(404 days)
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No
The description focuses on the physical characteristics of the catheter and its function in sensing electrical signals, with no mention of AI or ML for data analysis or interpretation.
No
The device's main function is described as "diagnostic sensing of electrical impulses in the heart muscles to provide precise, localized data," indicating a diagnostic rather than therapeutic purpose.
Yes
The "Intended Use / Indications for Use" section states: "The main function of both devices is diagnostic sensing of electrical impulses in the heart muscles to provide precise, localized data." The "Device Description" also explicitly refers to it as a "diagnostic medical device."
No
The device description clearly details a physical catheter with electrodes, wires, and connectors, which are hardware components. The software mentioned is for linking the catheter to an ECG system, but the core device is hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
- Device Function: The description clearly states the device's main function is "diagnostic sensing of electrical impulses in the heart muscles." This involves directly interacting with the patient's body to measure electrical activity, not analyzing a specimen taken from the body.
- Intended Use: The intended use is to "aid physicians specializing in cardiac electrophysiology, cardiac surgery and interventional cardiology in the management of abnormal rhythms of the heart." This is a direct diagnostic procedure performed on the patient.
The device is a diagnostic medical device, but it operates in vivo (within the living body) rather than in vitro (in glass, referring to laboratory testing of specimens).
N/A
Intended Use / Indications for Use
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.
Product codes
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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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Heart muscles, coronary sinus
Indicated Patient Age Range
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Intended User / Care Setting
Physicians specializing in cardiac electrophysiology, cardiac surgery and interventional cardiology.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 results indicated that the Pathfinder device is substantially equivalent to the Orthogonal device with respect to safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
0
JAN 29 1997
Image /page/0/Picture/1 description: The image shows a logo for CARDIMA. The logo features a stylized letter 'C' in a bold, sans-serif font. The 'C' is partially filled in, creating a sense of depth and dimension. Below the 'C', the word 'CARDIMA' is written in a smaller, sans-serif font.
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
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.
1
Image /page/1/Picture/0 description: The image shows a logo with a stylized letter 'C' in a bold, sans-serif font, positioned above the word 'CARDIMA'. The 'C' is designed with a thick stroke that curves around, creating a dynamic and modern feel. The word 'CARDIMA' is printed in a smaller, sans-serif font, placed directly below the 'C', serving as the brand name or identifier associated with the logo.
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.