(17 days)
Not Found
No
The document describes standard electrocardiograph functionality including acquisition, analysis, display, and printing of ECG data with interpretation for physician over-read. There is no mention of AI or ML in the device description, intended use, or any other section. The analysis and interpretation capabilities described are typical for traditional ECG devices and do not imply the use of AI/ML.
No
The device is described as an "Electrocardiograph," which is used to acquire, analyze, display, and print electrocardiograms, and provide interpretation for consideration by a physician. It is not intended as a sole means of diagnosis and is explicitly stated as "not intended to be used as a vital signs physiological monitor." Its purpose is diagnostic, not therapeutic.
Yes
The device is indicated for use to provide interpretation of the data for consideration by a physician, which is part of the diagnostic process. While it states it's not a sole means of diagnosis, it clearly states its role in providing interpretation for diagnostic consideration.
No
The device description explicitly mentions hardware components such as a color LCD with touch screen, custom keyboard, thermal writer, and patient cables (WAM and AM12). It also describes the acquisition of data through a "Mortara front-end amplifier." These are all physical components, indicating it is not a software-only device.
Based on the provided information, the Mortara ELI 280 Electrocardiograph is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- ELI 280 Function: The ELI 280 acquires, analyzes, displays, and prints electrocardiograms. This involves measuring electrical activity of the heart through electrodes placed on the body surface. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's a non-invasive prescription device used to acquire and analyze ECG data from the patient, not from a specimen.
Therefore, the ELI 280 falls under the category of a non-invasive diagnostic device, specifically an electrocardiograph, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ELI 280 is intended to be a high-performance, multi-channel, interpretive electrocardiograph. As a resting electrocardiograph, ELI 280 simultaneously acquires data from multiple channels. 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. It will be a device primarily intended for use in hospitals, but may be used in medical clinics and offices of any size.
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.
Product codes
74 DPS
Device Description
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 acquiré, 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric populations
Intended User / Care Setting
It will be a device primarily intended for use in hospitals, but may be used in medical clinics and offices of any size.
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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
510k Summary
Special 510(k) Notification
AUG 2 2012
510(k): ELI 280 Electrocardiograph Device Summary
Submitter:
Date: July 10, 2012
Chien Hui (Amy) Yang, Regulatory Affairs Engineer Mortara Instrument, Inc. 7865 N. 86" Street Milwaukee, WI 53224 (414) 354-4760 FAX: (414) 354-1600 Phone: Contact: Amy Yang (see above)
| Trade Name: | ELI 280 Electrocardiograph |
|---|---|
| Common Name: | Electrocardiograph |
| Classification Name: | Electrocardiograph |
| (Per 21 CFR 870.2340) |
Legally marketed devices to which S.E. is claimed:
The ELI 280 is an update to the ELI Series Electrocardiographs and is substantially equivalent to ELI 250(c) Electrocardiograph (K101403) and other Mortara devices presently in distribution
Description:
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 acquiré, 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.
1
Image /page/1/Picture/16 description: The image shows a white heart shape inside of a black square. The heart is centered in the square, and the top of the heart is slightly rounded. The black square provides a stark contrast to the white heart, making it stand out. The image is simple, but the contrast between the colors makes it visually appealing.
Special 510(k) Notification
Intended Use:
The ELI 280 is intended to be a high-performance, multi-channel, interpretive electrocardiograph. As a resting electrocardiograph, ELI 280 simultaneously acquires data from multiple channels. 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. 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 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.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle faces right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG 2 2012
Mortara Instrument, Inc. c/o Ms. Any Yang Regulatory Affairs Engineer 7865 N 86th Street Milwaukee, WI 53224
Re: K122073
Trade/Device Name: ELI 280 Electrocardiograph Regulatory Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: II (two) Product Code: 74 DPS Dated: July 11, 2012 Received: July 16, 2012
Dear Ms. Yang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Ms. Any Yang
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21. CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Mortara ELI 280 Electrocardiograph Device Name:
Indications for Use:
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 . coniunction 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.
Prescription Use × AND/OR (21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Vision Sign-Off) (Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K122023
Concurrence of CDRH, Office of Device Evaluation (ODE)
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