(58 days)
The NAVISTAR™ RMT Steerable Tip Diagnostic Catheter and related accessory devices are indicated for catheter-based atrial and ventricular electrophysiological mapping in adults and children four (4) years of age and older. This catheter is only compatible with the Stereotaxis Magnetic Navigation Systems (MNS).
When used with the CARTO™ RMT EP Navigation System, the NAVISTAR™ RMT Steerable Tip Diagnostic Catheter provides location information.
The NaviStar RMT Steerable Tip Diagnostic Catheter, is a 7 Fr 4mm, magnetically deflectable diagnostic catheter used in the magnetic field for catheter-based atrial and ventricular electrophysiological mapping in adults and children four (4) years of age and older.
The NAVISTAR™ RMT Steerable Tip Diagnostic Catheter is a 7 Fr 4mm, magnetically steerable diagnostic catheter. The catheter contains a location sensor, that, when used together with the CARTO RMT system, provides location information to construct a 3D electroanatomical maps of the human heart in real-time. The catheter has a high-torque shaft with a deflectable tip section containing an array of platinum irridium electrodes that can be used for stimulation and recording. The tip can be deflected in multiple planes.
The provided text describes a medical device, the NaviStar RMT Steerable Tip Diagnostic Catheter, and its clearance process (K052083) based on substantial equivalence to a predicate device (K954390). However, it does not contain detailed acceptance criteria, specific reported device performance metrics beyond general compliance, or information about a study designed to prove the device meets acceptance criteria in the manner typically seen for new, innovative devices requiring extensive clinical trials. Instead, the clearance is based on similarity to an existing device.
Therefore, the requested information cannot be fully extracted as structured in your request. I will articulate what is available from the text and note what is missing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (K954390) | "The Biosense Webster, Inc. NaviStar™ RMT 7Fr. 4mm Steerable Tip Diagnostic Catheter is substantially equivalent to the Biosense Webster NaviStar Diagnostic Catheter. (cleared under K954390). The indication for use is identical for both devices. The catheters meet the same design requirements and have similar technological characteristics. Bench and animal testing demonstrates that the devices are functionally equivalent." |
| Compliance with External Electrical and Performance Standards | "The NAVISTAR™ RMT Steerable Tip Diagnostic Catheter was tested under simulated use conditions, and complies with multiple external electrical and performance standards." |
| Indication for Use: Catheter-based atrial and ventricular electrophysiological mapping in adults and children four (4) years of age and older. | Device is stated to be for this indication, implying it meets this functional requirement. |
| When used with CARTO™ RMT EP Navigation System, provides location information. | Device is stated to provide location information when used with this system, implying it meets this functional requirement. |
Missing Information/Why it's not applicable based on the text:
The document does not specify quantitative acceptance criteria (e.g., minimum accuracy rates, precision metrics, sensitivity, specificity, or specific error tolerances) for the device's performance, nor does it provide detailed quantitative results from a specific study designed to measure these against acceptance thresholds. The primary "acceptance" was substantial equivalence to a predicate device.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated. The document refers to "Bench and animal testing" but does not give sample sizes for either.
- Data Provenance: "Bench and animal testing" are mentioned. No information regarding country of origin, retrospective, or prospective nature is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in the document. Given that the clearance is based on substantial equivalence and "bench and animal testing" rather than a clinical study requiring expert ground truth establishment for diagnostic accuracy, such details would likely not be included.
4. Adjudication method for the test set
- This information is not provided.
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 or AI-assisted study is mentioned. The device described here is a diagnostic catheter, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable as this is a physical medical device, not an algorithm.
7. The type of ground truth used
- For the "Bench and animal testing," the ground truth would typically be established by direct measurement during the tests or by physiological responses in the animal models, consistent with engineering and preclinical testing standards. No specific "type of ground truth" (like pathology or outcomes data) for a diagnostic accuracy study is mentioned because such a study is not described.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML product that undergoes a training phase with a dataset.
9. How the ground truth for the training set was established
- Not applicable for the same reason as point 8.
Summary of Study (as described in the document):
The document describes preclinical testing consisting of "Bench and animal testing" performed to demonstrate that the NaviStar RMT Steerable Tip Diagnostic Catheter is "functionally equivalent" to its predicate device, the Biosense Webster NaviStar Diagnostic Catheter (K954390). It also states that the device "was tested under simulated use conditions, and complies with multiple external electrical and performance standards."
The primary study presented for regulatory clearance is a substantial equivalence comparison to a legally marketed predicate device (K954390). The "study" (rather, the basis for clearance) hinges on demonstrating that the new device has identical indications for use, meets the same design requirements, and has similar technological characteristics to the predicate device, supported by the aforementioned bench and animal testing. No detailed quantitative clinical performance study is provided as the basis for clearance in this 510(k) summary.
§ 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).