(17 days)
Not Found
No
The summary describes a standard electrocardiograph that acquires, analyzes, displays, and prints ECG data and provides interpretations. There is no mention of AI, ML, or related terms, nor any description of training or test sets typically associated with such technologies. The analysis function appears to be based on traditional signal processing and interpretation algorithms.
No.
The device is used to acquire, analyze, display, and print electrocardiograms for diagnostic purposes, not to treat a condition.
Yes
The device acquires, analyzes, and interprets electrocardiogram data to assist physicians in the diagnosis of symptomatic patients, even though it states it is not intended as a sole means of diagnosis and requires physician over-read.
No
The device description explicitly states it is a "multi-channel, portable electrocardiograph utilizing a 4" graphic LCD" and describes hardware components like electrodes. 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 In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the body (in vitro), such as blood, urine, or tissue. This device acquires electrical signals from the body surface (in vivo) to measure the heart's activity.
- The intended use and device description clearly state that it acquires and analyzes electrocardiograms (ECGs), which are recordings of electrical activity from the heart. This is a physiological measurement taken directly from the patient.
- There is no mention of analyzing biological samples.
Therefore, this device falls under the category of a medical device that performs physiological measurements, not an IVD.
N/A
Intended Use / Indications for Use
The ELI 10 is intended to be a high-performance, multi-channel electrocardiograph. As a resting electrocardiograph, ELI 10 simultaneously acquires data from all 12 leads. Once the data is acquired, it can be reviewed and/or stored. 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 to acquire, analyze, display and print electrocardiograms. (Printing function . available only through an external, optional printer.)
- 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 populations.
- The device is indicated for use on pediatric populations for acquisition, display, and printing of multi-channel . ECGs.
- . The device is not intended to be used as a vital signs physiological monitor.
Product codes
DPS
Device Description
The proposed ELI 10 will be a multi-channel, portable electrocardiograph utilizing a 4" graphic LCD. The ELI 10 is a 12 lead resting interpretive electrocardiograph. The ELI 10 simultaneously acquires data from all 12 leads. Once the data is acquired, it can be reviewed, and/or stored, 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.
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 populations, pediatric populations
Intended User / Care Setting
Used in hospitals, but may be used in medical clinics and offices of any size.
Used 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
Image /page/0/Picture/1 description: The image shows the text "K070539" on the top line and "P 1/2" on the second line. The text is written in a handwritten style. The numbers are clear and legible.
Special 510(k): Device Modification
510(k): ELI 10 Electrocardiograph Device Summary
Submitter:
Date: February 20, 2007
Laura Spiegelhoff, Manager of Quality Assurance / Regulatory Affairs Mortara Instrument, Inc. 7865 N. 86" Street Milwaukee, WI 53224 Fax: (414) 354-4760 Phone: (414) 354-1600 Contact: Laura Spiegelhoff (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's ELI 10 Electrocardiograph is a current technology evolution of the Mortara EL-1 and is substantially equivalent to the legally marketed predicate device:
- EL-1 by Mortara Instrument (K851702) .
The proposed ELI 10 is the evolutionary market replacement of this Mortara predicate device.
Description:
The proposed ELI 10 will be a multi-channel, portable electrocardiograph utilizing a 4" graphic LCD. The ELI 10 is a 12 lead resting interpretive electrocardiograph. The ELI 10 simultaneously acquires data from all 12 leads. Once the data is acquired, it can be reviewed, and/or stored, 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.
Intended Use:
The ELI 10 is intended to be a high-performance, multi-channel electrocardiograph. As a resting electrocardiograph, ELI 10 simultaneously acquires data from all 12 leads. Once the data is acquired, it can be reviewed and/or stored. It will be a device primarily intended for use in hospitals, but may be used in medical clinics and offices of any size.
1
Special 510(k): Device Modification
Indications for Use:
- The device is indicated for use to acquire, analyze, display and print electrocardiograms. (Printing function . available only through an external, optional printer.)
- 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 populations.
- The device is indicated for use on pediatric populations for acquisition, display, and printing of multi-channel . ECGs.
- . The device is not intended to be used as a vital signs physiological monitor.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, with the profiles of three human faces incorporated into the design of the eagle's body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 5 2007
Mortara Instrument, Inc. c/o Ms. Laura Spiegelhoff Manager of Quality Assurance and Regulatory Affairs 7865 North 86th St. Milwaukee, WI 53224-3431
Re: K070539
Trade/Device Name: ELI 10 Electrocardiograph Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: February 20, 2007 Received: February 26, 2007
Dear Ms. Spiegelhoff:
This letter corrects our substantially equivalent letter of February 20, 2007.
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 (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
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Page 2 - Ms. Spiegelhoff
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 CFR Part 807); labeling (21 CFR Part 801); 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.
This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Bhimma for
Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Indications for Use
510(k) Number (if known):
Mortara ELI 10 Electrocardiograph Device Name:
Indications for Use:
- · The device is indicated for use to acquire, analyze, display and print electrocardiograms. (printing function available only through an external, optional printer)
- 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 populations. .
- The device is indicated for use on pediatric populations for acquisition, display, and . printing of multi-channel ECGs.
- The device is not intended to be used as a vital signs physiological monitor. .
Prescription Use X (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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C. L. Ammon
cular Devices