(17 days)
The proposed Mortara ELI 280 Electrocardiograph is a non-invasive prescription device.
- The device is indicated for use to acquire, analyze, display and print electrocardiograms.
- The device is indicated for use to provide interpretation of the data for consideration by a physician.
- The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis.
- The interpretations of ECG offered by the device are only significant when used in conjunction with a physician over-read as well as consideration of all other relevant patient data.
- The device is indicated for use on adult and pediatric populations.
- The device is not intended to be used as a vital signs physiological monitor.
The proposed Mortara Instrument ELI 280 is multi-channel, resting electrocardiograph utilizing a color LCD with touch screen for display of ECG waveforms, custom keyboard, menu options and status information. The proposed modification to the ELI 280 will simultaneously acquire data from 12 lead patient cables, up to 15 leads when available. Once the data is acquired, it can be reviewed, and/or stored, and/or printed with optional resting ECG interpretation provided for physician over-read.
The ELI 280 is able to acquire, analyze, display and print electrocardiograms acquired through the Mortara front-end amplifier. The size of the screen will allow preview of the record for technician to assess the quality of the acquired ECG.
The ELI 280 utilizes a color touch screen LCD for display of ECG waveforms, custom keyboard, menu options and status information. The touch screen overlay on the LCD display allows the user to interact with the cardiograph by touching areas on the screen for select functions, input demographic parameters and navigate through menus using the touch screen interface. The keyboard is part of the ELI 280 touch screen design and allows patient data entry as well as control of the functions and options available for the unit.
The ELI 280 incorporates a thermal writer that allows printouts using several formats available to the user, from the 6+6 channels to the Cabrera formats. The writer is also used by the unit for real time, continuous rhythm printouts. The ELI 280 offers, adult and pediatic interpretation capability to assist the physician over-read of the electrocardiogram, and review the electrocardiogram to identify the best 10 second sample based on noise.
The ELI 280 is intended to be used with the Mortara Wireless Acquisition Module (WAM) and Mortara Acquisition Module (AM12) patient cables. The ELI 280 acquires ECG waveforms from the AM12 patient cable. The ELI 280 also offers storage capability in order to retrieve or transmit stored records. Transmission can be achieved using one of the options communication media designed in the unit: LAN, WLAN, USB port and/or Modem.
The provided text is a 510(k) summary for the ELI 280 Electrocardiograph. It describes the device, its intended use, and indications for use. However, it does not contain information about acceptance criteria, device performance, studies conducted, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot fulfill your request for the specific details about acceptance criteria and study information as these are not present in the provided text.
The 510(k) summary primarily focuses on establishing substantial equivalence to a predicate device (ELI 250(c) Electrocardiograph (K101403)) and describing the device's basic functionalities and intended use. Performance claims and supporting data are typically detailed in the full 510(k) submission, which is not provided here.
§ 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).