(309 days)
No
The description focuses on computer-controlled magnetic navigation based on physician input, with no mention of AI or ML algorithms for decision-making or learning.
No.
The device (Niobe System) is described as an "interventional workstation" that uses magnetic fields to navigate and orient the tip of compatible interventional devices (like catheters or guidewires) within the body and to advance/retract specific types of catheters. It is a navigational and advancement system used in conjunction with other devices, rather than directly providing therapy itself. The therapy (e.g., ablation) is performed by the connected catheters.
No.
The Niobe System is an interventional workstation used for the intravascular navigation and advancement/retraction of catheters, primarily for ablation procedures, not for collecting diagnostic information about a patient's condition. While it interacts with EP mapping catheters, its described function is to steer or advance them, not to perform the diagnostic mapping itself.
No
The device description explicitly states that the system includes "computer-controlled permanent magnets" and is an "interventional workstation," indicating significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The Niobe System 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 uses magnetic fields to orient and steer devices inside the patient's body.
- Lack of Specimen Analysis: The description does not mention the device analyzing any biological specimens. Its function is purely related to the physical manipulation and navigation of medical devices within the patient.
Therefore, the Niobe System falls under the category of a therapeutic or interventional medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
PJB, NDO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
right and left heart and coronary vascular and peripheral vasculature
patient's heart
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)
Non-clinical mechanical performance testing:
- Magnetic field performance testing without the catheter connected uses a THM-7025 Hall Effect tesla meter to measure the applied field strength and accuracy in the cardinal direction and at 0.08T and 0.1T.
- 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: Testing demonstrates equivalent mechanical performance between the subject device and reference device.
- Safety Controls: Testing of four primary safety controls related to physical movement of magnet positioners, cover movement toward patient, continuous advancement of catheter, and motion e-stops was conducted on the proposed device. All passed.
- Simulated-use testing in a bench anatomic model or animal model: Four non-GLP animal validation studies were conducted using iterations of software after the reference device was cleared for features such as Navigant 4.4 (features and ablation lesion assessment, sheath visualization, zone mapping), Navigant 5.0.1 (Auto NaviLine/single step NaviLine), Navigant 5.0.2 (NaviLine, Targeting, Point and line ablation), Navigant 5.0.3 (Targeting/Electrode Targeting, NaviLine, Point and Line Ablation).
Non-clinical electrical testing:
- EMC and Electrical safety testing showing conformance with IEC 60601 were performed by TuV for the reference device.
- EMC testing for the proposed device hardware demonstrating conformance with IEC 60601 was performed by TuV. All tests passed.
- Electrical safety testing on the proposed device demonstrating compliance with IEC 60601, was performed by TuV.
- The proposed system has been tested for compatibility with specific x-ray, ablation generators, mapping systems. In addition, electrical isolation and emissions testing have been performed by TuV. All tests passed.
In vivo testing:
- Manipulation and Positioning: The VERSATILE Study (K141530) and in vivo animal testing (K071029) for the Cardiodrive system demonstrated the ability to manipulate compatible catheters to pre-specified cardiac locations.
- Safety: Clinical data from studies sponsored by Stereotaxis (P050029 Helios II ablation catheter (ATTRAC, ATTRAC II and HEART), K071029 Cardiodrive with Ablation Catheter (ATTRAC II), K140804 V-CAS (VERSATILE)) were reviewed.
- Sample size: Total of 511 patients from 4 studies.
- 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%)
- Reported major adverse events within 7 days post procedure: 1 cardiac tamponade related to right sided catheter, 1 cardiac tamponade related to transseptal puncture, 1 new focal wall abnormality, 1 change in LVEF (60% to 45-50%), 2 vena cava thrombi, 1 groin complication, 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.
- Efficacy: Data from the same clinical studies as above were reviewed.
- Sample size: Total of 511 patients from 4 studies.
- Acute Success Rates (RMN):
- ATTRAC: 175/182 (96.2%)
- ATTRAC II: 71/75 (94.7%)
- HEART Study: 108/121 (89.3%)
- VERSATILE: 119/120 (99.2%)
- Total: 473/498 (95.0%)
- 90 day success Rates (RMN):
- ATTRAC: 145/147 (98.6%)
- ATTRAC II: 51/54 (94.4%)
- HEART Study: 82/87 (94.3%)
- VERSATILE: Not reported
- Total: 278/288 (96.5%)
- 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.
- Fluoroscopy times:
- ATTRAC: 15.89+/-13.15 [1.05, 66.5] minutes
- ATTRAC II: 10.64 +/-9.78 [0.63, 61.0] minutes
- HEART Study: 16.91 +/- 9.92 [3.13, 44.18] minutes
- VERSATILE: 11.0 +/-10.5 [0.03, 55.2] minutes
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found. Acute success rates (95.0%) and 90-day success rates (96.5%) are provided, along with major complication rates (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.
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.
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
§ 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
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
1
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
2
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 Niobe System is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart and coronary vascular and peripheral vasculature by orienting the device tip in a desired direction.
The Cardiodrive Catheter Advancement System (CAS) is intended to automatically advance and retract compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis MNS.
The Cardiodrive system is not intended to advance the EP mapping and ablation catheters through the coronary vasculature or the coronary sinus.
The Cardiodrive system is not intended to advance or retract non-compatible catheters and/or other non-compatible devices into the neurovasculature.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the Stereotaxis logo. The logo consists of an orange abstract shape on the left and the word "STEREOTAXIS" in black font on the right. The abstract shape is made up of two curved shapes facing each other with a blue dot in the center.
I. SUBMITTER
| Date Prepared: | September 6, 2019 |
|---|---|
| Submitter: | Stereotaxis, Inc. |
| 4320 Forest Park Avenue | |
| St. Louis, MO 63108 USA | |
| Contact Person: | Kenneth H. Lock |
| Sr. Director, Clinical Affairs | |
| Phone: (314) 678-6123 | |
| Fax: (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
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.
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Image /page/4/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, with each letter in black.
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 Catheter Advancement System (CAS) is intended to automatically advance and retract compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis MNS.
The Cardiodrive system is not intended to advance the EP mapping and ablation catheters through the coronary vasculature or the coronary sinus.
The Cardiodrive system is not intended to advance or retract non-compatible catheters and/or other noncompatible devices into the neurovasculature.
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 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); | Using the proposed device, Magnetic field performance testing |
| without the catheter connected uses a THM-7025 Hall Effect tesla | |
| meter to measure the applied field strength and accuracy in the | |
| cardinal direction and at 0.08T and 0.1T (which represent worst | |
| case positions). | |
| 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 | 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. | |
| Remote Control Performance Testing | |
| The current version (proposed device) of the Niobe MNS | |
| Substantial Equivalence Application Testing demonstrates | |
| equivalent mechanical performance between the subject device | |
| and reference device. | |
| (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 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 and |
| tested the following using iterations of software after the | |
| reference device was cleared: | |
| Navigant 4.4 features and ablation lesion assessment | |
| • Sheath visualization | |
| • Zone mapping | |
| Navigant 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 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 | Manual Control Performance Testing |
| with compatible catheters connected | |
| to verify that the system does not | |
| impact catheter function or | EMC and Electrical safety testing showing conformance with IEC |
| 60601 were performed by TuV for the reference device. | |
| 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 | Remote Control Performance Testing |
| EMC testing for the proposed device hardware demonstrating | |
| conformance with IEC 60601 was performed by TuV. | |
| 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, was performed by TuV. | |
| 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, mapping systems. In addition, | |
| electrical isolation and emissions testing have been performed by | |
| TuV. | |
| All tests passed. |
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Image /page/6/Picture/1 description: The image shows the logo for Stereotaxis. The logo features 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/7/Picture/1 description: The image shows the Stereotaxis logo. The logo consists of an orange abstract shape on the left, resembling two leaves facing each other with a blue dot in the center. To the right of the shape is the word "STEREOTAXIS" in a simple, sans-serif font.
| 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 Major | ||
| Complication | ||||
| 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 success | ||||
| in comparison to literature and/or a | ||||
| manual comparison group for | ||||
| compatible ablation catheters to | ||||
| support the indications for use; and | Data to support the ablation success of the Niobe Magnetic | |||
| Navigation System which includes Niobe, Navigant Software, the | ||||
| Cardiodrive catheter advancement system and a compatible | ||||
| ablation catheter was reviewed. | ||||
| The following is a summary of data from clinical studies | ||||
| sponsored by Stereotaxis that have been submitted to the FDA in | ||||
| three separate submissions: | ||||
| P050029 Helios II ablation catheter (ATTRAC, ATTRAC II and HEART study) K071029 Cardiodrive with Ablation Catheter (ATTRAC) K140804 V-CAS (VERSATILE) A total of 511 patients from 4 studies were enrolled using the | ||||
| Niobe Magnetic Navigation System, which included the Niobe | ||||
| MNS, Cardiodrive, a Magnetic Ablation Catheter, and the | ||||
| Navigant software. The ATTRAC study series and the HEART | ||||
| Study used the Helios ablation catheter, and the Versatile study | ||||
| used the BWI RMT Thermocool catheter. The following table | ||||
| describes the acute and 90-day success rates reported in these | ||||
| trials. | ||||
| Study | RMN | |||
| Patients | Acute | |||
| Success | ||||
| RMN | 90 day | |||
| success | ||||
| RMN | ||||
| ATTRAC | 182 | 175/182 | ||
| (96.2%) | 145/147 | |||
| (98.6%) | ||||
| ATTRAC II | 80 | 71/75 | ||
| (94.7%) | 51/54 | |||
| (94.4%) | ||||
| HEART Study | 129 | 108/121 | ||
| (89.3) | 82/87 | |||
| (94.3%) | ||||
| VERSATILE | 120 | 119/120 | ||
| (99.2%) | Not reported | |||
| Total | 511 | 473/498 | ||
| (95.0%) | 278/288 | |||
| (96.5%) | ||||
| iv. | ||||
| User assessment of device remote | ||||
| controls and safety features. | The Navigant system was used to steer the catheter during the | |||
| evaluations performed for Navistar RMT, Celsius RMT and | ||||
| Helios II. Performance impressions were documented on | ||||
| physician feedback forms which are included in the reports. | ||||
| 4. Post-market surveillance (PMS) must be | ||||
| conducted and completed in accordance | ||||
| with FDA agreed upon PMS protocol. | Given the amount of clinical data from submitted studies and peer | |||
| reviewed publications, a post market surveillance study is not | ||||
| warranted. | ||||
| The following summarizes the overwhelming evidence available | ||||
| to support the safety and efficacy of the MNS system: | ||||
| Four studies submitted to the FDA demonstrated a major | ||||
| adverse event rate of 3.9%. Data from these four studies |
| | | |
8
Image /page/8/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/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 with | |
| sufficient educational elements that, upon | |
| completion of the training program, the | |
| clinical and supporting staff can: | |
| i. Identify the safe environments for | |
| device use, | |
| ii. Use all safety features of the device, | |
| and | |
| iii. Operate the device in simulated or | |
| actual use environments | |
| representative of indicated | |
| environments and use for the | |
| indication of compatible catheters. | Representatives from the company train the physician and staff in the use of the Niobe Magnetic Navigation system. |
| The Niobe ES User's Manual provides detailed operating | |
| instructions on the system and the navigation software. | |
| This information is reviewed with the physician and staff during simulation sessions and phantom training with the actual system | |
| 6. Performance data must demonstrate the | |
| sterility of the sterile disposable | |
| components of the system | The Niobe System is not provided in sterile form nor is it required to be sterilized prior to use, therefore, sterilization information is not applicable. The Niobe System does not include sterile disposable components as part of the system. |
| Cardiodrive includes a single-use disposable (QuikCAS) to interface with the compatible ablation catheter. The sterile components underwent sterilization testing. All sterilization testing resulted in a PASS. | |
| 7. Performance data must support shelf life | |
| by demonstrating continued sterility of the | |
| device (of the sterile disposable | |
| components), package integrity, and | |
| device functionality over the requested shelf life. | The Niobe System is not provided in sterile form nor is it required to be sterilized prior to use, therefore, shelf life information, |
| including package integrity and function of the device over the stated shelf life are not applicable. | |
| Cardiodrive includes a single-use disposable (QuikCAS) to interface with the compatible ablation catheter. The sterile components underwent shelf-life /packaging and sterilization testing. All sterilization and packaging testing resulted in a PASS, and each component was validated for a shelf life of 3 years. | |
| Special Controls | How Special Control Has Been Met |
| 8. Labeling must include: | |
| i. Appropriate instructions, warnings, cautions, limitations, and information related to the intended patient population, compatible ablation catheters, and the device safeguards for the device; | |
| ii. Specific instructions and clinical training needed for the safe use of the device, which includes: | Niobe ES User's Manual includes: |
| • Compatible Catheters | |
| • Indications for Use | |
| • Warnings | |
| • Safety Controls | |
| The 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 outputs | |
| D. Instructions on all safety features of the device and | |
| E. 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 codes | |
| The 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 the | |
| mechanical compatibility testing | |
| including: | |
| A. A table with a complete list of | |
| compatible catheters tested | |
| (manufacturer trade name and | |
| model 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, acceptance
criteria, and test results (i.e., pass
for meeting acceptance criteria); | Mechanical performance testing of compatible catheter is
included in the Niobe Users Guide. |
| 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; | - Biosense Webster Navistar RMT - Biosense Webster Navistar RMT Thermocool
- Biosense Webster Celsius RMT
- Biosense Webster Celsius RMT Thermocool
- Stereotaxis Helios II
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 |
| 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) |
| | 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 Niobe ES 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 |
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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.
12
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 DSM | ||||||||||||||||||||||||||||||
| adjudicated these events to be possibly and probably related tothe 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 | ||||||||||||||||||||||||||||||
| Patients 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] 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%) | ||||||||||||||||||||||||||||||
| V. Other labeling items: | ||||||||||||||||||||||||||||||
| A. A detailed summary of pertinent | ||||||||||||||||||||||||||||||
| non-clinical testing information: | ||||||||||||||||||||||||||||||
| EMC, mechanical, electrical, and | ||||||||||||||||||||||||||||||
| sterilization of device and | ||||||||||||||||||||||||||||||
| components; | These data have been summarized in Niobe ES User's Guide. | |||||||||||||||||||||||||||||
| EMC: The Niobe 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 Niobe ES User's | ||||||||||||||||||||||||||||||
| Guide | ||||||||||||||||||||||||||||||
| Sterilization: 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. | ||||||||||||||||||||||||||||||
| B. A detailed summary of the | ||||||||||||||||||||||||||||||
| device technical parameters; and | The Niobe 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 Niobe 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. |
14
Image /page/14/Picture/1 description: The image shows the Stereotaxis logo. 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, with each letter in black.
| 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, and | |
| B. 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.