(88 days)
The ELI 350 is intended to be a high-performance, 15-lead, multifunctional electrocardiograph. As a resting electrocardiograph, ELI 350 simultaneously acquires data from 15 leads. Once the data is acquired, it can be reviewed and/or stored, and/or printed. It will be a device primarily intended for use in hospitals, but may be used in medical clinics and offices of any size.
Indications for Use:
- 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 ELI 350 is a multi-channel, high-end resting interpretation electrocardiograph. The ELI 350 simultaneously acquires data from up to 15 leads. Once the data is acquired, it can be reviewed, and/or stored, and/or printed. The electrocardiogram (ECG) is a graphic description of the electrical activity of the heart. This activity is recorded from the body surface by a group of electrodes positioned at predefined places to reflect the activity from different perspectives. The cardiac data acquired and provided by the ELI 350 is used by trained medical personnel to assist in the diagnosis of symptomatic patients with various rhythm patterns. The ELI 350 is designed to be installed on a transport cart. 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 in use. 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 allow a full size preview of the record for the technician to assess the quality of the acquired ECG. The ELI 350 uses 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.
The provided document describes a 510(k) submission for a device modification (K082946: ELI 350 Electrocardiograph). This is a traditional 510(k) for a hardware device (electrocardiograph) and does not involve AI or a software algorithm requiring detailed performance studies with acceptance criteria in the manner requested. The document does not contain information on acceptance criteria for algorithm performance, study design, sample sizes, expert qualifications, or ground truth establishment relevant to AI/algorithm performance.
Therefore, I cannot extract the requested information as it is not present in the provided text. The document focuses on the device description, intended use, indications for use, and regulatory classification within the context of a 510(k) submission for a hardware device modification to an existing predicate.
§ 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).