IPACS Medical Image Management Software receives, stores and archives digital images and data from various sources (including but not limited to CT, MR, US, RF units, computed and direct radiographic devices, scanners, imaging gateways or imaging sources). IPACS Medical Image Management Software can be integrated with an institutions existing Hospital Information System (HIS) or Radiology Information System (RIS) for fully integrated electronic patient records.

IPACS Medical Image Management Software can be used to retrieve, process and display medical images and patient information from any connected workstation. Users have access to various image processing and measurement tools to assist them in viewing images. In addition, users can overlay templates on aid in pre-operative planning and annotations and measurements to aid in diagnosis.

Typical users of IPACS Medical Imagement Software are trained medical professionals, including but not limited to radiologists, technologists and clinicians.

Device Description

The Visbion IPACS (Integrated Picture Archiving and Communications System) Medical Image Management Software is a vendor-neutral PACS (Picture Archiving and Communication System) solution delivering enterprise-wide diagnostic images and patient reports, available for review at any time, from any location using a standard web browser.

IPACS is a single healthcare platform that allows the seamless acquisition of images from multiple types of imaging devices from a range of different equipment suppliers. It is a true clinical repository with the ability to harmonise all departments within a hospital. The approach to connectivity is based on three key standards; Digital Imaging and Communications in Medicine (DICOM) 3.0, Health Level Seven International (HL7) and Integrating the Healthcare Enterprise (IHE).

Using a standard web browser registered users have the ability to log in thus provide secure access to images from diagnostic workstation in hospitals and consulting rooms plus from off-site storage facilities. 24 hours a day.

The device is constructed from the four software elements. These elements are combined according to the configuration required by the user. These terms are used by the user, IPACs being a general term to consolidate the following four elements:

Image Archive
lmage Viewer
Image Web
Image Importer

AI/ML Overview

The provided document is a 510(k) premarket notification for the "IPACS Medical Image Management Software." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study. Therefore, the document does not contain the detailed information requested regarding clinical acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment.

Instead, it focuses on comparing the technological characteristics of the IPACS Medical Image Management Software to a predicate device, eFilm Workstation with Modules (K020995), to argue for substantial equivalence.

Based on the information provided, here's what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

This information is not available in the provided document. The 510(k) submission is for substantial equivalence, not for demonstrating specific performance metrics against pre-defined acceptance criteria in a clinical study. The "performance" described is a comparison of technical features to a predicate device.

Acceptance Criteria (Not applicable/provided)	Reported Device Performance (as presented in the document)
N/A (No specific efficacy or performance acceptance criteria are defined for this 510(k) submission)	The device's technological characteristics are deemed "the same" as the predicate device (eFilm Workstation with Modules) in terms of: - Type of Device (Software only on PC/server) - Type and Source of Images (Digital from various modalities) - Scope of Image Processing (Displays files from DICOM-compliant modalities) - Display of an Image (Visual display unit, hardcopy to laser printer) - Processing of an Image (Interactive positioning, sizing, rotation, contrast/brightness adjustment) - Means of Collecting Data (From pre-obtained digital images) - Processing of Data (Processes data, indicates quality loss, lossless storage) - Standards Compliance (DICOM 3.0, JPEG Standard, HL7, IHE) - Stand-alone Software (Yes) - Can be used on Multiple Hardware Platforms (Yes, with min. requirements) - Transmit Images to Remote Viewing Stations Over an Imaging Network (Yes)

Acceptance Criteria (Not applicable/provided)

Reported Device Performance (as presented in the document)

N/A (No specific efficacy or performance acceptance criteria are defined for this 510(k) submission)

The device's technological characteristics are deemed "the same" as the predicate device (eFilm Workstation with Modules) in terms of: - Type of Device (Software only on PC/server) - Type and Source of Images (Digital from various modalities) - Scope of Image Processing (Displays files from DICOM-compliant modalities) - Display of an Image (Visual display unit, hardcopy to laser printer) - Processing of an Image (Interactive positioning, sizing, rotation, contrast/brightness adjustment) - Means of Collecting Data (From pre-obtained digital images) - Processing of Data (Processes data, indicates quality loss, lossless storage) - Standards Compliance (DICOM 3.0, JPEG Standard, HL7, IHE) - Stand-alone Software (Yes) - Can be used on Multiple Hardware Platforms (Yes, with min. requirements) - Transmit Images to Remote Viewing Stations Over an Imaging Network (Yes)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not available. The document describes a comparison of device characteristics, not a clinical study with a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not available. No test set or ground truth established by experts is described for this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not available. No test set or adjudication method is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not available. The device (IPACS Medical Image Management Software) is a Picture Archiving and Communications System (PACS) for viewing, storing, and archiving medical images with basic processing and measurement tools. It is not an AI-assisted diagnostic device, and therefore, an MRMC comparative effectiveness study regarding "human readers improve with AI vs without AI assistance" would not be relevant to this specific product.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable/not available in the context of this device. The IPACS is a software platform intended for use by "trained medical professionals, including but not limited to radiologists, technologists and clinicians" for viewing and managing images. It is not an algorithm that provides a standalone diagnostic output. Its performance is defined by its ability to receive, store, process, and display images, and its technological equivalence to a predicate PACS.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not available as no clinical study involving ground truth establishment is described. The "ground truth" in this context is implicitly the functionally comparable performance of the predicate device.

8. The sample size for the training set

This information is not available. The device is not an AI/ML algorithm that requires a "training set" in the conventional sense for medical image analysis. It is image management software.

9. How the ground truth for the training set was established

This information is not available as no training set or ground truth establishment for a training set is described.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight.

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

December 12, 2014

Visbion Limited % Mr. Thomas Falcon Regulatory Manager Visbion House, Gogmore Lane Chertsey, Surrey KP16 9AP UNITED KINGDOM

Re: K140797

Trade/Device Name: IPACS Medical Image Management Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 13, 2014 Received: November 17, 2014

Dear Mr. Falcon:

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

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert A Ochs

for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K140797

Device Name

IPACS (Integrated Picture Archiving and Communications System) Medical Image Management Software.

Indications for Use (Describe)

IPACS Medical Image Management Software is used for viewing medical images.

Typical users of IPACS Medical Imagement Software are trained medical professionals, including but not limited to radiologists, technologists and clinicians.

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.

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 OMB number."

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Visbion Limited IPACS Medical Image Management Software 510(k) K140797 Response to Al e-mail December 3, 2014

Revised 510(k) Summary of Safety and Effectiveness

(in accordance with 21 CFR 807.87(h) and 21 CFR 807.92)

1. Submitter's name and address:

Visbion Ltd Visbion House Gogmore Lane Chertsey, Surrey KT16 9AP United Kingdom

FDA Establishment Registration No. - To be applied for after marketing clearance is given.

2. Submitter's telephone number and fax number: Tel: 011 44 870 850 3486 Fax: 011 44 870 850 3487

3. Contact person: Mr. Tom Falcon - Requlatory Manager and FDA Official Correspondent

Date this 510(k) summary prepared: ব December 12, 2014
1. Trade/proprietary name of the device: IPACS Medical Image Management Software
1. Classification name and number of the device: FDA Class - II FDA Classification Name - Picture Archiving and Communications System (PACS) FDA Regulation Number - 21 CFR 892.2050
1. Legally marketed predicate device to which substantial equivalence is claimed:

eFilm Workstation with Modules: FDA 510(k) No: K020995 Clearance to market this device was given by FDA on April 12, 2002 FDA Device Classification: Class 2 FDA Regulation Number: 21 CFR 892.2050 FDA Product Code: LLZ

8. Description of the device that is the subject of this premarket notification:

IPACS is a single healthcare platform that allows the seamless acquisition of images from multiple types of imaging devices from a range of different equipment suppliers. It

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Visbion Limited IPACS Medical Image Management Software 510(k) K140797 Response to Al e-mail December 3, 2014

is a true clinical repository with the ability to harmonise all departments within a hospital. The approach to connectivity is based on three key standards; Digital Imaging and Communications in Medicine (DICOM) 3.0, Health Level Seven International (HL7) and Integrating the Healthcare Enterprise (IHE).

Image Archive lmage Viewer Image Web Image Importer

9. Intended use and indication for use:

IPACS Medical Image Management Software is used for viewing medical images.

IPACS Medical Image Management Software receives, stores and archives digital images and data from various sources (including but not limited to CT, MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). IPACS Medical Image Management Software can be integrated with an institutions existing Hospital Information System (HIS) or Radiology Information System (RIS) for fully integrated electronic patient records.

IPACS Medical Image Management Software can be used to retrieve, process and display medical images and patient information from any connected workstation. Users have access to various image processing and measurement tools to assist them in viewing images. In addition, users can overlay templates on medical images to aid in pre-operative planning and annotations and measurements to aid in diagnosis.

Typical users of IPACS Medical Image Management Software are trained medical professionals, including but not limited to radiologists, technologists and clinicians.

10. Technoloqical characteristics:

IPACS is a stand-alone software package comprising four components that can be installed on a number of different hardware platforms, providing that the minimum hardware specification requirements are met. The system can transmit images to remote viewing workstations over a medical imaging network. None of the software components makes contact with the patient, nor do they control any life-sustaining devices. A qualified physician will review and interpret the images and information displayed in order to make clinical decisions.

The following comparison of the technological characteristics of the IPACS Medical Image Management Software and the predicate device, eFilm Workstation with Modules, illustrates that the characteristics are the same.

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Visbion Limited IPACS Medical Image Management Software - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Comparison of Technological Characteristics:

Ref.No.	TechnologicalCharacteristic	Candidate DeviceIPACS Medical ImageManagement Software	Predicate DeviceeFilm Workstationwith Modules
1	Type of Device	Software only productresiding on a PCWorkstation or server.	Software only productresiding on a PCWorkstation or server.
2	Type and Sourceof Images	Digital images receivedfrom various modalitiesand digitised images via anetwork or the internet.	Digital images received fromvarious modalities anddigitised images via anetwork or the internet.
3	Scope of ImageProcessing	Displays files received asimages from any thirdparty modality where thethird party manufacturerhas provided appropriateDICOM drivers	Displays files received asimages from any third partymodality where the thirdparty manufacturer hasprovided appropriateDICOM drivers
4	Display of anImage	On a visual display unit. Ahardcopy can be sent to asuitable third party laserprinter.	On a visual display unit. Ahardcopy can be sent to asuitable third party laserprinter.
5	Processing of anImage	Permits interactivepositioning of an image.Permits interactive sizingof an image (length, angle,area etc).Permits interactive rotationof an image.Permits interactiveadjustment of contrast andbrightness of an image.Not applicable.	Permits interactivepositioning of an image.Permits interactive sizing ofan image (length, angle,area etc).Permits interactive rotationof an image.Permits interactiveadjustment of contrast andbrightness of an image.Permits mechanical linkingof components associatedwith prosthetic templatesand trauma templates(fixation device) - via thirdparty accessories - seebelow.Permits integration of thirdparty accessories such asorthopaedic templating andtrauma processing.Permits interactive displayor three dimensionalimages.Permits interactiverendering on an image.Supports HangingProtocols.
Ref.No.	Feature	Candidate DeviceIPACS Medical ImageManagement Software	Predicate DeviceeFilm Workstationwith Modules
6	Means ofCollecting Data	From pre-obtained digitalimages.	From pre-obtained digitalimages.
7	Processing ofData	The software processesdata and provides anindication of the extent ofquality loss. Images arestored lossless.	The software processesdata and provides anindication of the extent ofquality loss. Images arestored lossless.
8	StandardsCompliance	Digital Imaging andCommunications inMedicine (DICOM) 3.0JointPhotographicExpertsGroup (JPEG)StandardHealth Level SevenInternational (HL7)Integrating the HealthcareEnterprise (IHE)	Digital Imaging andCommunications inMedicine (DICOM) 3.0Joint Photographic ExpertsGroup (JPEG) StandardHealth Level SevenInternational (HL7)Integrating the HealthcareEnterprise (IHE)
9	Stand-aloneSoftware	Yes	Yes
10	Can be used onMultiple HardwarePlatforms	Yes - provided that statedminimum hardwarerequirements are met.	Yes - provided that statedminimum hardwarerequirements are met.
11	Transmit Imagesto RemoteViewing StationsOver an ImagingNetwork	Yes	Yes

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Visbion Limited IPACS Medical Image Management Software 510(k) K140797 Response to Al e-mail December 3, 2014

From the above information it is concluded that the IPACS Medical Image Management Software is substantially equivalent to the eFilm Workstation with Modules predicate device.

This concludes the 510(k) Summary.

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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).