VDRIVE WITH V-LOOP/ VDRIVE DUO

{0}------------------------------------------------ Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 3, 2014 Stereotaxis. Inc. % Diane Horwitz, Ph.D., Rac Safis Solutions LLC 2995 Steven Martin Dr. Fairfax, Virginia 22031 Re: K140804 Trade/Device Name: Vdrive With V-loop/ Vdrive Duo Regulation Number: 21 CFR 870.1290 Regulation Name: System, Catheter Control, Steerable Regulatory Class: Class II (two) Product Codes: DXX, DOX Dated: July 29, 2014 Received: July 30, 2014 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 with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Image /page/0/Picture/11 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an emblem featuring three stylized human profiles facing to the right. The emblem is black and white. {1}------------------------------------------------ Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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. FDA forBram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K140804 Device Name Vdrive™ with V-Loop Vdrive Duo™ #### Indications for Use (Describe) The Vdrive™ system is intended to stabilize, navigate and remotely control: · 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. · 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. 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-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 Duo™ is an optional accessory intended for remotely controlling the Vdrive™ system when one arm of the device is equipped with a V-Loop™ disposable set and the other arm is equipped with the V-Sono™ disposable set. During the procedure, the Vdrive Duo™ allows selection between the disposable sets (V-Loop™ or V-Sono™). | Type of Use (Select one or both, as applicable) | | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------| | <table style="border:none"><tr><td><span style="font-size:14px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</td></tr><tr><td><span style="font-size:14px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</td></tr></table> | <span style="font-size:14px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:14px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | | <span style="font-size:14px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | | | | <span style="font-size:14px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | | | ### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) {3}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ 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, there is a tagline that reads "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™, Vdrive Duo™<br>Classification/Common name: System, Catheter Control, Steerable<br>Classification Number: 870.1290<br>Product Code: DXX, DQX<br>Classification Panel: Cardiovascular<br>Currently Marketed Substantially Equivalent Device: Vdrive™ with V-Sono™ (K122659) | | | | Device<br>description | The Vdrive™ with V-Loop™ is provides a remote method of controlling the<br>advancement, retraction, rotation, tip deflection, and loop size of a LASSO® Circular<br>Mapping catheter during electrophysiology procedures and is comprised of four<br>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 1) Tableside<br>Controller and 2) dedicated Vdrive™ Controller,<br>3. V-Loop™ Disposable Kit – Handle Clamps (w/catheter inserts),<br>Telescoping Catheter Support and Drape. These components are<br>disposable, sterile, single use devices, and<br>4. V-Sono™ Disposable Kit (K122659) if Vdrive Duo™ will be used. | | | | Intended use | The Vdrive™ system is intended to stabilize, navigate and remotely control:<br>• 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.<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.<br><br>The Vdrive™ with V-Loop™ disposable is indicated to remotely control the<br>advancement, retraction, rotation, tip deflection and loop size of compatible loop<br>catheters inserted across the septum into the left atrium using conventional<br>procedures. Compatible catheters at this time include Biosense Webster Lasso 2515<br>and Lasso 2515 NAV Circular Mapping Catheters. Other models of loop catheters<br>have not been tested with the Vdrive™ system. | | | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image is a 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 "STEREOTAXIS" 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 Duo™ is an optional accessory intended for remotely controlling the Vdrive™ system when one arm of the device is equipped with a V-Loop™ disposable set and the other arm is equipped with the V-Sono™ disposable set. During the procedure, the Vdrive Duo™ allows selection between the disposable sets (V-Loop™ or V-Sono™). ## Technological characteristics | Device<br>Characteristic | Proposed<br>Vdrive™ with V-Loop™,<br>Vdrive Duo™ | Currently Marketed<br>Vdrive™ with V-Sono™ | |----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------| | Location of<br>Catheter tip | Right side of heart | Right or left side of heart | | Initial Placement<br>of catheter | Manual placement by cardiac<br>electrophysiologist | Manual placement by cardiac<br>electrophysiologist | | Catheter Movement | Mechanical | Mechanical | | Variable Speed | Yes | Yes | | Catheter Movement | Continuous | Continuous | | Emergency Stop<br>Option | Manual | Manual | | Manual Override | Yes | Yes | | Single Use | Disposable is single use | Disposable is single use | | Sterilization<br>Method | EtO | EtO | | Control of catheter<br>movement | Mechanical | Mechanical | | Compatible<br>Catheters | LASSO® 2515 Variable<br>Circular Mapping Catheter,<br>LASSO® 2515 NAV<br>LASSO ® 2515 ECO NAV<br>Variable Circular Mapping<br>Catheter (Biosense Webster) | Soundstar™ 3D Ultrasound<br>Catheters (Biosense Webster)<br>AcuNav™ Ultrasound<br>Catheters (AcuNav) | | Catheter<br>movements | Advancement-retraction<br>Rotation<br>Tip deflection<br>Loop size | Advancement-retraction<br>Rotation<br>Anterior-posterior deflection | Continued on next page {6}------------------------------------------------ Image /page/6/Picture/0 description: The image is a logo for Stereotaxis. The logo features a stylized orange graphic on the left, resembling two leaves or petals enclosing a teal dot. To the right of the graphic is the company name, "STEREOTAXIS," in a bold, sans-serif font. Below the company name is the tagline, "Improving Life with Robotic Precision and Safety," in a smaller, lighter font. | Device<br>Characteristic | Proposed<br>Vdrive™ with V-Loop™,<br>Vdrive Duo™ | Currently Marketed<br>Vdrive™ with V-Sono™ | |---------------------------------------------------|--------------------------------------------------|--------------------------------------------| | Control Room User<br>Interface | Yes | Yes | | SW driven | Yes | Yes | | Simultaneous Use<br>of two Vdrive™<br>Disposables | Yes | No | #### Performance data Performance data established the substantial equivalence of the Vdrive™ with V-Loop™ compared to the predicate device. Performance data included software verification and validation data, bench performance testing to verify that specifications were met, animal testing, and a prospective randomized multi-center clinical trial of the Vdrive™ with V-Loop™ system in navigation of circular mapping catheters compared to conventional manual methods of navigation. Performance testing was conducted 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 the Vdrive™ with V-Loop™ to perform navigation, electrogram generation, mapping and pacing during navigation, product usability and extremes of use. This study demonstrated that Vdrive™ with V-Loop™ met its performance and user requirements. Clinical Testing: Stereotaxis performed a prospective, randomized multi-center clinical trial of the Vdrive™ with V-Loop™ system in navigation of circular mapping (loop) catheters compared to conventional manual methods of navigation. A total of 137 subjects were randomized 2:1 (Vdrive™: Control) at five (5) clinical sites. Actual enrollment was 77 Vdrive™ and 43 control group subjects who were scheduled to undergo electrophysiology (EP) studies and a planned ablation procedure for pulmonary vein (PV) isolation, and who required the use of a circular mapping catheter to evaluate the PVs. Results of the efficacy analysis demonstrated that the Stereotaxis Vdrive™ with V-Loop™ is effective when used to control a circular mapping system catheter when compared to manual navigation; the Vdrive™ with V-Loop™ is non-inferior to the manual procedure. The safety analysis led to the conclusion that similar adverse events between groups, and that the low rate of adverse events was unrelated to use of the Vdrive™ system. Vdrive Duo™ was used to control two different disposables in a total of 33 subjects in the VERSATILE trial. Based upon the documentation presented in this 510(k) it has been demonstrated that the Vdrive™ with V-Loop™ device is safe and effective for its intended use. Date summary prepared: September 3, 2014