Vdrive system, Vdrive Duo, Vdrive with V-Sono
Device Facts
| Record ID | K150312 |
|---|---|
| Device Name | Vdrive system, Vdrive Duo, Vdrive with V-Sono |
| Applicant | Stereotaxis, Inc. |
| Product Code | DXX · Cardiovascular |
| Decision Date | Jun 17, 2015 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1290 |
| Device Class | Class 2 |
Indications for Use
The Vdrive® system is intended to stabilize, navigate and remotely control: Compatible Intracardiac Echocardiography (ICE) catheters to facilitate visualization of cardiac structure during the performance of cardiac procedure when used in conjunction with the V-Sono™ disposable sets in the Vdrive® system, Compatible loop (circular) mapping catheters to facilitate movement of the catheter during the performance of electrophysiological procedures when used in conjunction with the V-Loop™ disposable sets in the Vdrive® system, and Compatible fixed curve transseptal sheaths and catheters to facilitate movement of the sheath and catheter when used in conjunction with the V-CAS™ disposable sets in the Vdrive® system and with the Niobe® Magnetic Navigation System (MNS).
Device Story
Vdrive system provides remote robotic control of cardiac catheters and sheaths. Hardware includes control box, adjustable arm, and drive unit; operated via tableside controller and dedicated Vdrive controller. Vmotion functionality adds automated ICE catheter movements: Spotlight (rotates to keep mapping catheter in view), Sweep (automated field-of-view scanning), and Stored Positions (returns to saved coordinates). Used in clinical electrophysiology labs by physicians. System facilitates visualization and navigation, reducing manual manipulation requirements. Benefits include precise, stable catheter positioning during cardiac procedures.
Clinical Evidence
Bench testing and animal study (porcine model) performed. Bench testing validated software-controlled movements (Spotlight, Sweep, Stored Positions), motion accuracy, motion limits, and safety features (emergency stops, user-controlled stops). Electrical safety, EMC, sterilization, and shelf-life testing completed. Animal study confirmed safety and effectiveness of Vdrive with V-Sono (including Vmotion) for performing ICE catheter movements per requirements.
Technological Characteristics
System comprises hardware (control box, adjustable arm, drive unit), software-driven user interface, and sterile single-use disposable kits (V-Sono, V-Loop, V-CAS). Employs robotic electromechanical actuation for catheter/sheath manipulation. Connectivity via dedicated controller. Software-controlled automation (Vmotion).
Indications for Use
Indicated for remote control of compatible ICE catheters (right atrium), loop mapping catheters (left atrium), and fixed curve transseptal sheaths/EP catheters (heart) during cardiac/electrophysiological procedures. Contraindicated for vascular access sites other than the groin; not for coronary vasculature or coronary sinus use. Transseptal sheath must not move during active therapy delivery.
Regulatory Classification
Identification
A steerable catheter control system is a device that is connected to the proximal end of a steerable guide wire that controls the motion of the steerable catheter.
Predicate Devices
- Vdrive® with V-CAS™, K141530 (Stereotaxis)
Reference Devices
Submission Summary (Full Text)
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Image /page/0/Picture/12 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized human figure or head in profile.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 17, 2015
Stereotaxis. Inc. % Diane Horwitz Regulatory Consultant Safis Solutions LLC 2995 Steven Martin Drive Fairfax, Virginia 22031
Re: K150312
Trade/Device Name: Vdrive, Vdrive With V-sono (Vmotion), Vdrive Duo Regulation Number: 21 CFR 870.1290 Regulation Name: Steerable Catheter Control System Regulatory Class: Class II Product Code: DXX, DQX Dated: May 8, 2015 Received: May 8, 2015
Dear Diane Horwitz:
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. 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
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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours
Arthell Stei
forBram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K150312
Device Name Vdrive® Vdrive® with V-Sono™ (Vmotion™) Vdrive Duo™M
Indications for Use (Describe)
The Vdrive® system is intended to stabilize, navigate and remotely control:
· Compatible Intracardiac Echocardiography (ICE) catheters to facilitate visualization of cardiac structure during the performance of cardiac procedure when used in conjunction with the V-Sono™ disposable sets in the Vdrive® system,
· Compatible loop (circular) mapping catheters to facilitate movement of the catheter during the performance of electrophysiological procedures when used in conjunction with the V-Loop™ disposable sets in the Vdrive® system, and
· Compatible fixed curve transseptal sheaths and catheters to facilitate movement of the sheath and catheter when used in conjunction with the V-CAS™ disposable sets in the Vdrive® system and with the Niobe® Magnetic Navigation System (MNS).
The Vdrive® with V-Sono™ disposable is indicated for remotely controlling the advancement, retraction, rotation and anterior-posterior deflection of compatible ultrasound catheters inserted into the right atrium. Compatible catheters at this time include Biosense Webster, Inc. Soundstar™ 3D Ultrasound Catheters and Acuson AcuNav™ Ultrasound Catheters. Other models of ICE catheters have not been tested with the Vdrive™ system.
The Vdrive® with V-Loop™ disposable is indicated to remotely control the advancement, retraction, tip deflection and loop size of compatible loop catheters inserted across the septum into the left atrium using conventional procedures. Compatible catheters at this time include Biosense Webster Lasso 2515 and Lasso 2515 NAV Circular Mapping Catheters. Other models of loop catheters have not been tested with the Vdrive® system.
The Vdrive® with V-CAS™ disposable is indicated for remotely controlling the advancement, retraction, and rotation of compatible fixed curve transseptal sheaths, and the advancement and retraction of compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System. Compatible fixed curve sheaths at this time include the St. Jude Medical® Transseptal Sheath and Swartz™ Braided Transseptal Sheath. Other models of transseptal sheaths and mapping/ablation catheters have not been tested with the Vdrive® system. Vdrive® with V-CAS™ is contraindicated for vascular access sites other than the groin. It is not intended to advance the EP mapping and ablation catheters through the coronary vasculature nor the coronary sinus. The transseptal sheath is not to be moved while the EP catheter is actively delivering therapy.
The Vdrive Duo™ is an optional accessory intended for remotely controlling the Vdrive® system when one arm of the device is equipped with one disposable set (V-Sono™, V-Loop™ or V-CAS™) and the other arm is equipped with a different available disposable set. During the procedure, the Vdrive Duo™ allows selection between the disposable sets. 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/4/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".
# 510(k) Summary per 21CFR §807.92
| Submitter's<br>information | Stereotaxis, Inc.<br>4320 Forest Park Ave, Suite 100<br>St. Louis, MO 63108<br>Contact: John Nadelin, VP Regulatory & Quality<br>Telephone: 314-678-6130 | | |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|--|
| Device/<br>classification<br>name | Device Name: | Vdrive®<br>Vdrive® with V-Sono™ (Vmotion™)<br>Vdrive Duo™ | |
| | Classification/Common name: | System, Catheter Control, Steerable | |
| | Classification Number: | 870.1290 | |
| | Product Code: | DXX, DQX | |
| | Classification Panel: | Cardiovascular | |
| | Predicate Devices: | Vdrive® with V-CAS™, K141530 (Stereotaxis) | |
| Device<br>description | Vdrive® with V-Sono™ is intended to control a compatible Intracardiac<br>Echocardiography (ICE) catheter during and therapeutic cardiac procedures and is<br>comprised of four major components:<br>1. Vdrive® Hardware - control box, adjustable arm, drive unit and support<br>structure or Vdrive Duo™ (K133396) - with two adjustable arms<br>2. Vdrive® User Interface – combination of software-driven<br>(a) Tableside Controller and (b) dedicated Vdrive® Controller<br>3. V-Sono™ Disposable Kit – Handle Clamps, Catheter Support Tube and<br>Drape. These components are disposable, sterile, single use devices<br>(K122659), including Vmotion™ functionality<br>4. V-Loop™ Disposable Kit (K140804)<br>5. V-CAS™ Disposable Kit (K141530) | | |
| Intended use | The Vdrive® system is intended to stabilize, navigate and remotely control:<br>Compatible Intracardiac Echocardiography (ICE) catheters to facilitate<br>visualization of cardiac structure during the performance of cardiac<br>procedure when used in conjunction with the V-Sono™ disposable sets in<br>the Vdrive® system, Compatible loop (circular) mapping catheters to facilitate movement of the<br>catheter during the performance of electrophysiological procedures when<br>used in conjunction with the V-Loop™ disposable sets in the Vdrive®<br>system, and Compatible fixed curve transseptal sheaths and catheters to facilitate<br>movement of the sheath and catheter when used in conjunction with the V-<br>CAS™ disposable sets in the Vdrive® system and with the Niobe® Magnetic<br>Navigation System (MNS) | | |
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Image /page/5/Picture/0 description: The image is the logo for Stereotaxis. The logo features an 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 bold, sans-serif font. Below the word is the tagline "Improving Life with Robotic Precision and Safety" in a smaller font.
The Vdrive® with V-Sono™ disposable is indicated for remotely controlling the advancement, retraction, rotation and anterior-posterior deflection of compatible ultrasound catheters inserted into the right atrium. Compatible catheters at this time include Biosense Webster. Inc. Soundstar™ 3D Ultrasound Catheters and Acuson AcuNav™ Ultrasound Catheters. Other models of ICE catheters have not been tested with the Vdrive® system.
The Vdrive® with V-Loop™ disposable is indicated to remotely control the advancement, retraction, rotation, tip deflection and loop size of compatible loop catheters inserted across the septum into the left atrium using conventional procedures. Compatible catheters at this time include Biosense Webster Lasso 2515 and Lasso 2515 NAV Circular Mapping Catheters. Other models of loop catheters have not been tested with the Vdrive® system.
The Vdrive® with V-CAS™ disposable is indicated for remotely controlling the advancement, retraction, and rotation of compatible fixed curve transseptal sheaths, and the advancement and retraction of compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System. Compatible fixed curve sheaths at this time include the St. Jude Medical® Transseptal Sheath and Swartz™ Braided Transseptal Sheath. Other models of transseptal sheaths and mapping/ablation catheters have not been tested with the Vdrive® system. Vdrive® with V-CAS™ is contraindicated for vascular access sites other than the groin. It is not intended to advance the EP mapping and ablation catheters through the coronary vasculature nor the coronary sinus. The transseptal sheath is not to be moved while the EP catheter is actively delivering therapy.
The Vdrive Duo™ is an optional accessory intended for remotely controlling the Vdrive® system when one arm of the device is equipped with one disposable set (V-Sono™, V-Loop™ or V-CAS™) and the other arm is equipped with a different available disposable set. During the procedure, the Vdrive Duo™ allows selection between the disposable sets.
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Image /page/6/Picture/0 description: The image shows the Stereotaxis logo. The logo features 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 bold, sans-serif font. Below the word is the tagline "Improving Life with Robotic Precision and Safety" in a smaller font.
| Device Characteristic | Subject Device<br>Vdrive®<br>Vdrive® with V-Sono™<br>(Vmotion™)<br>Vdrive Duo™ | Predicate<br>Vdrive® with V-CAS™, focusing<br>on V-Sono™ disposable<br>Vdrive Duo™ |
|-----------------------------------|--------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| Location of Catheter tip | Right atrium | Right atrium |
| Initial Placement of catheter | Manual placement by<br>electrophysiologist under<br>fluoroscopy | Manual placement by<br>electrophysiologist under<br>fluoroscopy |
| Type of Procedure | Cardiac imaging | Cardiac imaging |
| Sheath Movements | N/A (no sheath) | N/A (no sheath) |
| Catheter Movements | Advance/ retract, rotation,<br>deflection | Advance/ retract, rotation, deflection |
| Visualization During<br>Procedure | Same | Same |
| Catheter Tip Movement | Vdrive® manipulation | Vdrive® manipulation |
| Automated Movement | Vmotion™ for surveillance<br>by ICE catheter tip | No automated movements |
| Single Use Disposable | Sterile handle clamp<br>Catheter Support<br>Drape | Sterile handle clamp<br>Catheter Support<br>Drape |
| Compatible Disposables | Includes V-Sono™, V-<br>Loop™, V-CAS™ | Includes V-Sono™, V-Loop™, V-<br>CAS™ |
#### Technological Characteristics
The only difference between the subject device and the predicate device is the Vmotion™ control mode.
The Vmotion control mode provides three features to the ICE catheter:
- Spotlight (which rotates the ultrasound catheter to keep the mapping catheter in the field of view),
- . Sweep (which enables the ultrasound field of view to continuously sweep across an area of interest that is defined by the user), and
- Stored Positions (which moves the ultrasound catheter to a previously stored position).
Performance data establish the substantial equivalence of the Vdrive® with Performance data V-Sono™, including software verification and validation data, bench performance testing and animal testing. Performance testing was conducted for electrical safety, EMC compatibility, sterilization and shelf life and packaging.
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Image /page/7/Picture/0 description: The image is the logo for Stereotaxis. The logo has an orange graphic on the left that looks like two leaves with a blue dot in the middle. To the right of the graphic is the word "STEREOTAXIS" in a tall, sans-serif font. Below the word is the tagline "Improving Life with Robotic Precision and Safety".
Bench Testing: Stereotaxis performed the following bench tests to establish equivalence to the predicate device: bench testing of the system in general, softwarecontrolled movements (Spotlight, Stored Position, and Sweep), which included testing for motion accuracy (e.g., sweep speed increment/decrement, sweep angle increment/decrement, movement to stored positions), motion limits (e.g., deflect limit on sweep, rotation limit on sweep, deflect limit on spotlight), and motion safety (e.g., user controlled stop of automation, emergency stop of automation, disallowing some combinations of automations). Bench testing also included for electrical safety, EMC compatibility, sterilization and shelf life and packaging.
Animal Testing: Stereotaxis performed an animal study in a porcine model to evaluate the safety and effectiveness of Vdrive® with V-Sono™ (including Vmotion) to perform movements of the ICE catheter tip according to product requirements. This study demonstrated that Vdrive™ with V-Sono™ met its performance requirements.
Based upon the documentation presented in this 510(k) it has been demonstrated that the Vdrive® with V-Sono™ (including Vmotion™) device is safe and effective for its intended use.
Date summary prepared: June 16, 2015
