success: Acute success (immediate outcome of the ablation procedure) and 90-day success (long-term absence of arrhythmia recurrence). These are definitive clinical endpoints.
- Manipulation and Positioning: Demonstrated ability to reach pre-specified cardiac locations and achieve proper anatomical placement.
Bench Testing Data: For mechanical, electrical, and sterility testing, ground truth was established by:
- Measurements: Using instruments like a Hall Effect tesla meter for magnetic field strength.
- Conformance to Standards: Meeting established engineering and safety standards (e.g., IEC 60601-1, ISO 62304, ISO 14971).
- Pre-determined Requirements: The testing "demonstrated that the Niobe System met pre-determined requirements."
Animal Model Data: For simulated-use testing, the animal studies likely provided physiological and anatomical ground truth for the performance of the system and software features.

8. The Sample Size for the Training Set

The document refers to "software verification and validation activities" and "non-GLP animal validation studies" for specific software versions (Navigant 4.4, 5.0.1, 5.0.2, 5.0.3). These can be considered part of the development and testing process, but the document does not specify a distinct "training set" sample size in the context of an AI/machine learning model. The clinical studies (511 patients) would be considered the main validation or test set for clinical performance.

9. How the Ground Truth for the Training Set Was Established

As mentioned above, the concept of a "training set" in the context of AI/machine learning is not directly applicable here. For the non-clinical and animal studies used in development and validation:
- Non-clinical (bench) testing: Ground truth was established through direct physical measurements, adherence to engineering specifications, and compliance with recognized standards.
- Animal Validation Studies: The ground truth would have been established through controlled experimental conditions, physiological measurements, and post-procedure analysis (e.g., ablation lesion assessment).

In summary, this submission focuses on a mechanical-robotic system, not an AI diagnostic, thus many aspects related to AI performance metrics are not applicable. The core of the evidence relies on thorough non-clinical engineering validation and prospective human clinical trials demonstrating safety and efficacy.

Summary

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September 6, 2019

Stereotaxis. Inc. Kenneth Lock Sr. Director, Clinical Affairs 4320 Forest Park Avenue, Suite 100 St. Louis, Missouri 63108

Re: K183027

Trade/Device Name: Steerable catheter control system Regulation Number: 21 CFR 870.5700 Regulation Name: Steerable Cardiac Ablation Catheter Remote Control System Regulatory Class: Class II Product Code: PJB, NDO Dated: October 31, 2018 Received: November 1, 2018

Dear Kenneth Lock:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Mark Fellman Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K183027

Device Name

Niobe® Magnetic Navigation System (MNS) with Navigation Workstation (NWS) and Cardiodrive®

Indications for Use (Describe)

The Cardiodrive system is not intended to advance the EP mapping and ablation catheters through the coronary vasculature or the coronary sinus.

The Cardiodrive system is not intended to advance or retract non-compatible catheters and/or other non-compatible devices into the neurovasculature.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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I. SUBMITTER

Date Prepared:	September 6, 2019
Submitter:	Stereotaxis, Inc.4320 Forest Park AvenueSt. Louis, MO 63108 USA
Contact Person:	Kenneth H. LockSr. Director, Clinical AffairsPhone: (314) 678-6123Fax: (763) 493-7849

II. DEVICE

Name of Device:	Niobe® Magnetic Navigation System (MNS) with Navigant™Workstation (NWS) and Cardiodrive®
Common or Usual Name:	Steerable cardiac ablation catheter remote control system.
Classification Name:	Catheter remote control system
Regulatory Class:	Class II
Regulation Number:	21 CFR 870.5700
Product Code:	PJB
FDA Panel:	Cardiology

III. PREDICATE DEVICE

Predicate	510(k)	Regulation	Device Name	Manufacturer
Primary	K140394	820.5700	Amigo Remote Catheter System	Catheter Robotics, Inc.
Additional	K051760 K060967	820.1290	Niobe Magnetic Navigation system with Navigant Navigation Workstation	Stereotaxis, Inc.
Additional	K071029	820.1290	CardioDrive	Stereotaxis, Inc.

IV.DEVICE DESCRIPTION

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V. INDICATIONS FOR USE

The Niobe System is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart and coronary vasculature, neurovascular and peripheral vasculature by orienting the device tip in a desired direction.

The Cardiodrive system is not intended to advance the EP mapping and ablation catheters through the coronary vasculature or the coronary sinus.

The Cardiodrive system is not intended to advance or retract non-compatible catheters and/or other noncompatible devices into the neurovasculature.

VI.COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

The Niobe System has the same primary technological characteristics as the predicate device, including, but not limited to the following:

Primary Predicate Device:

. Remotely controlling PMA class III ablation catheter
Additional Reference Devices
. Primary Design Elements (magnets, positioners, software)
. Principle of Operation (magnetic navigation)
Performance Parameters (field modes and positions) .
User Interface Devices (controllers, keyboard, display monitors) .
Companion Devices and Systems (digital fluoroscopy systems,) .

Any minor differences in technological characteristics between the proposed and reference Niobe System have demonstrated continued performance and do not raise new issues of safety or effectiveness.

VII. NON-CLINICAL STUDIES

The Niobe System underwent verification and validation activities to ensure that the device continues to meet established performance criteria. Evaluations included:

A. Biocompatibility Testing

The Niobe System does not contain patient-contacting components. Biocompatibility testing was not required to support of this submission.

B. Electromagnetic Compatibility (EMC)

Stereotaxis conducted appropriate Electromagnetic compatibility testing (EMC) in accordance with IEC 60601-1 and collateral standards (i.e., ISO 60601-1-2) to ensure that the Niobe System device does not interfere with other medical equipment and is immune to interference from other equipment.

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Image /page/5/Picture/1 description: The image shows the logo for Stereotaxis. The logo consists of an orange abstract symbol on the left, resembling two curved shapes with a blue dot in the center. To the right of the symbol is the word "STEREOTAXIS" in a simple, sans-serif font, with each letter in black.

C. Software Verification and Validation

Stereotaxis performed software verification and validation activities in accordance with ISO 62304 and ISO 14971 for software utilized by the Niobe System device to ensure that the software is safe and appropriate risk control measures are effective.

D. Performance Testing

Where appropriate, system verification and validation activities were conducted to assess the performance of the device following software and/or hardware modifications. The testing demonstrated that the Niobe System met pre-determined requirements and continued to perform as intended.

E. Special Controls Testing Summary

Special Controls	How Special Control Has Been Met
1) Non-clinical mechanical performancetesting must demonstrate that the deviceperforms as intended under anticipatedconditions of use. The followingperformance testing must be performed:i. Mechanical performance of the system(without catheter connected);	Using the proposed device, Magnetic field performance testingwithout the catheter connected uses a THM-7025 Hall Effect teslameter to measure the applied field strength and accuracy in thecardinal direction and at 0.08T and 0.1T (which represent worstcase positions).
ii. Mechanical performance of the systemwith compatible catheters connected toverify that the system does not impactcatheter function or performance.Assessments must include thefollowing:(A) Side-by-side remote control andmanual comparisons of cathetermanipulation (including all rangesof motion of catheter deflection andtip curl) for all compatiblecatheters; must include testing forworst-case conditions, and	Manual Control Performance TestingPerformance testing data for the reference Niobe device includeddeflection testing, accuracy testing with target phantom andanatomical position testing with a plastic heart model. The resultsof this testing provide mechanical performance data for thereference device.Remote Control Performance TestingThe current version (proposed device) of the Niobe MNSSubstantial Equivalence Application Testing demonstratesequivalent mechanical performance between the subject deviceand reference device.
(B) Evaluation of the accuracy andfunction of all device control safetyfeatures; and	Testing of the four primary safety controls related to the physicalmotion of the system was conducted on the proposed device.These concern physical movement of the magnet positioners,movement of the covers toward the patient, continuousadvancement of the catheter, and motion e-stops. All four safetycontrols passed the test.
iii. Simulated-use testing in a benchanatomic model or animal model.	Four non-GLP animal validation studies were conducted andtested the following using iterations of software after thereference device was cleared:Navigant 4.4 features and ablation lesion assessment• Sheath visualization• Zone mappingNavigant 5.0.1 Validation Study
Special Controls	How Special Control Has Been Met
	• Auto NaviLine ./ single step NaviLine
	Navigant 5.0.2 Validation Study• NaviLine
	• Targeting• Point and line ablation
	Navigant 5.0.3 Validation Study• Targeting / Electrode Targeting• NaviLine• Point and Line Ablation
2. Non-clinical electrical testing mustinclude validation of electromagneticcompatibility (EMC), electrical safety,thermal safety, and electrical systemperformance. The following performancetesting must be performed:i. Electrical performance of the system	Manual Control Performance Testing
with compatible catheters connectedto verify that the system does notimpact catheter function or	EMC and Electrical safety testing showing conformance with IEC60601 were performed by TuV for the reference device.
performance. Assessments mustinclude the following:A. Side-by-side remote control andmanual comparisons of cathetermanipulation (including allranges of motion of catheterdeflection and tip curl) for allcompatible catheters; mustinclude testing for worst-caseconditions, and	Remote Control Performance TestingEMC testing for the proposed device hardware demonstratingconformance with IEC 60601 was performed by TuV.
	All tests passed.
B. Evaluation of the accuracy andfunction of all device controlsafety features; and	Electrical safety testing on the proposed device demonstratingcompliance with IEC 60601, was performed by TuV.
ii. Electrical safety between the deviceand ablation catheter system and withother electrical equipment expected inthe catheter lab or operating room.	The proposed system has been tested for compatibility withspecific x-ray, ablation generators, mapping systems. In addition,electrical isolation and emissions testing have been performed byTuV.All tests passed.

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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;	The VERSATILE Study used to support K141530 as well as in vivo animal testing provided in K071029 for the Cardiodrive system, demonstrated the ability to manipulate compatible catheters to pre-specified cardiac locations.
ii. Safety: Assess device-related complication rate and major procedural complication rate (regardless of device relatedness) in comparison to literature and/or manual comparison group for compatible ablation catheters to support the indications for use;	Clinical data to support the safety of the Niobe Magnetic Navigation System, which includes Niobe, Navigant Software, the Cardiodrive catheter advancement system and a compatible ablation catheter, was reviewed.The following is a summary of data from clinical studies sponsored by Stereotaxis that have been submitted to the FDA in three separate submissions:• P050029 Helios II ablation catheter (ATTRAC, ATTRAC II and HEART)• K071029 Cardiodrive with Ablation Catheter (ATTRAC II)• K140804 V-CAS (VERSATILE)A total of 511patients from 4 studies were enrolled using the Niobe Magnetic Navigation System, which included the Niobe MNS, Cardiodrive, a Magnetic Ablation Catheter, and the Navigant Software.The following table describes the major complication rates reported in these trials.
	Study	RMN Patients	7 Day MajorComplication
	ATTRAC	182	7/182 (3.8%)
	ATTRAC II	80	1/80 (1.3%)
	HEART Study	129	7/129 (5.4%)
	VERSATILE	120	5/120 (4.2%)
	Total	511	20/511 (3.9%)
Special Controls	How Special Control Has Been Met
iii.Efficacy: Assess ablation successin comparison to literature and/or amanual comparison group forcompatible ablation catheters tosupport the indications for use; and	Data to support the ablation success of the Niobe MagneticNavigation System which includes Niobe, Navigant Software, theCardiodrive catheter advancement system and a compatibleablation catheter was reviewed.The following is a summary of data from clinical studiessponsored by Stereotaxis that have been submitted to the FDA inthree 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 theNiobe Magnetic Navigation System, which included the NiobeMNS, Cardiodrive, a Magnetic Ablation Catheter, and theNavigant software. The ATTRAC study series and the HEARTStudy used the Helios ablation catheter, and the Versatile studyused the BWI RMT Thermocool catheter. The following tabledescribes the acute and 90-day success rates reported in thesetrials.
	Study	RMNPatients	AcuteSuccessRMN	90 daysuccessRMN
	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 remotecontrols and safety features.	The Navigant system was used to steer the catheter during theevaluations performed for Navistar RMT, Celsius RMT andHelios II. Performance impressions were documented onphysician feedback forms which are included in the reports.
4. Post-market surveillance (PMS) must beconducted and completed in accordancewith FDA agreed upon PMS protocol.	Given the amount of clinical data from submitted studies and peerreviewed publications, a post market surveillance study is notwarranted.The following summarizes the overwhelming evidence availableto support the safety and efficacy of the MNS system:Four studies submitted to the FDA demonstrated a majoradverse event rate of 3.9%. Data from these four studies

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Image /page/9/Picture/1 description: The image shows the logo for Stereotaxis. The logo consists of an abstract orange symbol on the left, resembling two leaves with a blue dot in the center. To the right of the symbol is the word "STEREOTAXIS" in a simple, sans-serif font.

Special Controls	How Special Control Has Been Met
	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 Niobe System through the literature and Post Marketing Surveillance program.
5. A training program must be included withsufficient educational elements that, uponcompletion of the training program, theclinical and supporting staff can:i. Identify the safe environments fordevice use,ii. Use all safety features of the device,andiii. Operate the device in simulated oractual use environmentsrepresentative of indicatedenvironments and use for theindication of compatible catheters.	Representatives from the company train the physician and staff in the use of the Niobe Magnetic Navigation system.The Niobe ES User's Manual provides detailed operatinginstructions 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 thesterility of the sterile disposablecomponents of the system	The Niobe System is not provided in sterile form nor is it required to be sterilized prior to use, therefore, sterilization information is not applicable. The Niobe System does not include sterile disposable components as part of the system.Cardiodrive includes a single-use disposable (QuikCAS) to interface with the compatible ablation catheter. The sterile components underwent sterilization testing. All sterilization testing resulted in a PASS.
7. Performance data must support shelf lifeby demonstrating continued sterility of thedevice (of the sterile disposablecomponents), package integrity, anddevice functionality over the requested shelf life.	The Niobe System is not provided in sterile form nor is it required to be sterilized prior to use, therefore, shelf life information,including package integrity and function of the device over the stated shelf life are not applicable.Cardiodrive includes a single-use disposable (QuikCAS) to interface with the compatible ablation catheter. The sterile components underwent shelf-life /packaging and sterilization testing. All sterilization and packaging testing resulted in a PASS, and each component was validated for a shelf life of 3 years.
Special Controls	How Special Control Has Been Met
8. Labeling must include:i. Appropriate instructions, warnings, cautions, limitations, and information related to the intended patient population, compatible ablation catheters, and the device safeguards for the device;ii. Specific instructions and clinical training needed for the safe use of the device, which includes:	Niobe ES User's Manual includes:• Compatible Catheters• Indications for Use• Warnings• Safety ControlsThe Niobe System does not require assembly of the device prior to use. The Niobe System is considered permanent equipment installed in a Stereotaxis Magnetic Navigation Lab. Stereotaxis performs all installation activities for each Niobe System; therefore, assembly and installation instructions to the physician user are not required.
A. Instructions on assembling the device in all available configurations, including installation and removal of compatible catheters;	With regard to use of magnetically-compatible devices with the Niobe System, assembly and installation of these devices to/with the Niobe System is not required. Magnetically-compatible catheters interface with the Cardiodrive CAS device which advances and retracts the device and instructions related to the catheter-CAS interface are provided in the Cardiodrive instructions for use. The Niobe System only applies a magnetic field to orient the distal tip of a magnetically-compatible device; therefore, the manipulation of the distal end of the device is by indirect (non-physical) means for which assembly or installation of other devices is not required.
B. Instructions on all available modes or states of the devices;C. Instructions and explanation of all controls, inputs, and outputsD. Instructions on all safety features of the device andE. Validated methods and instructions for reprocessing/disinfecting any reusable components	The Niobe System User Guide includes an explanation and instructions for the following, controls, modes, and states of the device:• Procedure room components• System positions• Tableside Magnet Controller• System power up• Cover Force Sensor• Navigation Position Assistance• Software Basic Information• Cardiodrive CAS user interface• Activation codesThe Niobe System is a medical device that does not have any reusable components that reprocessing or disinfection prior to use. The magnet pods are covered by drapes during the procedure and may be wiped clean using hospital-grade EPA-registered germicide solutions following each procedure. Cleaning instructions are provided in the "Cleaning the Niobe System" section of the Niobe System User Guide).
Special Controls	How Special Control Has Been Met
iii.A detailed summary of themechanical compatibility testingincluding:A. A table with a complete list ofcompatible catheters tested(manufacturer trade name andmodel number), and	- Biosense Webster Navistar RMT- Biosense Webster Navistar RMT Thermocool- Biosense Webster Celsius RMT- Biosense Webster Celsius RMT Thermocool- Stereotaxis Helios II
B. A table with detailed test results,including type of test, acceptancecriteria, and test results (i.e., passfor meeting acceptance criteria);	Mechanical performance testing of compatible catheter isincluded in the Niobe Users Guide.
iv.A detailed summary of the in vivotesting including:A. A table with a complete list ofcompatible catheters used duringtesting (manufacturer trade nameand model number);B. Adverse events encounteredpertinent to use of the deviceunder use conditions;	- Biosense Webster Navistar RMT- Biosense Webster Navistar RMT Thermocool- Biosense Webster Celsius RMT- Biosense Webster Celsius RMT Thermocool- Stereotaxis Helios IIData from four clinical studies involving 511 patients whounderwent catheter ablation using the Stereotaxis MagneticNavigation System (MNS) are summarized. Collectively, the datain these studies demonstrates the safety and effectiveness of theMagnetic Navigation System for catheter ablation.Study Design:All four studies were prospective in nature and included safetyendpoints. Data from all four studies were used to supportregulatory approvals. Evaluation of 7 day major adverse eventsfor safety is reported.Study Results:Adverse Events:The overall 7 day major complication rate for all four studies was20/511 (3.9%) Major adverse events that occurred within 7 dayspost procedure included:- 1 cardiac tamponade related to right sidedcatheter- 1 cardiac tamponade related to the transseptalpuncture- 1 new focal wall abnormality- 1 change in LVEF (60% to 45-50%)- 2 vena cava thrombi- 1 groin complication
Special Controls	How Special Control Has Been Met
	1 prolonged hospitalization for grogginess 1 pseudoaneurysm 1 bleeding 1 anemia 1 dementia 1 pericardial effusion 1 heart block requiring pacemaker 2 pulmonary embolisms 1 AV fistula 2 arrhythmia recurrence (per protocol requirement)
	ConclusionThe data in this summary support the reasonable assurance of safety and effectiveness of the Stereotaxis Magnetic Navigation System for cardiac ablation procedures.
	These data have been summarized in the Niobe ES User's Guide.
C. A detailed summary of device-and procedure-relatedcomplications; and	The following listing of the procedure related complications havebeen reported in clinical trials submitted to the agency:Two (2) patients out of 177 (1.1%) had an acute major adverseevent and 5/182 (2.7%) had a major adverse event within 7 daysof ablation in the ATTRAC Study. There was 1 death reportedin the study secondary to respiratory failure, unrelated to thedevice. No cardiac tamponades or perforations were reported.One patient experienced a groin complication, two patientsexperienced 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 majoradverse event which was a cardiac tamponade due to a rightsided non-study catheter. There were no deaths reported in thisstudy. There were no device related adverse events.
	In the HEART study, the overall acute major adverse event ratewas 5.4% for the magnetic arm. No deaths or cardiactamponades were reported. There was 1 pericardial effusion, 1heart block requiring pacemaker, 2 pulmonary embolisms, 1 AVfistula, and 2 arrhythmia recurrences (considered a majoradverse 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 Studywas 5/120 (4.2%) in this study. There was one cardiactamponade, one pseudo aneurysm, one bleeding, one patientpresented with anemia and dementia. The cardiac tamponadeevent started as a pericardial effusion and progressed into

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Image /page/10/Picture/1 description: The image shows the logo for Stereotaxis. The logo consists of an abstract orange graphic on the left, resembling two curved shapes with a blue dot in the center. To the right of the graphic is the word "STEREOTAXIS" in a simple, sans-serif font.

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Image /page/11/Picture/1 description: The image shows the logo for Stereotaxis. The logo consists of an orange abstract symbol on the left, resembling two curved shapes with a blue dot in the center. To the right of the symbol is the word "STEREOTAXIS" in a simple, sans-serif font.

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Image /page/12/Picture/1 description: The image shows the logo for Stereotaxis. The logo consists of an orange abstract shape on the left, resembling two curved leaves with a blue dot in the center. To the right of the shape is the word "STEREOTAXIS" in a simple, sans-serif font.

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Image /page/13/Picture/1 description: The image shows the Stereotaxis logo. The logo consists of an abstract orange graphic on the left, resembling two curved shapes with a blue dot in the center. To the right of the graphic is the word "STEREOTAXIS" in a simple, sans-serif font.

Special Controls	How Special Control Has Been Met
	cardiac tamponade due to the transseptal puncture. The DSMadjudicated these events to be possibly and probably related tothe procedure, respectively. There were no device relatedadverse events.
D. A summary of study outcomesand endpoints. Informationpertinent to the fluoroscopytimes/exposure for the procedure,patient, and operatorfluoroscopic exposure;	The following table summarizes the acute and long term successrates as well as fluoroscopy times reported in the clinical trials.
	Study RMNPatients AcuteSuccessRMN 90 day successRMN MeanFluoroscopytimeMean +/-S.D[range] ATTRAC 182 175/182(96.2%) 145/147(98.6%) 15.89+/-13.15[1.05, 66.5] ATTRAC II 80 71/75(94.7%) 51/54 (94.4%) 10.64 +/-9.78[0.63,61.0] HEARTStudy 129 108/121(89.3) 82/87 (94.3%) 16.91 +/- 9.92[3.13,44.18 VERSATILE 120 119/120(99.2%) Not reported 11.0 +/-10.5[0.03,55.2] Total 511 473/498(95.0%) 278/288(96.5%)
	V. Other labeling items:A. A detailed summary of pertinentnon-clinical testing information:EMC, mechanical, electrical, andsterilization of device andcomponents;	These data have been summarized in Niobe ES User's Guide.EMC: The Niobe System User Manual includes a summary ofElectromagnetic Compatibility (EMC) testing under the sectiontitled "Electromagnetic Compatibility Information".Electrical: In EMC section - Immunity (include ESD, etc.)Mechanical: Non-clinical performance testing of compatiblecatheters is included and summarized in the Niobe ES User'sGuideSterilization: The Niobe System is not provided in sterile formnor is it required to be sterilized prior to use, therefore,sterilization information is not applicable.
	B. A detailed summary of thedevice technical parameters; and	The Niobe system generates a directional 0.08T or 0.1T magneticfield within the patient's heart. The navigation volume is 6 inchesin diameter centered at X-ray isocenter.
	C. An expiration date/shelf life andstorage conditions for the sterileaccessories; and	The Niobe System is not provided in sterile form nor is it requiredto be sterilized prior to use, therefore, expiration date, shelf life,and storage conditions are not applicable.

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Special Controls	How Special Control Has Been Met
vi. When available, and according 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, andB. Inclusion of results and adverse events associated with utilization of the device during the PMS.	Relevant warnings based on complaints and clinical studies have been included in The Niobe User's Guide.

VIII. ANIMAL STUDIES

Animal studies were not required to support the modifications to the Niobe System however; non-GLP animal studies for validation of specific versions of software features are included in the special controls.

IX.CLINICAL STUDIES

Clinical studies were not required to support the modifications to the Niobe System however, human clinical data from other regulatory submissions are included in the special controls.

X. CONCLUSION

Based on the information presented in this Premarket Notification, Stereotaxis concludes that the Niobe System is substantially equivalent to the predicate and reference devices based on the same intended use and same primary technological characteristics. Any minor differences in technological characteristics between the proposed and reference Niobe System have demonstrated continued performance and do not raise new issues of safety or effectiveness.

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.