(113 days)
Genesis MNS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart and coronary vasculature, neurovascular and peripheral vasculature by orienting the device tip in a desired direction.
The Cardiodrive® Catheter Advancement System (CAS) is intended to automatically advance and retract compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis MNS.
The Cardiodrive® system is not intended to advance the EP mapping and ablation catheters through the coronary vasculature or the coronary sinus.
The Cardiodrive® system is not intended to advance or retract non-compatible catheters and/or other non-compatible devices into the neurovasculature.
Stereotaxis Genesis RMN® with Navigant™ Workstation (NWS) and Cardiodrive® System (Genesis MNS) is an interventional workstation for the intravascular navigation of appropriately equipped, magnetically adapted, devices (e.g., catheters or guidewires) through tissue to designated target sites using computer-controlled permanent magnets to orient or steer the tip of a magnetic device and remotely advance and retract only compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart. Genesis MNS incorporates software that determines the direction the magnetic field should be applied based on physician interaction with the user interface devices.
Here's a summary of the acceptance criteria and study information for the Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System (Genesis MNS) based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Special Control) | How Special Control Has Been Met (Reported Performance) |
|---|---|
| Non-clinical mechanical performance testing (without catheter connected): | Magnetic field performance testing (robotic field accuracy survey, reduced field mode angular resolution, isocenter offset) demonstrated that field characteristics (strength, direction, position, accuracy) meet the same requirements as the predicate Niobe, and these tests passed. |
| Non-clinical mechanical performance testing (with compatible catheters connected): | Deflection testing, accuracy testing with target phantom, and anatomical position testing with a plastic heart model were performed. Subject Genesis system performed at the same level with compatible devices as predicate Niobe System. |
| (A) Side-by-side remote control and manual comparisons of catheter manipulation: | The subject Genesis system performed at the same level with compatible devices as the predicate Niobe System. The subject device generates the same magnetic fields as the predicate device. Compatible catheter performance testing results identical to Niobe. |
| (B) Evaluation of accuracy and function of all device control safety features: | Testing of four primary safety controls (physical movement of magnet positioners, movement of covers toward patient, continuous advancement of catheter, motion e-stops) was conducted on the proposed device, and all passed. User testing of safety controls was the same between Niobe and Genesis. |
| Simulated-use testing in a bench anatomic model or animal model: | Validation testing included use testing of clinical workflows in a bench model. An animal study was performed employing typical clinical workflows (compatibility with mapping system, CardioDrive, fluoroscopy). Clinical workflow testing for Genesis with compatible devices was the same as Niobe, substantiating substantial equivalence. |
| Non-clinical electrical testing (EMC, electrical safety, thermal safety, electrical system performance): | EMC and Electrical safety testing showing conformance with IEC 60601 were performed by TuV for the reference Niobe device. EMC testing for the proposed device hardware demonstrating conformance with IEC 60601-1-2 was performed by Intertek, and all tests passed. Electrical safety testing on the proposed device demonstrating compliance with IEC 60601, and IEC 60601-1-2 was performed by Intertek. |
| (A) Electrical performance of system with compatible catheters connected (Side-by-side remote control and manual comparisons of catheter manipulation): | Both predicate and proposed devices tested according to IEC 60601-1-2 standards by Nationally Recognized Testing Labs; all tests passed. |
| (B) Evaluation of accuracy and function of all device control safety features: | Electrical safety testing on the proposed device demonstrating compliance with IEC 60601, and IEC 60601-1-2 was performed by Intertek. |
| Electrical safety between device and ablation catheter system and with other electrical equipment: | Proposed system tested for compatibility with specific x-ray, ablation generators, and mapping systems. Electrical isolation and emissions testing performed by Intertek. |
| In vivo testing (Manipulation and Positioning): | Animal study conducted with compatible devices showed that catheters were directed to predefined targets, and suitable contact was demonstrated. In vivo testing was conducted with the subject device, and all compatible catheters functioned similarly to the predicate device. |
| In vivo testing (Safety - device-related and major procedural complication rate): | 7 Day Major Complication Rate: - 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%) |
| In vivo testing (Efficacy - ablation success): | Acute Success 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 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: | Same user assessment testing (device remote controls and safety features) as the predicate device was performed, and all safety features passed. |
| Sterility of sterile disposable components: | Genesis System is not provided in sterile form. CardioDrive includes single-use disposable (QuikCAS) which underwent sterilization testing, resulting in a PASS. |
| Shelf life of sterile disposable components: | Genesis System is not provided in sterile form. CardioDrive's single-use disposable (QuikCAS) underwent shelf-life/packaging and sterilization testing. All testing resulted in a PASS, and each component was validated for a shelf life of 3 years. |
2. Sample Size Used for the Test Set and Data Provenance
The "test set" for clinical performance appears to be a collection of existing clinical studies that used the predicate device (Niobe MNS) and compatible components.
- Sample Size: A total of 511 patients were enrolled across 4 studies.
- Data Provenance: Clinical data from retrospective analyses of previously submitted studies to the FDA. These studies were sponsored by Stereotaxis. The specific countries of origin are not explicitly stated within the provided text, but these were part of FDA submissions (P050029, K071029, K140804) suggesting they are likely from clinical trials conducted in regions that align with FDA regulatory standards (e.g., US or international sites that adhere to similar clinical trial practices).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts used to establish the ground truth for the clinical outcomes (adverse events, acute success, 90-day success) in these studies, nor their specific qualifications. It mentions that "Clinical data to support the safety of the Magnetic Navigation System... was reviewed" and that "The DSM adjudicated these events to be possibly and probably related to the procedure, respectively" in the VERSATILE study. This suggests that a Data Safety Monitoring board or similar expert body was involved in reviewing adverse events.
4. Adjudication Method for the Test Set
For the VERSATILE study, adverse events were "adjudicated" by the DSM (Data Safety Monitoring board). The specific adjudication method (e.g., 2+1, 3+1) is not detailed, but it indicates an expert review process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC comparative effectiveness study is mentioned in the document. The comparative effectiveness assessment for the Genesis MNS is primarily against its predicate device (Niobe MNS) and historical clinical data for both the MNS system and manual ablation.
- Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable, as this is a robotic navigation system, not an AI-assisted diagnostic or interpretative device that augments human readers. The clinical studies compare outcomes of the magnetic navigation system to historical data or literature on manual ablation. The document states:
- "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%." (This implies a lower complication rate for MNS compared to manual.)
- "Acute success rates and long-term success rates were similar in both the MNS and manual groups."
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device itself is a "Steerable Cardiac Ablation Catheter Remote Control System" and "Magnetic Navigation System," which is inherently designed for human-in-the-loop operation (a physician interacts with the user interface to control the magnetic field and system). Therefore, a standalone (algorithm only) performance study of the entire system as a diagnostic or interventional tool would not be relevant. The performance data presented focuses on the mechanical and electrical performance of the system and its clinical outcomes when used by an operator.
7. The Type of Ground Truth Used
The ground truth used for the clinical performance assessment consists primarily of:
- Clinical Outcomes Data: Major complication rates, acute success rates, and 90-day success rates, as recorded and adjudicated in the patient studies (ATTRAC, ATTRAC II, HEART, VERSATILE). These outcomes intrinsically serve as the "ground truth" for safety and efficacy in a clinical setting.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning or AI. This device is a robotic system, and its development would typically involve engineering design, bench testing, and clinical validation rather than a distinct machine learning training phase. The "data" used for demonstrating its safety and effectiveness are the results from the various tests (mechanical, electrical, animal, and clinical studies of the predicate device).
9. How the Ground Truth for the Training Set Was Established
As there is no explicitly defined "training set" in the context of AI/ML, this question doesn't directly apply. The establishment of "ground truth" related to the device's design and operation would have been through engineering specifications, physics principles governing magnetic fields, and established clinical endpoints for cardiac ablation procedures (e.g., successful ablation, absence of major complications).
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March 5, 2020
Stereotaxis, Inc. Kenneth Lock Vice President, Clinical, Regulatory and Quality 4320 Forest Park Avenue, Suite 100 St. Louis, Missouri 63108
Re: K193147
Trade/Device Name: Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System (Genesis MNS) Regulation Number: 21 CFR 870.5700 Regulation Name: Steerable Cardiac Ablation Catheter Remote Control System Regulatory Class: Class II Product Code: PJB, NDQ Dated: February 1, 2020 Received: February 3, 2020
Dear Kenneth Lock:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark Fellman Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K193147
Device Name
Stereotaxis Genesis RMN® with Navigant™ Workstation (NWS) and Cardiodrive® System (Genesis MNS)
Indications for Use (Describe)
Genesis MNS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart and coronary vasculature, neurovascular and peripheral vasculature by orienting the device tip in a desired direction.
The Cardiodrive® Catheter Advancement System (CAS) is intended to automatically advance and retract compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis MNS.
The Cardiodrive® system is not intended to advance the EP mapping and ablation catheters through the coronary vasculature or the coronary sinus.
The Cardiodrive® system is not intended to advance or retract non-compatible catheters and/or other non-compatible devices into the neurovasculature.
Type of Use (Select one or both, as applicable):
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image is a logo for Stereotaxis. The logo features an orange graphic on the left, resembling two leaves with a blue dot in the center. To the right of the graphic is the word "STEREOTAXIS" in a bold, sans-serif font. Below the word is the tagline "Improving Life with Robotic Precision and Safety" in a smaller font.
510(k) Summary per 21CFR §807.92
| Submitter's information | Stereotaxis, Inc.4320 Forest Park Ave, Suite 100St. Louis, MO 63108Contact: Kenneth Lock, Vice President, Clinical, Regulatory and QualityTelephone: 314-678-6123 |
|---|---|
| Device/classification name | |
| Device Name: | Genesis RMN® with Navigant™ Workstation (NWS) and Cardiodrive® System (Genesis MNS) |
| Classification/Common name: | Steerable cardiac ablation catheter remote control system. |
| Classification Number: | 870.5700 |
| Product Code: | PJB |
| Classification Panel: | Cardiovascular |
| Predicate Devices: | Niobe MNS (K192775) |
| Device description | Stereotaxis Genesis RMN® with Navigant™ Workstation (NWS) and Cardiodrive® System (Genesis MNS) is an interventional workstation for the intravascular navigation of appropriately equipped, magnetically adapted, devices (e.g., catheters or guidewires) through tissue to designated target sites using computer-controlled permanent magnets to orient or steer the tip of a magnetic device and remotely advance and retract only compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart. Genesis MNS incorporates software that determines the direction the magnetic field should be applied based on physician interaction with the user interface devices. |
| Intended use | Genesis MNS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart and coronary vasculature, neurovascular and peripheral vasculature by orienting the device tip in a desired direction.The Cardiodrive® Catheter Advancement System (CAS) is intended to automatically advance and retract compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis MNS.The Cardiodrive® system is not intended to advance the EP mapping and ablation catheters through the coronary vasculature or the coronary sinus.The Cardiodrive® system is not intended to advance or retract non-compatible catheters and/or other non-compatible devices into the neurovasculature. |
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Image /page/4/Picture/0 description: The image shows the logo for Stereotaxis. The logo consists of an orange abstract shape on the left, resembling two leaves with a blue dot in the center. To the right of the shape is the word "STEREOTAXIS" in a bold, sans-serif font. Below the word is the tagline "Improving Life with Robotic Precision and Safety" in a smaller font.
Technological Characteristics
| SUBJECT DEVICEStereotaxis Genesis RMN® withNavigant™ Workstation (NWS)and Cardiodrive® System | PREDICATE DEVICEStereotaxis Niobe MNS withNavigantNWS, and CardiodriveK183027, K192775 | |
|---|---|---|
| Magnet System | ||
| Type of Magnets | Permanent, Positioned Mechanically,metal alloy | Permanent, PositionedMechanically, metal alloy |
| Magnet Position | Permanent, Positioned Mechanically | Permanent, Positioned Mechanically |
| Navigation Volume | 6 inch B field Sphere | 6 inch B field Sphere |
| Magnet System Design | Center of Mass design no floor track | Cantilevered with floor track |
| Magnet Weight and Size | 640 lb | 764 lb |
| Distance from Magnet to Cover | 8.17 mm | 74 mm |
| Response Time | Faster - movement from center lessmomentum | Slower- larger motion heaviermagnet more momentum |
| Articulating Arms | Biceps and forearm shoulder | Track mounted arc and fixedposition |
| Base Tilt Sensing | Available with continuous sensing | Not available |
| Control Cabinet | 81.7" (H) X 30.4" (W) X 32.1" (D) | 84.5"(H) X 59.1" (W) X 23.6" (D) |
| Control of Steerable Device Orientation | Remote and Computer Control | Remote and Computer Control |
| Devices Controlled by System | Specially Designed MagneticCatheters and Guidewires | Specially Designed MagneticCatheters and Guidewires |
| Adjusts Magnetic Field | Based on information received fromNavigant NWS Software | Based on information received fromNavigant NWS Software |
| Operating Magnetic Field Strength | 0.08-0.12 Tesla | 0.08-0.12 Tesla |
| Magnet Positioners | ||
| Number, Location | 2, positioned on right and left side ofpatient | 2, positioned on right and left side ofpatient |
| Magnet Covers | ||
| Material | Fiberglass | Fiberglass |
| Sensors | Yes, Contact Sensors | Yes, Contact Sensors |
| Magnetic Field Modes and Positions | ||
| Magnetic Field Modes | Applied, Reduced, Stowed | Applied, Reduced, Stowed |
| Magnetic Field Positions | Stowed, Pivoted, Retracted, NavigateAP, Navigate LAO, Navigate RAO | Stowed, Pivoted, Retracted,Navigate AP, Navigate LAO,Navigate RAO |
| NAVIGANT NAVIGATION WORKSTATION | ||
| User Interface Components | ||
| Navigant Software | V5.0.6 | V5.0.6 |
| Tableside Magnet Controller | 1, Located on the patient tableaccessory rail | 1, Located on the patient tableaccessory rail |
| Mouse | 1, Standard PC compatible wheelMouse | 1, Standard PC compatible wheelMouse |
| Keyboard | 1, Standard PC compatible Keyboard(without integrated keypad functions) | 1, Standard PC compatible Keyboard(without integrated keypadfunctions) |
| Keypad | 1, Separate component, contains thekeys from the predicate keyboard | 1, Separate component, contains thekeys from the predicate keyboard |
| Display Monitors, Location | 1+ (User preference) | 1+ (User preference) |
| SUBJECT DEVICEStereotaxis Genesis RMN® withNavigant™ Workstation (NWS) | PREDICATE DEVICEStereotaxis Niobe MNS withNavigant | |
| and Cardiodrive® System | NWS, and CardiodriveK183027, K192775 | |
| Procedure and Control Rooms | Procedure and Control Rooms | |
| Procedure Types | ||
| Electrophysiology (EP) | Yes | Yes |
| Interventional Cardiology (IC) | Yes | Yes |
| Cardiac Resynchronization Therapy(CRT) | Yes | Yes |
| Interventional Radiology (IR) | Yes | Yes |
| Interventional Neuroradiology (INR) | Yes | Yes |
| Control Panels | ||
| Clinical Workflow Manager (CWM) | Optional use feature that acts as amap and allows a physician to worktheir way through an entire procedure | Optional use feature that acts as amap and allows a physician to worktheir way through an entireprocedure |
| Control Panel - Navigations | • Pre-set navigations• Stored navigations• Rename stored navigations• Delete stored navigations | • Pre-set navigations• Stored navigations• Rename stored navigations• Delete stored navigations |
| Control Panel - Visible Objects | • Delete• Edits geometry• Right-click menu for vessels• Vessel properties• Manual vessel registration• Carto colors and Carto tags | • Delete• Edits geometry• Right-click menu for vessels• Vessel properties• Manual vessel registration• Carto colors and Carto tags |
| Control Panel - Bullseye Targeting | • Bullseye target colors• Altering bullseye targeting• Bullseye targeting automation | • Bullseye target colors• Altering bullseye targeting• Bullseye targeting automation |
| Control Toolbars | ||
| Control Toolbar – Main | Title Bar, Status Bar, ReferenceImages | Title Bar, Status Bar, ReferenceImages |
| Control Toolbar - Hardware | Status Indicator | Status Indicator |
| User Views | ||
| Pre-operative Navigation | Included | Included |
| 3D Constellation | Included | Included |
| 3D Anatomic | Included | Included |
| Navigation Fluoroscopy Images | Included | Included |
| Display Graphics on Live Fluoroscopy | ||
| Field Mode Indicator | Included | Included |
| Magnetic Fields | Included | Included |
| Reduced Fields | Included | Included |
| Virtual Catheter | Included | Included |
| Points and Constellations | Included | Included |
| Pre-Op Data | ||
| Load, Register, and Display Pre-operative Data | Included | Included |
| SUBJECT DEVICEStereotaxis Genesis RMN® withNavigant™ Workstation (NWS)and Cardiodrive® System | PREDICATE DEVICEStereotaxis Niobe MNS withNavigantNWS, and CardiodriveK183027, K192775 | |
| Apply and Reduce Magnetic Field | Included | Included |
| Image Transfer | Included | Included |
| 3D Anatomic, 3D Constellation,Naviline Fluoroscopy | Included | Included |
| Click and Go Targeting | Included | Included |
| Naviline | Included | Included |
| Auto-mapping | Included | Included |
| Ablation History Graph Display | Included | Included |
| Ablation History Volume Display | Included | Included |
| Digital Fluoroscopy | Compatible with Omega andSiemens | Compatible with Omega, Siemensand Philips |
| Physician Preference Companion Devices and Systems | ||
| Odyssey Workstation | FDA-cleared, compatible | Included |
| Compatibility with updated firmwarefor integrated video component | Included | Included |
| Vdrive Robotic Navigation System | FDA-cleared, compatible | Included |
| Cardiodrive Catheter AdvancementSystem (CAS) | FDA-cleared, compatible | Included |
| Cardiodrive Catheter AdvancementSystem (CAS) | Included | Included |
| Mapping Systems | FDA-cleared, compatible systemCarto, and AcQmap | Included |
| User Interface | Included | Included |
| Ablation Catheters | FDA-approved, magnetic compatible | Same |
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Image /page/5/Picture/0 description: The image shows the logo for Stereotaxis. The logo features an orange abstract design on the left, followed by the word "STEREOTAXIS" in a bold, sans-serif font. Below the word, there is a tagline that reads "Improving Life with Robotic Precision and Safety".
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Image /page/6/Picture/0 description: The image shows the logo for Stereotaxis. The logo consists of two orange shapes resembling leaves with a blue dot in the center, followed by the word "STEREOTAXIS" in a bold, sans-serif font. Below the word, there is a tagline that reads "Improving Life with Robotic Precision and Safety".
Performance data
Performance data establish the substantial equivalence of the Genesis MNS including software verification and validation data, bench performance testing and animal testing. Performance testing was conducted for electrical safety, and EMC compatibility.
Animal Testing: Stereotaxis performed an animal study in a porcine model to evaluate the safety and effectiveness of Genesis MNS to perform movements of multiple compatible ablation catheters, safety features, and mechanical performance testing according to the Special Controls. This study demonstrated that the Genesis MNS met its performance requirements.
Based upon the documentation presented in this 510(k) it has been demonstrated that the Genesis MNS device is safe and effective for its intended use.
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Image /page/7/Picture/0 description: The image is a logo for Stereotaxis. The logo features two orange shapes that resemble leaves or flames on the left side, with a blue dot in the center. To the right of the shapes is the word "STEREOTAXIS" in a bold, sans-serif font. Below the word is the tagline "Improving Life with Robotic Precision and Safety" in a smaller font.
Special Controls
| Special Controls | How Special Control Has Been Met | |
|---|---|---|
| 1) Non-clinical mechanical performancetesting must demonstrate that the deviceperforms as intended under anticipatedconditions of use. The followingperformance testing must be performed:i. Mechanical performance of thesystem (without catheter connected); | Using the proposed device, Magnetic field performance testing without thecatheter connected. Testing included:a robotic field accuracy survey. reduced field mode angular resolution isocenter offset (for heart position) Field characteristics (strength, direction, position and accuracy) meet thesame requirements for the predicate Niobe and the subject Genesis. | |
| ii. Mechanical performance of thesystem with compatible cathetersconnected to verify that the systemdoes not impact catheter function orperformance. Assessments mustinclude the following: | Manual Control Performance TestingPerformance testing data for the reference Niobe device included deflectiontesting, accuracy testing with target phantom and anatomical position testingwith a plastic heart model. The results of this testing provide mechanicalperformance data for the reference device. | |
| (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 TestingThe same performance testing of compatible devices was performed with thesubject Genesis system that included deflection testing, accuracy testingwith target phantom and anatomical position testing with a plastic heartmodel. The results of this testing provide mechanical performance data forthe reference device.The subject Genesis system performed at the same level with compatibledevices as the predicate Niobe System. The subject device generates thesame magnetic fields as the predicate device. The compatible catheterperformance testing results were the same for Genesis as it was for Niobeand demonstrates substantial equivalence. | |
| (B) Evaluation of the accuracy andfunction of all device controlsafety features; and | Testing of the four primary safety controls related to the physical motion ofthe system was conducted on the proposed device. These concern physicalmovement of the magnet positioners, movement of the covers toward thepatient, continuous advancement of the catheter, and motion e-stops. Allsafety controls passed the test.Successful user testing of safety controls was the same between Niobe andGenesis. Genesis is substantial equivalent to the predicate device in relationto the accuracy and function of the device control safety features. | |
| iii. Simulated-use testing in a benchanatomic model or animal model. | Validation testing for Genesis includes use testing of clinical workflows in abench model.An animal study was performed that employed typical clinical workflowsincluding compatibility with mapping system, CardioDrive, andfluoroscopy.Clinical workflow testing for Genesis with compatible devices was the same | |
| Special Controls | How Special Control Has Been Met | |
| as Niobe. Animal and simulated use testing provided objective evidence tosubstantiate that the Genesis MNS is substantially equivalent to the predicatedevice. | ||
| 2. Non-clinical electrical testing mustinclude validation of electromagneticcompatibility (EMC), electrical safety,thermal safety, and electrical systemperformance. The followingperformance testing must beperformed: | Manual Control Performance TestingEMC and Electrical safety testing showing conformance with IEC 60601were performed by TuV for the reference Niobe device. | |
| Remote Control Performance TestingEMC testing for the proposed device hardware demonstrating conformancewith IEC 60601-1-2 was performed by Intertek. | ||
| i. Electrical performance of thesystem with compatible cathetersconnected to verify that thesystem does not impact catheterfunction or performance.Assessments must include thefollowing:A. Side-by-side remote controland manual comparisons ofcatheter manipulation(including all ranges ofmotion of catheter deflectionand tip curl) for allcompatible catheters; mustinclude testing for worst-caseconditions, and | As required, both the predicate device and proposed device were testedaccording to IEC 60601-1-2 standards by Nationally Recognized TestingLabs. All tests passed. | |
| B. Evaluation of the accuracyand function of all devicecontrol safety features; and | Electrical safety testing on the proposed device demonstrating compliancewith IEC 60601, and IEC 60601-1-2 was performed by Intertek. | |
| ii. Electrical safety between thedevice and ablation cathetersystem and with other electricalequipment expected in thecatheter lab or operating room. | The proposed system has been tested for compatibility with specific x-ray,ablation generators, and mapping systems.In addition, electrical isolation and emissions testing have been performedby Intertek. | |
| Special Controls | How Special Control Has Been Met | |
| 3.In vivo testing must demonstrate thatthe device performs as intended underanticipated conditions of use,including an assessment of the systemimpact on the functionality andperformance of compatible catheters,and documentation of the adverseevent profile associated with clinicaluse. Evidence must be submitted toaddress the following:i.Manipulation and Positioning:Ability to manipulatecompatible catheters to pre-specified cardiac locations andconform proper anatomicplacement and tissue contact, inaccordance with the systemindications for use andcompatible catheter indicationsfor use; | Animal study was conducted with compatible devices to demonstratecompatibility. Catheters were directed to predefined targets and evidence ofsuitable contact was demonstrated.In vivo testing was conducted with the subject device and all compatibledevices functioned in a similar manner to the predicate device. This testingis equivalent to the testing performed for the predicate device. Thisdemonstrates that the subject device is substantially equivalent to thepredicate device with compatible catheters. | |
| ii.Safety: Assess device-relatedcomplication rate and majorprocedural complication rate(regardless of devicerelatedness) in comparison toliterature and/or manualcomparison group forcompatible ablation catheters tosupport the indications for use; | The subject device generates the same magnetic fields as the predicatedevice and works with the same compatible fluoroscopic, mapping andablation devices. Existing magnetic navigation clinical data are still relevant.The following information is sufficient enough to demonstrate substantialequivalency to the predicate device.Clinical data to support the safety of the Magnetic Navigation System,which includes Niobe, Navigant Software, the CardioDrive catheteradvancement system and a compatible ablation catheter, was reviewed.The following is a summary of data from clinical studies sponsored byStereotaxis that have been submitted to the FDA in three separatesubmissions:• P050029 Helios II ablation catheter (ATTRAC, ATTRAC II andHEART)• K071029 CardioDrive with Ablation Catheter (ATTRAC II)• K140804 V-CAS (VERSATILE)A total of 511patients from 4 studies were enrolled using the NiobeMagnetic 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 thesetrials. | |
| Study | RMN Patients | 7 Day MajorComplication |
| ATTRAC | 182 | 7/182 (3.8%) |
| ATTRAC II | 80 | 1/80 (1.3%) |
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Image /page/8/Picture/0 description: The image is a logo for Stereotaxis. The logo features an orange abstract shape on the left, followed by the word "STEREOTAXIS" in a bold, sans-serif font. Below the word, there is a tagline that reads "Improving Life with Robotic Precision and Safety".
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Image /page/9/Picture/0 description: The image is the logo for Stereotaxis. The logo features an orange graphic on the left, followed by the word "STEREOTAXIS" in a tall, sans-serif font. Below the word is the tagline "Improving Life with Robotic Precision and Safety."
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Image /page/10/Picture/0 description: The image shows the logo for Stereotaxis. The logo features an orange abstract shape on the left, resembling two leaves with a blue dot in the center. To the right of the shape is the word "STEREOTAXIS" in a bold, sans-serif font, and below that is the tagline "Improving Life with Robotic Precision and Safety".
| Special Controls | How Special Control Has Been Met | |||
|---|---|---|---|---|
| HEART Study | 129 | 7/129 (5.4%) | ||
| VERSATILE | 120 | 5/120 (4.2%) | ||
| Total | 511 | 20/511 (3.9%) | ||
| iii.Efficacy: Assess ablationsuccess in comparison toliterature and/or a manualcomparison group forcompatible ablation catheters tosupport the indications for use;and | The subject device generates the same magnetic fields as the predicatedevice and works with the same compatible fluoroscopic, mapping andablation devices. Existing magnetic navigation clinical data are still relevant.The following information is sufficient enough to demonstrate substantialequivalency to the predicate device.Data to support the ablation success of the Magnetic Navigation Systemwhich includes Niobe, Navigant Software, the CardioDrive catheteradvancement system and a compatible ablation catheter was reviewed.The following is a summary of data from clinical studies sponsored byStereotaxis that have been submitted to the FDA in three separatesubmissions:P050029 Helios II ablation catheter (ATTRAC ,ATTRAC II andHEART study)K071029 CardioDrive with Ablation Catheter (ATTRAC)K140804 V-CAS (VERSATILE)A total of 511 patients from 4 studies were enrolled using the NiobeMagnetic Navigation System, which included the Niobe MNS, CardioDrive,a Magnetic Ablation Catheter, and the Navigant software. The ATTRACstudy series and the HEART Study used the Helios ablation catheter, and theVersatile study used the BWI RMT Thermocool catheter. The following | |||
| Study | RMN Patients | Acute SuccessRMN | 90 day successRMN | |
| 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 deviceremote controls and safetyfeatures. | The same user assessment testing of the predicate device was performedwith the subject device and all safety features passed testing. This issufficient to demonstrate substantial equivalency to the predicate device withregard to the safety controls. | |||
| 4.Post-market surveillance (PMS) mustbe conducted and completed inaccordance with FDA agreed uponPMS protocol. | The subject device generates the same magnetic fields as the predicatedevice and works with the same compatible fluoroscopic, mapping andablation devices. Existing magnetic navigation clinical data are still relevant.The following information is sufficient enough to demonstrate substantialequivalency to the predicate device. |
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Image /page/11/Picture/0 description: The image shows the logo for Stereotaxis. The logo consists of an orange abstract shape on the left, followed by the word "STEREOTAXIS" in a bold, sans-serif font. Below the word is the tagline "Improving Life with Robotic Precision and Safety" in a smaller font.
| Special Controls | How Special Control Has Been Met |
|---|---|
| Given the amount of clinical data from submitted studies and peer reviewed publications for magnetic navigation, a post market surveillance study is not warranted. The following summarizes the overwhelming evidence available to support the safety and efficacy of the MNS system: Four studies submitted to the FDA demonstrated a major adverse event rate of 3.9%. Data from these four studies supported 510(k) clearances for K071029, and K140804 and PMA approval in P050029. Acute success and 90 success rates were 95.0% and 96.5% respectively in those studies More than 8,000 patients were reported in the literature using the MNS System with a major complication rate of 0.72% compared to a manual rate of 2.1% Acute success rates and long-term success rates were similar in both the MNS and manual groups Stereotaxis proposes to continue monitoring the safety and efficacy of the Genesis System through the literature and Post Marketing Surveillance program. | |
| 5. A training program must be included with sufficient educational elements that, upon completion of the training program, the clinical and supporting staff can: Identify the safe environments for device use, Use all safety features of the device, and Operate the device in simulated or actual use environments representative of indicated environments and use for the indication of compatible catheters. | Representatives from the company train the physician and staff in the use of the Genesis Magnetic Navigation system using simulator and phantom testing. The Genesis User's Manual provides detailed operating instructions on the system and the navigation software. This information is reviewed with the physician and staff during simulation sessions and phantom training with the actual system |
| 6. Performance data must demonstrate the sterility of the sterile disposable components of the system | The Genesis System is not provided in sterile form nor is it required to be sterilized prior to use, therefore, sterilization information is not applicable. The Genesis System does not include sterile disposable components as part of the system. CardioDrive includes a single-use disposable (QuikCAS) to interface with the compatible ablation catheter. The sterile components underwent sterilization testing. All sterilization testing resulted in a PASS. |
| Special Controls | How Special Control Has Been Met |
| 7. Performance data must support shelf life by demonstrating continued sterility of the device (of the sterile disposable components), package integrity, and device functionality over the requested shelf life. | The Genesis System is not provided in sterile form nor is it required to be sterilized prior to use, therefore, shelf life information, including package integrity and function of the device over the stated shelf life are not applicable.CardioDrive includes a single-use disposable (QuikCAS) to interface with the compatible ablation catheter. The sterile components underwent shelf-life /packaging and sterilization testing. All sterilization and packaging testing resulted in a PASS, and each component was validated for a shelf life of 3 years. |
| 8. Labeling must include:i. Appropriate instructions, warnings, cautions, limitations, and information related to the intended patient population, compatible ablation catheters, and the device safeguards for the device;ii. Specific instructions and clinical training needed for the safe use of the device, which includes:A. Instructions on assembling the device in all available configurations, including installation and removal of compatible catheters; | Genesis User's Manual includes:• Compatible Catheters• Indications for Use• Warnings• Safety ControlsThe Genesis System does not require assembly of the device prior to use. The Genesis System is considered permanent equipment installed in a Stereotaxis Magnetic Navigation Lab. Stereotaxis performs all installation activities for each Genesis System; therefore, assembly and installation instructions to the physician user are not required.With regard to use of magnetically-compatible devices with the Genesis System, assembly and installation of these devices to/with the Genesis System is not required. Magnetically-compatible catheters interface with the CardioDrive CAS device which advances and retracts the device and instructions related to the catheter-CAS interface are provided in the CardioDrive instructions for use. The Genesis System only applies a magnetic field to orient the distal tip of a magnetically-compatible device; therefore, the manipulation of the distal end of the device is by indirect (non-physical) means for which assembly or installation of other devices is not required. |
| Special Controls | How Special Control Has Been Met |
| B. Instructions on all availablemodes or states of thedevices;C. Instructions and explanationof all controls, inputs, andoutputsD. Instructions on all safetyfeatures of the device andE. Validated methods andinstructions forreprocessing/disinfecting anyreusable components | The Genesis System User Guide includes an explanation and instructions forthe following, controls, modes, and states of the device:Procedure room components System positions Tableside Magnet Controller System power up Cover Force Sensor Navigation Position Assistance Software Basic Information CardioDrive CAS user interface Activation codes The Genesis System is a medical device that does not have any reusablecomponents that reprocessing or disinfection prior to use. The magnet podsare covered by drapes during the procedure and may be wiped clean usinghospital-grade EPA-registered germicide solutions following eachprocedure. Cleaning instructions are provided in the "Cleaning the GenesisSystem" section of the Genesis System User Guide). |
| iii.A detailed summary of themechanical compatibility testingincluding:A. A table with a complete listof compatible catheters tested(manufacturer trade name andmodel number), andB. A table with detailed testresults, including type of test,acceptance criteria, and testresults (i.e., pass for meetingacceptance criteria); | Biosense Webster Navistar RMT Biosense Webster Navistar RMT Thermocool Biosense Webster Celsius RMT Biosense Webster Celsius RMT Thermocool Mechanical testing for both the predicate device and the subject deviceincluded accessing pre-defined geometric targets from multiple positionswith each of the compatible catheters. Testing also included anatomicalphantom navigation to pre-defined anatomical targets with each of thecompatible catheters. All tests passed successfully. The subject devicedemonstrated substantial equivalence to the predicate device. |
| iv.A detailed summary of the invivo testing including:A. A table with a complete listof compatible catheters usedduring testing (manufacturertrade name and modelnumber); | Biosense Webster Navistar RMT Biosense Webster Navistar RMT Thermocool Biosense Webster Celsius RMT Biosense Webster Celsius RMT Thermocool In vivo testing was performed with the subject device that included thelisted compatible catheters. In the subject device, all compatible cathetersfunctioned in a similar manner to the predicate device. The Genesis system |
| Special Controls | How Special Control Has Been Met |
| system as Niobe. | |
| B. Adverse events encounteredpertinent to use of the deviceunder use conditions; | The Genesis system provides the same magnetic field, works with the sameCardioDrive system and same compatible catheters as Niobe. Performancedata has shown that the catheters respond to the field in the same manner.Data from four clinical studies involving 511 patients who underwentcatheter ablation using the Stereotaxis Magnetic Navigation System (MNS)are summarized. Collectively, the data in these studies demonstrates thesafety and effectiveness of the Magnetic Navigation System for catheterablation.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 procedureincluded:1 cardiac tamponade related to right sided catheter 1 cardiac tamponade related to the transseptal puncture 1 new focal wall abnormality 1 change in LVEF (60% to 45-50%) 2 vena cava thrombi 1 groin complication 1 chest soreness 1 prolonged hospitalization for grogginess 1 pseudoaneurysm 1 bleeding 1 anemia 1 dementia 1 pericardial effusion 1 heart block requiring pacemaker 2 pulmonary embolisms 1 AV fistula |
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Image /page/12/Picture/0 description: The image shows the logo for Stereotaxis. The logo features an orange abstract shape on the left, followed by the word "STEREOTAXIS" in a bold, sans-serif font. Below the word, there is a tagline that reads "Improving Life with Robotic Precision and Safety."
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Image /page/13/Picture/0 description: The image is a logo for Stereotaxis. The logo features an orange abstract shape on the left, followed by the word "STEREOTAXIS" in a bold, sans-serif font. Below the word, there is a tagline that reads "Improving Life with Robotic Precision and Safety."
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Image /page/14/Picture/0 description: The image shows the logo for Stereotaxis. The logo features an orange abstract shape on the left, resembling two leaves with a blue dot in the center. To the right of the shape is the word "STEREOTAXIS" in a bold, sans-serif font. Below the word is the tagline "Improving Life with Robotic Precision and Safety" in a smaller font.
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Image /page/15/Picture/0 description: The image shows the logo for Stereotaxis. The logo features an orange abstract shape on the left, resembling two leaves with a blue dot in the center. To the right of the shape is the word "STEREOTAXIS" in a bold, sans-serif font. Below the word is the tagline "Improving Life with Robotic Precision and Safety".
| Special Controls | How Special Control Has Been Met | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| ConclusionThe data in this summary support the reasonable assurance of safety andeffectiveness of the Stereotaxis Magnetic Navigation System for cardiacablation procedures. | |||||||||||
| These data have been summarized in the Genesis User's Guide. | |||||||||||
| C. A detailed summary ofdevice- and procedure-relatedcomplications; and | The following listing of the procedure related complications have beenreported in clinical trials submitted to the agency:Two (2) patients out of 177 (1.1%) had an acute major adverse event and5/182 (2.7%) had a major adverse event within 7 days of ablation in theATTRAC Study. There was 1 death reported in the study secondary torespiratory 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 chestsoreness, 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 eventwhich was a cardiac tamponade due to a right sided non-study catheter.There were no deaths reported in this study. There were no device relatedadverse 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, 2pulmonary embolisms, 1 AV fistula, and 2 arrhythmia recurrences(considered a major adverse event per the protocol) in the magnetic arm ofthe 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 pseudoaneurysm, one bleeding, one patient presented with anemia and dementia.The cardiac tamponade event started as a pericardial effusion andprogressed into cardiac tamponade due to the transseptal puncture. TheDSM adjudicated these events to be possibly and probably related to theprocedure, respectively. There were no device related adverse events. | |||||||||||
| D. A summary of studyoutcomes and endpoints.Information pertinent to thefluoroscopy times/exposurefor the procedure, patient, andoperator fluoroscopicexposure; | The following table summarizes the acute and long term success rates aswell as fluoroscopy times reported in the clinical trials.Study RMNPatients Acute SuccessRMN 90 day successRMN MeanFluoroscopy timeMean +/-S.D[range] ATTRAC 182 175/182 (96.2%) 145/147 (98.6%) 15.89+/-13.15[1.05, 66.5] |
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Image /page/16/Picture/0 description: The image shows the logo for Stereotaxis. The logo features an orange abstract shape on the left, resembling two leaves with a blue dot in the center. To the right of the shape is the company name, "STEREOTAXIS," in a bold, sans-serif font. Below the name is the tagline, "Improving Life with Robotic Precision and Safety," in a smaller font.
| Special Controls | How Special Control Has Been Met | |||||
|---|---|---|---|---|---|---|
| ATTRAC II | 80 | 71/75 (94.7%) | 51/54 (94.4%) | 10.64 +/-9.78[0.63,61.0] | ||
| HEART Study | 129 | 108/121 (89.3) | 82/87 (94.3%) | 16.91 +/-9.92[3.13,44.18] | ||
| VERSATILE | 120 | 119/120 (99.2%) | Not reported | 11.0 +/-10.5[0.03,55.2] | ||
| Total | 511 | 473/498 (95.0%) | 278/288 (96.5%) | |||
| These data have been summarized in Genesis User's Guide. | ||||||
| Other labeling items:v.A. A detailed summary ofpertinent non-clinical testinginformation: EMC,mechanical, electrical, andsterilization of device andcomponents; | EMC: The Genesis System User Manual includes a summary ofElectromagnetic 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 isincluded and summarized in the Genesis User's GuideSterilization: The Genesis System is not provided in sterile form nor is itrequired to be sterilized prior to use, therefore, sterilization information isnot applicable. | |||||
| B.A detailed summary of thedevice technical parameters;and | The Genesis system generates a directional 0.08T or 0.1T magnetic fieldwithin the patient's heart. The navigation volume is 6 inches in diametercentered at X-ray isocenter. | |||||
| C.An expiration date/shelf lifeand storage conditions for thesterile accessories; and | The Genesis System is not provided in sterile form nor is it required to besterilized prior to use, therefore, expiration date, shelf life, and storageconditions are not applicable. | |||||
| vi.When available, and accordingto the timeframe included in thePMS protocol agreed upon withFDA, provide a detailedsummary of the PMS dataincluding:A. Updates to the labeling toaccurately reflect outcomesor necessary modificationsbased upon data collectedduring the PMS experience,andB. Inclusion of results andadverse events associatedwith utilization of the device | Relevant warnings based on complaints and clinical studies have been included in The Genesis User's Guide. |
Date 510 (k) Summary revised: March 4, 2020
§ 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.