(24 days)
The COR12 ECG is intended for measuring the surface electrocardiogram (ECG) of a patient. The acquired ECG can be recorded and displayed on a screen or printed on paper. The COR12 ECG can be used for applications in patients age 4 years and older and a weight of 20 kg or higher. The COR12 ECG is intended to be used for routine ECG collection, recording both under resting and stress conditions. The measurement is performed by trained healthcare professionals under the direction of a physician in healthcare facilities (e.g. the doctor's office or hospital).
The COR12 ECG is intended for the recording of 12-lead ECG data of a patient by trained staff, e.g., nurse, doctor's assistant or the doctor. This can be performed as a resting or a stress ECG. It transmits the ECG data in a specified format by Bluetooth transmission to a customer-defined host software running with its own display, which is not part of the COR12. There is no display of ECG waveforms on the COR12.
Here's a breakdown of the acceptance criteria and study information for the COR12 ECG device, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The device is claiming substantial equivalence to its predicate (Vyntus ECG – K150810) by stating that they are identical in all aspects. Therefore, the "acceptance criteria" and "reported device performance" are assumed to be the same as the predicate device, as per the submission's claim of identicality.
| Feature / Acceptance Criteria | Reported Device Performance (COR12 ECG & Predicate) | Comment |
|---|---|---|
| Indications for Use | ||
| Measures Surface ECG | Yes | Identical |
| Records & Displays/Prints ECG | Yes | Identical |
| Patient Age | 4 years and older | Identical |
| Patient Weight | 20 kg or higher | Identical |
| Use Conditions | Routine ECG, resting and stress conditions | Identical |
| User | Trained healthcare professionals | Identical |
| Environment of Use | Healthcare facilities (doctor's office/hospital) | Identical |
| Technical Specifications | ||
| Records ECG only | Yes | Identical |
| Data output | Recorded and displayed on screen or printed | Identical |
| Records under | Resting and stress conditions | Identical |
| Dimensions (W x H x D) | 8.0 x 9.3 x 2.1 cm (3.3 x 3.7 x 0.8 in) | Identical |
| Weight (without battery) | 200 g (0.4 lbs) | Identical |
| 12-channel Surface ECG | Yes | Identical |
| Electrodes | Standard ECG electrodes | Identical |
| Electrode Connection | 4 mm snap, gilded | Identical |
| ECG signal Technology | Impedance measurement | Identical |
| Accuracy of ECG signal | 1.94 μV/bit resolution (at 500 Hz sampling) | Identical |
| Filter | Bandpass 0.05 Hz – 150 Hz, No line filter | Identical |
| Pacemaker detection | 4000 Hz | Identical |
| Operating Temperature | 10 – 37 °C | Identical |
| Ambient Pressure | 700 to 1060 hPa | Identical |
| Humidity | 5 – 95% RH (not condensing) | Identical |
| Power Supply | 1x AA Alkaline or rechargeable NiMH battery | Identical |
| Runtime (with AA battery) | > 5h | Identical |
| Runtime (with NiMH battery) | > 8h (2850 mAh) | Identical |
| Current Consumption | 230 mA (Operation) / 185 mA (Idle) | Identical |
| Protection Classification | Device with internal power supply, Type CF | Identical |
| Recovery Time (defibrillation) |
§ 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).