(135 days)
The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology [EP] mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System (MNS). It is not intended to advance the EP mapping and ablation catheters through the coronary vasculature nor the coronary sinus.
The Cardiodrive® provides a User Interface to control the motorized navigation of the catheter, in conjunction with the MNS magnetic fields. It is a tool that provides the physician with the ability to advance and retract magnetic EP catheters. The Cardiodrive® is designed only for use with compatible magnetic EP mapping catheters inside the patient's heart steered with a Stereotaxis MNS.
The Stereotaxis Cardiodrive® Catheter Advancement System (CAS) received 510(k) clearance (K071029) based on substantial equivalence to the previously marketed Cardiodrive® Catheter Advancement System. The device is intended for automatically advancing and retracting compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart in conjunction with a Stereotaxis Magnetic Navigation System (MNS).
Here's an analysis of the provided information:
1. Table of acceptance criteria and the reported device performance
The provided document does not explicitly state "acceptance criteria" in terms of specific performance metrics with numerical thresholds (e.g., accuracy > 90%). Instead, the substantial equivalence determination is based on the device having no modifications to its technological characteristics compared to the predicate device.
| Device Characteristic | Proposed Cardiodrive® CAS | Predicate Cardiodrive® CAS |
|---|---|---|
| Catheter Retraction/Advancement | Mechanical | Mechanical |
| Variable Speed | Yes | Yes |
| Catheter Movement | Stepped or Continuous | Stepped or Continuous |
| Emergency Stop Option | Mechanical or Manual | Mechanical or Manual |
| Manual Override | Yes | Yes |
| Stop Switch | Yes | Yes |
Reported Device Performance:
The document states: "Based upon the objective evidence presented in this 510(k) it has been demonstrated that any compatible magnetically tipped EP ablation catheter can be used safely and effectively when used with the Cardiodrive® CAS."
This statement serves as the overall conclusion of the device's performance, implying it meets the necessary safety and effectiveness standards, likely through the comparison of technological characteristics and potentially other non-clinical tests (though not detailed here) to demonstrate equivalence.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The provided documents do not mention any specific test set size, data provenance, or the nature of any clinical studies involving human subjects or real-world data. The clearance is based on technological equivalence.
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)
No information is provided regarding experts, ground truth establishment, or clinical performance studies typically requiring such elements. The submission primarily focuses on technical characteristics for substantial equivalence.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
No information is provided regarding adjudication methods, as there is no mention of a clinical test set requiring expert review.
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
No MRMC study was conducted or referenced. This device is a mechanical catheter advancement system, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to an algorithm's performance without human interaction. This is a medical device, a catheter advancement system, not a software algorithm. Therefore, "standalone" algorithm performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
No specific "ground truth" as typically defined for diagnostic or predictive algorithms is mentioned. The ground for clearance is based on the technological characteristics being substantially equivalent to a predicate device and a general demonstration of safe and effective use through objective evidence, which predominantly would be engineering tests and comparisons rather than clinical outcomes.
8. The sample size for the training set
No training set is mentioned or applicable, as this device is not an AI/ML model for which training data would be used.
9. How the ground truth for the training set was established
Not applicable, as there is no AI/ML model or training set.
§ 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.