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.

Device Description

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.

AI/ML Overview

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.

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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.

Summary

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JAN 29 1997

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Pathfinder 510 (k)

12/22/95

ummary of Safety

This submission is prepared to show equivalence between the Cordis Webster Orthogonal (bredicate) and the Cardima Pathfinder (new) electrode recording devices, according to the Safe Medical Device Act of 1990.

The criteria for equivalence included comparing labeling, physical characteristics and clinical performances of the new and predicate devices as well as physical and animal testing of the new device with biocompatibility and sterilization information.

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. While the predicate device is also indicated for pacing, the new device is not intended for pacing and it is labeled so.

Longitudinal characteristics of both catheters are the same, both were designed to access the heart through the peripheral vasculature using the standard Seldinger technique.

Both devices are capable to change direction during advancement using proximal torque control. Leading the change in direction of the relatively stiff predicate device is a deflectable tip, while the new device is designed with a soft, shapeable tip, much like coronary guidewires.

While the 7 Fr. predicate device exposes larger electrodes to the heart, the signal from the 2.5 Fr. smaller diameter new device vields the same quality diagnostic information to the physician. Included with this submission is the clinical data and a conclusive statement from the independent reviewers supporting the equivalence claim.

Device Description

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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.

Nonclinical Tests

Bench Studies: A series of tests were performed using the FDA "Electrode Recording Catheter Preliminary Guidance. June 1994" as a quide. The tests were used to assess the mechanical and electrical properties of both the catheter and the connector cable. Mechanical testing included tensile and torsional strength, angular rotation, coil/tip stiffness and flexural fatigue. Electrical testing included electrical phase shift and dielectric voltage breakdown. All test samples met the defined acceptance criteria for each performance test. In addition to mechanical and electrical testing, a full series of biocompatibility testing was performed on final, sterilized product. Testing included cytotoxicity, hemolysis, mutagenicity, systemic/ intracutaneous/intravenous toxicity, muscle implantation. and delaved contact sensitization.

Animal Studies: A pre-clinical GLP animal study was conducted to evaluate the performance of the Pathfinder device in recording cardiac signal recording from the coronary sinus when compared to the Orthogonal 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, and did not present any increase in device associated complications as compared to the Orthogonal catheter.

Clinical Tests

A controlled clinical investigation was conducted at two clinical sites consisting of a total of 20 patients undergoing an electrophysiology study for arrhythmia. The purpose of the investigation was to demonstrate equivalent safety and effectiveness of the Pathfinder device when compared to the Orthogonal device. The study design was to use patients as their own control, in which, in the same patient, signal recordings were obtained with the Pathfinder device immediately followed by signal recordings obtained with the Orthogonal device in the coronary sinus. To demonstrate safety and effectiveness, signal recordings, device maneuverability/placement, and complications were compared. The results indicated that the Pathfinder device is substantially equivalent to the Orthogonal device with respect to safety and effectiveness.

Conclusions Drawn from Nonclinical and Clinical Tests

The results of the nonclinical and clinical tests summarized in sections (b)(1) and (b)(2) above, indicate that the Cardima Pathfinder Electrode Recording Catheter exhibits substantially equivalent safety and effectiveness when compared to the Cordis Webster Orthogonal Electrode Recording Catheter.

Regulation Number and Section

§ 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).