Merge Cardio

K192276 · Merge Healthcare Incorporated · LLZ · Sep 20, 2019 · Radiology

Device Facts

• Record ID: K192276
• Device Name: Merge Cardio
• Applicant: Merge Healthcare Incorporated
• Product Code: LLZ · Radiology
• Decision Date: Sep 20, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Merge Cardio software product is an integrated multi-modality image and information system designed to perform the necessary functions required for import, export, review, analysis, quantification, reporting, and database management of digital cardiovascular images, documents, and data related to cardiology. Merge Cardio offers support for third-party applications in order to enable the use of commercially available tools and specified applications for analysis, quantification, and reporting. Merge Cardio software runs on standard information technology hardware and software, using standard information technology operating systems and user interfaces. Communication and data exchange are done using standard protocols. The modular design allows configurability to tailor the image import and communications solution to the needs of the user. The number of modalities and reporting and/or viewing sites can be configured per system.

Device Story

Merge Cardio is a multi-modality cardiovascular PACS software. It ingests digital images, documents, and data from various cardiovascular modalities (e.g., US, XA, CT, MR, ECG). The system provides tools for image review (brightness, contrast, zoom, cine playback, R-wave/frame rate sync), annotation, digital subtraction (XA), and quantitative measurements (QCA, LVA, distance, angle, velocity, volume). It supports clinical report generation for various cardiology subspecialties. Used in clinical environments by healthcare professionals, it facilitates workflow management via a study list. The system runs on standard IT hardware/OS and uses standard protocols (DICOM, HL7) for data exchange. It enables clinicians to review diagnostic data and generate reports, supporting clinical decision-making by providing organized, accessible patient cardiovascular information.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including risk analysis, requirements review, design reviews, code reviews, integration testing, and performance testing.

Technological Characteristics

Software-only PACS. Runs on standard IT hardware/OS. Supports DICOM and HL7 protocols. Features include image processing (subtraction, measurement, sync), reporting, and database management. Complies with ISO 14971 (risk management), IEC 62304 (software lifecycle), and NEMA-PS 3.1-3.20 (DICOM).

Indications for Use

Indicated for healthcare professionals to import, export, review, analyze, quantify, report, and manage digital cardiovascular images, documents, and data. Supports modalities including US, XA, NM, IVUS, IVOCT, DX, CR, MR, CT, PET, ECG, and EP.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• Vericis Cardiovascular Image and Information System (K051649)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA acronym is in blue, and the full name of the agency, "U.S. Food & Drug Administration," is in a smaller font size below the acronym.

September 20, 2019

Merge Healthcare Incorporated % Ms. Lisa Baumhardt Sr. Regulatory Affairs Program Manager 900 Walnut Ridge Drive HARTLAND WI 53209

Re: K192276

Trade/Device Name: Merge Cardio Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: August 21, 2019 Received: August 22, 2019

Dear Ms. Baumhardt:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Section 4

### Indications for Use Statement

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### Indications for Use

510(k) Number (if known)

### K192276

Device Name Merge Cardio

### Indications for Use (Describe)

Merge Cardio software product is an integrated multi-modality image and information system designed to perform the necessary functions required for import, export, review, analysis, quantification, reporting, and database management of digital cardiovascular images, documents, and data related to cardiology. Merge Cardio offers support for third-party applications in order to enable the use of commercially available tools and specified applications for analysis, quantification, and reporting. Merge Cardio software runs on standard information technology hardware and software, using standard information technology operating systems and user interfaces. Communication and data exchange are done using standard protocols. The modular design allows configurability to tailor the image import and communications solution to the needs of the user. The number of modalities and reporting and/or viewing sites can be configured per system.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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## Section 5

## 510(k) Summary

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## 510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

| Submitter Information<br>Submitter: | Merge Healthcare Incorporated<br>900 Walnut Ridge Drive<br>Hartland, Wisconsin 53209 USA |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | August 21, 2019 |
| Contact Person: | Lisa M. Baumhardt<br>Sr. Regulatory Affairs Program Manager<br>Phone: [phone]<br>Email: [e-mail] |
| Secondary Contact: | Tracey Fox<br>RAQA Executive, Regulatory Affairs<br>Phone: [phone]<br>Email: [e-mail] |

## Identification of the Device

| Trade Name: | Merge Cardio |
|-------------------------------------------|-------------------------------------------------------------|
| Common Name: | Picture Archiving and Communication System (PACS) |
| Classification Name: | Radiological Image Processing System<br>21 CFR 892.2050 |
| Product Code: | LLZ |
| Device Class: | Class II |
| Predicate Device(s):<br>Predicate Device: | Vericis Cardiovascular Image and Information System K051649 |

## Device Description

Merge Cardio is a software medical device that is an integrated multi-modality image cardiovascular information management system. The Merge Cardio system is intended to allow authorized health care professionals the ability to import, export, review, analyze, quantify, report and manage digital cardiovascular images, documents, and data related to cardiology. The study list supports workflow management by providing a robust study list with configurable

Image /page/5/Picture/8 description: The image shows the logo for Watson Health. The logo consists of a stylized image of a globe with lines radiating outwards, resembling a sun or a burst of energy. To the right of the image is the text "Watson Health" in a bold, sans-serif font. The letters are black, and there is a small trademark symbol in the bottom right corner of the word "Health".

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informational columns supporting navigation, current study and reporting status, and prior study availability and relevancy. The system offers standard image controls such as brightness, contrast, zoom, and cine playback controls; as well modality specific tools such as R-wave sync and frame rate sync. The system allows users to review images, annotate images, perform digital subtraction on XA images, perform quantitative measurements on images (based on modality and anatomy including quantitative coronary analysis, left ventricular analysis, distance, angle, velocity, slope, area, velocity time integral, and volume), derive US measurements, and generate clinical reports. The system provides the ability to create clinical reports for Adult Echo, Pediatric Echo, Vascular US, Nuclear Medicine, Cath/Peripheral Invasive, Electrophysiology, Cardiac CT, and Cardiac MR. Merge Cardio runs on standard information technology hardware and software, using standard technology operating systems and user interfaces. Communication and data exchange are done using standard protocols.

## Intended Use/ Indications for Use

Merge Cardio software product is an integrated multi-modality image and information system designed to perform the necessary functions required for import, export, review, analysis, quantification, reporting, and data management of digital cardiovascular images, documents, and data related to cardiology.

Merge Cardio offers support for third-party applications in order to enable the use of commercially available tools and specified applications for analysis, quantification, and reporting.

Merge Cardio software runs on standard information technology hardware and software, using standard information technology operating systems and user interfaces. Communication and data exchange are done using standard protocols.

The modular design allows configurability to tailor the image import and communications solution to the needs of the user. The number of modalities and reporting and/or viewing sites can be configured per system.

# Technological Characteristics

Merge Cardio employs the same fundamental scientific technology as its predicate device.

# Determination of Substantial Equivalence

The modifications to the Merge Cardio device include updates to the software and labeling. The Merge Cardio device has the same intended use and equivalent indications for use as the cleared Vericis Cardiovascular Image and Information System K051649 predicate device. The table below summarizes the changed features being introduced to market:

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## Comparison to Predicate

| Information | Vericis Cardiovascular Image<br>and Information System<br>(K051649) | Merge Cardio V12 |
|-------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name of<br>Device/ Classification/<br>Product Code | Cardiology PACS | Cardiology PACS |
| | 21 CFR 892.2050 | 21 CFR 892.2050 |
| | LLZ | LLZ |
| Indications for Use | Vericis is a system intended to be used to<br>acquire, store, print, transfer and archive<br>clinical information from Camtronics and<br>other vendors systems including images,<br>Hemodynamic studies and reports,<br>measurements (via import from DICOM<br>Structured Reporting, text files or optical<br>character recognition of measurements<br>captured on images) and cardiology<br>signal (waveform) data. Vericis is<br>intended to allow users to review<br>diagnostic and non-diagnostic quality<br>images, annotate studies, perform digital<br>subtraction on images, to perform<br>quantitative measurements on images<br>(including but not limited to quantitative<br>coronary analysis, left ventricular<br>analysis, time, area, length, velocity,<br>angle, volume, and velocity-time<br>integrals), to generate physician-<br>generated clinical reports (via structured<br>reporting and template based tools), and<br>to store this information in a database.<br>Vericis is software comprised of modules<br>that perform under standard off-the-shelf<br>personal computers and servers running<br>the Microsoft Windows 2000/2003/XP<br>operating system.<br>Vericis is image data storage and display<br>software that accepts DICOM (Digital<br>Imaging and Communications in<br>Medicine) image data files from multiple<br>modalities. It accepts text data using<br>standards-based formats including but<br>not limited to HL7 and XML.<br>Vericis is an Internet/Intranet network<br>system that is designed for small and<br>large, multi-use environments. The<br>Vericis network structure (including<br>server and workstation) provides for the<br>system's database management, storage,<br>printing, and all DICOM/HL7 interface<br>services. | Merge Cardio software product is an<br>integrated multi-modality image and<br>information system designed to<br>perform the necessary functions<br>required for import, export, review,<br>analysis, quantification, reporting, and<br>database management of digital<br>cardiovascular images, documents, and<br>data related to cardiology. Merge<br>Cardio offers support for third-party<br>applications in order to enable the use<br>of commercially available tools and<br>specified applications for analysis,<br>quantification, and reporting. Merge<br>Cardio software runs on standard<br>information technology operating<br>systems and user interface.<br>Communication and data exchange are<br>done using standard protocols. The<br>modular design allows configurability<br>to tailor the image import and<br>communications solution to the needs<br>of the user. The number of modalities<br>and reporting and/or viewing sites can<br>be configured per system. |
| Information | Vericis Cardiovascular Image<br>and Information System<br>(K051649) | Merge Cardio V12 |
| Features/Specifications | Vericis (K051649) | Merge Cardio V12 |
| System Overview | | |
| CAS, Workstation<br>(thick client), Web<br>Client (thin client) | Yes | Yes |
| Software Only | No | Yes |
| Standard off the Shelf<br>Hardware and Operating<br>System requirements | Yes | Yes |
| Dual Monitor Support | Yes | Yes, added wide monitor |
| Speech Recognition | No | Yes |
| VMware Support | No | Yes |
| Network | LAN | LAN, MAN, WAN |
| User Interface | Yes | Yes, updated look and feel and added<br>light/dark themes |
| CD/DVD | Yes | Yes |
| Printer | Yes | Yes |
| Fax | Yes | Yes |
| Modalities | | |
| Modalities Supported | US, XA, NM | US, XA, NM, IVUS, IVOCT, DX, CR,<br>MR, CT, PET, ECG, EP |
| System Features | | |
| Study List | Yes | Yes, expanded filters, identification of<br>study status, priors, |
|…