(329 days)
Not Found
No
The summary describes a robotic system for controlling ICE catheters, focusing on mechanical manipulation and user interface. There is no mention of AI, ML, or image processing for analysis or decision-making.
No
The device is described as stabilizing, navigating, and controlling compatible intracardiac echocardiography (ICE) catheters for visualization, not actively treating a condition or disease.
No.
The Vdrive™ system is described as a device to stabilize, navigate, and control compatible intracardiac echocardiography (ICE) catheters for visualization of cardiac structures, not to diagnose conditions. It facilitates the use of diagnostic tools (ICE catheters) but is not itself a diagnostic device.
No
The device description explicitly lists "Vdrive™ Hardware - control box, adjustable arm, drive unit and support structure" as a major component, indicating it is not software-only.
Based on the provided information, the Vdrive™ System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Vdrive™ System Function: The Vdrive™ System is described as a device intended to stabilize, navigate, and control intracardiac echocardiography (ICE) catheters. It facilitates the visualization of cardiac structures during a procedure.
- No Specimen Analysis: The system does not analyze any biological specimens taken from the patient. Its function is entirely focused on manipulating a catheter within the body to acquire imaging data.
Therefore, the Vdrive™ System falls under the category of a medical device used for image acquisition and procedural assistance, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Vdrive™ System is intended to stabilize, navigate and control compatible intracardiac echocardiography (ICE) catheters to facilitate visualization of cardiac structures during the performance of cardiac procedures when used in conjunction with Stereotaxis compatible V-Sono™ disposable sets in the Vdrive™ system. 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.
Vdrive™ with V-Sono™ is indicated for remotely controlling the advancement, retraction. rotation and anterior-posterior deflection of compatible ultrasound catheters inserted into the right atrium.
Product codes
DQX, DXX
Device Description
The Vdrive™ with V-Sono™ is comprised of three major components,
- Vdrive™ Hardware - control box, adjustable arm, drive unit and support structure
- Vdrive™ User Interface - combination of software driven 1) Tableside Controller and 2) dedicated Vdrive™ Controller
- V-Sono™ Disposable Kit - Handle Clamps (w/catheter inserts), Telescoping Catheter Support and Drape. These components are disposable, sterile, single use devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Cardiac structures, 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
Clinical performance data from a related Vdrive™ system was submitted in support data of this application. A comparative preclinical study has been conducted in animals with manual versus Vdriv™e manipulation of an Intracardiac Echocardiography (ICE) catheter using the V-Sono™ disposable.
Performance testing for electrical safety, EMC compatibility, sterility, packaging, and verification and validation testing were presented.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
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 Affairs & Quality Systems
Phone: 314-678-6130 | | |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|--|
| Device/
classification
name | Device Name: | Vdrive™ with V-Sono™ | |
| | Classification/Common name: | Wire, Guide, Catheter | |
| | Classification Number: | 870.1330 | |
| | Product Code: | DQX | |
| | Classification Panel: | Cardiovascular | |
| | Currently Marketed Substantially
Equivalent Device: | Cardiodrive™ Advancement System
(K071029) | |
| Device
description | The Vdrive™ with V-Sono™ is comprised of three major components, | | |
| | 1. Vdrive™ Hardware - control box, adjustable arm, drive unit and support
structure | | |
| | 2. Vdrive™ User Interface - combination of software driven 1) Tableside
Controller and 2) dedicated Vdrive™ Controller | | |
| | 3. V-Sono™ Disposable Kit - Handle Clamps (w/catheter inserts),
Telescoping Catheter Support and Drape. These components are
disposable, sterile, single use devices. | | |
| Intended use | The Vdrive™ System is intended to stabilize, navigate and control compatible
intracardiac echocardiography (ICE) catheters to facilitate visualization of cardiac
structures during the performance of cardiac procedures when used in conjunction
with Stereotaxis compatible V-Sono™ disposable sets in the Vdrive™ system.
Compatible catheters at this time include Biosense Webster, Inc. Soundstart™ 3D
Ultrasound Catheters and Acuson AcuNav™ Ultrasound Catheters. Other models of
ICE catheters have not been tested with the Vdrive™ system. | | |
| | Vdrive™ with V-Sono™ is indicated for remotely controlling the advancement,
retraction, rotation and anterior-posterior deflection of compatible ultrasound
catheters inserted into the right atrium. | | |
Continued on next page
1
Appendix 1: 510(k) Summary per 21CFR §807.92, Continued
| Device
Characteristic | Proposed Vdrive™ with V-
Sono™ | Currently Marketed
Cardiodrive® CAS |
|-------------------------------------|---------------------------------------------------------------------------------------|--------------------------------------------------------|
| Location of
Catheter tip | Right side of heart | Right or left side of heart |
| Placement of
catheter | Manual placement by
surgeon | Manual placement by
surgeon |
| Catheter Retraction/
Advancement | Mechanical | Mechanical |
| Variable Speed | Yes | Yes |
| Catheter Movement | Continuous | Stepped or Continuous |
| Emergency Stop
Option | Manual | Manual |
| Manual Override | Yes | Yes |
| Single Use | Yes | Yes |
| Sterilization
Method | EtO | EtO |
| Control of catheter
movement | Mechanical | Mechanical (advance &
retract) and Magnetic (steer) |
| Compatible
Catheters | BWI Soundstar 3D
Ultrasound Catheters and
Acuson AcuNav Ultrasound
Catheters | BWI Magnetic EP Catheters |
| No: axes of
movement | 3 | 1 |
| Control Room User
Interface | Yes | Yes |
| SW driven | Yes | Yes |
Performance Clinical performance data from a related Vdrive™ system was submitted in support data of this application. A comparative preclinical study has been conducted in animals with manual versus Vdriv™e manipulation of an Intracardiac Echocardiography (ICE) catheter using the V-Sono™ disposable.
Performance testing for electrical safety, EMC compatibility, sterility, packaging, and verification and validation testing were presented.
Based upon the documentation presented in this 510(k) it has been demonstrated that the Vdrive™ with V-Sono™ device is safe and effective for its intended use.
Date summary prepared: July 25, 2013
Technological characteristics
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 26, 2013
Stereotaxis, Inc. c/o Diane Horwitz, Ph.D., RAC Regulatory Affairs Stereotaxis 4320 Forest Park Avenue, Suite 100 St. Louis, MO 63108
Re: K122659
Trade/Device Names: Vdrive with V-sono Regulatory Number: 21 CFR 870.1330 Regulation Name: Wires. Guide, Catheter Regulatory Class: Class II (Two) Product Code: DQX, DXX Dated: July 22, 2013 Received: July 22, 2013
Dear Dr. 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.
3
Page 2 - Diane Horwitz, Ph.D., RAC
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 801); medical device reporting (reporting of medical device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 vours.
M. A. Zillmann
for Bram D. Zuckerman Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number: K122659
Device Name: Vdrive™ with V-SonoTM
The Vdrive™ System is intended to stabilize, navigate and control compatible intracardiac echocardiography (ICE) catheters to facilitate visualization of cardiac structures during the performance of cardiac procedures when used in conjunction with Stereotaxis compatible V-Sono™ disposable sets in the Vdrive™ system. 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.
Vdrive™ with V-Sono™ is indicated for remotely controlling the advancement, retraction. rotation and anterior-posterior deflection of compatible ultrasound catheters inserted into the right atrium.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
M. Z. Hillerman