(29 days)
Not Found
No
The document describes a standard cardiovascular image and information management system with image processing and quantitative measurement tools, but there is no mention of AI or ML capabilities.
No
The device is described as an image and information management system for cardiovascular data, assisting healthcare professionals in reviewing, analyzing, and managing digital images and data, rather than directly treating a condition.
Yes
The device is described as 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." It allows authorized healthcare professionals to "review, analyze, quantify," and "perform quantitative measurements on images." These functions directly support the process of making a diagnosis.
Yes
The device description explicitly states "Merge Cardio is a software medical device". While it runs on standard IT hardware, the device itself is the software component.
Based on the provided information, the Merge Cardio software product is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The intended use and device description of Merge Cardio clearly state that it is designed for the import, export, review, analysis, quantification, reporting, and management of digital cardiovascular images, documents, and data. It processes images and data obtained from imaging modalities like US, XA, NM, etc., which are external imaging techniques, not tests performed on bodily specimens.
- The functions described are related to image processing, data management, and reporting. These are typical functions of a medical image management and analysis system, not an IVD device which would involve analyzing blood, urine, tissue, or other bodily fluids or samples.
In summary, Merge Cardio is a software medical device for managing and analyzing cardiovascular imaging data, not for performing tests on in vitro specimens.
N/A
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 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.
Product codes
LLZ
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 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
US, XA, NM, IVUS, IVOCT, DX, CR, MR, CT, PET, ECG, EP
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
authorized health care professionals
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)
The following quality assurance measures were applied to the Merge Cardio system:
- Risk Analysis .
- . Requirements Review
- Design Reviews .
- Unit level code reviews .
- Integration testing ●
- Performance testing ●
- . Safety testing from risk analysis
No performance standards for PACS systems or components have been issued under the authority of Section 514. Non-clinical testing has been performed on Merge Cardio and demonstrates compliance with the following international and FDA-recognized consensus standards and FDA guidance documents:
- ISO 14971 Medical devices Application of risk management to medical devices .
- IEC 62304 Medical device software -Software life cycle processes ●
- NEMA-PS 3.1-PS3.20 Digital Imaging and Communications in Medicine (DICOM)
- Guidance for the Content of Premarket Submissions for Software Contained in Medical ● Devices
The software documentation was provided at a moderate level of concern following the FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
Results from internal verification and validation testing performed in accordance with Watson Health Imaging design control processes confirm that Merge Cardio product specifications have been met. Supporting documentation is included in this 510(k) Premarket Notification and supports the claims of substantial equivalence to the predicate device.
The subject of this submission, Merge Cardio, did not require animal testing, biological testing, sterility testing, electrical safety testing or electromagnetic compatibility testing.
The subject of this premarket submission. Merge Cardio, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Vericis Cardiovascular Image and Information System K051649
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
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.(b)
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).
0
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
Section 4
Indications for Use Statement
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Image /page/2/Picture/2 description: The image shows the logo for Watson Health. The logo consists of a stylized sun-like graphic on the left, followed by the text "Watson Health." The text is in a bold, sans-serif font, and there is a green line above the logo.
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3
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
Image /page/4/Picture/2 description: The image contains the logo for Watson Health. The logo consists of a stylized image of a lightbulb with circular lines around it, followed by the text "Watson Health" in a bold, sans-serif font. The letters are black, and there is a trademark symbol after the word "Health". There is a green line above the logo.
5
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Submitter Information
Submitter: | Merge Healthcare Incorporated
900 Walnut Ridge Drive
Hartland, Wisconsin 53209 USA |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | August 21, 2019 |
| Contact Person: | Lisa M. Baumhardt
Sr. Regulatory Affairs Program Manager
Phone: (262) 369-3364
Email: lisa.baumhardt@ibm.com |
| Secondary Contact: | Tracey Fox
RAQA Executive, Regulatory Affairs
Phone: (262) 369-3156
Email: tracey.fox@ibm.com |
Identification of the Device
| Trade Name: | Merge Cardio |
|---|---|
| Common Name: | Picture Archiving and Communication System (PACS) |
| Classification Name: | Radiological Image Processing System |
| 21 CFR 892.2050 | |
| Product Code: | LLZ |
| Device Class: | Class II |
| Predicate Device(s): | |
| 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".
6
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:
Image /page/6/Picture/10 description: The image shows the logo for Watson Health. The logo consists of a stylized image of a sun or starburst to the left of the text "Watson Health". The text is in a bold, sans-serif font. There is a green bar above the logo.
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Comparison to Predicate
| Information | Vericis Cardiovascular Image
and Information System
(K051649) | Merge Cardio V12 |
|-------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name of
Device/ Classification/
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
acquire, store, print, transfer and archive
clinical information from Camtronics and
other vendors systems including images,
Hemodynamic studies and reports,
measurements (via import from DICOM
Structured Reporting, text files or optical
character recognition of measurements
captured on images) and cardiology
signal (waveform) data. Vericis is
intended to allow users to review
diagnostic and non-diagnostic quality
images, annotate studies, perform digital
subtraction on images, to perform
quantitative measurements on images
(including but not limited to quantitative
coronary analysis, left ventricular
analysis, time, area, length, velocity,
angle, volume, and velocity-time
integrals), to generate physician-
generated clinical reports (via structured
reporting and template based tools), and
to store this information in a database.
Vericis is software comprised of modules
that perform under standard off-the-shelf
personal computers and servers running
the Microsoft Windows 2000/2003/XP
operating system.
Vericis is image data storage and display
software that accepts DICOM (Digital
Imaging and Communications in
Medicine) image data files from multiple
modalities. It accepts text data using
standards-based formats including but
not limited to HL7 and XML.
Vericis is an Internet/Intranet network
system that is designed for small and
large, multi-use environments. The
Vericis network structure (including
server and workstation) provides for the
system's database management, storage,
printing, and all DICOM/HL7 interface
services. | 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 operating
systems and user interface.
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. |
| Information | Vericis Cardiovascular Image
and Information System
(K051649) | Merge Cardio V12 |
| Features/Specifications | Vericis (K051649) | Merge Cardio V12 |
| System Overview | | |
| CAS, Workstation
(thick client), Web
Client (thin client) | Yes | Yes |
| Software Only | No | Yes |
| Standard off the Shelf
Hardware and Operating
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
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,
MR, CT, PET, ECG, EP |
| System Features | | |
| Study List | Yes | Yes, expanded filters, identification of
study status, priors, |
| Image Review | Yes | Yes, expanded frame rate sync, added
ability to view PDFs |
| Image Enhancement | Yes | Yes |
| Patient Centric View | No | Yes |
| Study Annotation | Yes | Yes |
| Study Editing | Yes | Yes, streamlined workflow |
| AVI Study Tools | Yes | Yes |
| Screen Snip Study
Tools | No | Yes |
| Information | Vericis Cardiovascular Image
and Information System
(K051649) | Merge Cardio V12 |
| Bookmarking Study
Tools | No | Yes |
| Data Imports | Yes, images, non-image data | Yes, images, non-image data, DICOM
encapsulated PDFs |
| US Primitive
Measurements | Yes, measured, averaged,
imported | Yes, measured, averaged, manual,
imported |
| US Measurement
Shapes | Yes | Yes, enhanced workflow |
| US Derived
Measurements | Yes | Yes, added additional derived
measurements |
| US Sticky/Non-sticky
measurements | Sticky measurements | Sticky and non-sticky measurements |
| Reference
Measurements | Yes, XA, XRF | Yes, but expanded ability XA, XRF,
IVOCT, IVUS |
| DSA | Yes | Yes |
| QCA/LVA | Yes | Yes |
| Clinical Reporting | Yes | Yes, expanded support and improved
workflow |
| Archive and Administration Functions | | |
| Storage | Yes | Yes, added vendor neutral archive |
| Administrative
Reporting | Yes | Yes, added scheduling reports |
| System Administration
Tool | Yes | Yes |
Image /page/7/Picture/2 description: The image shows the logo for Watson Health. The logo consists of a stylized image of a globe with lines radiating outward, followed by the text "Watson Health" in a bold, sans-serif font. The letters are black, and there is a trademark symbol after the word "Health".
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Image /page/8/Picture/1 description: The image shows the logo for Watson Health. The logo consists of a stylized atom symbol to the left of the text "Watson Health". The text is in a bold, sans-serif font. There is a green bar at the top of the image.
9
Summary of Non-Clinical Tests
The following quality assurance measures were applied to the Merge Cardio system:
- Risk Analysis .
- . Requirements Review
- Design Reviews .
- Unit level code reviews .
- Integration testing ●
- Performance testing ●
Image /page/9/Picture/9 description: The image shows the logo for Watson Health. The logo consists of a stylized globe-like icon on the left, followed by the text "Watson Health" in a bold, sans-serif font. The word "Health" is followed by the trademark symbol. There is a green line above the logo.
10
-
. Safety testing from risk analysis
No performance standards for PACS systems or components have been issued under the authority of Section 514. Non-clinical testing has been performed on Merge Cardio and demonstrates compliance with the following international and FDA-recognized consensus standards and FDA guidance documents: -
ISO 14971 Medical devices Application of risk management to medical devices .
-
IEC 62304 Medical device software -Software life cycle processes ●
-
NEMA-PS 3.1-PS3.20 Digital Imaging and Communications in Medicine (DICOM)
-
Guidance for the Content of Premarket Submissions for Software Contained in Medical ● Devices
The software documentation was provided at a moderate level of concern following the FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
Results from internal verification and validation testing performed in accordance with Watson Health Imaging design control processes confirm that Merge Cardio product specifications have been met. Supporting documentation is included in this 510(k) Premarket Notification and supports the claims of substantial equivalence to the predicate device.
The subject of this submission, Merge Cardio, did not require animal testing, biological testing, sterility testing, electrical safety testing or electromagnetic compatibility testing.
Summary of Clinical Tests
The subject of this premarket submission. Merge Cardio, did not require clinical studies to support substantial equivalence.
Conclusion
Comparison of the Intended Uses/Indications for Use, the technological characteristics, and performance specifications demonstrate the functional equivalence of the subject device to the predicate device. Verification and validation test results established that the device meets its design requirements and intended uses and that no new issues relative to safety and effectiveness were raised. Watson Health Imaging considers the Merge Cardio to be as safe and as effective as the predicate device, with performance substantially equivalent to the predicate device.
Image /page/10/Picture/13 description: The image shows the logo for Watson Health. The logo consists of a stylized image of a sun or starburst to the left of the words "Watson Health" in bold, black font. There is a green line above the logo.