(92 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 (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.
The provided text describes a 510(k) summary for the Vdrive™ with V-Sono™ device. This document focuses on demonstrating substantial equivalence to a predicate device and includes performance data related to electrical safety, EMC compatibility, and software verification and validation. However, it does not contain specific acceptance criteria or a study detailing device performance against such criteria in the manner requested for AI/diagnostic devices.
Based on the provided text, here's what can be answered:
1. A table of acceptance criteria and the reported device performance
The provided document describes the device as being substantially equivalent to a predicate device (Vdrive™ with V-Sono™ K122659). The "Performance data" section states: "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."
This indicates that the acceptance criteria are implicitly tied to meeting the design input requirements and demonstrating safety and effectiveness comparable to the predicate device through:
- Electrical safety performance
- EMC compatibility performance
- Software verification and validation performance
The document does not provide specific quantitative acceptance criteria (e.g., specific thresholds for electrical leakage or EMC emissions) or detailed performance results (e.g., measured values) for these tests. It only states that these tests were "performed" and that the device was deemed "safe and effective for its intended use" based on the documentation.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Electrical Safety | Performed (met requirements) |
| EMC Compatibility | Performed (met requirements) |
| Software V&V | Performed (met requirements) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. The document does not describe a test set or data provenance in the context of a clinical performance study using patient data. It refers to "performance testing for electrical safety, EMC compatibility and software verification and validation," which are engineering and software testing activities, not clinical trials with patient samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. As noted above, this document describes engineering and software testing, not a clinical study involving expert interpretation of medical data to establish ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. There is no mention of a test set requiring adjudication in the context of clinical performance.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a mechanical system for controlling intracardiac echocardiography catheters, not an AI or diagnostic imaging device that would typically undergo an MRMC study related to human reader performance with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm. Its performance is inherent in its mechanical and software functions to control the catheter.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The performance testing mentioned (electrical safety, EMC, software V&V) uses engineering standards and software validation methods as their "ground truth," rather than clinical ground truth like pathology or expert consensus.
8. The sample size for the training set
Not applicable. This is not an AI device that would have a training set.
9. How the ground truth for the training set was established
Not applicable. As this is not an AI device, there is no training set or associated ground truth.
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FEB - 6 2014
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:Classification/Common name:Classification Number:Product Code:Classification Panel:Currently Marketed SubstantiallyEquivalent Device: | Vdrive™ with V-Sono™Wire, Guide, Catheter870.1330DQXCardiovascularVdrive™ with V-Sono™ (K122659) |
| Devicedescription | The Vdrive™ with V-Sono™ is comprised of three major components,1. Vdrive™ Hardware - control box, adjustable arm, drive unit and support structure2. Vdrive™ User Interface - combination of software driven (a) Tableside Controller and (b) dedicated Vdrive™ Controller3. 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
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Appendix 1: 510(k) Summary per 21CFR §807.92, Continued
Technological characteristics
| DeviceCharacteristic | Proposed Vdrive™ withV-Sono™ | Vdrive™ with V-Sono™(K122659) |
|---|---|---|
| Location ofCatheter tip | Right side of heart | Right side of heart |
| Placement ofcatheter | Manual placement bysurgeon | Manual placement bysurgeon |
| Catheter Retraction/Advancement | Mechanical | Mechanical |
| Variable Speed | Yes | Yes |
| Catheter Movement | Continuous | Continuous |
| Emergency StopOption | Manual | Manual |
| Manual Override | Yes | Yes |
| Single Use | Yes | Yes |
| SterilizationMethod | EtO | EtO |
| Control of cathetermovement | Mechanical | Mechanical |
| CompatibleCatheters | BWI Soundstar 3DUltrasound Catheters andAcuson AcuNav UltrasoundCatheters | BWI Soundstar 3DUltrasound Catheters andAcuson AcuNav UltrasoundCatheters |
| No. axes ofmovement | 3 | 3 |
| Control Room UserInterface | 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
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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
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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
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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)
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Digitally signed by Owen P. Farls -S Date: 2014.02.06 15:21:02
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§ 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.