(104 days)
The device is a handheld, personal electrocardiograph unit, which can measure electrical activities of the heart easily and conveniently. It is immediately available at any time to manually record transient cardiac events, suitable for hospital or home health care use, which can detect, display and store ECG signal, and if possible, provide average heart rate message after ECG measurement. The users can use it themselves to check their heart condition.
It is suitable for the adult users, who suffers from cardio-vascular diseases, or the adult people who are caring about their heart working conditions during their daily life. This device is not intended for use as a conventional diagnostic tool, but use as a healthcare tool which can provide doctor the recorded data as references.
The product is not a conventional diagnostic tool.
The applicant device of Handheld ECG Monitor MD100 is a handheld device, which can records cardiac event data and displays the data in a clear and precise waveform. The ECG Monitor is made up of signal input unit, signal amplify unit, CPU, Display unit, power unit, and storage chip.
The MD100 Handheld ECG Monitor is activated by the user whenever symptoms are experienced. The recorded data serves as reliable evidence and are later shown to user or physicians or other health care professionals for confirmation of these symptoms. When a user feels that a cardiac event is occurring, the utilization of MD100 has the feature of recording this real time data that is normally difficult to capture. When tested, the Heart Rate Value is displayed.
The applicant device has "data upload" function which controlled by hardware, it can transmit the data measured by the device to computer via the USB port. The software attached with the device named " Keep-it-easy" in CD ROM, which is use for store and playback the data collected by MD100 ECG monitor. The "Keep-it-Easy" software needs to install in the computer by user. The "Keep-it-Easy" software CD ROM is the accessory of the applicant device.
The applicant device has low battery voltage indication function. The power of the monitor works supplied by 2* AAA batteries.
The provided text does not contain detailed acceptance criteria or a specific study proving the device meets said criteria in the format requested. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results.
Here's a breakdown of what can be extracted and what is missing, based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the device's ECG measurement accuracy, sensitivity, specificity, or similar. The document focuses on compliance with general safety and performance standards (IEC 60601-1, IEC 60601-1-2, AAMI EC38) and equivalence to the predicate device.
- Reported Device Performance: The document states that "Bench testing is performed to demonstrate safety and effectiveness and equivalency to the predicate device." It also mentions that the device "can detect, display and store ECG signal, and if possible, provide average heart rate message after ECG measurement." However, no specific performance metrics or comparative results from this bench testing are provided.
What would typically be expected for this section (but is missing):
| Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ECG Signal Quality | e.g., Meets AAMI EC38 standards for bandwidth, noise | (Specific SNR, bandwidth values) |
| Heart Rate Accuracy | e.g., ±5 bpm or 5% of true heart rate | (Specific accuracy, bias, precision) |
| Event Detection Rate | e.g., >90% sensitivity for specified arrhythmias | (Sensitivity, Specificity values) |
| Artifact Rejection | e.g., |
§ 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).