(191 days)
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No
The summary describes a system for recording, viewing, and analyzing electrograms and tracking catheter locations using ultrasound ranging. There is no mention of AI, ML, or any algorithms that would typically fall under those categories for analysis or decision-making. The performance studies focus on electrical, mechanical, and tracking accuracy, not on the performance of any AI/ML model.
No.
The device is indicated for diagnostic purposes (mapping, tracking, and analysis of intracardiac electrograms and EKG signals) to aid in the diagnosis and localization of cardiac arrhythmias, not for treating them.
Yes
The device explicitly states its intended use is for "diagnosis and localization of cardiac arrhythmias" and it records, views, and analyzes "intracardiac electrograms and EKG signals to aid in the diagnosis." It also describes the use of "diagnostic EP mapping" catheters.
No
The device description explicitly lists multiple hardware components, including a computer system, amplifier electronics, ultrasound electronics, catheters with transducers and electrodes, and cabling, in addition to the software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue). The intended use and device description clearly state that this system is used for intracardiac electrophysiological mapping and delivering pacing stimuli within the body. It's interacting directly with the patient's heart.
- The system records and analyzes in vivo signals. It's capturing electrical signals and tracking catheter locations within the living patient, not analyzing samples outside the body.
The device is a system for in vivo diagnostic procedures related to cardiac arrhythmias.
N/A
Intended Use / Indications for Use
The Cardiac Pathways Tracking System catheters are indicated for cardiac electrophysiological mapping and delivering diagnostic pacing stimuli. In addition, the Tracking catheters are used with the Arrhythmia Mapping and Tracking System to provide catheter location information.
Product codes (comma separated list FDA assigned to the subject device)
DRF, DQK
Device Description
The Cardiac Pathways Arrhythmia Mapping and Tracking System allows the recording, viewing, and analysis of intracardiac electrograms and EKG signals to aid in the diagnosis and localization of cardiac arrhythmias. The System also allows the recording, viewing, and annotation of diagnostic electrophysiology (EP) catheter positions and electrode positions. The system facilitates the simultaneous recording of signals through connections to standard EP mapping catheters, specialized EP mapping catheters, and a 12-lead EKG.
The Cardiac Pathway Arrhythmia Mapping and Tracking System is intended for use in applications of diagnostic EP mapping and consists of the following:
- a signal recording computer system for interpreting mapping signals and documenting . locations of catheters and catheter electrodes,
- . electrogram signal amplifier electronics,
- ultrasound transmit and receive electronics,
- . a set of diagnostic electrophysiology reference catheters containing ultrasound ranging transducers and mapping electrodes (referred to as Reference Catheters, RV Reference Catheters, and CS Reference Catheters),
- one or more diagnostic electrophysiology tracking catheters containing ultrasound ranging transducers and mapping electrodes (referred to as Tracking Catheters, Steerable Catheters, and Radii Catheters with Tracking),
- . cabling to connect transducers and electrodes to recording equipment, and
- . software for interfacing the electronics and displaying catheter locations to the operator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Cardiac / Heart (intracardiac)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Arrhythmia Mapping and Tracking System was subjected to a battery of electrical and functional tests to verify that the devices met the specifications. Testing included, but was not limited to, electrical safety, verification that certain electrical parameters were within specification, and functional performance. The devices individually and collectively met the specifications. Software verification testing was also performed on the system and the software was deemed acceptable for clinical use. The Reference Diagnostic Electrophysiology Catheters (RV and CS), the Steerable Diagnostic Electrophysiology Catheters, and the various cables for use with the Arrhythmia Mapping and Tracking System were subjected to a battery of electrical and mechanical tests to verify that the devices met the specifications. Electrical testing included, but was not limited to, assessment for continuity and short circuits, DC impedance, AC impedance, capacitance, dielectric strength, and current leakage. The accuracy of the transducers was also tested. Mechanical testing included, but was not limited to, assessment of joint strengths, torque response, and the ability to withstand multiple deflections. The devices met the electrical and mechanical specifications. Accuracy of the tracking function was assessed in vitro and in vivo. The accuracy was comparable to the predicate device and appropriate for the clinical application. Biocompatibility testing was performed with the catheters and indicated that the devices did not elicit toxicological responses.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Overall system accuracy of distance measurements and catheter images is a function of transducer performance, electrical system performance, and software performance. As demonstrated with bench testing, the accuracy of the representation of tip location is
§ 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).
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510(k) SUMMARY
Indications
The Cardiac Pathways Tracking System catheters are indicated for cardiac electrophysiological mapping and delivering diagnostic pacing stimuli. In addition, the Tracking catheters are used with the Arrhythmia Mapping and Tracking System to provide catheter location information.
Device Description
The Cardiac Pathways Arrhythmia Mapping and Tracking System allows the recording, viewing, and analysis of intracardiac electrograms and EKG signals to aid in the diagnosis and localization of cardiac arrhythmias. The System also allows the recording, viewing, and annotation of diagnostic electrophysiology (EP) catheter positions and electrode positions. The system facilitates the simultaneous recording of signals through connections to standard EP mapping catheters, specialized EP mapping catheters, and a 12-lead EKG.
The Cardiac Pathway Arrhythmia Mapping and Tracking System is intended for use in applications of diagnostic EP mapping and consists of the following:
- a signal recording computer system for interpreting mapping signals and documenting . locations of catheters and catheter electrodes,
- . electrogram signal amplifier electronics,
- ultrasound transmit and receive electronics,
- . a set of diagnostic electrophysiology reference catheters containing ultrasound ranging transducers and mapping electrodes (referred to as Reference Catheters, RV Reference Catheters, and CS Reference Catheters),
- one or more diagnostic electrophysiology tracking catheters containing ultrasound ranging transducers and mapping electrodes (referred to as Tracking Catheters, Steerable Catheters, and Radii Catheters with Tracking),
- . cabling to connect transducers and electrodes to recording equipment, and
- . software for interfacing the electronics and displaying catheter locations to the operator.
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Premarket Notification
Image /page/1/Figure/3 description: This image shows a diagram of the Model 8200 PAM, Model 8100 AMC, and Model 8300 SAM. The Model 8200 PAM includes a position acquisition module, interface box, and fiber optic cables. The Model 8100 AMC includes a workstation computer, graphics display, keyboard, color printer, optical disk, and mouse. The Model 8300 SAM includes a signal acquisition module, array catheter connector, and stimulator.
Figure 1: Arrhythmia Mapping and Tracking System
The system can be used either with standard electrophysiology catheters or with the specially designed diagnostic catheters that provide information regarding catheter position during the procedure.
System Overview
As shown in Figure 1 above, the Arrhythmia Mapping and Tracking System consists of these main components:
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- Model 8100 Mapping Computer - a Sun UltraSPARC computer with a high-speed fiber optic communication link, consisting of:
- Two monitors one containing a real time screen that displays live signals and the other containing an analysis screen that displays realtime catheter positions, recorded signals, journal events, and a main menu bar for accessing dialogs and controls
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- An internal optical disk drive -- for storing patient data on removable optical disks
- A laser printer for printing the analysis screens and isochronal maps । in color, and printing signals and the contents of the journal in black and white
- An uninterruptible power supply -- for ensuring the system continues to t operate for approximately 5 minutes when there is a power failure.
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- Model 8200 Position Acquisition Module (PAM) an ultrasound transmit and receive instrument that uses ultrasound ranging techniques to measure the distance between transducers that are mounted on specialized diagnostic EP catheters. Distance data measured by the PAM is transferred to the Mapping Computer for processing.
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- Model 8300 Signal Acquisition Module (SAM) an amplifier system that filters cardiac signal data and transfers it to the Mapping Computer for processing and display.
The following signal sources can be connected to the SAM:
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- one or more standard EP catheter electrodes (up to 48 auxiliary inputs) from any standard diagnostic catheters or the specially designed Cardiac Pathways tracking catheters,
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- a 64-electrode high-density array catheter
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- a pacing input from an external pacing stimulator, which the Mapping System software can route to any catheter bipole or unipole
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- a 12-lead EKG, and
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- a pressure transducer
The SAM collects these signals, applies gain and filter settings as programmed through the Mapping System software, samples them at 3 kHz, and transfers them to the Mapping Computer over the fiber optic data link for further processing and display.
The following signal sources can be connected to PAM:
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- two specialized EP catheters referred to as reference catheters for the positioning system,
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- one to five additional specialized EP catheters referred to as tracking catheters for the positioning system, and
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- one signal ground connection that is common between the SAM and the PAM
The PAM transmits ultrasound pulses to transducers built into the specialized reference catheters. It then measures the time delay between the transmit pulse and the reception of the sound wave on the other transducers that are on the reference catheters and tracking
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catheters. These time measurements are directly proportional to the distance between the transducers. The distance/time data is transferred to the Mapping Computer over the fiber optic data link for further processing and ultimately for the display of the catheter representations in 3D orientation. This use of ultrasound transducers is known as ultrasound ranging.
A continuous cycle of transmit pulses is sent in round-robin fashion to each of the transducers on the Reference Catheters. The resulting reception from each transmit pulse on each of the other transducers on the Reference and Tracking Catheters is used to determine the distance between all the transducers. The Arrhythmia Mapping and Tracking System software uses the distance information to triangulate 3D coordinates for all transducers. Because the dimensional and the constructional characteristics of the catheters are known by the Arrhythmia Mapping Computer, it uses the 3D coordinate information along with the catheter information to reconstruct a 3D graphical representation of the catheter positions and orientation. The resulting 3D graphical image of the catheter is adjustable as a 3D graphical object on the computer screen.
The Arrhythmia Mapping and Tracking System has the following features:
- Accepts input electrogram signals from: .
- standard EP catheters up to 48 inputs
- high density catheter arrays up to 64 inputs
- a 12-lead EKG and a pressure transducer
- Accepts catheter position data from specialized EP catheters. Up to 28 channels of . position data may be communicated from the PAM to the Mapping Computer.
- Routes a pacing signal from an external pacing stimulator to any connected bipole or ● unipole.
- . Displays up to 16 real time signals (one Signal Page), and allows rapid switching among twenty such user-defined Signal Pages.
- . Displays real-time signals at a maximum sweep speed of 800mm/S. A triggered sweep feature can be used to stabilize the display of signal complexes, allowing the point of early activation to be determined with high resolution.
- . Displays real-time catheter position graphics that are gated to the EKG to filter heart movement artifacts. One of the catheters in the graphical display can be selected for displaying a real time tip. This utilizes a graphical circle with a disappearing tail to indicate tip movement in "real time" to facilitate catheter steering.
- Displays real-time heart rate (one second average) and ventricular cycle length (beat-. to-beat) from any EKG signal.
- . Allows for adjustment of signal filters and gain over a wide range of values.
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- Records signals and catheter positions to the optical disk via continuous recording of . the 16 real-time signals and/or an 8-second snapshot recording of the Signal Page, EKGs, and the 64-inputs from a high density array catheter.
- With Auto Save enabled, automatically initiates recording during pacing or when the . heart rate exceeds specified thresholds. Automatically aligns recorded signals with the last pulse in the pacing train.
- Provides tools to make time measurements, add text, and quickly zoom in to review . and analyze signals. Keyboard shortcuts are provided for most common features such as recording, changing signal gain, and changing sweep speed.
- Provides tools to recall and display the 3D position of a catheter relative to stored . annotations and electrograms.
- Provides tools to adjust the 3D view of the graphical representation of the catheter . positions.
- Automatically detects catheter movement from the original positions, after an initial . reference position is selected by the operator, and indicates correct position information for the operator.
- Automatically detects RF interference with the ultrasound ranging circuits, freezes the . display for the operator, and then resumes real-time display when the interference stops.
- Automatically generates color-coded isochronal maps from high density array signal . data using a peak slope or peak amplitude detection algorithm to place activation marks.
- . Prints color isochronal maps, signals, and the events from the journal for archiving with the patient record.
Catheter Overview
The two types of Reference Catheters, that are positioned in the CS and RV and are used to form the reference frame for the Tracking System, have nearly identical functional requirements. Both catheters have a fixed-curve 6F distal shaft section and a 7F proximal braided shaft. The fixed-curve provides for directional placement of the catheter in the CS or RV. The braided shaft provides torque control for catheter placement. All catheters contain electrodes used for EP mapping. Non-tracking versions of the CS and RV Reference Catheters are nearly identical to their counterparts but have no transducers for tracking catheter position. They contain only EP electrodes for collection of diagnostic cardiac electrograms.
The Reference Catheter designed for typical EP usage in the CS has 4 ultrasound transducers, nine 1 mm EP ring electrodes, and one 2 mm EP tip electrode. To position the catheter within the CS, the catheter is introduced into either a jugular or subclavian vein and advanced into the superior vena cava. The catheter is then passed through the chamber of the right atrium into the os of the CS. The catheter is advanced into the CS
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until the distal tip of the catheter is at or near the left heart border. The ultrasound transducers are spaced on the distal portion of the catheter shaft so that a single transducer resides in the right atrium and distal transducers reside within the CS so that the most distal transducer is at or near the left heart border. The EP tip electrode provides an atraumatic tip for the catheter.
The Reference Catheter designed for typical EP usage in the RV has 4 ultrasound transducers, three 1 mm EP ring electrodes, and one 2 mm EP tip electrode. The catheter is introduced into a femoral vein and advanced into the inferior vena cava and right atrium. The catheter is then passed across the tricuspid valve, and the distal tip is positioned in the RV apex. The ultrasound transducers are spaced on the distal portion of the catheter shaft to approximately cover the distance from the mid point of the right atrium above the tricuspid valve to the apex of the RV. The EP ring electrode and the tip electrode spacing are arranged in a commonly used configuration for recording electrograms and pacing from the RV. The EP tip electrode provides an atraumatic tip for the catheter.
Reference Catheters are deployed at the beginning of an EP mapping procedure. Once in place, they are not moved until the end of the procedure. The ultrasound transducers on these catheters provide a fixed reference frame that is used to determine the position of ultrasound transducers that are integrated into other mapping catheters, for example Tracking Catheters. The Arrhythmia Mapping and Tracking System contains software that generates 3D graphical representations of the Reference and Tracking Catheters based on the position of their transducers. These graphical representations are used to facilitate navigation and placement of these catheters during the procedure. The Reference Catheters have EP electrodes for both sensing and pacing. They are intended to replace competitive RV mapping/pacing and CS mapping/pacing catheters in EP procedures. The Reference Catheters provide EP functionality that is equivalent to currently used CS and RV mapping and pacing catheters.
The Tracking Catheters used with the system are steerable, deflectable EP mapping and pacing catheters that contain three ultrasound transducers, one tip electrode, and three ring electrodes. The Tracking Catheter is placed into any heart chamber and is used to record activation patterns to diagnose arrhythmias. The Tracking Catheter is rendered as a 3D graphical catheter representation. Since the third transducer is proximal to the deflection point of the catheter, the computer image displays the curve of the catheter
Overall system accuracy of distance measurements and catheter images is a function of transducer performance, electrical system performance, and software performance. As demonstrated with bench testing, the accuracy of the representation of tip location is