(68 days)
- 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 populations.
- The device is indicated for use on pediatric populations for acquisition, display, and printing of multi-. channel ECGs.
- The device is not intended to be used as a vital signs physiological monitor. .
The ELI 350 is a multi-channel, high-end interpretive electrocardiograph. The ELI 350 provides simultaneous multi-channel acquisition and is designed to be installed on a transport car. Its design is a "clam-shell" style, with a 17" color LCD screen that can be closed over the printer when the unit is shipped or not used. The ELI 350 is able to acquire, analyze, display and print electrocardiograms acquired through its internal Mortara front-end amplifier. The size of the screen will size preview of the record for the technician to assess the quality of the acquired ECG.
The ELI 350 will use a 17" SXGA (1280 x 1024 pixel) color LCD for display of ECG waveforms, menu options and status information. A full size keyboard is part of the ELI 350 design and allows patient data entry as well as control of the functions available for the unit. The ELI 350 custom keyboard will include alphabetic, numeric, symbol, cursor control and special function keys. The ELI 350 incorporates a full size thermal writer (8.5" x 11") 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 printout.
The ELI 350 will offer storage capability in order to retrieve or transmit stored records. Transmission can be achieved using one of the optional communication media designed in the unit: RS 232, LAN, WLAN, USB port, GSM module.
This document describes a 510(k) submission for the Mortara ELI 350 Electrocardiograph, a device for acquiring, analyzing, displaying, and printing electrocardiograms. However, the provided text does not contain any information regarding specific acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement.
The document primarily focuses on:
- Device Description: Features and capabilities of the ELI 350.
- Intended Use: The general purpose of the device.
- Indications for Use: Specific clinical applications approved by the FDA.
- Predicate Device: The ELI 300, to which substantial equivalence is claimed.
- FDA 510(k) Clearance Letter: Confirming the device's substantial equivalence.
Therefore, I cannot fulfill your request to describe the acceptance criteria and study that proves the device meets them because that information is not present in the provided text. The document is for a "Special 510(k): Device Modification," which often means the core safety and effectiveness studies were conducted for the predicate device, and the current submission focuses on demonstrating that the modifications do not negatively impact those aspects.
To answer your questions, I would need a different document (e.g., the test report, clinical study protocol, or detailed specifications) that outlines the performance evaluation of the ELI 350.
§ 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).