Search Results

The Vdrive® system is intended to stabilize, navigate and remotely control:

· 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,

· 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, and

· Compatible fixed curve transseptal sheaths and catheters to facilitate movement of the sheath and catheter when used in conjunction with the V-CAS™ disposable sets in the Vdrive® system and with the Niobe® Magnetic Navigation System (MNS).

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® with V-Loop™ disposable is indicated to remotely control the advancement, retraction, 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-CAS™ disposable is indicated for remotely controlling the advancement, retraction, and rotation of compatible fixed curve transseptal sheaths, and the advancement and retraction of compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System. Compatible fixed curve sheaths at this time include the St. Jude Medical® Transseptal Sheath and Swartz™ Braided Transseptal Sheath. Other models of transseptal sheaths and mapping/ablation catheters have not been tested with the Vdrive® system. Vdrive® with V-CAS™ is contraindicated for vascular access sites other than the groin. It is not intended to advance the EP mapping and ablation catheters through the coronary vasculature nor the coronary sinus. The transseptal sheath is not to be moved while the EP catheter is actively delivering therapy.

The Vdrive Duo™ is an optional accessory intended for remotely controlling the Vdrive® system when one arm of the device is equipped with one disposable set (V-Sono™, V-Loop™ or V-CAS™) and the other arm is equipped with a different available disposable set. During the procedure, the Vdrive Duo™ allows selection between the disposable sets.

Vdrive® with V-Sono™ is intended to control a compatible Intracardiac Echocardiography (ICE) catheter during and therapeutic cardiac procedures and is comprised of four major components:

1. Vdrive® Hardware - control box, adjustable arm, drive unit and support structure or Vdrive Duo™ (K133396) - with two adjustable arms
2. Vdrive® User Interface – combination of software-driven (a) Tableside Controller and (b) dedicated Vdrive® Controller
3. V-Sono™ Disposable Kit – Handle Clamps, Catheter Support Tube and Drape. These components are disposable, sterile, single use devices (K122659), including Vmotion™ functionality
4. V-Loop™ Disposable Kit (K140804)
5. V-CAS™ Disposable Kit (K141530)

The provided text describes the Stereotaxis Vdrive, Vdrive With V-sono (Vmotion), and Vdrive Duo system. Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance results in a quantitative manner. Instead, it describes general performance tests and states that the device "met its performance requirements" without providing specific metrics or thresholds.

2. Sample Size Used for the Test Set and Data Provenance

• Animal Testing (for safety and effectiveness): The document states "an animal study in a porcine model." It does not specify the exact number of animals (sample size).
• Bench Testing: No specific sample sizes for bench tests are provided.
• Data Provenance: The animal study was conducted in a porcine model, indicating an animal study rather than human clinical data. The document implies these were prospective tests (bench and animal) conducted as part of the device's development and submission. No country of origin for the data is explicitly mentioned beyond the submitter's location (St. Louis, MO, USA).

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. The animal study evaluated the device's ability to perform movements, but it doesn't mention expert assessment of a "ground truth" in the way one might for diagnostic accuracy. The "ground truth" for the animal study appears to be the successful execution of programmed movements as per product requirements.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the tests (bench and animal), a clinical adjudication method in the traditional sense is unlikely to apply.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned in this document.
• The study described is an animal study and bench testing, focusing on the device's functional performance, not human reader performance with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance Study

• The document describes the device, including its "Vmotion control mode," which provides automated features like Spotlight, Sweep, and Stored Positions. These features imply an algorithm guiding the catheter movements.
• The "Performance data establish the substantial equivalence of the Vdrive® with Performance data V-Sono™, including software verification and validation data, bench performance testing and animal testing." The bench testing specifically included "software-controlled movements (Spotlight, Stored Position, and Sweep), which included testing for motion accuracy... motion limits... and motion safety..."
• This indicates that the performance of these automated/software-controlled movements (the "algorithm") was tested in a standalone manner (bench tests and animal study) to ensure they met specifications.

7. Type of Ground Truth Used

• For the bench testing, the ground truth appears to be the device's design specifications and predetermined performance requirements (e.g., specific sweep speeds, angles, limits, and safety stops).
• For the animal study, the ground truth was the device's ability to "perform movements of the ICE catheter tip according to product requirements," which aligns with predefined performance criteria and expected functional outcomes in a biological setting.

8. Sample Size for the Training Set

This information is not provided. The document describes a device with automated functions, but it does not detail any machine learning or AI models that would typically require a training set. The "Vmotion" features are described as "software-controlled movements," implying programmed logic rather than a trained AI model in the modern sense.

9. How the Ground Truth for the Training Set Was Established

Since there is no mention of a "training set" or a machine learning model requiring one, this information is not applicable/provided.

Ask a specific question about this device

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,

1. Vdrive™ Hardware - control box, adjustable arm, drive unit and support structure

2. Vdrive™ User Interface - combination of software driven (a) Tableside Controller and (b) 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.

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.

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.

Ask a specific question about this device