(133 days)
PURE EP™ is a computerized system intended for acquiring, digitizing, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory under the supervision of licensed healthcare practitioners who are responsible for interpreting the data.
PURE EP™ is a system consists of two main parts: the amplifier, and the personal computer (PC), which are connected over a high-speed fiber optic cable. The patient is connected to the amplifier via a set of supplied ECG cables and commercially available intracardiac (IC) catheters. The amplifier includes hardware and embedded software necessary for acquiring ECG and IC signals from patients. The device is not intended for active patient monitoring. It consists of one ECG and seven IC modules designed to acquire 12-lead ECG and 56 IC signals and send the digitized data to the PC. The PC has preinstalled PURE-EP software and is connected to display monitors. The pre-installed software provides visualization of received data from the amplifier on real-time and review screens. It also includes a signal processing module that provides various filter options for real-time and review screens.
The provided text describes the PURE EP™ system, a computerized system for acquiring, digitizing, filtering, measuring, calculating, displaying, recording, and storing electrocardiographic and intracardiac signals during electrophysiology (EP) procedures. The document does not contain specific acceptance criteria for device performance, nor does it detail a clinical study proving the device meets such criteria in terms of diagnostic accuracy or equivalent clinical outcomes.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (GE Healthcare's CardioLab) through engineering and safety testing, rather than a statistical study against a specific performance benchmark.
Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is absent:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state specific acceptance criteria in terms of diagnostic performance metrics (e.g., sensitivity, specificity, accuracy). The "Performance Testing" section lists compliance with a variety of industry standards for software, electrical, and mechanical testing, which implies that the device achieved performance within the specified limits of those standards. However, these are general safety and engineering standards, not specific performance criteria for signal interpretation accuracy.
| Performance Aspect | Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Functional/Performance Requirements | Device design meets its functional and performance requirements as verified through software, electrical, and mechanical testing in accordance with industry standards. | Representative samples underwent software, electrical, and mechanical testing in accordance with listed industry standards (e.g., ANSI/AAMI/IEC 62366-1, AAMI/ANSI/ISO 14971, IEC 60601-1-6, AAMI/ANSI HE75, IEC 62304, AAMI/ANSI ES60601-1, AAMI/ANSI IEC 60601-1-2). User validation was also performed. |
| Electrical Safety | Compliance with AAMI/ANSI ES60601-1: 2012. Patient Source: |
§ 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).