(195 days)
The MNS is intended to navigate a magnetic device through tissue to designated target sites in the right and left heart and coronary vasculature by orienting the device tip in a desired direction.
The Telstar™ Bi-plane Imaging System provides the utility of fluoroscopic imaging of vascular systems for applications including vascular angiography and electrophysiology (EP) studies. This x-ray system may be used stand-alone, or in conjunction with an associated Stereotaxis Magnetic Navigation System
The Niobe EP Catheter is intended for intracardiac electrophysiological recording and/or stimulation for pacing in the right heart.
The Telstar™ Magnetic Navigation System [MNS] is an interventional workstation for the intravascular navigation of a magnetic device through tissue to designated target sites in the heart and coronary vasculature. It combines a bi-planar fluoroscopy system with a computer controlled magnetic field generator, to provide both visualization and control of a magnetically actuated catheter. The system employs magnetic fields to orient the catheter.
The Telstar" 14 Bi-plane Imaging System [TIS] is a digital fluoroscopic system providing bi-plane fluoroscopic clinical images of both patients and medical devices during conventional and magnetic procedures.
The Niobe™ EP Catheter is a conventional 5-8F mapping catheter modified to accommodate magnetic actuation and control. It is designed to navigate into the right heart in order to measure and record electrical activity, and to pace the heart. A separate two-conductor junction box cord is supplied to allow electrical signals to be transmitted from the sterile catheter to a nonsterile signal recorder junction box.
Here's a breakdown of the acceptance criteria and the study details for the Telstar™ Magnetic Navigation System, Telstar™ Bi-plane Imaging System, and Niobe™ EP Catheter, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in a quantitative manner (e.g., "sensitivity must be >X%"). Instead, the primary acceptance criterion appears to be the successful navigation of the catheter to target sites and clinical acceptability of electrograms, demonstrating substantial equivalence to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Magnetic Navigation System (MNS) & Niobe EP Catheter: | |
| Ability to steer and reach designated target sites | Successful navigation of the catheter was achieved to 198 of 200 designated targets (99%) in the 20 patients. The Niobe EP Catheter's ability to steer to target sites was equivalent to the predicate Steerocath in preclinical animal studies. |
| Clinically acceptable electrophysiological recording/pacing | Niobe EP Catheter recorded clinically acceptable, comparable, intracardiac electrograms at each site, equivalent to the predicate Steerocath in preclinical animal studies. The clinical study also confirmed safety and effectiveness. |
| Telstar™ Bi-plane Imaging System (TIS): | |
| Compliance with fluoroscopic equipment requirements | The Bi-plane X-ray System is designed and tested in compliance with the requirements of 21 CFR §1020.32 (Fluoroscopic Equipment). This implies it met the safety and performance standards for fluoroscopic imaging. |
| Niobe™ EP Catheter (Physical & Biocompatibility): | |
| Compliance with Electrode Recording Catheter Guidance | Testing of the EP Catheter was performed in accordance with the FDA "Electrode Recording Catheter Preliminary Guidance" (March, 1995). The catheter met or exceeded all requirements for biocompatibility and physical characteristics. This implies it passed all specified physical integrity and biocompatibility tests outlined in the guidance. |
| Overall Safety and Effectiveness (all components) | Demonstrated to be substantially equivalent to their respective predicate devices. Clinical evaluation confirmed safety and effectiveness. |
2. Sample Size and Data Provenance for the Test Set
- Sample Size: 20 patients in the clinical study.
- Data Provenance: Single site, retrospective/prospective is not explicitly stated, but clinical evaluation often implies prospective data collection. The country of origin is not specified but is implicitly the US given the submission to the FDA.
- An additional preclinical animal study was conducted using canine hearts.
3. Number of Experts and Qualifications for Ground Truth - Test Set
The document does not explicitly state the number or qualifications of experts used to establish ground truth for the 20-patient clinical test set. However, a "clinical evaluation" implies that the assessment of "successful navigation" and "clinically acceptable" electrograms would have been made by qualified medical professionals (e.g., electrophysiologists, cardiologists) involved in the study.
For the preclinical animal study, the assessment of "clinically acceptable, comparable, intracardiac electrograms" would also have been made by experts, likely veterinary cardiologists or researchers with electrophysiology expertise, although not explicitly detailed.
4. Adjudication Method for the Test Set
The document does not specify any formal adjudication method (e.g., 2+1, 3+1). The "clinical evaluation" suggests direct assessment by the treating/researching physicians.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The study assessed the device's performance in navigating and recording electrograms. It did not directly compare human readers with and without AI assistance for interpretation.
6. Standalone Performance (Algorithm Only)
The device is an interventional system with a human-in-the-loop (physician controlling the navigation). Therefore, a standalone (algorithm only) performance study in the context of interpretation or diagnosis is not applicable. The device's "performance" is in its ability to facilitate catheter navigation and data acquisition under physician control.
7. Type of Ground Truth Used
- Clinical Study: The ground truth for successful navigation and clinically acceptable electrograms was established by the performing clinicians based on direct observation during the procedure (e.g., fluoroscopic visualization) and analysis of the recorded electrograms. This is a form of expert assessment/clinical outcome.
- Preclinical Animal Study: Similar to the clinical study, ground truth for steering ability and electrogram quality was established by expert assessment in the animal model.
- Physical Testing: Ground truth was based on pre-defined specifications and guidance documents (e.g., FDA "Electrode Recording Catheter Preliminary Guidance" and 21 CFR §1020.32 for fluoroscopic equipment).
8. Sample Size for the Training Set
The document does not mention a separate "training set" in the context of machine learning or AI models. This device is a magnetic navigation system, not an AI-driven diagnostic or image analysis tool that typically requires large training datasets. The "training" for the device would have been its design, engineering, and iterative development leading to the final product.
9. How Ground Truth for the Training Set Was Established
As no specific "training set" for an AI model is mentioned or applicable to this device type, this question is not relevant. The device development would have involved engineering specifications, bench testing, and design verification/validation against intended performance characteristics.
§ 870.1220 Electrode recording catheter or electrode recording probe.
(a)
Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.(b)
Classification. Class II (performance standards).