(38 days)
No
The document describes standard PACS functionalities and image processing tools, with no mention of AI or ML.
No
Merge PACS is a picture archiving and communication system (PACS) used for image processing, display, diagnostic reading, reporting, communication, printing, and storage of medical imaging studies. It is a diagnostic workstation that assists clinicians in viewing, reading, and reporting findings, not a device that provides therapy.
Yes
This device is a Picture Archiving and Communication System (PACS) specifically designed for "diagnostic reading and reporting" of multi-modality medical images. It is described as a "standards-based medical imaging diagnostic workstation" that serves to "assist the clinician to view, read, and report their findings," indicating its role in the diagnostic process.
Yes
The device description explicitly states "Merge PACS, a software medical device". While it runs on off-the-shelf hardware, the device itself is defined as the software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Merge PACS Functionality: The description of Merge PACS clearly states its purpose is for "image processing and display, diagnostic reading and reporting, communication, printing, and storage of medical imaging studies and other patient data." It processes images from various medical imaging modalities (CT, MR, etc.).
- No Mention of Biological Samples: There is no mention of the device analyzing biological samples or performing tests on bodily fluids or tissues.
Therefore, Merge PACS falls under the category of medical imaging software and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Merge PACS™ is a Picture Archiving and Communication System (PACS) for multi-modality (CT, MR, PT, US, MG, BTO, CR, DR/DX, NM, XA, RF, secondary capture (SC), and other DICOM-compliant modalities) image processing and display, diagnostic reading and reporting, communication, printing, and storage of medical imaging studies and other patient data. Intended clinical users include radiologists, orthopedic and other surgeons, referring physicians, technologists, and other qualified medical professionals.
Data can be received directly from acquisition modalities, CAD systems, and other image processing systems, or indirectly via importing. Data that is not DICOM-compliant, such as photos, can be converted to DICOM format by Merge PACS.
Merge PACS provides image manipulation tools to enable users to view and compare images such as: linking, MPR, MIP, 3D image fusion/registration of CT, MR, and PET; as well as CVR (Color Volume Rendering), measurements (linear distances, angles, areas, SUV, etc.), and annotations (for example, outline and label regions of interest, label spinal vertebrae).
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
Merge PACS, a software medical device, is a standards-based medical imaging diagnostic workstation that serves as an adjunct to assist the clinician to view, read, and report their findings. Merge PACS processes and displays medical images from DICOM-compliant modalities. The device is designed to enable efficient workflows by maintaining clinicians' worklists and retrieving and managing studies for reading, reporting, communication, and storage.
Merge PACS software runs on off-the-shelf computer hardware and can be configured to operate standalone or to integrate with vendor-neutral imaging archives (VNAs) such as iConnect Enterprise Archive (iCEA) via DICOM protocol, for image storage, and with radiological and hospital information systems (RIS and HIS) and medical record systems (EMR, EHR, etc.) via HL7.
Merge PACS can be accessed from within the hospital or enterprise, or from remote locations via web-based access. Images viewed on mobile devices should not be used for diagnostic purposes.
The focus of this premarket notification is on the addition of the Region Analysis Area and Region Analysis Volume tools, which allows for additional clinical analysis of images, including volumetric Standard Uptake Value (SUV) calculation. There has been a minor change in the indications for use statement from the previous Merge PACS device, with the removal of the optional Reach component which is no longer offered. Additional non-significant changes since the previous submission will be discussed.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR, PT, US, MG, BTO, CR, DR/DX, NM, XA, RF, secondary capture (SC), and other DICOM-compliant modalities
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Intended clinical users include radiologists, orthopedic and other surgeons, referring physicians, technologists, and other qualified medical professionals.
Can be accessed from within the hospital or enterprise, or from remote locations via web-based access.
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)
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.
Non-Clinical Tests:
- Risk Analysis
- Requirements Review
- Design Reviews
- Testing on unit level
- Integration testing
- Performance testing
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". Non-clinical testing has been performed on Merge PACS and demonstrates compliance with international and FDA-recognized consensus standards and FDA guidance documents. This Traditional 510(k) has been written in accordance with the applicable FDA Guidance Document for the Submission of Premarket Notifications for Medical Image Management Devices (July 2000), and meets the following voluntary standard(s):
- DICOM - Digital Imaging and Communications in Medicine, for the format of medical images and data, NEMA PS 3.1 - 3.20 Set (2016)
Results from internal verification and validation testing performed in accordance with Watson Health Imaging design control processes confirm that Merge PACS 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. Cybersecurity is also addressed in this submission.
Clinical Tests: The subject of this premarket submission, Merge PACS, did not require clinical studies to support substantial equivalence.
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.
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
§ 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
October 17, 2019
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is the Department of Health & Human Services logo. The right side of the logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Merge Healthcare Incorporated % Ms. Amy Tannenbaum Regulatory Affairs Specialist 900 Walnut Ridge Drive HARTLAND WA 53209
Re: K192455
Trade/Device Name: Merge PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: September 16, 2019 Received: September 17, 2019
Dear Ms. Tannenbaum:
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/cfpmp/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 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
1
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,
For
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
2
Section 4
Indications for Use Statement (Form 3881)
Image /page/2/Picture/5 description: The image shows the logo for Watson Health. The logo consists of a stylized image of a sun or globe with radiating lines on the left. 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 trademark symbol after the word "Health".
3
Indications for Use
510(k) Number (if known) K192455
Device Name Merge PACS
Indications for Use (Describe)
Merge PACS™ is a Picture Archiving and Communication System (PACS) for multi-modality (CT, MR, PT, US, MG, BTO, CR, DR/DX, NM, XA, RF, secondary capture (SC), and other DICOM-compliant modalities) image processing and display, diagnostic reading and reporting, communication, printing, and storage of medical imaging studies and other patient data. Intended clinical users include radiologists, orthopedic and other surgeons, referring physicians, and other qualified medical professionals.
Data can be received directly from acquisities, CAD systems, and other image processing systems, or indirectly via importing. Data that is not DICOM-compliant, such as photos, can be converted to DICOM format by Merge PACS.
Merge PACS provides image manipulation tools to enable users to view and compare images such as: linking, MPR, MIP, 3D image fusion/registration of CT, MR, and PET; as well as CVR (Color Volume Rendering), measurements (linear distances, angles, areas, SUV, etc.), and annotations (for example, outline and label regions of interest, label spinal vertebrae).
The Real Time Worklist (RTWL) displays the real-time status of radiology activity and provides customizable workflow management capabilities. Communication of critical results is facilitated and documented through optional, configurable components.
The Patient Dashboard provides a composite view of patient data, both imaging. Multi-tier patient identity matching provides a comprehensive view even when dealing with multiple disparate patient identities.
Order and report information generated by the HIS/RIS and report creation systems are received and displayed via the transmission of HL7 messaging.
Lossless (reversible) and lossy (irreversible) image compression are supported for viewing, storage and communication. Merge PACS displays full fidelity DICOM images for use in the diagnostic interpretation of mammography using MG or BTO images. Thick slab MIP presentation can be applied to BTO images.
Lossy compressed images and digitized screen film images must not be used for primary diagnosis of mammography studies, and only display monitors that have regulatory clearance for mammography interpretation should be used for the interpretation of mammography studies.
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) |
|---|---|
| -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
4
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid 0MB number."
5
510(k) Summary - Merge PACS K192455
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 | |
| 510(k) Number: | K192455 |
| Date Prepared: | September 6, 2019 |
| Contact Person: | Amy Tannenbaum |
| Regulatory Affairs Specialist | |
| Phone: 617-528-3087 | |
| Email: amy.tannenbaum@ibm.com | |
| Secondary Contact: | Tracey Fox |
| Global Regulatory Affairs, Manager | |
| Phone: 1-262-369-3156 | |
| Email: tracey.fox@ibm.com | |
| Identification of the Device | |
| Trade Name: | Merge PACS |
| Common Name: | Picture Archiving and Communication System (PACS) |
| Classification Name: | Radiological Image Processing System |
| 21 CFR 892 2050 |
Product Code:
Device Class:
Predicate Device(s) Primary Predicate: Merge PACS (K173475) Reference Predicate: Xelis Fusion (K111613)
LLZ
Class II
Image /page/5/Picture/6 description: The image shows the logo for Watson Health. The logo consists of a stylized image of a sun or lightbulb on the left, followed by the text "Watson Health" in a bold, sans-serif font. There is a green bar at the top of the image.
6
Device Description
Merge PACS, a software medical device, is a standards-based medical imaging diagnostic workstation that serves as an adjunct to assist the clinician to view, read, and report their findings. Merge PACS processes and displays medical images from DICOM-compliant modalities. The device is designed to enable efficient workflows by maintaining clinicians' worklists and retrieving and managing studies for reading, reporting, communication, and storage.
Merge PACS software runs on off-the-shelf computer hardware and can be configured to operate standalone or to integrate with vendor-neutral imaging archives (VNAs) such as iConnect Enterprise Archive (iCEA) via DICOM protocol, for image storage, and with radiological and hospital information systems (RIS and HIS) and medical record systems (EMR, EHR, etc.) via HL7.
Merge PACS can be accessed from within the hospital or enterprise, or from remote locations via web-based access. Images viewed on mobile devices should not be used for diagnostic purposes.
The focus of this premarket notification is on the addition of the Region Analysis Area and Region Analysis Volume tools, which allows for additional clinical analysis of images, including volumetric Standard Uptake Value (SUV) calculation. There has been a minor change in the indications for use statement from the previous Merge PACS device, with the removal of the optional Reach component which is no longer offered. Additional non-significant changes since the previous submission will be discussed.
Intended Use/ Indications for Use
Merge PACS™ is a Picture Archiving and Communication System (PACS) for multi-modality (CT, MR, PT, US, MG, BTO, CR, DR/DX, NM, XA, RF, secondary capture (SC), and other DICOM-compliant modalities) image processing and display, diagnostic reading and reporting, communication, printing, and storage of medical imaging studies and other patient data. Intended clinical users include radiologists, orthopedic and other surgeons, referring physicians, technologists, and other qualified medical professionals.
Data can be received directly from acquisition modalities, CAD systems, and other image processing systems, or indirectly via importing. Data that is not DICOM-compliant, such as photos, can be converted to DICOM format by Merge PACS.
Merge PACS provides image manipulation tools to enable users to view and compare images such as: linking, MPR, MIP, 3D image fusion/registration of CT, MR, and PET; as well as CVR (Color Volume Rendering), measurements (linear distances, angles, areas, SUV, etc.), and annotations (for example, outline and label regions of interest, label spinal vertebrae).
Image /page/6/Picture/9 description: The image shows the logo for Watson Health. The logo consists of a stylized image of a globe with lines emanating from 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".
7
The Real Time Worklist (RTWL) displays the real-time status of radiology activity and provides customizable workflow management capabilities. Communication of critical results is facilitated and documented through optional, configurable components.
The Patient Dashboard provides a composite view of patient data, both imaging and nonimaging. Multi-tier patient identity matching provides a comprehensive view even when dealing with multiple disparate patient identities.
Order and report information generated by the HIS/RIS and report creation systems are received and displayed via the transmission of HL7 messaging.
Lossless (reversible) and lossy (irreversible) image compression are supported for viewing, storage and communication. Merge PACS displays full fidelity DICOM images for use in the diagnostic interpretation of mammography using MG or BTO images. Thick slab MIP presentation can be applied to BTO images.
Lossy compressed images and digitized screen film images must not be used for primary diagnosis of mammography studies, and only display monitors that have regulatory clearance for mammography interpretation should be used for the interpretation of mammography studies.
Technological Characteristics
Merge PACS and its predicate device(s) have the same fundamental scientific technology. The primary predicate is the previous Merge PACS (K173475) for which the subject device is a modification of, with reference predicate Xelis Fusion (K111613).
The subject device has the same basic intended use as the predicates and near identical indications for use as Merge PACS (K173475). The devices have essentially the same basic image processing, display, storage, and communication features, based on the same or similar technology. Availability and bundling and naming of additional features and toolsets may vary between the devices, but the technology behind each feature is essentially the same regardless of how it is catered to a specific user.
It is our opinion that the subject Merge PACS device is substantially equivalent to the previous Merge PACS (K173475) as it is an earlier version of the device that contains the same technology and functionality. The subject device is also substantially equivalent to the reference predicate, Xelis Fusion (K111613), sharing essentially the same basic image processing, display. storage and communication features as well as the new capability of volumetric SUV measurements.
Determination of Substantial Equivalence
The modifications to Merge PACS include updates to the software and labeling from the previous Merge PACS K173475. A summary of the key changes in the subject Merge PACS
Image /page/7/Picture/11 description: The image shows the logo for Watson Health. The logo consists of a stylized image of a sun or globe with rays emanating from it, followed by the text "Watson Health" in bold, black font. The letters are sans-serif and the word "Health" is followed by the trademark symbol.
8
device are summarized below with comparison to its predicates. Additional non-significant changes and bug fixes have been made to improve workflow and security, and do not have an impact on clinical functionality of the device.
Image /page/8/Picture/1 description: The image shows the logo for Watson Health. The logo consists of a stylized sun-like graphic on the left, followed by the words "Watson Health" in a bold, sans-serif font. A small trademark symbol appears to the right of the word "Health".
9
Table 1: Comparison to predicates
| Category | Feature/
Information | Subject Merge PACS
(K192455) | Primary Predicate: Merge
PACS (K173475) | Reference
Predicate: Xelis
Fusion (K111613) | Clinically Significant
Change? |
|---------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General | Common Name
of Device/
Classification
Product code | Picture Archiving and
Communications System
(PACS)
21 CFR 892.2050
LLZ- Radiological Image
Processing System | Picture Archiving and
Communications System
(PACS)
21 CFR 892.2050
LLZ- Radiological Image
Processing System | Picture Archiving
and
Communications
System (PACS)
21 CFR 892.2050
LLZ- Radiological
Image Processing
System | No changes |
| | Operating
System | Windows 10 | Windows 7/8.1/10 | Unknown | Not a clinically significant
difference - support for
latest Windows OS. |
| | Browser
Support | Internet Explorer 11,
Edge, Chrome | Internet Explorer 7, 8, 9,
10, 11 | Unknown | Not a clinically significant
difference - support for new
browser only |
| | Server OS
Support | Windows 2016 64-bit,
Windows 2012 R2 | Windows 2012 R2 | Windows 32 and 64-
bit | Not a clinically significant
difference - support for
latest server OS |
| | Indication for
Use Statement | Merge PACS™ is a Picture
Archiving and
Communication System
(PACS) for multi-modality
(CT, MR, PT, US, MG,
BTO, CR, DB/DX, NM, XA | Merge PACS™ is a Picture
Archiving and
Communication System
(PACS) for multi-modality
(CT, MR, PT, US, MG, BTO,
CR, DB/DX, NM, XA, RF | The Xelis Fusion is a
software device that
receives digital
images and data
from various
sources (e.g. CT | There is only a minor change
in the indications for use
statement from the
previous Merge PACS
device, with the removal of
the optional Reach |
| Category | Feature/
Information | Subject Merge PACS
(K192455) | Primary Predicate: Merge
PACS (K173475) | Reference
Predicate: Xelis
Fusion (K111613) | Clinically Significant
Change? |
| | | RF, secondary capture
(SC), and other DICOM-
compliant modalities)
image processing and
display, diagnostic
reading and reporting,
communication, printing,
and storage of medical
imaging studies and
other patient data.
Intended clinical users
include radiologists,
orthopedic and other
surgeons, referring
physicians, technologists,
and other qualified
medical professionals. | secondary capture (SC),
and other DICOM-
compliant modalities)
image processing and
display, diagnostic reading
and reporting,
communication, printing,
and storage of medical
imaging studies and other
patient data. Intended
clinical users include
radiologists, orthopedic
and other surgeons,
referring physicians,
technologists, and other
qualified medical
professionals. | scanners, MR
ultrasound systems,
R/F Units, computed
& direct
radiographic
devices, secondary
capture devices,
scanners, imaging
gateways or other
image sources).
Diagnosis or
computer aided
diagnosis is not
performed by the
software but by
Radiologists. | component which is no
longer offered. Similar
indications to reference
predicate. There is no
clinically significant
difference as Reach was not
used by radiologists for
diagnosis. |
| | | Data can be received
directly from acquisition
modalities, CAD systems,
and other image
processing systems, or
indirectly via importing.
Data that is not DICOM-
compliant, such as
photos, can be converted | Data can be received
directly from acquisition
modalities, CAD systems,
and other image
processing systems, or
indirectly via importing.
Data that is not DICOM-
compliant, such as photos,
can be converted to | Images (including
mammographic)
and data can be
stored,
communicated,
processed and
displayed within the
system and or
across computer
networks at | |
| Category | Feature/
Information | Subject Merge PACS
(K192455) | Primary Predicate: Merge
PACS (K173475) | Reference
Predicate: Xelis
Fusion (K111613) | Clinically Significant
Change? |
| | | to DICOM format by
Merge PACS.
Merge PACS provides
image manipulation tools
to enable users to view
and compare images
such as: linking, MPR,
MIP, 3D image
fusion/registration of CT,
MR, and PET; as well as
CVR (Color Volume
Rendering),
measurements (linear
distances, angles, areas,
SUV, etc.), and
annotations (for
example, outline and
label regions of interest,
label spinal vertebrae).
The Real Time Worklist
(RTWL) displays the real-
time status of radiology
activity and provides
customizable workflow
management capabilities. | DICOM format by Merge
PACS.
Merge PACS provides
image manipulation tools
to enable users to view
and compare images such
as: linking, MPR, MIP, 3D
image fusion/registration
of CT, MR, and PET; as
well as CVR (Color Volume
Rendering),
measurements (linear
distances, angles, areas,
SUV, etc.), and
annotations (for example,
outline and label regions
of interest, label spinal
vertebrae).
The Real Time Worklist
(RTWL) displays the real-
time status of radiology
activity and provides
customizable workflow
management capabilities.
Communication of critical | distributed
locations. In
addition, Xelis
Fusion can be
integrated with an
institution's HIS or
RIS for an integrated
and electronic
patient record.
Lossy compressed
mammographic
images and digitized
film screen images
must not be
reviewed for
primary image
interpretation.
Mammographic
images may only be
interpreted using
and FDA approved
monitor that offers
at least 5 Mega-
pixel resolution and
meets other
technical
specifications | |
| Category | Feature/
Information | Subject Merge PACS
(K192455) | Primary Predicate: Merge
PACS (K173475) | Reference
Predicate: Xelis
Fusion (K111613) | Clinically Significant
Change? |
| | | Communication of critical
results is facilitated and
documented through
optional, configurable
components.
The Patient Dashboard
provides a composite
view of patient data,
both imaging and non-
imaging. Multi-tier
patient identity matching
provides a
comprehensive view
even when dealing with
multiple disparate
patient identities.
Order and report
information generated by
the HIS/RIS and report
creation systems are
received and displayed
via the transmission of
HL7 messaging. | results is facilitated and
documented through
optional, configurable
components.
The Patient Dashboard
provides a composite view
of patient data, both
imaging and non-imaging.
The optional Reach
component provides
clinicians with secure,
proactive communication
and access to clinical
reports and images. Multi-
tier patient identity
matching provides a
comprehensive view even
when dealing with
multiple disparate patient
identities.
Order and report
information generated by
the HIS/RIS and report
creation systems are
received and displayed via | reviewed and
accepted by FDA. | |
| Category | Feature/
Information | Subject Merge PACS
(K192455) | Primary Predicate: Merge
PACS (K173475) | Reference
Predicate: Xelis
Fusion (K111613) | Clinically Significant
Change? |
| | | Lossless (reversible) and
lossy (irreversible) image
compression are
supported for viewing,
storage and
communication. Merge
PACS displays full fidelity
DICOM images for use in
the diagnostic
interpretation of
mammography using MG
or BTO images. Thick slab
MIP presentation can be
applied to BTO images.
Lossy compressed images
and digitized screen film
images must not be used
for primary diagnosis of
mammography studies,
and only display monitors
that have regulatory
clearance for
mammography
interpretation should be
used for the | the transmission of HL7
messaging.
Lossless (reversible) and
lossy (irreversible) image
compression are
supported for viewing,
storage and
communication. Merge
PACS displays full fidelity
DICOM images for use in
the diagnostic
interpretation of
mammography using MG
or BTO images. Thick slab
MIP presentation can be
applied to BTO images.
Lossy compressed images
and digitized screen film
images must not be used
for primary diagnosis of
mammography studies,
and only display monitors
that have regulatory
clearance for
mammography | | |
| Category | Feature/
Information | Subject Merge PACS
(K192455) | Primary Predicate: Merge
PACS (K173475) | Reference
Predicate: Xelis
Fusion (K111613) | Clinically Significant
Change? |
| | | interpretation of
mammography studies. | interpretation should be
used for the
interpretation of
mammography studies. | | |
| Significant change(s) introduced in subject device Merge PACS: | | | | | |
| Measurement | SUV Calculation
(PET) | Probe Tool, ROI Tool
Regional Area Analysis
and Regional Volume
Analysis
2D and 3D SUV
calculations | Probe Tool and ROI Tool
2D SUV calculations only | Supports 3D region
of interest (ROI) SUV
analysis | Addition of Region Area and
Volume Analysis tools allows
for additional clinical
analysis of PET images for
patient treatment, including
3D SUV calculations. The
reference predicate device
shares this new feature with
the subject Merge PACS.
Applicable verification and
validation testing has been
performed to justify the
safety and efficacy of this
difference from the primary
predicate. |
| Category | Feature/
Information | Subject Merge PACS
(K192455) | Primary Predicate: Merge
PACS (K173475) | Reference
Predicate: Xelis
Fusion (K111613) | Clinically Significant
Change? |
| Non-significant changes(s) introduced in subject device Merge PACS: | | | | | |
| Viewer | Terarecon
Integration | Yes - Terarecon
embedded in Merge
PACS, opens in same
window | Yes - Terarecon opens in
separate window | Unknown | Not a clinically significant
difference. End functionality
owned by Terarecon.
Smoother integration with
Merge PACS for user
convenience, but no clinical
impact to the patient. |
| | Automatic
Registration for
series that do
not share a
common frame
of reference | Yes | No - Automatic linking of
series with same frame of
reference UID and
manually linking of series
that do not share a
common frame of
reference only | Yes | Not a clinically significant
difference for Merge PACS.
Automatic registration is
through the functionality of
Blackford to deliver DICOM
objects to Merge PACS for
automatic registration of
series that do not share a
common frame of
reference. No impact to
safety or effectiveness. |
| | Patient Synopsis
information
within Patient
Record | Yes | No | Similar functionality
- can Integrate with
patient record | Not a clinically significant
different, Watson Imaging
Patient Synopsis provides a
new option for clinicians to
view patient information. |
| Category | Feature/
Information | Subject Merge PACS
(K192455) | Primary Predicate: Merge
PACS (K173475) | Reference
Predicate: Xelis
Fusion (K111613) | Clinically Significant
Change? |
| | | | | | No clinical impact to the
patient. |
| Viewer — Mammo
Support | 2D/3D Mammo
toggle tool | Yes | No – user must perform
additional key clicks to go
between 2D and 3D
images | Unknown | Not a clinically significant
difference. Provides a user
convenience only to more
quickly toggle between
views. No clinical impact to
the patient. |
| DICOM user
accounts | Allow flexibility
in choosing the
desired local,
network (e.g
LDAP), or Merge
PACS accounts
of various user
services | Yes | No | Unknown | Security enhancements only
and allows for more
customizable controls. No
impact to safety or
effectiveness. |
| Other changes | Security
enhancements,
and updates to
graphics in
About Screen | Yes | No | Unknown | Not a clinically significant
difference. About Screen
provides information only
and security enhancements
have no impact to safety or
effectiveness. |
Image /page/9/Picture/2 description: The image contains the logo for Watson Health. The logo consists of a stylized image of a sun or 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".
10
Image /page/10/Picture/1 description: The image features the logo for Watson Health. The logo consists of a stylized graphic of interconnected circles with radiating lines, resembling a sun or a network. To the right of the graphic, the words "Watson Health" are written in a bold, sans-serif font. A trademark symbol appears next to the word "Health".
11
Image /page/11/Picture/1 description: The image shows the logo for Watson Health. The logo consists of a stylized image of a sun with rays emanating from a central circle, 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".
12
Image /page/12/Picture/1 description: The image shows the logo for Watson Health. The logo consists of a stylized image of a sun or lightbulb on the left, 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".
13
Image /page/13/Picture/1 description: The image shows the logo for Watson Health. The logo consists of a stylized lightbulb icon on the left, followed by the text "Watson Health" in a bold, sans-serif font. A trademark symbol appears next to the word "Health".
14
Image /page/14/Picture/1 description: The image shows the logo for Watson Health. The logo consists of a stylized image of a sun or a globe with radiating lines, 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".
15
Image /page/15/Picture/1 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 words "Watson Health" in bold, black font. A small trademark symbol appears after the word "Health".
16
Image /page/16/Picture/1 description: The image shows the logo for Watson Health. The logo consists of a stylized globe with radiating lines on the left and the words "Watson Health" in bold black font on the right. A trademark symbol appears next to the word "Health".
17
Summary of Non-Clinical Tests
The following quality assurance measures were applied to the Merge PACS product:
- Risk Analysis
- Requirements Review
- Design Reviews
- Testing on unit level
- Integration testing
- Performance testing
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".
No performance standards for PACS system or components have been issued under the authority of Section 514. Non-clinical testing has been performed on Merge PACS and demonstrates compliance with international and FDA-recognized consensus standards and FDA guidance documents. This Traditional 510(k) has been written in accordance with the applicable FDA Guidance Document for the Submission of Premarket Notifications for Medical Image Management Devices (July 2000), and meets the following voluntary standard(s):
- DICOM - Digital Imaging and Communications in Medicine, for the format of medical images and data, NEMA PS 3.1 - 3.20 Set (2016)
Results from internal verification and validation testing performed in accordance with Watson Health Imaging design control processes confirm that Merge PACS 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. Cybersecurity is also addressed in this submission.
The subject of this submission, Merge PACS, 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 PACS, 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
Image /page/17/Picture/17 description: The image shows the logo for Watson Health. The logo consists of a stylized image of a sun or a globe with rays emanating from it, followed by the text "Watson Health". The text is in a bold, sans-serif font, and the logo is placed against a white background with a green bar at the top.
18
design requirements and intended uses and that no new issues relative to safety and effectiveness were raised. Watson Health Imaging considers the Merge PACS to be as safe and as effective as its predicate devices.
Image /page/18/Picture/1 description: The image shows the logo for Watson Health. The logo consists of a stylized lightbulb on the left and the words "Watson Health" on the right. The word "Health" has a trademark symbol next to it.