(192 days)
Not Found
No
The summary describes a robotic system for controlling catheters and sheaths, focusing on remote manipulation and navigation. There is no mention of AI, ML, or any algorithms that would suggest learning or intelligent decision-making capabilities. The system appears to be based on direct remote control.
No.
The device is intended to stabilize, navigate, and remotely control catheters for visualization, movement, and facilitation during cardiac and electrophysiological procedures; it does not directly provide therapy.
No.
Explanation: The device is intended to stabilize, navigate, and remotely control catheters for visualization and movement during cardiac and electrophysiological procedures. It facilitates the use of diagnostic tools (like ICE catheters) but is not itself a diagnostic device. Its primary function is mechanical control and navigation, not direct diagnosis.
No
The device description explicitly lists "Vdrive® Hardware - control box, adjustable arm, drive unit and support structure or Vdrive Duo™" as a major component, indicating it includes physical hardware beyond just software.
Based on the provided text, the Vdrive® system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the Vdrive® system is designed to stabilize, navigate, and remotely control catheters within the body (intracardiac). This involves manipulating devices during procedures performed on a patient.
- Device Description: The device description details hardware and software components used for controlling catheters and sheaths inserted into the patient's heart.
- Lack of In Vitro Activities: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide diagnostic information. IVDs are specifically designed for testing biological samples in a laboratory or clinical setting.
The Vdrive® system is a medical device used for interventional procedures, specifically in the field of electrophysiology and cardiac imaging, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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).
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 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 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
Prescription Use (Part 21 CFR 801 Subpart D)
Product codes (comma separated list FDA assigned to the subject device)
DXX, DQX
Device Description
Vdrive® with V-CAST™ is intended to control a compatible fixed curve transseptal sheath and catheter during diagnostic and therapeutic cardiac procedures and is comprised of four major components:
- Vdrive® Hardware - control box, adjustable arm, drive unit and support structure or Vdrive Duo™ (K133396) - with two adjustable arms
- Vdrive® User Interface – combination of software-driven (a) Tableside Controller and (b) dedicated Vdrive® Controller
- V-CAST™ Disposable Kit – Handle Clamps, Catheter Support Tube and Drape. These components are disposable, sterile, single use devices.
- V-Loop™ Disposable Kit (K140804)
- V-Sono™ Disposable Kit (K122659)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
Anatomical Site
Right atrium or left atrium
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Electrophysiologist
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data
Performance data establish the substantial equivalence of the Vdrive® with V-CAS™ compared to the predicate devices. Performance data included software verification and validation data, bench performance testing, animal testing, and reference to 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 Vdrive® with V-CAS™ to perform sheath and catheter movements according to product requirements, product usability and extremes of use. This study demonstrated that Vdrive™ with V-CAS™ met its performance and user requirements.
Clinical Testing: Stereotaxis performed a prospective, randomized multi-center clinical trial of the Vdrive® with V-Loop™ system compared to conventional manual methods of navigation in patients who underwent a pulmonary vein (PV) isolation procedure for treatment of atrial fibrillation (The VERSATILE Study, http://clinicaltrials.gov/show/NCT01656772). Out of the 120 enrolled subjects in this trial, investigators employed Vdrive Duo™ in 33 subjects, providing safety data on use of the combinations V-Loop™ + V-Sono™ (n=18) and V-Loop™ + V-CAS™ (n=15). V-Sono™ was used to control the Biosense Webster, Inc. Soundstar™ 3D Ultrasound Catheter; V-Loop™ was used to control the Lasso 2515 NAV Circular Mapping Catheter; and V-CAS™ was used to control compatible magnetic electrophysiology mapping and ablation catheters in conjunction with a Stereotaxis Magnetic Navigation System and the St. Jude Medical® Transseptal Sheath or the Swartz™ Braided Transseptal Sheath. Results of this study supported the safety and effectiveness of the Vdrive® system, including the use of Vdrive Duo™ with combinations of two disposables. Analysis of safety data showed that no adverse events related to the Vdrive® system occurred. Electrical PV isolation was achieved in 57/59 (96.6%) of targeted PVs using the ablation catheters controlled by the V-CAS™ disposable in the 15 subjects who underwent the ablation procedure using Vdrive Duo™ with V-CAS™.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Electrical PV isolation was achieved in 57/59 (96.6%) of targeted PVs.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K071029, K140804, K122659, K133396, K090365
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1290 Steerable catheter control system.
(a)
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.(b)
Classification. Class II (performance standards).
0
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 18, 2014
Stereotaxis. Inc. % Diana Horwitz, Ph.D., Rac Regulatory Consultant 2995 Steven Martin Dr, Fairfax, Virginia 22031
Re: K141530
Trade/Device Name: Vdrive, Vdrive with V-CAS, Vdrive Duo Regulation Number: 21 CFR 870.1290 Regulation Name: Steerable Catheter Control System Regulatory Class: Class II Product Code: DXX. DOX Dated: November 12, 2014 Received: November 12, 2014
Dear Diana Horwitz, Ph.D., Rac,
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
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,
Melissa A. Torres -S
For Bram 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) K141530
Device Name Vdrive® Vdrive® with V-CASTM Vdrive Duo™
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 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 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)
ال Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
3
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4
510(k) Summary per 21CFR §807.92
| Submitter's
information | Stereotaxis, Inc.
4320 Forest Park Ave, Suite 100
St. Louis, MO 63108
Contact: John Nadelin, VP Regulatory & Quality
Telephone: 314-678-6130 |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device/
classification
name | Device Name: Vdrive®, Vdrive® with V-CAST™, Vdrive Duo™
Classification/Common name: System, Catheter Control, Steerable
Classification Number: 870.1290
Product Code: DXX, DQX
Classification Panel: Cardiovascular
Predicate Devices:
• Cardiodrive® Catheter Advancement System, K071029 (Stereotaxis)
• Vdrive® with V-Loop™, K140804 (Stereotaxis)
• Vdrive® with V-Sono™, K122659 (Stereotaxis)
• Vdrive Duo™, K133396 (Stereotaxis)
• Artisan S Control Catheter, K090365 (Hansen Medical) |
| Device
description | Vdrive® with V-CAST™ is intended to control a compatible fixed curve transseptal
sheath and catheter during diagnostic and therapeutic cardiac procedures and is
comprised of four major components:
- Vdrive® Hardware - control box, adjustable arm, drive unit and support
structure or Vdrive Duo™ (K133396) - with two adjustable arms - Vdrive® User Interface – combination of software-driven
(a) Tableside Controller and (b) dedicated Vdrive® Controller - V-CAST™ Disposable Kit – Handle Clamps, Catheter Support Tube and
Drape. These components are disposable, sterile, single use devices. - V-Loop™ Disposable Kit (K140804)
- V-Sono™ Disposable Kit (K122659) |
| Intended 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® |
5
Image /page/5/Picture/1 description: The image is a 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" in a smaller font.
system, and
- Compatible fixed curve transseptal sheaths and catheters to facilitate movement of the sheath and catheter when used in conjunction with the V-CASTM 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, 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-CASTM 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.
6
Image /page/6/Picture/1 description: The image shows the Stereotaxis logo. 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.
Technological Characteristics
| Device
Character-
istic | Subject
Device
Vdrive® with
V-CASTM.
Vdrive Duo™M | Predicate 1
Cardiodrive®
(K071029) | Predicate 2
Vdrive® with
V-LoopTM
(K140804) | Predicate 3 & 4
Vdrive® with
V-Sono™
(K122659.
K133396) | Predicate 5
Artisan S
Control
Catheter
(K090365) |
|---------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------|---------------------------------------------------------------|---------------------------------------------------------------------|--------------------------------------------------------------|
| Location of
Catheter tip | Right atrium
or left atrium | Same | Same | Right atrium | Same |
| Initial
Placement of
catheter | Manual
placement by
electrophysiol
ogist under
fluoroscopy | Same | Same | Same | Same |
| Type of
Procedure | Diagnostic or
therapeutic EP
procedures | Same | Diagnostic EP
procedures | Cardiac imaging | Diagnostic
EP
procedures |
| Sheath
Movements | Remote
retraction and
advancement.
rotation | Does not
control sheath
(this is done
manually) | N/A
(no sheath) | N/A
(no sheath) | Remote
retraction,
advance-
ment, and
deflection |
| Catheter
Movements | Advance-
retract
Magnetic
steering | Same | Advance/
retract,
rotation,
deflection,
loop size | Advance/ retract,
rotation,
deflection | None.
Catheter is
captured by
sheath |
| Visualiza-tion
During
Procedure | Fluoroscopy,
standard of
care | Same | Same | Same | Same |
| Catheter Tip
Movement | Niobe
(magnetic
navigation) | Same | Vdrive
manipulation | Vdrive
manipulation | Articulating
sheath
moves
catheter tip |
| Single Use
Disposable | Sterile handle
clamp
Catheter
Support
Drape | Sterile Drive
unit
Bracket | Same | Same | Sheath
cassette
Irrigation
manifold
Drape |
Performance data
Performance data establish the substantial equivalence of the Vdrive® with V-CAS™ compared to the predicate devices. Performance data included software verification and validation data, bench performance testing, animal testing, and reference to 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.
7
Image /page/7/Picture/1 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."
Animal Testing: Stereotaxis performed an animal study in a porcine model to evaluate the safety and effectiveness of Vdrive® with V-CAS™ to perform sheath and catheter movements according to product requirements, product usability and extremes of use. This study demonstrated that Vdrive™ with V-CASTM met its performance and user requirements.
Clinical Testing: Stereotaxis performed a prospective, randomized multi-center clinical trial of the Vdrive® with V-Loop™ system compared to conventional manual methods of navigation in patients who underwent a pulmonary vein (PV) isolation procedure for treatment of atrial fibrillation (The VERSATILE Study, http://clinicaltrials.gov/show/NCT01656772). Out of the 120 enrolled subjects in this trial, investigators employed Vdrive Duo™ in 33 subjects, providing safety data on use of the combinations V-Loop™ + V-Sono™ (n=18) and V-Loop™ + V-CASTM (n=15). V-Sono™ was used to control the Biosense Webster, Inc. Soundstar™ 3D Ultrasound Catheter; V-Loop™ was used to control the Lasso 2515 NAV Circular Mapping Catheter; and V-CAS™ was used to control compatible magnetic electrophysiology mapping and ablation catheters in conjunction with a Stereotaxis Magnetic Navigation System and the St. Jude Medical® Transseptal Sheath or the Swartz™ Braided Transseptal Sheath. Results of this study supported the safety and effectiveness of the Vdrive® system, including the use of Vdrive Duo™ with combinations of two disposables. Analysis of safety data showed that no adverse events related to the Vdrive® system occurred. Electrical PV isolation was achieved in 57/59 (96.6%) of targeted PVs using the ablation catheters controlled by the V-CASTM disposable in the 15 subjects who underwent the ablation procedure using Vdrive Duo™ with V-CASTM.
Based upon the documentation presented in this 510(k) it has been demonstrated that the Vdrive® with V-CAS™ device is safe and effective for its intended use.
Date summary prepared: December 16, 2014