(116 days)
Not Found
No
The document mentions "Mortara Resting Interpretation (adults and pediatric)" and "Mortara's VERITAS™ interpretive algorithms," which are standard ECG analysis algorithms, not explicitly AI or ML. There is no mention of AI, ML, or related terms like neural networks or deep learning.
No
The device is an electrocardiograph used for diagnosis, not for treatment. Its intended use explicitly states it is "to acquire, analyze, display and print electrocardiograms" and "not intended as a sole means of diagnosis."
Yes
Explanation: The "Intended Use / Indications for Use" section states, "The device is indicated for use to provide interpretation of the data for consideration by a physician." and "The cardiac data and analysis provided is reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various rhythm patterns." While it explicitly states "It is not intended as a sole means of diagnosis," it provides data and analysis for the purpose of diagnosis.
No
The device description explicitly states that the system is based on two major components: a wireless acquisition module with memory (WAM PC) and USB-transceiver key (UTK) combination, and a software application (MEPA). The WAM PC and UTK are described as hardware components that acquire and transmit the ECG data.
Based on the provided text, the Mortara ELI PC Electrocardiograph is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside the body (in vitro).
- ELI PC Function: The ELI PC Electrocardiograph is described as a non-invasive prescription device that acquires, analyzes, displays, and prints electrocardiograms. This process involves placing electrodes on the patient's skin to measure electrical activity of the heart. This is a measurement taken from the body, not a test performed on a sample taken from the body.
- Intended Use: The intended use clearly states it's for acquiring and analyzing ECG data from patients, not for testing biological samples.
- Device Description: The description focuses on the hardware (acquisition module, PC) and software used to capture and process electrical signals from the body.
Therefore, the ELI PC Electrocardiograph falls under the category of a non-invasive medical device used for physiological measurement and analysis, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended purpose of the ELI PC Electrocardiograph system is to collect and wirelessly transmit in real time or deferred mode 12-lead (typically) resting Electrocardiograms from patients to a host PC system participating. The complete system includes an acquisition Module WAM PC with patient applied part, the USB Transceiver Key for WAM PC which attaches to a host PC, and the PC Application MEPA to connect bi-directionally to the Clinical Server (CTS) and gather/transmit information about the patient's demographics, visit information as well as acquired ECG data. The WAM PC part of the device will be used in a medically equipped room in a patient environment, and will be in direct contact with the patient. The MEPA software and the UTK key may be installed in an office computer in a normal room.
The proposed Mortara ELI PC Electrocardiograph is a non-invasive prescription device
- The ELI-PC device is indicated for use to acquire, analyze, display and print electrocardiograms.
- The device is indicated for use for patients of any age, diseased or non-diseased. .
- The device is indicated for use to provide interpretation of the data for consideration by a physician. 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 in a clinical setting, by qualified medical professionals, property trained . for ECG monitoring and use of the system. The personnel must be experienced in cardiovascular problematic situations and emergency procedures or pathologies related to cardiac involvements, It is not intended as a sole means of diagnosis.
- The device is not intended to be used as a vital signs physiological monitor.
- It is not designed for out of hospital transport. .
- It is not designed for use in highly invasive environments, such as an operating theatre.
- The cardiac data and analysis provided is reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various rhythm patterns.
Product codes (comma separated list FDA assigned to the subject device)
DPS
Device Description
The proposed Mortara Instrument ELI PC utilizes previously approved predicate Mortara legacy technology and design features from the Mortara electrocardiograph device family, together with other currently touring technologies, to achieve a highly reliable electrocardiograph. The ELI PC is a standard 12-lead internretive electrocardiograph system that is indicated for use by qualified medical professionals in a clinical solting. The ELI PC combines proprietary hardware and an off-the-shelf personal computer. The concept behind the LI PC is to provide the user with an acquisition module that can transfer the acquired ECG record to a minut the he processing, display, printing and storage. The device may be used in medical clinics and offices of or urlier, to include Clinical Research Organizations.
The system will be based on two major components:
- A wireless acquisition module with memory (WAM PC) and USB-transceiver key (UTK) combination that . will allow the acquisition of a 12-lead ECG that will be stored on the module and subsequently wires you transmitted to a PC Station. The Wireless Acquisition Module system will operate at 2.4GHz,
- A software Application (MEPA) that will receive the ECG from the WAM PC and will communicate bi-. directionally to the Clinical Server (CTS) and gather/transmit information about the patient's demographics, visit information as well as acquired ECG data. The application controls user access and cutherning top, submits the resulting ECG and demographic and visit information to the Clinical Server and allowing the user to select the appropriate visit protocol and enter patient's demographic and visit data.
The wireless acquisition module with memory (WAM PC) and USB-transceiver key (UTK) combination will be able to acquire multi-lead ECG signals, store the record on the module in an internal non-volation many and subsequently wirelessly transmit the record to a PC Station. The PC side of the system will recoverner your her yeard and will process it. The received ECG data will be first analyzed to determined the quality of the ECG, then the record will be analyzed using the Mortara Resting Interpretation (adults and pediatric). The proprietary software configuration incorporates Mortara's VERITAS™ interpretive algorithms. The analyzed ECG will be displayed on the PC screen and will include all the measurements performed by the interpretation algorithm and he text of the automatic analysis. The user will have the possibility to edit the patient demographic data and, in some versions of the product, also the interpretation text.
The acquisition module (WAM or ELI series) can be offered in various models, with or without internal printer. depending on the market and the customers' requirements. The WAM PC acquisition module requirers unne of a supplied Mortara proprietary 10-wire ECG patient cable for patient connection. The cable is unique to the WAM PC and is distributed as a device component with the WAM PC.
The UTK will interface to the PC host via a USB 2.0 compliant interface and a USB type-A connector. The USB connection will transfer data from the UTK to the PC host. The user will be able to store the record on the local hard disk or on a networked server. In addition, printouts will be possible as well as file export in several formals (DICOM, UNIPRO32, XML, FDA-XML). The ELI PC is capable of being interfaced with Hospital Information Systems (or similar) in order to receive patient demographics.
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
The patient population for which the device will be used may be healthy or diseased of any age.
The device is indicated for use for patients of any age, diseased or non-diseased.
Intended User / Care Setting
Operating environments are general hospitals but may also be used in specialized hospitals that participate with research protocols. Operators of the device will be medical doctors or qualified ECG technicians. The device is intended to be used frequently, in normal office hours and in normal lighting conditions.
The device is indicated for use in a clinical setting, by qualified medical professionals, properly trained for ECG monitoring and use of the system. The personnel must be experienced in cardiovascular problematic situations and emergency procedures or pathologies related to cardiac involvements, It is not intended as a sole means of diagnosis.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 a logo for "Mortara". The logo consists of a heart shape above the word "Mortara". The heart is white and the background is black. The word "Mortara" is in a sans-serif font and is also black.
Abbreviated 510(k) Notification
FEB 1 9 2010
510(k): ELI PC Electrocardiograph Device Summary
Submitter:
Date: October 23, 2009
Charles Morreale, Manager of Regulatory Affairs 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 PC Electrocardiograph Common Name: Electrocardiograph Classification Name: Electrocardiograph (Per 21 CFR 870.2340)
Legally marketed devices to which S.E. is claimed:
The Mortara Instruments ELI PC is substantially equivalent to the legally marketed devices presently in distribution:
- Mortara Instrument ELI 350 Electrocardiograph (K082946) ψ
- Midmark Brentwood IQmark-ECG Analysis System (K955023) .
Description:
The proposed Mortara Instrument ELI PC utilizes previously approved predicate Mortara legacy technology and design features from the Mortara electrocardiograph device family, together with other currently touring technologies, to achieve a highly reliable electrocardiograph. The ELI PC is a standard 12-lead internretive electrocardiograph system that is indicated for use by qualified medical professionals in a clinical solting. The ELI PC combines proprietary hardware and an off-the-shelf personal computer. The concept behind the LI PC is to provide the user with an acquisition module that can transfer the acquired ECG record to a minut the he processing, display, printing and storage. The device may be used in medical clinics and offices of or urlier, to include Clinical Research Organizations.
The system will be based on two major components:
- A wireless acquisition module with memory (WAM PC) and USB-transceiver key (UTK) combination that . will allow the acquisition of a 12-lead ECG that will be stored on the module and subsequently wires you transmitted to a PC Station. The Wireless Acquisition Module system will operate at 2.4GHz,
- A software Application (MEPA) that will receive the ECG from the WAM PC and will communicate bi-. directionally to the Clinical Server (CTS) and gather/transmit information about the patient's demographics, visit information as well as acquired ECG data. The application controls user access and cutherning top, submits the resulting ECG and demographic and visit information to the Clinical Server and allowing the user to select the appropriate visit protocol and enter patient's demographic and visit data.
The wireless acquisition module with memory (WAM PC) and USB-transceiver key (UTK) combination will be able to acquire multi-lead ECG signals, store the record on the module in an internal non-volation many and subsequently wirelessly transmit the record to a PC Station. The PC side of the system will recoverner your her yeard and will process it. The received ECG data will be first analyzed to determined the quality of the ECG, then the
1
Image /page/1/Picture/1 description: The image shows a logo for "Mortara". The logo consists of a heart shape above the word "Mortara". The heart is white and the word "Mortara" is in black, bold font.
Abbreviated 510(k) Notification
record will be analyzed using the Mortara Resting Interpretation (adults and pediatric). The proprietary software configuration incorporates Mortara's VERITAS™ interpretive algorithms. The analyzed ECG will be displayed on the PC screen and will include all the measurements performed by the interpretation algorithm and he text of the automatic analysis. The user will have the possibility to edit the patient demographic data and, in some versions of the product, also the interpretation text.
The acquisition module (WAM or ELI series) can be offered in various models, with or without internal printer. depending on the market and the customers' requirements. The WAM PC acquisition module requirers unne of a supplied Mortara proprietary 10-wire ECG patient cable for patient connection. The cable is unique to the WAM PC and is distributed as a device component with the WAM PC.
The UTK will interface to the PC host via a USB 2.0 compliant interface and a USB type-A connector. The USB connection will transfer data from the UTK to the PC host. The user will be able to store the record on the local hard disk or on a networked server. In addition, printouts will be possible as well as file export in several formals (DICOM, UNIPRO32, XML, FDA-XML). The ELI PC is capable of being interfaced with Hospital Information i Systems (or similar) in order to receive patient demographics.
Intended Use:
The intended purpose of the ELI PC Electrocardiograph system is to collect and wirelessly transmit in real time or deferred mode 12-lead (typically) resting Electrocardiograms from patients to a host PC system participating. The complete system includes an acquisition Module WAM PC with patient applied part, the USB Transceiver Key for WAM PC which attaches to a host PC, and the PC Application MEPA to connect bi-directionally to the Clinical Server (CTS) and gather/transmit information about the patient's demographics, visit information as well as acquired ECG data. The WAM PC part of the device will be used in a medically equipped room in a patient environment, and will be in direct contact with the patient. The MEPA software and the UTK key may be installed in an office computer in a normal room.
The patient population for which the device will be used may be healthy or diseased of any age. Patients will usually be ambulatory, however the patient will be in a supine position for ECG acquisition.
Operating environments are general hospitals but may also be used in specialized hospitals that participate with research protocols. Operators of the device will be medical doctors or qualified ECG technicians. The device is intended to be used frequently, in normal office hours and in normal lighting conditions.
Indications for Use:
The proposed Mortara ELI PC Electrocardiograph is a non-invasive prescription device
- The ELI-PC device is indicated for use to acquire, analyze, display and print electrocardiograms.
- The device is indicated for use for patients of any age, diseased or non-diseased. .
- The device is indicated for use to provide interpretation of the data for consideration by a physician. 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 in a clinical setting, by qualified medical professionals, property trained . for ECG monitoring and use of the system. The personnel must be experienced in cardiovascular problematic situations and emergency procedures or pathologies related to cardiac involvements, It is not intended as a sole means of diagnosis.
- The device is not intended to be used as a vital signs physiological monitor. �
- It is not designed for out of hospital transport. .
- It is not designed for use in highly invasive environments, such as an operating theatre.
- The cardiac data and analysis provided is reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various rhythm patterns.
C 2009 Mortara Instrument, Inc.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 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 an abstract symbol that resembles a stylized caduceus or a bird-like figure, representing health and human services.
Public Health Service ·
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
FEB 1 9 2010
Mr. Charles Morreale Regulatory Affairs Manager Mortara Instrument, Inc. 7865 North 86th Street Milwaukee, WI 53224 - 3431
Re: K093339
Device Name: ELI PC Electrocardiograph Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (Two) Product Code: DPS Dated: February 12, 2010 Received: February 16, 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 requrements 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 (OS) 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.
Sincercly vours.
Dmn R. bulmer
$\xi$
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
K093339 510(k) Number (if known):
Device Name: Mortara ELI PC Electrocardiograph
Indications for Use:
The ELI PC Electrocardiograph is a non-invasive prescription device
- The proposed Mortara ELI-PC Electrocardiograph is indicated for use to acquire, . analyze, display and print electrocardiograms.
- The device is indicated for use for patients of any age, diseased or non-diseased. .
- The device Is Indicated for use to provide interpretation of the data for consideration by a . physician.
- The interpretations of ECG offered by the device are only significant when used in 0 conjunction with a physician over-read as well as consideration of all other relevant patient data.
- The device is indicated for use in a clinical setting, by qualified medical professionals, . properly trained for ECG monitoring and use of the system. The personnel must be experienced in cardiovascular problematic situations and emergency procedures or pathologies related to cardiac involvements. It is not intended as a sole means of diagnosis.
- The device is not intended to be used as a vital signs physiological monitor. .
- It is not designed for out of hospital transport. .
- It is not designed for use in highly invasive environments, such as an operating theatre. ♥
- The cardiac data and analysis provided is reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various rhythm patterns.
Prescription Use (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 __
uma R. vi lner
ion Sian-C Division of Cardiovascular Devices
510(k) Number