Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard PACS functionalities, image processing tools, and workflow management. There is no mention of AI or ML algorithms being used for image analysis, diagnosis, or any other function. The focus of the submission is on image fusion and SUV measurement, which are not inherently AI/ML features.

Therapeutic

No
The device 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 an adjunct to assist clinicians in viewing, reading, and reporting findings, not for providing therapy.

Diagnostic

Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "diagnostic reading and reporting" and "diagnostic interpretation of mammography." The "Device Description" also mentions it is a "medical imaging diagnostic workstation."

SaMD (Software as a Medical Device)

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.

IVD (In Vitro Diagnostic)

Based on the provided text, the Merge PACS™ device is not an In Vitro Diagnostic (IVD).

Here's why:

Definition of IVD: 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 clearly states that Merge PACS is a Picture Archiving and Communication System (PACS) that processes and displays medical images from various imaging modalities (CT, MR, PET, etc.). It deals with in vivo imaging data, not in vitro samples.
Intended Use: The intended use is for image processing and display, diagnostic reading and reporting, communication, printing, and storage of medical imaging studies. This aligns with the functions of a medical imaging workstation, not an IVD.

Therefore, Merge PACS falls under the category of a medical imaging device, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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 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 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 inage manipulation tools to view and compare images such as: linking. MPR, MP, 3D image fusion! reqistration of CT, MR, and PET; as well as CVR (Color Volume Rendering), measurements (linear distances, angles, 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, components.

The Patient Dashboard provides a composite view of patient data, both imaging. The optional Reach component provides clinicians with secure, proactive communication 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 HS/R/S 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 of mammography studies.

Product codes

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) for image storage, and with radiological and hospital information systems (RIS and HIS) and medical record systems (EMR, EHR, etc.).

Merge PACS can be accessed from within the hospital or enterprise, or from remote locations via web-based access. Images viewed on mobile devices must not be used for diagnostic review.

The focus of this premarket notification is on the addition of the ability to "fuse" images for viewing (image fusion) and on the ability to measure Standardized Uptake Values (SUV) on PET (Positron Emission Tomography) images.

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.

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)

Non-Clinical Tests:
In-house non-clinical testing of the features of Merge PACS, a software device, was performed in compliance with design control processes.
The results of software testing confirmed that the Merge PACS device with image fusion and SUV measurement features performs as expected, and documented evidence was provided in this submission.

Clinical Tests:
Clinical studies were not required to demonstrate the safety and effectiveness of Merge PACS.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K082144, K160108

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

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December 8, 2017

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Merge Healthcare Incorporated % Ms. Carol Nakagawa Senior Manager of Regulatory Affairs 900 Walnut Ridge Drive HARTLAND WI 53029

Re: K173475

Trade/Device Name: Merge PACS™ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 2, 2017 Received: November 9, 2017

Dear Ms. Nakagawa:

We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

1

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn

(http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K173475

Device Name

Merge PACS(TM)

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 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 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 inage manipulation tools to view and compare images such as: linking. MPR, MP, 3D image fusion! reqistration 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, components.

The Patient Dashboard provides a composite view of patient data, both imaging. The optional Reach component provides clinicians with secure, proactive communication 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 HS/R/S 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 of mammography studies.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows the logo for Merge, an IBM company. The word "MERGE" is written in a combination of blue and orange colors, with the top half of each letter in orange and the bottom half in blue. Below the word "MERGE", the text "An IBM Company" is written in a smaller, blue font. The logo is simple and modern, reflecting the company's focus on technology and innovation.

510(k) Summary

l. SUBMITTER

Merge Healthcare Incorporated 900 Walnut Ridge Drive Hartland, Wisconsin 53029 U.S.A.

Tel: 262.367.0700 Fax: 262.367.0717

Contact Person: Carol Nakagawa, RAC Sr. Manager of Requlatory Affairs Merge Healthcare, an IBM Company Tel.: 905.364.8027 Fax: 905.364.8100

November 3, 2017 Date Prepared:

ll. DEVICE

Merge PACS™ Proprietary Name of Device:

Picture Archiving and Communications Common or Usual Name: System (PACS)
Radiological Image Processing System (21 Classification Name: CFR 892.2050)
Regulatory Class: Class II
LLZ Product Code:

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Image /page/4/Picture/0 description: The image shows the logo for Merge, an IBM company. The word "MERGE" is written in large, bold letters, with the first half of the word in blue and the second half in orange. Below the word "MERGE" is the text "An IBM Company" in a smaller, blue font. The logo is simple and modern, and it clearly identifies the company as a subsidiary of IBM.

III. PREDICATE DEVICES

Trade Name	510(k) Submitter	510(k) Number
Primary Predicate Device:
AMICAS PACS 6.0	AMICAS, Inc.	K082144
Class II
Product Code LLZ
Synapse PACS	Fujifilm Medical Systems
U.S.A., Inc.	K160108
Class II
Product Code LLZ

DEVICE DESCRIPTION IV.

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) for image storage, and with radiological and hospital information systems (RIS and HIS) and medical record systems (EMR, EHR, etc.).

Merge PACS can be accessed from within the hospital or enterprise, or from remote locations via web-based access. Images viewed on mobile devices must not be used for diagnostic review.

The focus of this premarket notification is on the addition of the ability to "fuse" images for viewing (image fusion) and on the ability to measure Standardized Uptake Values (SUV) on PET (Positron Emission Tomography) images.

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Image /page/5/Picture/0 description: The image shows the logo for Merge, an IBM company. The word "MERGE" is written in large, bold letters, with the first half of the word in blue and the second half in orange. Below the word "MERGE" is the text "An IBM Company" in a smaller font size.

Image Fusion

The primary use for image fusion is to view PET and CT images overlaid on top of each other in addition to the previously available ability to view them side-by side in different viewports, or sequentially one after the other.

The ability to view images overlaid on top of each other in one viewport does not change the intended use of Merge PACS, which is intended to be used for multi-modality image viewinq in 2D and 3D. The fusion of the display of two images does not change the fundamental image processing that is used. The original images are always available and each can be faded completely in or out in the fused display. The unfused image is the default display.

PET and CT images from modern scanners are acquired with a common DICOM frame of reference. The spatial processing of the PET and CT image objects uses the same algorithms (i.e., having a common DICOM frame of reference provides the basis from which the images can either be crossreferenced with localizer lines or registered with each other). The DICOM frame of reference, pixel spacinq, slice spacinq, orientation vector and other data already provide the technological basis for the display of localizer or cross reference lines and the 3D cursor tool. These are core functions of most PACS viewers including those that support 3D operations (such as Merge PACS under its previous 510(k) clearance) and are applied now to image registration for image fusion.

Alignment is done as a simple rigid transformation allowing for translation and rotation about each of the axes of the 3D image volumes. This is similar to the existing technology used to provide manual linking of studies (e.q., to enable side-by-side simultaneous scrolling of two studies in different viewports) or to allow re-linking with an offset for common-frame-ofreference series or studies, as was previously cleared for Merge PACS.

Merge PACS does not enable warping or non-rigid transformation of the images, nor automation of the realignment or registration adjustment process.

The original images are always available and the most common viewing paradigm is to view the fused (corrected PET and CT) images alongside the unfused corrected PET images.

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Image /page/6/Picture/0 description: The image shows the logo for Merge, an IBM company. The word "MERGE" is written in large, bold letters, with the top half of each letter in blue and the bottom half in orange. Below the word "MERGE" is the text "An IBM Company" in a smaller font size and blue color.

Standardized Uptake Values (SUV)

SUVs (Standardized Uptake Values) are calculated for FDG PET studies to judge the biological activity of a tumor and its response to therapy.

The SUV calculation can be performed for individual pixels or on a Region Of Interest (ROI) as an adjunct to viewing the relative intensities of different areas of the PET images.

SUV measurements can be made in Merge PACS discretely via a point / pixel measurement tool, or via SUVmean measurements via a planar elliptical ROI measurement tool. These raw measurements can be normalized according to any of the four common normalizations:

· Body Weight (BW)
· Lean Body Mass (LBM)
Body Surface Area (BSA) .
Ideal Body Weight (IBW) .

Merge PACS does not provide automated or semi-automated segmentation of PET lesion volumes. Merge PACS provides manual single point SUV values and SUVs for manually defined ROI. The user determines where they want to measure SUV on the image and decides how to interpret the information, for example whether activity is related to tumor activity or to other processes such as infection or inflammation. Merge PACS does not provide a diagnosis or treatment recommendation.

Merge PACS SUV measurements and image registration meet the RSNA (Radiological Society of North America)/ QIBA (Quantitative Imaging Biomarkers Alliance) guidelines using the DRO (Digital Reference Object) that they developed in conjunction with their guideline document.

The SUV measurements in Merge PACS are based on the existing pixel value and ROI tools of AMICAS PACS 6.0. The RSNA/ QIBA testing and qualification process for SUV measurements is being implemented to have an independent means of assessing the measurement and registration accuracy.

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Image /page/7/Picture/0 description: The image shows the logo for Merge, an IBM company. The word "MERGE" is written in a combination of blue and orange colors. The letters "M, E, R" are in blue, while the letters "G, E" are in orange. Below the word "MERGE" is the text "An IBM Company" in a smaller font size.

INTENDED USE / INDICATIONS FOR USE V.

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: linkinq, 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 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 the transmission of HL7 messaging. Lossless (reversible) and lossy (irreversible) image compression are supported for viewing, storage and communication.

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Image /page/8/Picture/0 description: The image shows the logo for Merge, an IBM company. The word "MERGE" is written in large, bold letters, with the first half of the word in blue and the second half in orange. Below the word "MERGE" is the text "An IBM Company" in a smaller font size. The logo is simple and modern, with a clear emphasis on the company name.

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.

COMPARISON WITH PREDICATES VI.

Merge PACS and the predicate devices are software products and physical technological characteristics do not apply. The comparison of Merge PACS to the predicate devices is based primarily on the functionality and technological design of their software features.

Merge PACS, AMICAS PACS 6.0, and Synapse PACS devices have the same intended use. Each is a multi-modality diagnostic workstation for viewing, reading, and reporting on medical images from various imaging modalities. They are all "tool type" devices that have the same general indications for use that do not specify a disease, condition, or population.

Each device has essentially the same basic image processing, display, storage, and communication features, based on the same or similar technology as the primary predicate device. The availability of additional specific features may vary between devices. Bundling of subsets of features or toolsets makes the workflow more suitable for clinicians with different specializations, such as mammography or orthopedics, however the image processing technology behind each feature is essentially the same regardless of how the features are bundled.

It is our opinion that Merge PACS is substantially equivalent to AMICAS PACS 6.0, a multi-modality diagnostic workstation that represents an earlier version of Merge PACS and shares the same basic technology and intended uses as Merge PACS.

It is also our opinion that Merge PACS is substantially equivalent to Synapse PACS, which is a multi-modality diagnostic workstation. Synapse PACS has

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Image /page/9/Picture/0 description: The image shows the logo for MERGE, an IBM company. The word "MERGE" is written in a large, sans-serif font, with the letters "M", "E", "R", and "G" in blue and the letter "E" in orange. Below the word "MERGE" is the text "An IBM Company" in a smaller, sans-serif font.

essentially the same basic image processing, display, storage, and communication features as Merge PACS. Synapse PACS supports 3D image fusion and is capable of performing SUV measurements.

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Image /page/10/Picture/0 description: The image shows the logo for MERGE, an IBM company. The word "MERGE" is written in a bold, sans-serif font, with the letters "M", "E", "R", and "G" in blue and the letter "E" in orange. Below the word "MERGE" is the text "An IBM Company" in a smaller, sans-serif font.

VII. The following table compares features/technologies of changes

| Category
New Features: | Feature | Subject 510(k):
Merge PACS | Primary Predicate:
AMICAS PACS 6.0
510(k) K082144
Cleared Sept. 5,
2008 | Predicate:
Fuji Synapse PACS
K160108
Cleared Feb. 3,
2016 |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|-------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | | |
| Image Display | PET/CT/MR Image Fusion | Yes | No | Yes
Rigid 3D fusion
(MIP/MPR) of CT,
MR, PET, SPECT
Non-Rigid 3D fusion
(MIP/MPR) of CT,
MR, PET, SPECT
2D Multi-modality
fusion |
| Image Display | PET/CT Fusion enhancements:
Rotation of MIP images, manual
entry of missing SUV attributes
(height, weight, BSA) | Yes | No | Has PET/CT fusion
and SUV
No significant
difference |
| Measurement | SUV Calculation (PET) | Yes | No | Yes |
| Non-Significant
Changes: | | | | |
| Category | Feature | Subject 510(k):
Merge PACS | Primary Predicate:
AMICAS PACS 6.0
510(k) K082144
Cleared Sept. 5, 2008 | Predicate:
Fuji Synapse PACS
K160108
Cleared Feb. 3, 2016 |
| Image Display | Enhanced mammography tools:
Stacked scrolling, Dual
magnifier, Binocular, Hotlight | Yes | No | Supports
mammography
reading

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Image /page/11/Picture/0 description: The image shows the logo for MERGE, an IBM company. The word "MERGE" is written in a combination of blue and orange colors, with the letters "M", "R", and "G" in blue and the letters "E" in orange. Below the word "MERGE" is the text "An IBM Company" in a smaller font size and blue color. The logo is simple and modern, with a clear emphasis on the company name and its affiliation with IBM.

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Image /page/12/Picture/0 description: The image shows the logo for Merge Healthcare, an IBM company. The word "MERGE" is written in large, bold letters, with the first half of the word in blue and the second half in orange. Below the word "MERGE" is the text "An IBM Company" in a smaller font size. The logo is simple and modern, with a focus on the company's name and its affiliation with IBM.

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Image /page/13/Picture/0 description: The image shows the logo for MERGE, an IBM company. The word "MERGE" is written in a large, bold font, with the letters "M", "R", and "G" in blue and the letters "E" in orange. Below the word "MERGE" is the text "An IBM Company" in a smaller font. The logo is simple and modern, and the use of blue and orange gives it a professional look.

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Image /page/14/Picture/0 description: The image shows the logo for Merge Healthcare, an IBM company. The word "MERGE" is written in large, bold letters, with the first half of the word in blue and the second half in orange. Below the word "MERGE" is the text "An IBM Company" in a smaller font size. The logo is simple and modern, with a focus on the company's name and its affiliation with IBM.

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Image /page/16/Picture/0 description: The image shows the logo for Merge, an IBM company. The word "MERGE" is written in a combination of blue and orange colors. The letters "M", "E", "R", and "G" are blue, while the letter "E" is orange. Below the word "MERGE", the text "An IBM Company" is written in a smaller font size.

VIII. PERFORMANCE DATA

Mandatory performance specifications or special controls applicable to diagnostic workstation devices or to image fusion or SUV features specifically, have not been established by the FDA.

Merge PACS and the primary predicate device AMICAS PACS 6.0 comply with the following voluntary standards and quidelines:

· DICOM Digital Imaging and Communications in Medicine, for the format of medical images and data
· JPEG Joint Photographic Experts Group, for image compression standards
FDA Guidance, "Guidance for the Submission of Premarket Notifications for Medical Image Management Devices", July 27, 2000

The determination of substantial equivalence is based on a comparison of features and software technology and on tests to confirm the correct behavior or result for each feature or measurement.

Non-Clinical Tests

In-house non-clinical testing of the features of Merge PACS, a software device, was performed in compliance with design control processes.

The results of software testing confirmed that the Merge PACS device with image fusion and SUV measurement features performs as expected, and documented evidence was provided in this submission.

Clinical Tests

Clinical studies were not required to demonstrate the safety and effectiveness of Merge PACS.

Conclusion

The intended uses and indications for use of Merqe PACS are, in our opinion, substantially equivalent to the primary predicate device AMICAS PACS 6.0 as well as to the predicate device Synapse PACS.

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The majority of features and functionalities, including image fusion and SUV measurements, were compared and found to be similar or the same as each other. We believe that any differences in features and their underlying technologies between the subject and predicate devices are minor and not siqnificant since all comply with the same fundamental standards such as DICOM, and the resulting displayed images and measurements would be essentially equivalent.

The results of non-clinical testing and compliance with design controls demonstrate that the subject device, Merge PACS, is safe and effective, and performs as intended.