(329 days)
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.
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.
This 510(k) summary describes a medical device, the Vdrive™ with V-Sono™, which is a system intended to stabilize, navigate, and control compatible intracardiac echocardiography (ICE) catheters during cardiac procedures.
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific quantifiable acceptance criteria for the device's performance nor does it report detailed performance metrics against such criteria in a table format.
Instead, it indicates that the device's performance was evaluated through:
- Comparative preclinical study: Conducted in animals with manual versus Vdrive™ manipulation of an ICE catheter using the V-Sono™ disposable.
- Performance testing for electrical safety, EMC compatibility, sterility, packaging, and verification and validation testing.
The conclusion drawn is: "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." This is an overall statement of efficacy and safety rather than a report against specific, numerical acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document mentions a "comparative preclinical study ... in animals." However, the exact number of animals (sample size) used in this preclinical study is not specified.
- Data Provenance: The study was a "preclinical study ... in animals." This suggests the data is preclinical/animal data, not human clinical data. The country of origin is not specified. It can be assumed to be prospective as it's a study designed to evaluate the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. As it was an animal preclinical study, "ground truth" might refer to direct observation, imaging, or post-mortem analysis by veterinary or lab experts, but no details are given.
4. Adjudication Method for the Test Set
This information is not provided.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not explicitly mentioned or described. The study mentioned is a "comparative preclinical study in animals with manual versus Vdriv™e manipulation of an Intracardiac Echocardiography (ICE) catheter." This is a comparison between two methods of catheter manipulation, but not a human reader study evaluating improved performance with AI assistance.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
The Vdrive™ with V-Sono™ is a system that physically manipulates catheters and has a user interface. It is described as remotely controlling catheter advancement, retraction, rotation, and deflection. Therefore, it inherently involves human interaction for operation and is not a standalone algorithm in the sense of an AI-only diagnostic tool. Its performance is tied to its mechanical and software functions under human control.
7. Type of Ground Truth Used
For the "comparative preclinical study in animals," the "ground truth" would likely be established through:
- Direct observation of catheter manipulation and visualization of cardiac structures.
- Imaging (e.g., the ICE images themselves, or other imaging modalities used to confirm catheter position/movement).
- Potentially pathological examination or other scientific methods to assess any adverse effects or successful manipulation in the animal models.
The document does not detail this, but the context of a preclinical animal study suggests these types of 'ground truth' would be relevant.
8. Sample Size for the Training Set
The document does not mention a training set sample size. This device is primarily a mechanical and software-controlled system, not an AI/machine learning device that typically requires extensive training data for its core function of catheter manipulation. The "software driven" user interface would involve verification and validation testing, but not a "training set" in the common AI sense.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned in the context of AI/machine learning, this information is not applicable/provided. The "ground truth" for the device's functional and safety testing would be based on engineering specifications, regulatory standards, and established medical principles.
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510(k) Summary per 21CFR §807.92
... '
| Submitter'sinformation | Stereotaxis, Inc.4320 Forest Park Ave, Suite 100St. Louis, MO 63108Contact: John Nadelin, VP Regulatory Affairs & Quality SystemsPhone: 314-678-6130 | ||
|---|---|---|---|
| Device/classificationname | Device Name: | Vdrive™ with V-Sono™ | |
| Classification/Common name: | Wire, Guide, Catheter | ||
| Classification Number: | 870.1330 | ||
| Product Code: | DQX | ||
| Classification Panel: | Cardiovascular | ||
| Currently Marketed SubstantiallyEquivalent Device: | Cardiodrive™ Advancement System(K071029) | ||
| Devicedescription | The Vdrive™ with V-Sono™ is comprised of three major components, | ||
| 1. Vdrive™ Hardware - control box, adjustable arm, drive unit and supportstructure | |||
| 2. Vdrive™ User Interface - combination of software driven 1) TablesideController and 2) dedicated Vdrive™ Controller | |||
| 3. V-Sono™ Disposable Kit - Handle Clamps (w/catheter inserts),Telescoping Catheter Support and Drape. These components aredisposable, sterile, single use devices. | |||
| Intended use | The Vdrive™ System is intended to stabilize, navigate and control compatibleintracardiac echocardiography (ICE) catheters to facilitate visualization of cardiacstructures during the performance of cardiac procedures when used in conjunctionwith Stereotaxis compatible V-Sono™ disposable sets in the Vdrive™ system.Compatible catheters at this time include Biosense Webster, Inc. Soundstart™ 3DUltrasound Catheters and Acuson AcuNav™ Ultrasound Catheters. Other models ofICE 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 ultrasoundcatheters inserted into the right atrium. |
Continued on next page
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Appendix 1: 510(k) Summary per 21CFR §807.92, Continued
| DeviceCharacteristic | Proposed Vdrive™ with V-Sono™ | Currently MarketedCardiodrive® CAS |
|---|---|---|
| Location ofCatheter tip | Right side of heart | Right or left side of heart |
| Placement ofcatheter | Manual placement bysurgeon | Manual placement bysurgeon |
| Catheter Retraction/Advancement | Mechanical | Mechanical |
| Variable Speed | Yes | Yes |
| Catheter Movement | Continuous | Stepped or Continuous |
| Emergency StopOption | Manual | Manual |
| Manual Override | Yes | Yes |
| Single Use | Yes | Yes |
| SterilizationMethod | EtO | EtO |
| Control of cathetermovement | Mechanical | Mechanical (advance &retract) and Magnetic (steer) |
| CompatibleCatheters | BWI Soundstar 3DUltrasound Catheters andAcuson AcuNav UltrasoundCatheters | BWI Magnetic EP Catheters |
| No: axes ofmovement | 3 | 1 |
| Control Room UserInterface | 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
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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.
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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
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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
§ 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.