(191 days)
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.
The Cardiac Pathways Tracking diagnostic catheters are indicated for cardiac electrophysiological mapping and delivering pacing stimuli. In addition, the Tracking and Reference Catheters are used with the Arrhythmia Mapping and Tracking System to provide catheter location information.
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.
Here's an analysis of the provided text, focusing on acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state formal acceptance criteria with numerical targets. Instead, it describes general verification and validation activities. However, based on the performance data section, we can infer some criteria and the reported performance.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Electrical Safety | Devices met specifications. |
| Electrical Parameters within Specification | Devices met specifications (ee.g., continuity, short circuits, DC impedance, AC impedance, capacitance, dielectric strength, current leakage). |
| Functional Performance | Devices met specifications. Software verification testing was performed and deemed acceptable for clinical use. |
| Transducer Accuracy | Accuracy of the transducers was tested. (No specific numerical value given for transducers, but implied to be within acceptable limits for overall accuracy) |
| Catheter Mechanical Properties (Joint strength, torque, deflection) | Devices met mechanical specifications. |
| Biocompatibility | Testing indicated devices did not elicit toxicological responses. |
| Tracking Function Accuracy (Key performance claim) | **In vitro and in vivo assessment showed tip location accuracy of |
§ 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).