(59 days)
The NeuTrace EP Mapping System v2.1 is indicated for catheter-based cardiac electrophysiological (EP) procedures. The NeuTrace EP Mapping System v2.1 provides information about the electrical activity of the heart and about catheter location during the procedure. The system can be used on patients who are eligible for a conventional electrophysiological procedure in the right atrium. The system has no special contraindications.
The NeuTrace EP Mapping System v2.1 (NeuTrace System) is an advanced 3D electroanatomical mapping (EAM) and analysis system capable of:
- Displaying catheter location during electrophysiology mapping procedures
- Displaving 3D images of cardiac structures
- Displaying cardiac activity signals as waveforms (ECGs and EGMs)
- Displaying derived voltage and time metric overlays over cardiac models -. including Peak-to-Peak Voltage, Local Activation Time (LAT), Fractionation, and Minimum dV/dt
The NeuTrace System comprises the following software and hardware components:
- NeuTrace Workstation
- Window field generator
- System control unit
- System interface unit
- Interface switches and connection cables
- NeuTrace Software Application v2.1
- NeuTrace Streaming Application Software v2.0 0
The NeuTrace System is used together with compatible recording systems and compatible catheters listed in the device labeling to perform its intended use to support electrophysiology procedures in the right atrium.
Here's an analysis of the provided text, extracting information related to the acceptance criteria and the study proving the device meets those criteria:
Device Name: NeuTrace EP Mapping System v.2.1
Product Code: DQK
Regulatory Class: Class II
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly present a formal "acceptance criteria" table with pre-defined thresholds. Instead, it describes performance metrics that were measured and the results achieved, which implicitly serve as the "met criteria." The "Comments" column indicates whether the observed performance meets or aligns with expectations for substantial equivalence.
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance | Comments |
|---|---|---|---|
| Ground-truth Accuracy | Expected to be low (e.g., |
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).