The ELI 150 is intended to be a high-performance, 12-lead, multifunctional electrocardiograph. As a resting electrocardiograph, ELI 150 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.

Device Description

The ELI 150 is multi-channel, resting interpretation electrocardiographs. The ELI 150 simultaneously acquires data from up to 12 leads. Once the data is acquired, it can be reviewed, and/or printed.

The electrocardiogram (ECG) is a graphic description 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 150 is used by trained medical personnel to assist in the diagnosis of symptomatic patients with various rhythm patterns.

The ELI 150 is designed to be installed on a transport cart. The ELI 150 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 150 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 150 design and allows patient data entry as well as control of the functions and options available for the unit. The ELI 150 custom keyboard will include alphabetic, numeric, symbol and special function keys. The ELI 150 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 150 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, Modem, and / or GSM/GPRS module.

AI/ML Overview

The sponsor, Mortara Instrument, Inc., did not provide specific quantitative acceptance criteria for the ELI 150 Electrocardiograph in this 510(k) summary. Instead, the submission focuses on demonstrating substantial equivalence to its predicate devices, the ELI 100 (K920627) and ELI 350 (K082946), by highlighting the addition of pediatric criteria to the existing VERITAS™ Interpretive Algorithm.

The study described is a performance evaluation of the VERITAS Pediatric ECG Interpretation algorithm.

Here's the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Not explicitly stated as such, but inferred from the submission)	Reported Device Performance
Preamble: The device's primary goal is to be substantially equivalent to its predicate devices and function safely and effectively. The specific performance criteria for the VERITAS Pediatric ECG Interpretation algorithm are related to its diagnostic accuracy for pediatric ECGs.	"This data was utilized to calculate the Sensitivity, Specificity, Positive 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." (Specific numerical values for these metrics are not provided in this 510(k) summary).

Note: The 510(k) summary does not explicitly state numerical acceptance criteria for sensitivity, specificity, or accuracy. It only states that these metrics were calculated and are available in a separate physician's guide.

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

Sample Size: Not explicitly stated. The document mentions "Clinical ECG's were randomly collected from various pediatric cardiology centers."
Data Provenance:
- Country of Origin: Not explicitly stated, but "various pediatric cardiology centers" suggests multiple locations, likely within the US, given the FDA submission.
- Retrospective or Prospective: Not explicitly stated. The collection of "Clinical ECG's" and subsequent submission to a cardiologist suggests a retrospective collection of existing de-identified data.

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

Number of Experts: "a cardiologist" (singular).
Qualifications: "a cardiologist" (no further details on experience or sub-specialization are provided).

4. Adjudication Method for the Test Set:

Method: Not explicitly described. The text states "These ECG's were then submitted to a cardiologist for reading without automatic interpretation (blind reading)." This implies a single expert's reading was used as the ground truth, rather than a consensus or adjudication process among multiple experts.

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

Was it done? No. The submission focuses on the algorithm's performance against a human reader's interpretation, not on how human readers improve with AI assistance.

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

Was it done? Yes. The study compared the algorithm's interpretations to the "blind reading" of a cardiologist. "The same ECGs were also interpreted by the VERITAS Pediatric ECG Interpretation algorithm."

7. Type of Ground Truth Used:

Type: Expert consensus (from a single expert) / Expert interpretation. The ground truth was established by "a cardiologist for reading without automatic interpretation (blind reading)."

8. Sample Size for the Training Set:

Not mentioned. The submission describes the evaluation of the VERITAS Pediatric ECG Interpretation algorithm, which would have been developed and trained prior to this evaluation. The training set details are not provided in this 510(k) summary.

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

Not mentioned. The submission describes the evaluation of the algorithm and how its performance data was calculated, but not the specifics of its development or how the ground truth for its training was established.

Summary

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K101115

Image /page/0/Picture/1 description: The image shows the logo for Mortara. The logo consists of a heart shape above the word "Mortara". The heart is white and is surrounded by a black square. The word "Mortara" is in black, sans-serif font.

Abbreviated 510(k) Notification

510(k): ELI 150 Electrocardiograph Device Summary

JUN 1 8 2010

Date: May 25, 2010

Charles Morreale, Regulatory Affairs Manager Mortara Instrument, Inc. 7865 North 86" Street Milwaukee, WI 53224 (414) 354-4760 Fax: Phone: (414) 354-1600 Contact: Charles Morreale (see above)

Trade Name: ELI 150 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 150 Electrocardiograph is the next generation and is substantially equivalent to the legally marketed predicate device:

ELI 100 by Mortara Instrument (K920627) .
ELI 350 by Mortara Instrument (K082946) .

The proposed ELI 150 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 150 Electrocardiograph.

Description:

Submitter:

The ELI 150 is multi-channel, resting interpretation electrocardiographs. The ELI 150 simultaneously acquires data from up to 12 leads. Once the data is acquired, it can be reviewed, and/or printed.

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Image /page/1/Picture/0 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 set against a black background. The word "Mortara" is in a bold, sans-serif font.

Abbreviated 510(k) Notification

Intended Use:

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 150 modification includes the addition of pediatric criteria to the VERITAS Interpretive Algorithm that was previously cleared through 510(k) Premarket Notification (K082946). Clinical ECG's were randomly collected from various pediatric cardiology centers. These ECG's 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 Accuracy and Neqative Predictive Accuracy for the algorithm. This information is provided within the Physician's Guide to VERITAS with Adult and Pediatric Resting ECG Interpretation.

ELI 150 utilizes the same VERITAS Interpretive Algorithm as the predicate device. The main subject of this 510/k) submission is the evolution of the ELI 150 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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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol is a stylized representation of three human profiles facing right, with flowing lines suggesting movement or progress. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

JUN 1 8 2010

Mortara Instrument, Inc. c/o Charles Morreale Regulatory Affairs Manager 7865 North 86th Street Milwaukee, WI 53224

Re: K101115

Trade/Device Name: ELI 150 Electrocardiograph Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiographs Regulatory Class: Class II (two) Product Code: DPS Dated: April 16, 2010 Received: April 21, 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.

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 – Mr. Charles Morreale

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.

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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

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

510(k) Number (if known): _

Device Name: Mortara ELI 150 Electrocardiograph

Indications for Use:

The device is indicated for use to acquire, analyze, display and print electrocardiograms.
1101115
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.

AND/OR Prescription Use × (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)

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W.M.C

vascular Devi

510(k) Number K10

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).