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.

Device Description

The ELI 250 is multi-channel, resting interpretation electrocardiographs. The ELI 250 simultaneously acquires data from up to 12 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 250 is used by trained medical personnel to assist in the diagnosis of symptomatic patients with various rhythm patterns.
The ELI 250 is designed to be installed on a transport cart. The ELI 250 is able to acquire, analyze, display and print electrocardiograms acquired through its internal Mortara front-end amplifier. The size of the screen will allow preview of the record for the technician to assess the quality of the acquired ECG.
The ELI 250 utilizes a monochrome (or optional color) LCD for display of ECG waveforms, menu options and status information. A custom keyboard is part of the ELI 250 design and allows patient data entry as well as control of the functions and options available for the unit. The ELI 250 custom keyboard will include alphabetic, numeric, symbol, cursor control and special function keys. The ELI 250 incorporates a thermal writer that allows printouts using several formats available to the user, from the standard to the Cabrera formats. The writer is also used by the unit for real time, continuous rhythm printout.
The ELI 250 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, and / or Modem.

AI/ML Overview

The Mortara ELI 250 Electrocardiograph is intended to acquire, analyze, display, and print electrocardiograms, providing interpretation of data for physician consideration in a clinical setting for both adult and pediatric populations. It is not intended as a sole means of diagnosis or a vital signs monitor. Its primary upgrade from the predicate device (ELI 200) is the addition of pediatric criteria to the VERITAS Interpretive Algorithm.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state numerical "acceptance criteria" for the VERITAS Interpretive Algorithm's performance concerning pediatric criteria. Instead, it states that the algorithm's performance was evaluated by calculating Sensitivity, Specificity, Positive Predictive Accuracy, and Negative Predictive Accuracy. These metrics are then included in the "Physician's Guide to VERITAS with Adult and Pediatric Resting ECG Interpretation."

Since specific numerical acceptance criteria and the exact reported performance values are not provided in this 510(k) summary, the table below reflects the general approach.

Performance Metric	Acceptance Criteria (Not explicitly stated in the document)	Reported Device Performance (Not explicitly stated in the document)
Sensitivity	(Implied to be clinically acceptable)	Calculated and provided in the Physician's Guide
Specificity	(Implied to be clinically acceptable)	Calculated and provided in the Physician's Guide
Positive Predictive Accuracy	(Implied to be clinically acceptable)	Calculated and provided in the Physician's Guide
Negative Predictive Accuracy	(Implied to be clinically acceptable)	Calculated and provided in the Physician's Guide

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: "Clinical ECGs were randomly collected from various pediatric cardiology centers." The exact number of ECGs in the test set is not specified in the document.
Data Provenance:
- Country of Origin: Not explicitly stated, but "various pediatric cardiology centers" suggests a clinical environment, likely within the United States given the FDA submission.
- Retrospective or Prospective: Not explicitly stated, but the description "clinical ECGs were randomly collected" suggests a retrospective collection of existing data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Number of Experts: "submitted to a cardiologist for reading" - This implies one expert was used.
Qualifications of Experts: This expert was a "cardiologist." No further details on years of experience or sub-specialty (e.g., pediatric cardiologist) are provided.

4. Adjudication Method for the Test Set

The document states that the ECGs were "submitted to a cardiologist for reading without automatic interpretation (blind reading)." This indicates a single-reader assessment.
There's no mention of an adjudication method involving multiple experts (e.g., 2+1, 3+1).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was explicitly mentioned or described. The study focused on the algorithm's standalone performance against a cardiologist's blind reading.
Therefore, there is no reported effect size of human readers improving with AI vs. without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

Yes, a standalone performance evaluation was conducted. The study compared the "VERITAS Pediatric ECG Interpretation algorithm" directly against the "cardiologist for reading without automatic interpretation (blind reading)."

7. Type of Ground Truth Used

The ground truth was established by expert opinion/reading. Specifically, it was the "reading without automatic interpretation (blind reading)" performed by a cardiologist.

8. Sample Size for the Training Set

The document does not specify the sample size used for training the VERITAS Interpretive Algorithm for its pediatric criteria. It only mentions that the "ELI 250 utilizes the same VERITAS Interpretive Algorithm as the predicate device" and that the current submission is for the addition of "pediatric criteria."

9. How the Ground Truth for the Training Set Was Established

The document does not describe how the ground truth for the training set was established. It only focuses on the evaluation (test set) of the added pediatric criteria. Given that the algorithm existed prior (in the predicate device), the training process for previous versions and for the pediatric criteria is not detailed here.

Summary

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Image /page/0/Picture/1 description: The image shows the Mortara logo. The logo consists of a heart shape above the word "Mortara" in a bold, sans-serif font. The heart shape is white against a black background, while the word "Mortara" is black.

Abbreviated 510(k) Notification

510(k): ELI 250 Electrocardiograph Device Summary

JUL-2 2010

Submitter:

Date: May 25, 2010

Primary Contact:	Chien Hui (Amy) Yang, Regulatory Affairs Engineer(414) 354-1600 Ext. 7727(414) 354-4760 (facsimile)amy.yang@mortara.com
Secondary Contact:	Charles Morreale, Regulatory Affairs Manager(414) 354-1600 Ext. 7768(414) 354-4760 (facsimile)chuck.morreale@mortara.com
Mortara Instrument, Inc.7865 N. 86 th StreetMilwaukee, WI 53224
Trade Name:	ELI 250 Electrocardiograph

Common Name:	Electrocardiograph
Classification Name:	Electrocardiograph
	(Per 21 CFR 870.2340)

Legally marketed devices to which S. E. is claimed

The Mortara Instrument's ELI 250 Electrocardiograph is the Mortara ELI 200 and is substantially equivalent to the legally marketed predicate devices:

ELI 200 by Mortara Instrument (K920626) .
. ELI 200+ Audicor by Mortara Instrument (K031182)
ELI 350 by Mortara Instrument (K082946) ●

The proposed ELI 250 is a modification of the Mortara predicate device. It will include the addition of Pediatric Criteria for the VERITAS™ Interpretive Algorithm with the current technology resulting in the next generation Mortara ELI 250 Electrocardiograph.

Description:

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 250 is used by trained medical personnel to assist in the diagnosis of symptomatic patients with various rhythm patterns.

The ELI 250 is designed to be installed on a transport cart. The ELI 250 is able to acquire, analyze, display and print electrocardiograms acquired through its internal Mortara front-end amplifier. The size of the screen will allow preview of the record for the technician to assess the quality of the acquired ECG.

The ELI 250 utilizes a monochrome (or optional color) LCD for display of ECG waveforms, menu options and status information. A custom keyboard is part of the ELI 250 design and allows patient data entry as well as control of the functions and options available for the unit. The ELI 250 custom keyboard will include

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Image /page/1/Picture/1 description: The image shows the logo for Mortara. The logo consists of a stylized heart shape above the word "Mortara". The heart is white and is surrounded by a black border. The word "Mortara" is in a bold, sans-serif font and is also black.

Abbreviated 510(k) Notification

alphabetic, numeric, symbol, cursor control and special function keys. The ELI 250 incorporates a thermal writer that allows printouts using several formats available to the user, from the standard to the Cabrera formats. The writer is also used by the unit for real time, continuous rhythm printout.

The ELI 250 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, and / or Modem.

Intended Use:

The ELI 250 is intended to be a high-performance, 12-lead, multifunctional electrocardiograph. As a resting electrocardiograph, ELI 250 simultaneously acquires data from 12 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. .

Summary discussion:

The ELI 250 modification includes the addition of pediatric criteria to the VERITAS Interpretive Algorithm that was previously cleared through 510(k) Premarket Notification (K082946). Clinical ECGs were randomly collected from various pediatric cardiology centers. These ECGs were then submitted to a cardiologist for reading without automatic interpretation (blind reading) and in a standard 3x5 format at 10 mm/mV and 25 mm/s. The same ECGs were also interpreted by the VERITAS Pediatric ECG Interpretation algorithm.

This data was utilized to calculate the Sensitivity, Specificity, Positive Predictive Accuracy and Negative Predictive Accuracy for the algorithm. This information is provided within the Physician's Guide to VERITAS with Adult and Pediatric Resting ECG Interpretation.

ELI 250 utilizes the same VERITAS Interpretive Algorithm as the predicate device. The main subject of this 510(k) submission is the evolution of the ELI 250 through a software modification to incorporate the Mortara VERITAS Interpretive Algorithm with pediatric criteria. Therefore, the modified device performs as safety and effectively as the legally marketed predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an image of an abstract eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUL -- 2 2010

Mortara Instrument, Inc. c/o Chien Hui (Amy) Yang Regulatory Affairs Engineer 7865 North 86th Street Milwaukee, WI 53224

Re: K101403

Trade/Device Name: ELI 250 Electrocardiograph Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiographs Regulatory Class: Class II (two) Product Code: DPS Dated: May 14, 2010 Received: May 19, 2010

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. Iisting 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.

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

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Page 2 - Ms. Chien Hui (Amy) Yang

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.

1f you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.tda.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

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Indications for Use

1/101403 510(k) Number (if known):

Device Name: Mortara ELI 250 Electrocardiograph

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 re device is indicated for use in a simisal obtaing, by a provinced as a sole means of diagnosis.
· The interpretations of ECG offered by the device are only significant when used in conjunctions deta 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 (Part 21 CFR 801 Subpart D) AND/OR

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)

Page 1 of 1

W. Ward

Division Sian-C on of Cardiovascular Devices

510(k) Number K10403

Regulation Number and Section

§ 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).