(116 days)
Digital Electrocardiograph is 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 disease. Digital Electrocardiograph shall be used in healthcare facilities by doctors and/or trained healthcare professionals.
Digital Electrocardiograph, ECG-2000, is intended to acquire ECG signals from adult patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease.
It consists of the acquisition box, optional accessories, installation CD, and USB dongle. The acquisition box is connected with ECG electrodes, and intends to acquire ECG signals from patient. The acquired ECG signal is filtered and amplified, then transferred to the working station. The acquisition box is powered by the working station via a USB line. The working station is a Personal Computer installed with ECG-2000 Software, it intends to receive the processed ECG signal from the acquisition box, and further display and record the signals. Optional accessories include lead wires, limb electrodes and chest electrodes, and general-purpose printer (with USB interface, support PCL language, such as HP1010, P2035, and P2055d series). The CD contains Digital Electrocardiograph installer and dongle installation program module.
The provided document is a 510(k) premarket notification for a Digital Electrocardiograph, Model: ECG-2000. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study to prove the device meets acceptance criteria derived from a novel clinical trial.
Here's an analysis based on the provided text:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly define "acceptance criteria" in the context of a clinical performance study with specific metrics like sensitivity, specificity, accuracy, etc. Instead, it demonstrates compliance with technical specifications and safety standards to establish substantial equivalence. The "performance" reported is primarily in terms of meeting these engineering and safety benchmarks.
| Feature | Predicate Device 1 (K092010)
Description / Value | Proposed Device (ECG-2000)
Reported Performance |
|-----------------------|----------------------------------------------------|---------------------------------------------------|
| Product Code | DPS | DPS (Same) |
| Regulation Number | 21 CFR 870.2340 | 21 CFR 870.2340 (Same) |
| Class | Class II | Class II (Same) |
| Intended Use | Acquire ECG signals from adult patients to help analyze and diagnose heart disease. Used by healthcare professionals. | Acquire ECG signals from adult and pediatric patients to help analyze and diagnose heart disease. Used by healthcare professionals. (Similar: extended to pediatric patients)|
| Configuration | Chest Electrode and Limb Electrode | Chest Electrode and Limb Electrode (Same) |
| ECG Lead | Standard 12-lead | Standard 12-lead (Same) |
| ECG Gain | (Implied range from "Similar" to proposed device) | 1.25, 2.5, 5, 10, 20, 10-5, 20-10 (mm/mV) (More options than Predicate 1, Same as Predicate 2) |
| Sampling rate | 1000Hz | 1000Hz (Same) |
| Input circuit current | (Implied value from "Similar" to proposed device, complies with IEC 60601-1) | $\leq$ 0.1 μA (Complies with IEC 60601-1) |
| Noise level | (Implied value from "Similar" to proposed device, complies with IEC 60601-1) | $
§ 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).