(156 days)
The Vdrive™ system is intended to stabilize, navigate and remotely control:
• 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.
• 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.
The Vdrive™ with V-Loop™ disposable is indicated to remotely control the advancement, retraction, rotation, 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-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 Duo™ is an optional accessory intended for remotely controlling the Vdrive™ system when one arm of the device is equipped with a V-Loop™ disposable set and the other arm is equipped with the V-Sono™ disposable set. During the procedure, the Vdrive Duo™ allows selection between the disposable sets (V-Loop™ or V-Sono™).
The Vdrive™ with V-Loop™ is provides a remote method of controlling the advancement, retraction, rotation, tip deflection, and loop size of a LASSO® Circular Mapping catheter during electrophysiology 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 1) Tableside Controller and 2) dedicated Vdrive™ Controller,
- V-Loop™ Disposable Kit – Handle Clamps (w/catheter inserts), Telescoping Catheter Support and Drape. These components are disposable, sterile, single use devices, and
- V-Sono™ Disposable Kit (K122659) if Vdrive Duo™ will be used.
The STERETAXIS Vdrive™ with V-Loop™ and Vdrive Duo™ system is a catheter control system designed to stabilize, navigate, and remotely control compatible loop mapping catheters and Intracardiac Echocardiography (ICE) catheters during electrophysiological and cardiac procedures, respectively. The following information details the acceptance criteria and the study proving the device meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state quantitative acceptance criteria in a table format. However, based on the performance data section, the implicit acceptance criteria are:
| Acceptance Criteria Category | Implicit Acceptance Criteria | Reported Device Performance/Conclusion |
|---|---|---|
| Software Verification & Validation | Software functions as intended and meets specifications. | Performance data includes "software verification and validation data." While specific metrics are not detailed, the overall conclusion is that this data contributed to establishing substantial equivalence. |
| Bench Performance Testing | Device meets all specified bench performance requirements (e.g., control of advancement, retraction, rotation, tip deflection, loop size, variable speed, continuous movement, emergency stop). | Performance data includes "bench performance testing to verify that specifications were met." No specific quantitative results are provided for individual functions, but the overall statement implies successful fulfillment of these technical specifications. |
| Electrical Safety | Device is electrically safe. | "Performance testing was conducted for electrical safety." (Implied successful) |
| EMC Compatibility | Device is electromagnetically compatible. | "Performance testing was conducted for...EMC compatibility." (Implied successful) |
| Sterilization & Shelf Life | Disposable components can be effectively sterilized and maintain sterility over their shelf life, and packaging is adequate. | "Performance testing was conducted for...sterilization and shelf life and packaging." (Implied successful) |
| Animal Testing (Safety & Effectiveness) | Device safely and effectively performs navigation, electrogram generation, mapping, and pacing during navigation; meets product usability and extremes of use requirements in an animal model. | "This study demonstrated that Vdrive™ with V-Loop™ met its performance and user requirements." |
| Clinical Efficacy (Non-Inferiority to Manual Navigation) | Vdrive™ with V-Loop™ system is non-inferior to conventional manual methods for navigation of circular mapping (loop) catheters in terms of efficacy. | "Results of the efficacy analysis demonstrated that the Stereotaxis Vdrive™ with V-Loop™ is effective when used to control a circular mapping system catheter when compared to manual navigation; the Vdrive™ with V-Loop™ is non-inferior to the manual procedure." Specific metrics for non-inferiority are not provided in this summary, but the conclusion states it was met. |
| Clinical Safety | The device does not introduce an unacceptable rate or type of adverse events compared to manual methods. | "The safety analysis led to the conclusion that similar adverse events between groups, and that the low rate of adverse events was unrelated to use of the Vdrive™ system." |
| Vdrive Duo™ Performance | Vdrive Duo™ effectively controls two different disposables (V-Loop™ and V-Sono™). | "Vdrive Duo™ was used to control two different disposables in a total of 33 subjects in the VERSATILE trial." (Implied successful, as it contributes to the overall safety and effectiveness conclusion). |
2. Sample Size Used for the Test Set and Data Provenance
The primary clinical study supporting efficacy and safety was a prospective, randomized multi-center clinical trial.
- Sample Size: A total of 137 subjects were randomized.
- Vdrive Group: 77 subjects
- Control (Manual) Group: 43 subjects
- (Note: The total of 77 + 43 = 120 subjects is less than the stated 137 randomized subjects. This may indicate some exclusions post-randomization or that 137 was the total randomized and 120 subjects actually underwent the procedure for data collection).
- Vdrive Duo™ specific performance: 33 subjects used Vdrive Duo™ in the VERSATILE trial.
- Data Provenance:
- Country of Origin: Not explicitly stated, but given the FDA review and the company being based in St. Louis, MO, USA, it is highly likely the clinical sites were in the United States.
- Retrospective or Prospective: Prospective. The study is described as a "prospective, randomized multi-center clinical trial."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not describe the establishment of a "ground truth" in the typical sense of expert annotation for an AI device. This is a medical device for catheter control, and the "ground truth" for its performance would be the clinical outcomes and procedural success, evaluated by the participating physicians.
- The study was a randomized clinical trial comparing the device to manual navigation. The clinical outcomes (e.g., efficacy of PV isolation, safety profile) were the direct measures of performance, as assessed by the clinical trial investigators.
- The qualifications of the experts (physicians) performing the procedures and assessing outcomes are implicitly assumed to be board-certified electrophysiologists, as they are conducting complex EP studies and ablation procedures. However, their specific qualifications (e.g., years of experience) are not detailed in this summary.
4. Adjudication Method for the Test Set
The document does not describe an explicit "adjudication method" for the clinical trial data in the way one might for image interpretation studies (e.g., 2+1, 3+1). Clinical trial data for efficacy and safety would typically be collected and analyzed according to a predefined statistical analysis plan, with internal and external monitoring to ensure data integrity. Adverse events would be reported and reviewed by the investigators and potentially an independent Data Safety Monitoring Board (DSMB), but this is not typically referred to as "adjudication" in the same context as ground truth establishment for AI.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not conducted in the context of human readers improving with AI assistance. The study was a clinical trial comparing a device-assisted procedure (Vdrive™ with V-Loop™) directly against a manual procedure, not an evaluation of how AI assistance impacts human interpretation. Therefore, there is no mention of an effect size for human readers improving with AI vs. without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, this is a robotic catheter control system, not an AI algorithm for diagnostic interpretation. The device's function is to assist in real-time catheter manipulation. Therefore, a "standalone algorithm only" performance evaluation is not relevant or applicable for this type of medical device. The device's performance is inherently tied to its use by a human operator in a procedural context.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance was established through:
- Clinical Outcomes/Procedural Success: In the randomized clinical trial, the effectiveness was measured by the ability to achieve the procedural goal (e.g., PV isolation where a circular mapping catheter is used to evaluate PVs), with non-inferiority to the manual method as the success criterion.
- Safety Profile: Comparison of adverse events between the device and control groups.
- Performance Requirements: Meeting specific technical "performance and user requirements" evaluated in bench and animal testing.
It is a performance-based ground truth, not an "expert consensus," "pathology," or "outcomes data" in the typical AI diagnostic context, but rather a direct assessment of the device's ability to perform its intended function safely and effectively in a clinical setting compared to standard of care.
8. The Sample Size for the Training Set
This document describes a premarket notification (510(k)) for a medical device that is not an AI/ML-driven diagnostic or therapeutic algorithm that relies on a "training set" of data for its core function. The device is a robotic control system. Therefore, the concept of a "training set" as it applies to machine learning models is not relevant here, and no such sample size is reported.
The "training" for this device would refer to the developmental and testing phases, including bench testing, animal studies, and the clinical trial, which validate its mechanical and software functions as designed.
9. How the Ground Truth for the Training Set Was Established
As explained in point 8, the concept of a "training set" and its "ground truth" in the context of machine learning does not apply to this robotic catheter control system as described in the provided document. The device's functionality is based on engineering principles and validated through a traditional medical device development pathway (bench, animal, and human clinical studies) rather than a data-driven model learning from a labeled training set.
§ 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).