(89 days)
The intended use of the 3-Channel Electrocardiograph is to acquire ECG signals from adult and pediatric patients (beginning at birth through 21 years of age) through body surface ECG electrodes. The electrocardiograph is intended to be used only in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the 3-Channel Electrocardiograph can help users to analyze and diagnose heart disease. However, the ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only.
SE-3 Series (including SE-3, SE-300A, SE-300B, and SE-301) 3-channel electrocardiograph gathers ECG signals of 12 leads simultaneously. While all 12 leads are recorded and analyzed, printouts will only have 3 leads on a page, with 4 pages in series to output all 12 leads. It displays the operation menu, ECG parameters as well as electrocardiograms.
This document describes a 510(k) premarket notification for Electrocardiographs Models SE-3, SE-300A, SE-300B, and SE-301 by Edan Instruments, Inc. It seeks to demonstrate substantial equivalence to previously cleared predicate devices.
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as quantitative targets in terms of diagnostic accuracy metrics. Instead, the document relies on demonstrating that the proposed devices (SE-3, SE-300A, SE-300B, and SE-301) perform comparably to the predicate devices (SE-3, SE-300A, SE-300B - K091513, and reference devices SE-601C - K131503, SE-12 Series - K160876). The comparison is primarily focused on technical specifications and safety standards.
The closest to "performance" in a diagnostic sense relates to the ECG interpretation features.
| Acceptance Criteria Category | Specific Criteria (Implicitly "comparable to predicate") | Reported Device Performance |
|---|---|---|
| Intended Use | Same as predicate (acquire ECG from adult and pediatric patients, analyze and diagnose heart disease on an advisory basis). | Same |
| Safety Specifications | Compliance with relevant IEC standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-25). | Complies with IEC 60601-1:2005/A1:2012, IEC 60601-1-2:2007 (for all models). SE-301 specifically mentions compliance to IEC 60601-1:2005/A1:2012 and EN 60601-1:2006/A1:2013, IEC 60601-1-2:2007, EN 60601-1-2:2007/AC:2010, IEC 60601-2-25:2011. |
| Biocompatibility | Compliance with ISO 10993-1 for surface-contacting devices ( |
§ 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).