CardioConfirm

K161465 · Mortara Instrument, Inc. · DQK · Sep 3, 2016 · Cardiovascular

Device Facts

• Record ID: K161465
• Device Name: CardioConfirm
• Applicant: Mortara Instrument, Inc.
• Product Code: DQK · Cardiovascular
• Decision Date: Sep 3, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended Use

CardioConfirm is intended to be used by qualified clinicians to finalize cardiology reports for adult and pediatric patients. To aid the clinician's interpretation of resting ECGs, CardioConfirm supports the display and onscreen measurement of ECG waveforms. CardioConfirm also supports the algorithmic comparison of serial adult ECGs and allows the user to edit the automatic comparison statements. CardioConfirm is intended to be controlled by a host application that manages user authentication, user permissions, and secure persistent storage of the tests.

Device Story

CardioConfirm is a software component (DLL or executable) embedded in host applications (e.g., EMR) to manage diagnostic cardiology reports. It receives DICOM 12-lead ECG waveforms and encapsulated PDF objects from Mortara or third-party equipment. Clinicians use the device to view, measure, and perform serial comparisons of resting ECGs; edit patient demographics, interpretations, and conclusions; and electronically sign reports. The VERITAS SERIAL COMPARISON algorithm automatically generates comparative statements for adult ECGs based on prior interpretations and waveforms. The device provides tools like an onscreen magnifying loupe and conclusion templates. It facilitates clinical decision-making by allowing physicians to review, amend, and finalize diagnostic tests, which are then stored in the host application. It is intended for use by qualified clinicians in clinical settings.

Clinical Evidence

No clinical data was required to support substantial equivalence. Evidence is based on non-clinical software verification and validation testing conducted in accordance with FDA guidance for software in medical devices.

Technological Characteristics

Windows-based software (DLL or executable) designed per 21 CFR Part 820. Functions as a data management and analysis tool for ECG, stress, and Holter reports. Supports DICOM 12-lead ECG waveform and encapsulated PDF objects. Features include onscreen measurement, magnifying loupe, and serial comparison algorithms. Connectivity is managed via host application integration. No specific hardware materials or energy sources; software-only device.

Indications for Use

Indicated for adult and pediatric patients requiring cardiology report finalization, including resting ECG, stress, and Holter reports.

Regulatory Classification

Identification

A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.

Predicate Devices

• E-Scribe (K930558)
• Pyramis ECG Management System (K032038)

Submission Summary (Full Text)

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Public Health Service

September 3, 2016

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

Mortara Instrument, Inc. Margaret Mucha Director of Global Regulatory Affairs 7865 North 86th Street Milwaukee. Wisconsin 53224

Re: K161465

Trade/Device Name: CardioConfirm Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: August 1, 2016 Received: August 2, 2016

Dear Margaret Mucha:

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.

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); medical device reporting (reporting of medical devicerelated 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] 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)

#### K161465

Device Name CardioConfirm

Indications for Use (Describe)

CardioConfirm is intended to be used by qualified clinicians to finalize cardiology reports for adult and pediatric patients. To aid the clinician's interpretation of resting ECGs, CardioConfirm supports the display and onscreen measurement of ECG waveforms. CardioConfirm also supports the algorithmic comparison of serial adult ECGs and allows the user to edit the automatic comparison statements.

Cardio Confirm is intended to be controlled by a host application that manages user authentication, user permissions, and secure persistent storage of the tests.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# Section 5

#### 510(k) Summary Statement

#### 1. Submitter

Primary Contact Mortara Instrument, Inc. 7865 North 86th Street Margaret Mucha Milwaukee, WI 53224 Director of Global Requlatory Affairs [e-mail] Telephone [phone] Secondary Contact Fax [phone] Sarah Weber Senior Regulatory Affairs Manager [e-mail]

## 2. Product Names

CardioConfirm Device Trade Name

Common/ Usual Name

Classification

Electrocardiograph

870.2340 DPS Electrocardiograph 870.1425 DQK Computer, diagnostic, programmable Cardiovascular

Note: There are no previous submissions for this device

## 3. Predicate Devices to which this is Substantially Equivalent

| E-Scribe (primary) | K930558 |
|-------------------------------|---------|
| Pyramis ECG Management System | K032038 |

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These predicate devices have not been subject to a design-related recall

#### 4. Device Description

CardioConfirm is a software component that is embedded into a host application (e.g. EMR) as a Dynamic Link Library (DLL) or launched as an executable application. CardioConfirm allows the user to display, edit and finalize diagnostic cardiology ECG, Stress and Holter reports. A Clinician can open a diaqnostic cardiology test from a workstation application and pass it to CardioConfirm as a DICOM object for viewing or editing. CardioConfirm is able to open and edit diagnostic cardiology ECG, Stress and Holter reports from Mortara Instrument, Inc. devices and offers an optional version which can edit diagnostic cardiology ECG, Stress and Holter reports from multiple diagnostic cardiology equipment vendors.

CardioConfirm allows the clinician the ability to view, measure, and compare previously acquired resting ECGs as well as perform visual and textual serial comparison of acquired ECGs. With visual serial comparison, the clinician can view current and previous ECG's simultaneously superimposed on the screen. Textual serial comparison allows the clinician to enter or edit text that describes the significant differences between the ECG's. For adult ECG's the initial text can be generated by the VERITAS SERIAL COMPARISON algorithm. The algorithm generates comparative statements automatically on the basis of the VERITAS INTERPRETATION statements originally made by the Mortara acquiring devices, measurements and the ECG waveforms. The clinician can edit the patient demographics, previous measurements and interpretations and the serial comparison statements, and then sign final ECG reports.

The clinician can also view and edit stress and Holter reports that includes editing patient demographics, summary statistics and physician conclusions. The clinician can electronically sign both stress and Holter final reports in CardioConfirm and print final reports or generate PDF copies to store in the host application. If a physician wants to amend a previously finalized report with additional information, CardioConfirm has an option to perform amendments to final reports and store the updated test in the host application.

CardioConfirm is available in two versions. The standard version is intended to be used with tests generated by Mortara equipment. The professional version is intended to be used with tests generated by any

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equipment that produces DICOM 12-lead ECG Waveform and Encapsulated PDF objects.

#### 5. Intended Use

CardioConfirm is intended to be used by qualified clinicians to finalize cardiology reports for adult and pediatric patients. To aid the clinician's interpretation of resting ECGs, CardioConfirm supports the display and onscreen measurement of ECG waveforms. CardioConfirm also supports the algorithmic comparison of serial adult ECGs and allows the user to edit the automatic comparison statements.

CardioConfirm is intended to be controlled by a host application that manages user authentication, user permissions, and secure persistent storage of the tests.

#### 6. Technological characteristics

CardioConfirm employs the same functional scientific technology as its predicate device E-Scribe (K930558) and Pyramis ECG Management System (K032038). At a high level, all three devices employ a Windows based tool to transfer electrocardiographic data from resting ECGs, stress, and Holter exams to further process and analyze the data, prepare final reports, and archive the data and reports.

CardioConfirm was designed and manufactured by Mortara Instrument according to 21 CFR Part 820. CardioConfirm is substantially equivalent to E-Scribe (Predicate K930558) and Pyramis ECG Management System (Predicate K032038) with the following technological differences:

- CardioConfirm is imbedded as a DLL in a host application such as an ● EMR or EHR
- CardioConfirm can be made available as a Windows executable file . that can be controlled by a host application
- CardioConfirm can print reports and waveforms ●
- CardioConfirm can accept demographic updates outside of ● CardioConfirm
- For Resting ECG Reports: .
- o CardioConfirm reads DICOM 12-Lead ECG waveform objects
- o CardioConfirm allows the user to edit previously-signed interpretations

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- CardioConfirm provides an onscreen magnifying loupe for Resting o ECG waveforms
- o CardioConfirm allows the user to edit the statement prediction in reports
- For Stress and Holter Reports: .
- o CardioConfirm will read DICOM Encapsulated PDF objects
- o CardioConfirm will write DICOM Encapsulated PDF objects
- o CardioConfirm will allow the user to use conclusion templates

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| Data<br>Management<br>System | CardioConfirm | E-scribe (Primary) | Pyramis ECG<br>Management System | Change<br>explanation | |
|----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|----------------------------------|
| BRAND | Mortara | Mortara | Quinton | | |
| COMPANY | Mortara Instrument, Inc. | Mortara Instrument, Inc. | Quinton Inc. | | |
| 510 (K) Number | Present Application | K930558 | K032038 | | |
| Intended Use | CardioConfirm is intended to<br>be used by qualified<br>clinicians to finalize<br>cardiology reports for adult<br>and pediatric patients. To<br>aid the clinician's<br>interpretation of resting<br>ECGs, CardioConfirm<br>supports the display and<br>onscreen measurement of<br>ECG waveforms.<br>CardioConfirm also supports<br>the algorithmic comparison<br>of serial adult ECGs and<br>allows the user to edit the<br>automatic comparison<br>statements.<br>CardioConfirm is intended to<br>be controlled by a host<br>application that manages<br>user authentication, user<br>permissions, and secure | This system is designed to<br>be used as a storage<br>system for ECG data in<br>hospitals and large<br>medical clinics. The E-<br>Scribe allows the user to<br>store, edit and retrieve<br>patient ECG information | The Pyramis ECG<br>Management System is an<br>ECG data management<br>and information system.<br>Its primary function is to<br>store records of biologic<br>origin such as ECG,<br>Stress and Holter records<br>received from those<br>respective recording<br>devices in a database and<br>subsequently allow the<br>user to select, view, edit,<br>print/fax/email and export<br>(distribute) those records | Equivalent | |
| | persistent storage of the | | (distribute) those records | | |
| Data<br>Management<br>System | CardioConfirm | E-scribe (Primary) | Pyramis ECG<br>Management System | Change<br>explanation | |
| BRAND | Mortara | Mortara | Quinton | | |
| COMPANY | Mortara Instrument, Inc. | Mortara Instrument, Inc. | Quinton Inc. | | |
| 510 (K) Number | Present Application<br>tests. | K930558 | K032038 | | |
| Operating<br>System | Windows 7, Windows 8.1, etc. | Windows 2008 R2, Windows 7 | Windows 2008, Windows 7 | Equivalent | |
| Form: DLL for<br>embedding in a<br>host application | Yes | Not applicable | Not applicable | New feature | |
| Form: executable<br>controlled by a<br>host application | Yes | Not applicable | Not applicable | New feature | |
| IO: option to limit<br>to Mortara device<br>data only | Yes | Yes | Yes | Equivalent | |
| IO: offline PDF<br>generation of<br>reports | Yes | Yes | Yes | Equivalent | |
| IO: report printing | Yes | Yes | Yes | Equivalent | |
| Data<br>Management<br>System | CardioConfirm | E-scribe (Primary) | Pyramis ECG<br>Management System | Change<br>explanation | |
| BRAND | Mortara | Mortara | Quinton | | |
| COMPANY | Mortara Instrument, Inc. | Mortara Instrument, Inc. | Quinton Inc. | | |
| 510 (K) Number | Present Application | K930558 | K032038 | | |
| User<br>Permissions:<br>view only | Yes | Yes | Yes | Equivalent | |
| | User<br>Permissions:<br>view and save | Yes | Yes | Yes | Equivalent |
| | | User<br>Permissions:<br>view and<br>electronically<br>sign | Yes | Yes | Yes |
| User<br>Permissions: edit<br>demographics | | | Yes | Yes | Yes |
| | User<br>Permissions: edit<br>measurements | | Yes | Yes | Yes |
| | | Data<br>Management<br>System | CardioConfirm | E-scribe (Primary) | Pyramis ECG<br>Management System |
| BRAND | | Mortara | Mortara | Quinton | |
| COMPANY | Mortara Instrument, Inc. | Mortara Instrument, Inc. | Quinton Inc. | | |
| 510 (K) Number | Present Application | K930558 | K032038 | | |
| View: patient<br>identity always<br>visible | Yes | Yes | Yes | Equivalent | |
| View: pan and<br>zoom | Yes | Yes | Yes | Equivalent | |
| Edit: patient<br>demographics | Yes | Yes | Yes | Equivalent | |
| Edit: accepts<br>demographic<br>updates outside<br>of CardioConfirm | Yes | Not applicable | Not applicable | New feature | |
| Sign:<br>electronically<br>sign | Yes | Yes | Yes | Equivalent | |
| Resting ECG | | | | | |
| IO: option to<br>support non- | Yes for professional | No | Yes | Equivalent to | |
| Data<br>Management<br>System | CardioConfirm | E-scribe (Primary) | Pyramis ECG<br>Management System | Change<br>explanation | |
| BRAND | Mortara | Mortara | Quinton | | |
| COMPANY | Mortara Instrument, Inc. | Mortara Instrument, Inc. | Quinton Inc. | | |
| 510 (K) Number | Present Application | K930558 | K032038 | | |
| Mortara device<br>data | version | | | Pyramis | |
| IO: reads DICOM<br>12-Lead ECG<br>Waveform<br>objects | Yes | Not applicable | Not applicable | Equivalent to<br>Pyramis | |
| IO: writes DICOM<br>12-lead ECG<br>Waveform<br>objects | Yes | Yes | No | Equivalent to E-<br>Scribe | |
| User<br>Permissions: edit<br>interpretation<br>including serial<br>comparison and<br>conclusion | Yes | Yes | Yes | Equivalent | |
| View: waveform<br>zoom | Optimizes for display of<br>full 10s waveforms over a | Fit page, Fit width, 75%,<br>100%, 150%, 200%, | Fit width, Fit height, 25%,<br>50%, 75%, 100%, 125%,…