(156 days)
No
The summary describes a robotic system for remotely controlling catheters. There is no mention of AI, ML, or any algorithms that would suggest autonomous decision-making, learning, or complex pattern recognition beyond basic remote control.
Yes
The device is described as "intended to stabilize, navigate and remotely control" compatible catheters used during electrophysiological and cardiac procedures, which implies direct interaction and control over medical instruments for therapeutic or diagnostic purposes. The clinical testing further supports its use in actual patient procedures.
No
The Vdrive™ system is described as a device intended to stabilize, navigate, and remotely control catheters for facilitating movement or visualization during electrophysiological or cardiac procedures. It mentions controlling the advancement, retraction, rotation, tip deflection, and loop size of mapping or ultrasound catheters. The primary function outlined is mechanical manipulation and control of other devices (catheters), rather than directly diagnosing. While it facilitates procedures that might lead to a diagnosis, it is not presented as a device that performs the diagnosis itself by analyzing data or producing a diagnostic output.
No
The device description explicitly lists "Vdrive™ Hardware - control box, adjustable arm, drive unit and support structure" as a major component, indicating it includes physical hardware beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Vdrive™ system is for stabilizing, navigating, and remotely controlling catheters during electrophysiological and cardiac procedures. This is a mechanical and control function performed in vivo (within the body), not in vitro (outside the body).
- Device Description: The device description details hardware components, a user interface, and disposable kits for controlling catheters. There is no mention of analyzing biological samples or performing tests on specimens outside the body, which are hallmarks of IVDs.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Reagents or assays
- Analysis of biological samples (blood, urine, tissue, etc.)
- Diagnostic testing or measurement of analytes
- Providing information for diagnosis, monitoring, or prognosis based on in vitro analysis.
The device is a tool for assisting in medical procedures performed directly on the patient, not for performing diagnostic tests on samples.
N/A
Intended Use / Indications for Use
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™).
Product codes
DXX, DOX, DQX
Device Description
The Vdrive™ with V-Loop™ is provides a remote method of controlling the advancement, retraction, rotation, tip deflection, and loop size of a LASSO® Circular Mapping catheter during electrophysiology 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 1) Tableside Controller and 2) dedicated Vdrive™ Controller,
- V-Loop™ Disposable Kit – Handle Clamps (w/catheter inserts), Telescoping Catheter Support and Drape. These components are disposable, sterile, single use devices, and
- V-Sono™ Disposable Kit (K122659) if Vdrive Duo™ will be used.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
left atrium, right atrium
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data:
software verification and validation data
bench performance testing to verify that specifications were met
animal testing
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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
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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) | ||
|---|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D)☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ||
| ☐ 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
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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, there is a tagline that reads "Improving Life with Robotic Precision and Safety."
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 Duo™
Classification/Common name: System, Catheter Control, Steerable
Classification Number: 870.1290
Product Code: DXX, DQX
Classification Panel: Cardiovascular
Currently Marketed Substantially Equivalent Device: Vdrive™ with V-Sono™ (K122659) | | |
| Device
description | The Vdrive™ with V-Loop™ is provides a remote method of controlling the
advancement, retraction, rotation, tip deflection, and loop size of a LASSO® Circular
Mapping catheter during electrophysiology 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 1) Tableside
Controller and 2) dedicated Vdrive™ Controller, - V-Loop™ Disposable Kit – Handle Clamps (w/catheter inserts),
Telescoping Catheter Support and Drape. These components are
disposable, sterile, single use devices, and - V-Sono™ Disposable Kit (K122659) if Vdrive Duo™ will be used. | | |
| Intended use | 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. | | |
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
Characteristic | Proposed
Vdrive™ with V-Loop™,
Vdrive Duo™ | Currently Marketed
Vdrive™ with V-Sono™ |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| Location of
Catheter tip | Right side of heart | Right or left side of heart |
| Initial Placement
of catheter | Manual placement by cardiac
electrophysiologist | Manual placement by cardiac
electrophysiologist |
| Catheter Movement | Mechanical | Mechanical |
| Variable Speed | Yes | Yes |
| Catheter Movement | Continuous | Continuous |
| Emergency Stop
Option | Manual | Manual |
| Manual Override | Yes | Yes |
| Single Use | Disposable is single use | Disposable is single use |
| Sterilization
Method | EtO | EtO |
| Control of catheter
movement | Mechanical | Mechanical |
| Compatible
Catheters | LASSO® 2515 Variable
Circular Mapping Catheter,
LASSO® 2515 NAV
LASSO ® 2515 ECO NAV
Variable Circular Mapping
Catheter (Biosense Webster) | Soundstar™ 3D Ultrasound
Catheters (Biosense Webster)
AcuNav™ Ultrasound
Catheters (AcuNav) |
| Catheter
movements | Advancement-retraction
Rotation
Tip deflection
Loop size | Advancement-retraction
Rotation
Anterior-posterior deflection |
Continued on next page
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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
Characteristic | Proposed
Vdrive™ with V-Loop™,
Vdrive Duo™ | Currently Marketed
Vdrive™ with V-Sono™ |
|---------------------------------------------------|--------------------------------------------------|--------------------------------------------|
| Control Room User
Interface | Yes | Yes |
| SW driven | Yes | Yes |
| Simultaneous Use
of two Vdrive™
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