(128 days)
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:
- Vdrive® Hardware - control box, adjustable arm, drive unit and support structure or Vdrive Duo™ (K133396) - with two adjustable arms
- Vdrive® User Interface – combination of software-driven (a) Tableside Controller and (b) dedicated Vdrive® Controller
- V-Sono™ Disposable Kit – Handle Clamps, Catheter Support Tube and Drape. These components are disposable, sterile, single use devices (K122659), including Vmotion™ functionality
- V-Loop™ Disposable Kit (K140804)
- 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.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Motion Accuracy | Tested for sweep speed increment/decrement, sweep angle increment/decrement, movement to stored positions. |
| Motion Limits | Tested for deflect limit on sweep, rotation limit on sweep, and deflect limit on spotlight. |
| Motion Safety | Tested for user-controlled stop of automation, emergency stop of automation, and disallowing some combinations of automations. |
| Electrical Safety | Bench testing conducted. |
| EMC Compatibility | Bench testing conducted. |
| Sterilization | Testing conducted. |
| Shelf Life | Testing conducted. |
| Packaging | Testing conducted. |
| Safety and Effectiveness (for ICE catheter tip movements) | Demonstrated in animal study that Vdrive™ with V-Sono™ met its performance requirements. |
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.
§ 870.1290 Steerable catheter control system.
(a)
Identification. A steerable catheter control system is a device that is connected to the proximal end of a steerable guide wire that controls the motion of the steerable catheter.(b)
Classification. Class II (performance standards).