(92 days)
Not Found
No
The summary describes a robotic system for controlling ICE catheters, focusing on mechanical and software control of movement. There is no mention of AI, ML, or image processing for analysis or decision-making.
No.
The Vdrive™ System is designed to stabilize, navigate, and control compatible intracardiac echocardiography (ICE) catheters for visualization of cardiac structures, not for directly treating a disease or condition. It is a control system for diagnostic tools rather than a therapeutic intervention itself.
No
The Vdrive™ System is described as a device to stabilize, navigate, and control compatible intracardiac echocardiography (ICE) catheters to facilitate visualization of cardiac structures. It is not described as performing diagnostic analysis or interpretation on its own.
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.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Vdrive™ System Function: The Vdrive™ System is a medical device designed to control and navigate an intracardiac echocardiography (ICE) catheter. The ICE catheter itself is used to visualize cardiac structures inside the body.
- Intended Use: The intended use clearly states that the system is for "stabilize, navigate and control compatible intracardiac echocardiography (ICE) catheters to facilitate visualization of cardiac structures during the performance of cardiac procedures". This is a procedural control and visualization tool, not a diagnostic test performed on a sample outside the body.
The Vdrive™ System is a medical device used in conjunction with an imaging modality (ICE) to assist in medical procedures. It does not perform a diagnostic test on a biological sample.
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 (comma separated list FDA assigned to the subject device)
DQX
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 (a) Tableside Controller and (b) 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
Not Found
Anatomical Site
Right side of heart, 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)
Changes were made under Design Controls to ensure that the modified device is as safe and effective as the predicate device and that the design outputs of the modified device meet the design input requirements. Performance testing for electrical safety, EMC compatibility and software verification and validation testing were performed.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
§ 870.1330 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
FEB - 6 2014
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:
Classification/Common name:
Classification Number:
Product Code:
Classification Panel:
Currently Marketed Substantially
Equivalent Device: | Vdrive™ with V-Sono™
Wire, Guide, Catheter
870.1330
DQX
Cardiovascular
Vdrive™ with V-Sono™ (K122659) |
| 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 (a) Tableside Controller and (b) 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. | |
| 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. 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. | |
Continued on next page
1
Appendix 1: 510(k) Summary per 21CFR §807.92, Continued
Technological characteristics
| Device
Characteristic | Proposed Vdrive™ with
V-Sono™ | Vdrive™ with V-Sono™
(K122659) |
|-------------------------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Location of
Catheter tip | Right side of heart | Right 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 | Continuous |
| Emergency Stop
Option | Manual | Manual |
| Manual Override | Yes | Yes |
| Single Use | Yes | Yes |
| Sterilization
Method | EtO | EtO |
| Control of catheter
movement | Mechanical | Mechanical |
| Compatible
Catheters | BWI Soundstar 3D
Ultrasound Catheters and
Acuson AcuNav Ultrasound
Catheters | BWI Soundstar 3D
Ultrasound Catheters and
Acuson AcuNav Ultrasound
Catheters |
| No. axes of
movement | 3 | 3 |
| Control Room User
Interface | Yes | Yes |
| SW driven | Yes | Yes |
Performance data
Changes were made under Design Controls to ensure that the modified device is as safe and effective as the predicate device and that the design outputs of the modified device meet the design input requirements. Performance testing for electrical safety, EMC compatibility and software verification and validation testing were performed.
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: October 31, 2013
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image contains the words "Public Health Service" in a bold, sans-serif font. The text is arranged in a single line, with each word clearly legible. The background of the image is plain white.
February 6, 2014
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Stereotaxis, Inc. C/O Diane Horwitz, Ph.D. Senior Regulatory Advisor 4320 Forest Park Avenue, Suite 100 St. Louis, MO 63108
Re: K133396
Trade/Device Name: Vdrive™ with V-Sono™ Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: January 8, 2014 Received: January 8, 2014
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.
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
3
Page 2 - Dr. Diane Horwitz
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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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Owen P. Faris -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number: K133396
Device Name: Vdrive™ with V-Sono™
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 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.
AND/OR Prescription Use _ X __ (Part 2) 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)
Di
P.
Da
-0
Digitally signed by Owen P. Farls -S Date: 2014.02.06 15:21:02
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