(269 days)
EP.XT, Dynamic Tip, and Dynamic XT Unidirectional Steerable Diagnostic Catheters are indicated for use to diagnose cardiac arrhythmia.
The unidirectional steerable diagnostic catheters acquire electrical signals from the cardiac tissue, which are transmitted via the electrode wiring through the connector and cable to an amplifier, where the signals are displayed on an EP recording system for the physician to view and interpret in diagnosing cardiac arrhythmias. The physician inserts the diagnostic catheter(s) percutaneously via either the anterior approach using the internal jugular vein or the subclavian vein or via the femoral vein or for a retrograde approach, via the femoral artery. In some cases, the radial artery may be used to access the targeted cardiac chamber. Using fluoroscopic guidance, the physician then navigates the diagnostic catheter to the target site using the catheter steering mechanism as confirmed by the intracardiac electrograms and/or pacing threshold, confirming electrode to endocardium interface.
The steerable diagnostic electrode catheters are radiopaque, flexible, insulated catheters with a polymer shaft, each having a mechanical operating mechanism. In each catheter the polymer shaft connects to the catheter handle whereby the curve or loop is actuated by a single pull cable. The EP+XT Catheter has a white rotating handle mechanism which provides curve actuation of the distal tip. The Dynamic Tip and Dynamic XT Catheters have a plunger mechanism, which, when moved forward or back, results in curvature of the distal tip.
The EP•XT, Dynamic Tip, and Dynamic XT Catheters are offered pre-packaged sterile and are a single use product not to be reused, reprocessed, or resterilized. The method of sterilization is ethylene oxide (EO).
This document describes the FDA's decision to clear Boston Scientific's EP.XT, Dynamic Tip, and Dynamic XT Unidirectional Steerable Diagnostic Catheters for marketing based on a determination of substantial equivalence to predicate devices. This clearance is not based on a study proving the device meets specific performance criteria for diagnostic accuracy in the same way an AI/ML diagnostic would be; rather, it relates to the device's physical and functional characteristics and its ability to acquire electrical signals.
Therefore, the requested information (acceptance criteria and study details related to diagnostic performance, human reader improvement with AI, ground truth, expert adjudication, etc.) is not applicable to this 510(k) submission. This is a clearance for a physical medical device (catheter) used to acquire data, not a software-based diagnostic algorithm.
Here's a breakdown based on the provided document, addressing what is relevant and noting what is not:
1. Acceptance Criteria and Reported Device Performance
The "acceptance criteria" here are based on the device's physical and functional performance, sterilization, and packaging, demonstrating it is substantially equivalent to a predicate device. There are no diagnostic performance metrics (e.g., sensitivity, specificity, AUC) reported because this is not a diagnostic algorithm.
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility | Implied by "substantially equivalent ... to predicate device." Specific testing not detailed in summary. |
| Sterilization | EO (Ethylene Oxide) sterilization validated; packaging maintains sterility. |
| Mechanical Performance | Demonstrated through "Design Verification Testing" at baseline and 37 months accelerated aging. Ensured adherence to "applicable product specifications." Examples of specific tests would likely include steerability, durability, electrical signal acquisition integrity, etc., but these are not detailed in the summary. |
| Packaging Integrity | "Packaging Design Verification testing... meet[s] predetermined design input specification and maintain sterility in conformance with ISO 11607-1." |
2. Sample Size Used for the Test Set and Data Provenance
N/A. This 510(k) summary does not describe a clinical study for diagnostic performance with a test set of patient data. The "test set" for this device would refer to units of the manufactured catheters themselves undergoing engineering and bench testing. The document states "Design verification testing was performed on the EP.XT, Dynamic Tip, and Dynamic XT Catheters," implying a sample of the manufactured devices were tested, but specific numbers are not provided in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
N/A. This is not a diagnostic algorithm requiring expert-established ground truth on patient data. The ground truth for this device's performance relates to engineering specifications and international standards (e.g., ISO 11607-1 for packaging, ISO 11737-1 for bioburden).
4. Adjudication Method for the Test Set
N/A. Not applicable to a physical device's engineering and performance testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is relevant for evaluating the impact of AI on human reader performance for diagnostic tasks. This device is a diagnostic tool that acquires electrical signals, not an AI-powered diagnostic system.
6. If a Standalone Performance Study Was Done
No, not in the context of an algorithm's diagnostic performance. The "performance data" described (Bioburden, Design Verification, Packaging Verification) are standalone tests of the device's physical and functional attributes against engineering specifications and regulatory standards.
7. The Type of Ground Truth Used
The "ground truth" for this device's clearance is based on:
- Engineering Specifications: The design inputs and performance requirements set by Boston Scientific for the catheters.
- International Standards: E.g., ISO 11737-1 for bioburden, ISO 11607-1 for packaging, and likely other ISO standards for biocompatibility and electrical safety (though not explicitly listed in the summary).
- Predicate Device Performance: The primary "ground truth" for 510(k) clearance is that the new device performs "substantially equivalent" to legally marketed predicate devices, meaning it has similar technological characteristics and the same intended use.
8. The Sample Size for the Training Set
N/A. This is not an AI/ML device that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
N/A. Not applicable as there is no training set for an AI/ML algorithm.
In summary: The provided document is a 510(k) clearance letter for a medical device (catheter) based on substantial equivalence. It does not contain information about acceptance criteria or studies related to the diagnostic accuracy of an AI/ML algorithm, nor does it describe human-in-the-loop performance studies. The "performance data" refers to the physical and functional characteristics of the catheter itself, not its diagnostic accuracy in interpreting patient data.
§ 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).