ELI 250 ELECTROCARDIOGRAPH

K101403 · Mortara Instrument, Inc. · DPS · Jul 2, 2010 · Cardiovascular

Device Facts

• Record ID: K101403
• Device Name: ELI 250 ELECTROCARDIOGRAPH
• Applicant: Mortara Instrument, Inc.
• Product Code: DPS · Cardiovascular
• Decision Date: Jul 2, 2010
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

The ELI 250 is a multi-channel, resting 12-lead electrocardiograph used in hospitals and clinics. It acquires cardiac electrical signals via surface electrodes connected to an internal front-end amplifier. The device features a monochrome or color LCD for waveform preview and a custom keyboard for data entry. It processes acquired data using the VERITAS Interpretive Algorithm to provide automated ECG interpretations. Outputs include on-screen display, thermal printouts in various formats (including Cabrera), and digital storage or transmission via RS-232, LAN, WLAN, or modem. Operated by physicians or trained personnel, the device assists in diagnosing symptomatic patients. The output serves as a clinical decision support tool, requiring physician over-read and integration with other patient data to inform clinical decisions. The device benefits patients by providing rapid, standardized ECG analysis and interpretation.

Clinical Evidence

Clinical data collected from pediatric cardiology centers. ECGs were interpreted by a cardiologist (blind reading) and compared against the VERITAS Pediatric ECG Interpretation algorithm. Metrics calculated include sensitivity, specificity, positive predictive accuracy, and negative predictive accuracy. Results are documented in the Physician's Guide to VERITAS with Adult and Pediatric Resting ECG Interpretation.

Technological Characteristics

12-lead resting electrocardiograph; monochrome or optional color LCD; thermal writer; internal front-end amplifier. Connectivity via RS-232, LAN, WLAN, or modem. Software-based VERITAS Interpretive Algorithm (rule-based/algorithmic). Designed for transport cart mounting.

Indications for Use

Indicated for acquisition, analysis, display, and printing of ECGs in clinical settings by physicians or trained personnel. Intended for adult and pediatric populations. Provides data interpretation for physician consideration; not a sole means of diagnosis. Requires physician over-read and consideration of other patient data. Not for use as a vital signs physiological monitor.

Regulatory Classification

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.

Predicate Devices

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

Submission Summary (Full Text)

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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<br>[phone] Ext. 7727<br>[phone] (facsimile)<br>[e-mail] |
|------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Secondary Contact: | Charles Morreale, Regulatory Affairs Manager<br>[phone] Ext. 7768<br>[phone] (facsimile)<br>[e-mail] |
| Mortara Instrument, Inc.<br>7865 N. 86 ^th Street<br>Milwaukee, 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 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

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#### 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 [phone] or [phone] 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)

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W. Ward

Division Sian-C on of Cardiovascular Devices

510(k) Number K10403