(211 days)
The intended use of electrocardiograph is to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However the ECG with measurements and interpretive statements is offered to clinician on an advisory basis only.
Digital Electrocardiograph, iE 3/ iE 6/ iE 12/ iE 12A/ iE 15/ ECG-1210/ ECG-3010/ ECG-6010, are intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However the ECG with measurements and interpretive statements is offered to clinician on an advisory basis only.
All the proposed models, iE 3/ iE 6/ iE 12/ iE 12A/ iE 15/ ECG1210/ ECG3010/ ECG6010, follow the same design principle, main components, accessories and software; they acquire ECG electrical signals from patient body surface by ECG electrodes. After been amplified, filtered and transferred, the ECG signal waveforms are displayed on the LCD and recorded on the paper through thermal printer.
They consist of four modules, which are power supply module, signal collection module, amplification module, and control module.
They can acquire ECG signal via twelve leads simultaneously, display or print waveform of ECG signal via three channel, six channel, twelve channel or fifteen channel.
The CardioPro analysis program is the analysis program used in this proposed device.
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative manner for specific performance metrics like accuracy, sensitivity, or specificity regarding the analysis and diagnosis of heart disease. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices and compliance with international safety and performance standards.
The table below summarizes the technical specifications and standards compliance, which implicitly serve as performance requirements for the device's functionality.
| Feature / Standard | Acceptance Criteria (Implied by Predicate & Standards) | Reported Device Performance |
|---|---|---|
| Product Code | DPS | DPS |
| Regulation Number | 21 CFR 870.2340 | 21 CFR 870.2340 |
| Lead Acquisition | Standard 12-lead (or 15-lead for proposed device) | Standard 12-lead or 15 lead |
| Acquisition mode | Simultaneous 12-lead acquisition | Simultaneous 12-lead or 15 lead acquisition |
| Recording format | Automatic / Manual / Rhythm | Automatic / Manual / Rhythm |
| Analysis mode | Yes (presence of analysis program) | Yes (CardioPro analysis program) |
| CMRR | >60dB | >60dB, >100 with AC filter |
| Paper Speed | Multiple levels (e.g., 6.25, 12.5, 25, 50mm/s) | 4-6 levels (e.g., 6.25, 12.5, 25, 50mm/s) |
| Input CIR current | ≤0.1μA | ≤0.1μA |
| Input impedance | >50MΩ | >50MΩ |
| Patient leak current |
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).