(98 days)
The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures.
The system allows the user to monitor, display and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.
The EP-TRACER system is a computerized electrophysiology measurement system designed for both regular and experimental EP studies.
The EP-TRACER is comprised of these major components:
EP-TRACER hardware – Amplifier/stimulator
EP-TRACER Software – Software pre-installed
This document describes the EP-TRACER System V2.2, an electrophysiology measurement system. The FDA 510(k) clearance (K183266) states its substantial equivalence to the predicate device, EP-TRACER System V2.0 (K161245). This submission primarily focuses on software modifications affecting the user interface, with no changes to the hardware.
Here's an analysis of the acceptance criteria and the study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state "acceptance criteria" in a quantitative, measurable format like sensitivity/specificity thresholds for a diagnostic device. Instead, the "acceptance criteria" for this submission are implicitly defined by demonstrating that the modifications to the device (V2.2 compared to V2.0) do not adversely affect safety and effectiveness and that the device conforms to relevant harmonized standards.
The "device performance" is therefore described by showing that the new device (V2.2) maintains the same fundamental technological characteristics and meets all applicable standards as the predicate device (V2.0).
| Characteristic / Acceptance Criteria Type | Predicate Device EP-TRACER V2.0 Performance (Implicit Acceptance Baseline) | New Device EP-TRACER V2.2 Performance (Reported) | Met? |
|---|---|---|---|
| Hardware Components | Same as listed in "Technological Characteristics" table | Same | Yes |
| Amplifier Dimensions | 38 channels: 28x27x7 cm; 70/102 channels: 28x27x12 cm | Same | Yes |
| Environmental Specs (Temp, Humidity) | Operating: +10°C to +30°C, 20-80% rH; Storage: -29°C to +66°C, 100 dB, 20 MΩ, |
§ 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).