(197 days)
Yes
The summary explicitly mentions the "VERITAS Pediatric ECG Interpretation algorithm" and describes a performance study comparing its interpretations to those of a cardiologist. While not explicitly labeled as AI/ML, the term "algorithm" in the context of automated interpretation of complex biological signals like ECGs, especially with a focus on performance evaluation against human experts, strongly suggests the use of advanced computational techniques, likely including ML. The description of a test set and performance evaluation further supports this.
No
The device is an electrocardiograph used for acquiring, analyzing, and displaying ECG data for diagnostic purposes, not for providing therapy.
Yes
The device provides "interpretation of the data for consideration by a physician" and assists in assessing the quality of acquired ECGs, even though it is not intended as a sole means of diagnosis and requires physician over-read.
No
The device description explicitly details hardware components such as a multi-channel portable electrocardiograph, internal Mortara front-end amplifier, monochrome LCD, and a custom keyboard. It also mentions the ability to connect to external, optional printers and various communication media. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine specimens outside of the body.
- Device function: The ELI 10 Electrocardiograph acquires, analyzes, displays, transmits, prints, records, and stores electrocardiograms. This involves measuring electrical activity of the heart directly from the patient's body using electrodes placed on the skin.
- No mention of samples: The description does not mention the analysis of any biological samples taken from the patient.
Therefore, the ELI 10 Electrocardiograph is a medical device used for physiological measurement, not an in vitro diagnostic device.
No
The provided text does not contain any explicit statement that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
- The device is intended to be a high-performance, multifunctional electrocardiograph. As a resting electrocardiograph, ELI 10 simultaneously acquires data from multiple channels. Once is is acquired, it can be reviewed, stored, transmitted and/or printed. It will be a device primarily intended for use in hospitals, but may be used in mobile environments (including pre-hospital, emergency meticals enviras, ambulance and patient transport), medical clinics and offices of any size.
Indications for Use:
- . The device is indicated for use to acquire, analyze, display, transmit, print, record and store 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, or mobile environments (including pre-hospital, emergency medical services, ambulance and patient transport), 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
DPS
Device Description
The ELI 10 is a multi-channel, portable electrocardiograph. The ELI 10 simultaneously acquires data from up to 12 leads. Once the data is acquired, it can be reviewed, stored, transmitted and/or printed (using an external, optional printer).
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 10 is used by trained medical personnel to assist in the diagnosis of symptomatic patients with various rhythm patterns.
The ELI 10 is designed to be installed on a transport cart. The ELI 10 is able to acquire, analyze, display, transmit, print, record and store electrocardiograms acquired through its internal Mortara front-end amplifier. The size of the screen will allow preview of the technician to assess the quality of the acquired ECG.
The ELI 10 utilizes a monochrome LCD for display of ECG waveforms, menu options and status information. A custom keyboard is part of the ELI 10 design and allows patient data entry as well as control of the functions and options available for the unit. The ELI 10 custom keyboard includes alphabetic, numeric, symbol, cursor control and special function keys. When an ECG is acquired, a preview will be displayed in this window. The ECG format used to display the waveforms will the configured printing format. Gain, speed and filter are applied to both screen and printout at the same time (Printing function available only through an external optional printer).
The ELI 10 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: Modem, LAN, VolvaN, GSM/GPRS, and/or USB port.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart
Indicated Patient Age Range
adult and pediatric populations
Intended User / Care Setting
used in hospitals, but may be used in mobile environments (including pre-hospital, emergency meticals enviras, ambulance and patient transport), medical clinics and offices of any size.
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
Approximately 1300 15-lead ECG's (standard 12 leads plus V3R. V4R and V7) were randomly collected in various pediatric cardiology centers. ECG's from this database were submitted to a cardiologist without automatic interpretation (blind reading) and in a standard 3x5 format at 10 mm/mV and 25 mm/s. The same ECGs were interpreted by the VERITAS Pediatic ECG Interpretation algorithm.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance obtained by the algorithm is considered clinically acceptable. ELI 10 utilizes the same VERITAS Interpretive Algorithm as the ELI 350 (K082946).
The performance of the ELI 10 Electrocardiograph within a mobile environment has been süccessfully evaluated. The device therefore, performs as safety and effectively as the legally marketed predicate device.
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
Image /page/0/Picture/1 description: The image shows the word "Mortara" in bold, black font. Above the word is a black geometric shape that resembles an abstract letter "M". The logo is simple and modern, with a focus on the company name.
Abbreviated 510(k) Notification
510(k): ELI 10 Electrocardiograph Device Summary
FEB 1 8 2011
Submitter:
Date: November 18, 2010
Charles Morreale, Regulatory Affairs Manager Mortara Instrument, Inc. 7865 N. 86th Street Milwaukee, WI 53224 Fax: (414) 354-4760 Phone: (414) 354-1600 Contact: Charles Morreale (see above)
Trade Name: ELI 10 Electrocardiograph Common Name: Electrocardiograph Classification Name: Electrocardiograph (Per 21 CFR 870.2340)
Legally marketed devices to which S. E. is claimed
The Mortara Instrument ELI 10 Electrocardiograph is the next generation of the Mortara ELI 10 and is substantially equivalent to the legally marketed predicate device:
The proposed ELI 10 is a modification of the Mortara predicate device. It will include the addition of Pediatric Criteria for the VERITAS™ Interpretive Algorithm and the ability to be utilized in a mobile environ or n (including pre-hospital, emergency medical services, ambulance and patient transport) with the current technology resulting in the next generation, Mortara ELI 10 Electrocardiograph.
Description:
The ELI 10 is a multi-channel, portable electrocardiograph. The ELI 10 simultaneously acquires data from up to 12 leads. Once the data is acquired, it can be reviewed, stored, transmitted and/or printed (using an external, optional printer).
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 10 is used by trained medical personnel to assist in the diagnosis of symptomatic patients with various rhythm patterns.
The ELI 10 is designed to be installed on a transport cart. The ELI 10 is able to acquire, analyze, display, transmit, print, record and store electrocardiograms acquired through its internal Mortara front-end amplifier. The size of the screen will allow preview of the technician to assess the quality of the acquired ECG.
The ELI 10 utilizes a monochrome LCD for display of ECG waveforms, menu options and status information. A custom keyboard is part of the ELI 10 design and allows patient data entry as well as control of the functions and options available for the unit. The ELI 10 custom keyboard includes alphabetic, numeric, symbol, cursor control and special function keys. When an ECG is acquired, a preview will be displayed in this window. The ECG format used to display the waveforms will the configured printing format. Gain, speed and filter are applied to both screen and printout at the same time (Printing function available only through an external optional printer).
1
Abbreviated 510(k) Notification
The ELI 10 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: Modem, LAN, VolvaN, GSM/GPRS, and/or USB port.
Intended Use:
The ELI 10 is intended to be a high-performance, multifunctional electrocardiograph. As a resting electrocardiograph, ELI 10 simultaneously acquires data from multiple channels. Once is is acquired, it can be reviewed, stored, transmitted and/or printed. It will be a device primarily intended for use in hospitals, but may be used in mobile environments (including pre-hospital, emergency meticals enviras, ambulance and patient transport), medical clinics and offices of any size.
Indications for Use:
- . The device is indicated for use to acquire, analyze, display, transmit, print, record and store 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, or mobile environments (including pre-hospital, emergency medical services, ambulance and patient transport), 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.
Testing Performed and Summary Discussion:
The following testing was performed to support a determination of substantial equivalence for the ELI 10 Electrocardiograph: Medical Electrical Equipment - General Requirements for Safety, Electromagnetic Compatibility, Safety Requirements for Medical Electrical Systems, Particular Requirements for the Safety of Electrocardiographs and Protection Against Hazardous Output; Operating Temperature; Mobile Configuration Operating and Non-operating Vibration; Mobile Configuration Operating and Non-operating Shock; ECG Safe Current Limits for Electromechanical Apparatus; and ECG Performance.
The ELI 10 modification includes the capability for the addition of Pediatric Criteria for the VERITAS Interpretive Algorithm that was included within the cleared 510(k) Premarket Notification (K082946) and the ability utilize the ELI 10 within mobile environments (including pre-hospital, emergency medical services, ambulance and patient transport).
Approximately 1300 15-lead ECG's (standard 12 leads plus V3R. V4R and V7) were randomly collected in various pediatric cardiology centers. ECG's from this database were submitted to a cardiologist without automatic interpretation (blind reading) and in a standard 3x5 format at 10 mm/mV and 25 mm/s. The same ECGs were interpreted by the VERITAS Pediatic ECG Interpretation algorithm. The performance obtained by the algorithm is considered clinically acceptable. ELI 10 utilizes the same VERITAS Interpretive Algorithm as the ELI 350 (K082946).
The performance of the ELI 10 Electrocardiograph within a mobile environment has been süccessfully evaluated. The device therefore, performs as safety and effectively as the legally marketed predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Mortara Instruments, Inc. c/o Mr. Charles Morreale Regulatory Affairs Manager 7865 North 86th Street Milwaukee, WI 53224-3431
FEB 18 20:1
Re: K102206
Trade/Device Name: ELI 10 Electrocardiograph Regulatory Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (Two) Product Code: DPS Dated: December 27, 2010 Received: December 28, 2010
Dear Mr. Morreale:
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 - Mr. Charles Morreale
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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
lf 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,
0: 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): K1022
Device Name: Mortara ELI 10 Electrocardiograph
Indications for Use:
- . The device is indicated for use to acquire, analyze, display, transmit, print, record and store 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, or mobile environment (including prehospital, emergency services, ambulance and patient transport), 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. .
Prescription Use × AND/OR (Part 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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
W.M.S.
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K102206
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