(195 days)
Digital Electrocardiographs, IE3/ IE12/ IE12P/ IE15, are intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.
Digital Electrocardiographs, IE3/ IE12/ IE12/ IE15, are designed to acquire, analyze, display and record ECG signals from patient body surface by ECG electrodes. After been amplified, filtered and analyzed, the ECG signals waveforms and analysis results are displayed in the LCD and recorded in the paper through thermal printer. ECG data, analysis result and patient information could be stored in the memory of the device.
The device consists of three modules, which are power supply module, amplification module, and control module.
The device has three recording mode, AUTO mode, MAN mode and RHY mode,
They are standard twelve leads, including bipolar limb leads, augmented unipolar limb leads and unipolar chest leads.
The provided 510(k) summary for K131262 does not contain information related to a clinical study or performance data against specific acceptance criteria for the device's diagnostic capabilities. Instead, it focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing and technical specifications.
Therefore, many of the requested sections regarding acceptance criteria, study details, and performance metrics cannot be directly addressed from the provided document.
Here's a breakdown of what can be extracted and what is missing:
Description of Acceptance Criteria and Device Performance
The submission focuses on establishing substantial equivalence to predicate devices (K122712 and K123816) based on technical specifications and compliance with international standards, rather than defining specific diagnostic acceptance criteria for the device's analytical function.
The non-clinical tests were conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate devices. The test results demonstrated compliance with the following standards:
- IEC 60601-1:1990+ A1:1993+ A11:1993+ A12:1993+ A13:1996, Medical electrical equipment, Part 1: General requirements for safety.
- IEC 60601-2-25:1993+A1:1999. Medical electrical equipment, Part 2-25: Particular requirements for the safety of electrocardiographs.
- IEC 60601-1-2: 2007, Medical electrical equipment, Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and tests.
Table of Acceptance Criteria and Reported Device Performance (Based on Technical Specifications and Compliance to Standards):
| Acceptance Criteria (from Predicate/Standard Compliance) | Reported Device Performance (K131262 Device) |
|---|---|
| Intended Use (Similar to predicates) | Acquires ECG signals, helps users analyze/diagnose heart disease |
| Lead (Standard 12-lead) | Standard 12-lead |
| Acquisition mode (Simultaneous 12-lead acquisition) | Simultaneous 12-lead acquisition |
| Recording format (Automatic / Manual / Rhythm) | Automatic / Manual / Rhythm |
| Analysis mode (No integrated analysis) | No (similar to predicates) |
| CMRR (>60dB, >100 with AC filter) | >60dB, >100 with AC filter |
| Paper Speed (4 or 6 levels) | 4 levels (6.25, 12.5, 25, 50mm/s) OR 6 levels (5, 6.25, 10, 12.5, 25, 50mm/s) |
| Input CIR current (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).