(404 days)
Both devices are made to aid physicians specializing in cardiac electrophysiology, cardiac surgery and interventional cardiology in the management of abnormal rhythms of the heart. The main function of both devices is diagnostic sensing of electrical impulses in the heart muscles to provide precise, localized data.
The 2.5 Fr. Pathfinder Electrode Recording Catheter is a diagnostic medical device designed to sense electrical signals by use of multiple electrodes placed on the distal end of the catheter, each of which is connected to a connector at the proximal end of the catheter by means of a conductor wire. The connector is matched with a connector cable which functions to link the catheter to a standard ECG recording/monitoring system. The device is a composite construction of biocompatible materials commonly used in other (FDA) approved catheters. The catheter is available in 4. 8 and 16 electrode configurations and provides for a distal electrode recording length of up to 7 cm. The working outer diameter of the catheter is 2.3F or 2.5F depending upon the number of electrodes. The useable lengths are 100, 135. 150 and 200cm.
This document describes a 510(k) submission for the Cardima Pathfinder electrode recording device, comparing it to the Cordis Webster Orthogonal device. The focus is on demonstrating equivalence in safety and effectiveness.
Here's an analysis of the provided text in relation to your request:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Properties | Tensile strength, torsional strength, angular rotation, coil/tip stiffness, flexural fatigue (against defined acceptance criteria from "Electrode Recording Catheter Preliminary Guidance. June 1994") | "All test samples met the defined acceptance criteria for each performance test." |
| Electrical Properties | Electrical phase shift, dielectric voltage breakdown (against defined acceptance criteria from "Electrode Recording Catheter Preliminary Guidance. June 1994") | "All test samples met the defined acceptance criteria for each performance test." |
| Biocompatibility | Cytotoxicity, hemolysis, mutagenicity, systemic/intracutaneous/intravenous toxicity, muscle implantation, delayed contact sensitization (performed on final, sterilized product) | Implied successful, as the conclusion states "substantially equivalent safety." The text does not explicitly state "all passed," but the overall conclusion strongly suggests compliance. |
| Clinical Effectiveness | Equivalent ability to successfully place the device and record cardiac signals of adequate quality from the coronary sinus, compared to the predicate device. | "The study demonstrated that the Pathfinder could be successfully placed in the coronary sinus, could record cardiac signals of adequate quality from the coronary sinus..." |
| Clinical Safety | No increase in device-associated complications compared to the predicate device. | "...and did not present any increase in device associated complications as compared to the Orthogonal catheter." |
| Substantial Equivalence (Overall) | Equivalence in labeling, physical characteristics, and clinical performances, including safety and effectiveness, compared to the predicate device. The new device is not intended for pacing, but the predicate is. | "The results indicated that the Pathfinder device is substantially equivalent to the Orthogonal device with respect to safety and effectiveness." |
Study Details
-
Sample size used for the test set and the data provenance:
- Clinical Test Set Sample Size: 20 patients.
- Data Provenance: Clinical investigation conducted at two clinical sites. The text does not specify the country of origin, but it is a "controlled clinical investigation." Given the FDA context, it's likely U.S.-based or compliant with U.S. regulatory standards. It is a prospective study design, as patients "undergoing an electrophysiology study for arrhythmia" were enrolled for the purpose of the investigation.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document mentions "a conclusive statement from the independent reviewers supporting the equivalence claim" in the general summary. However, for the clinical study itself, it does not specify the number of experts or their qualifications for establishing ground truth (e.g., assessing signal quality, maneuverability, complications, or drawing equivalence conclusions). The study design used patients as their own controls, where "signal recordings, device maneuverability/placement, and complications were compared." This suggests direct clinical observation and comparison by the treating/investigating physicians, whose expert judgment would implicitly form the "ground truth" for the observed parameters.
-
Adjudication method for the test set:
- The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). The "patients as their own control" design implies direct comparison of data collected from the same patient using both devices. The assessment of "signal recordings, device maneuverability/placement, and complications" would likely have been performed by the clinical investigators at the two sites.
-
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study is comparing two medical devices (catheters) for signal recording capabilities and safety, not an AI-assisted diagnostic tool. Therefore, the concept of "human readers improve with AI" is not applicable here.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this is not an algorithm-only device. It is a physical medical device (catheter) used by physicians to record electrical signals. Its performance is inherently tied to human use and interpretation.
-
The type of ground truth used:
- For the animal study: The "ground truth" for signal quality and safety was established by direct comparison to the predicate device in a GLP animal study.
- For the clinical study: The "ground truth" was established by direct within-patient comparison of signal quality, device maneuverability/placement, and observed complications between the new device and the predicate device. This is a form of expert clinical observation and comparison. The ultimate "ground truth" for equivalence in safety and effectiveness was based on the interpretation of these clinical observations by the independent reviewers/investigators.
-
The sample size for the training set:
- This submission describes a medical device, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI. The "training" of the device itself would refer to its design and engineering, not data-driven model training.
-
How the ground truth for the training set was established:
- As there is no "training set" in the AI sense, this question is not applicable. The "ground truth" for the device's design and manufacturing would be based on engineering specifications, regulatory guidelines (e.g., "Electrode Recording Catheter Preliminary Guidance. June 1994"), and biocompatibility standards.
§ 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).