miPlatform medical imaging suite v3.0 (miPlaftorm v3.0) is an upgrade of miPlatform medical imaging suite v2.0, previous cleared under K131424. miPlatform v3.0 is an internet-based image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is a software package that is used with general purpose computing hardware to acquire, store, distribute, process and display images and associated patient data. The software supports and performs reviewing, communication and storage from the following modalities through DICOM 3.0 standard: CT, MR, NM, US, XA, PET, DX, CR/DR, RF, RT, MG, SC, VL, ES, OP, XC, PT, OT, as well as hospital/radiology information systems and any other information systems that support DICOM 3.0 standards. Non-radiology modalities are not for diagnostic use. For radiology modalities, only FDA cleared monitors shall be used to review images for diagnostic use.

miPlatform ZFP Viewer is offered as extension application to miPlatform medical imaging suite system. This software technology uses HTML5 which allows a browser-enabled device to run the software application, and thus requires no installation (zero foot print). The user is able to access patient images and study reports from a mobile device, such as iPad3, as well as personal computer using Microsoft Windows System, anywhere through a wireless and 3G, 4G network. miPlatform ZFP Viewer has a simple GUI for viewing and includes tools such as zoom, pan, windowing, basic measurement, and 3D visualization functions, including volume rendering and multi-planar reconstruction. Only FDA cleared monitors shall be used to review images for diagnostic use.

miPlatform ZFP Viewer provides wireless and portable access to medical images, in addition to standard intranet or internet access. This device is not intended to replace full workstations and should be used only when there is no access to a workstation. When used on a mobile device, the miPlatform ZFP Viewer is not for diagnostic use.

For primary interpretation and review of mammography images, only use display hardware that is specifically designed for and cleared by the FDA for mammography. MIP/MRP tools are not supported for mammography images for diagnostic use.

Device Description

miPlatform v3.0 and miPlatform ZFP Viewer is the extension application software of miPlatform medical imaging information system. User can achieve mobile office through the software which is installed in PC, smart mobile phone and other mobile terminals.

. Understanding and analyzing patient's information and medical image in real time.
. Processing, diagnosing and sharing images in real time. Note that when used on a mobile device, the miPlatform ZFP Viewer is not for diagnostic use.
. Support three-dimensional image viewing and processing.
Support image analysis and real-time data synchronization exchange in real-time conference.

AI/ML Overview

The provided text describes the miPlatform medical imaging suite v3.0 and miPlatform ZFP Viewer, an image management system intended for use by trained professionals to acquire, store, distribute, process, and display medical images. The submission aims to demonstrate substantial equivalence to predicate devices, namely miPlatform Medical Imaging Suite (K131424) and CARESTREAM Vue PACS v11.4 Vue Motion (K132824).

The document details the device's indications for use, technological characteristics, and performance based on non-clinical testing. It explicitly states that performance comparison testing on retrospective images was conducted to demonstrate substantial equivalence. However, it does not provide specific acceptance criteria or detailed results in a quantitative manner. The document asserts that "all tests successfully passed" and "designated individuals performed all verification and validation activities and results demonstrated that the predetermined acceptance criteria were met. The system passed all testing criteria." This indicates a qualitative assessment against internal criteria rather than a formally presented analytical study with specific metrics.

Here's an analysis based on the given text, addressing your questions:

Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria in the form of specific thresholds (e.g., sensitivity, specificity, accuracy percentages, or error margins). Instead, it broadly claims that the device "passed all testing criteria" and "all tests successfully passed" based on its software requirements specification, design verification, and validation documents.

The "Performance" section generally states: "Support of the substantial equivalence of the miPlatform v3.0 and miPlatform ZFP Viewer device was provided as a result of software validation, which confirms all features of the miPlatform v3.0 and miPlatform ZFP Viewer device were compliant with the software requirements."

Without specific metrics or thresholds, a direct table of acceptance criteria vs. reported performance cannot be constructed from the provided text. The document focuses on demonstrating feature parity and compliance with established standards (DICOM, HL7) and internal quality control processes.
Sample Size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: The document states that "performance comparison testing on retrospective images" was conducted, but it does not specify the sample size (number of cases or images) used for this test set.
- Data Provenance: The data used was retrospective. The country of origin of the data is not specified.
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):

The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The nature of the device (an image management and viewing system) suggests that "ground truth" might pertain to accurate display, processing, and measurement capabilities rather than diagnostic accuracy against a clinical reference standard.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:

The document does not specify any adjudication method for the test set.
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:
- A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or detailed.
- The device being reviewed (miPlatform medical imaging suite v3.0, miPlatform ZFP Viewer) is described as an image management and viewing system, not an AI-assisted diagnostic tool. Its functionality includes displaying, processing, and measuring images. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not directly apply to the described function of this particular device. The study described is "performance comparison testing on retrospective images to help demonstrate that the proposed device is substantially equivalent to the predicate devices" in terms of its ability to perform its specified functions.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The term "standalone" in the context of an algorithm's diagnostic performance is also not directly applicable here, as the device is an image management system designed for use by trained professionals, implying human-in-the-loop interaction. The non-clinical testing focused on software validation, functionality, and compliance, not on an algorithm's independent diagnostic interpretation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The document does not explicitly state the type of ground truth used. Given the device's function (image management, display, basic processing, and measurement), the "ground truth" likely refers to the accuracy of image display, correct implementation of tools (zoom, pan, windowing, measurement), and data synchronization as per DICOM standards, rather than diagnostic outcomes from pathology or long-term clinical follow-up. This "ground truth" would be established through verification against known valid image properties and expected software behavior.
The sample size for the training set:

The document does not mention a training set or any machine learning/AI components that would require a distinct training set. The device is described as a software package for image management and viewing, not a predictive or diagnostic AI algorithm.
How the ground truth for the training set was established:

Since no training set is mentioned in the context of machine learning, this question is not applicable. The ground truth for the verification and validation of the software's functionality would have been established through a combination of engineering specifications, DICOM standards, and expected behavior documented in the software requirements.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of the symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of "ADMINISTRATION".

Hinacom Software and Technology, Ltd. % Yi Isabelle Sun Executive VP Suite B301, R&D Plaza, Tsinghua Science Park Haidian District, Beijing 100084 CHINA

August 2, 2018

Re: K171977

Trade/Device Name: miPlatform medical imaging suite v3.0, (miPlatform v3.0) miPlatform ZFP Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 20, 2018 Received: June 25, 2018

Dear Yi Sun:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

{1}------------------------------------------------

devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/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,

Jeff Bargo

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

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K171977

Device Name

miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer

Indications for Use (Describe)

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)

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."

{3}------------------------------------------------

7. 510(k) Summary

7.1. Identification of Submitter

Submitter:	Hinacom Software and Technology Ltd. Co.
Address:	Suite B-301, R&D Plaza, Tsinghua Science Park,
	Haidian District, Beijing, China 100084
Phone:	+1-872-2391620
Fax:	+86-10-62701652

Contact:	Yi Isabelle Sun
Title:	Executive VP
E-mail:	yi@hinacom.com
Phone:	+1-872-2391620
Fax:	+86-10-6270-1652

Summary Date: 11/08/2017

7.2. Identification of Product

Trade name:	miPlatform medical imaging suite v3.0 (miPlatform v3.0),miPlatform ZFP Viewer
Common/Usual Name:	Picture Archiving and Communications System
Classification Name:	System, Image Processing Radiological (21 C.F.R. 892.2050, LLZ)
Device Classification:	Class II
Manufacturer:	Hinacom Software and Technology, Ltd.

Primary predicate device:

Trade/Device Name:	miPlatform Medical Imaging Suite
Common/Usual Name:	Picture Archiving and Communications System
Classification Name:	LLZ, Class II, 21 CFR 892.2050
510(k) Number:	K131424

Secondary predicate device:

Trade Name:	CARESTREAM Vue PACS v11.4 Vue Motion
Common/Usual Name:	Picture Archiving and Communications System
Classification Name:	LLZ, Class II, 21 CFR 892.2050
510(k) Number:	K132824

{4}------------------------------------------------

7.3. Indication for Use

miPlatform medical imaging suite v3.0 (miPlatform v3.0) is an upgrade of miPlatform medical imaging suite v2.0, previous cleared under K131424. miPlatform v3.0 is an internet-based image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is a software package that is used with general purpose computing hardware to acquire, store, distribute, process and display images and associated patient data. The software supports and performs reviewing, communication and storage from the following modalities through DICOM 3.0 standard: CT, MR, NM, US, XA, PET, DX, CR/DR, RF, RT, MG, SC, VL, ES, OP, XC, PT, OT, as well as hospital/radiology information systems and any other information systems that support DICOM 3.0 standards. Non-radiology modalities are not for diagnostic use. For radiology modalities, only FDA cleared monitors shall be used to review images for diagnostic use.

7.4.Device description

. Understanding and analyzing patient's information and medical image in real time.
. Processing, diagnosing and sharing images in real time. Note that when used on a mobile device, the miPlatform ZFP Viewer is not for diagnostic use.
. Support three-dimensional image viewing and processing.

{5}------------------------------------------------

Support image analysis and real-time data synchronization exchange in real-time conference.
Detail description of functionalities and technical characteristics can be found in Section 7.6 of this document.

7.5. Software Development

Hinacom certifies that the miPlatform v3.0 and miPlatform ZFP Viewer software are designed, developed, tested and validated according to written procedures. These procedures identify individuals within the organization responsible for developing and approving product specifications, coding and testing, validation testing and field maintenance. The software developed for this product is used to provide diagnostic quality images and associated information to the intended users.

	Device being submitted for510(k)	Predicate device	Predicate device
Device	miPlatform MedicalImaging Suite v3.0,miPlatform ZFP Viewer	miPlatform MedicalImaging Suite v2.0	CARESTREAMVue PACS v11.4Vue Motion
510(k)number	K171977	K131424	K132824
Manufacturer	Hinacom Software andTechnology, Ltd	Hinacom Software andTechnology, Ltd	CarestreamHealth, Inc.
Class	Class II	Class II	Class II
Productcode	LLZ	LLZ	LLZ
Indicationfor Use	miPlatform medical imagingsuite v3.0 (miPlatform v3.0)is an upgrade of miPlatformmedical imaging suite v2.0,previous cleared underK131424. miPlatform v3.0is an internet-based imagemanagement systemintended to be used bytrained professionals,including but not limited to	miPlatform is an internet-based imagemanagement systemintended to be used bytrained professionals,including but not limitedto physicians, nurses andmedical technicians.The system is a softwarepackage that is used with	TheCarestreamVuePACS is an imagemanagementsystem whoseintended use is toprovide completelyscalable local andwide area PACSsolution forhospital and related
physicians, nurses andmedical technicians. Thesystem is a software packagethat is used with generalpurpose computinghardware to acquire, store,distribute, process anddisplay images andassociated patient data. Thesoftware supports andperforms reviewing,communication and storagefrom the followingmodalities through DICOM3.0 standard: CT, MR, NM,US, XA, PET, DX, CR/DR,RF, RT, MG, SC, VL, ES,OP, XC, PT, OT, as well ashospital/radiologyinformation systems and anyother information systemsthat support DICOM 3.0standards. Non-radiologymodalities are not fordiagnostic use. Forradiology modalities, onlyFDA cleared monitors shallbe used to review images fordiagnostic use.	general purposecomputing hardware toacquire, store, distribute,process and displayimages and associateddata. The softwareperforms digital imageprocessing, analysis,reviewing,communication andstorage.miPlatform supportsreceiving, sending,printing, storing anddisplaying studiesreceived from thefollowing modality typesvia DICOM: CT, MR,NM, US, XA, PET, DX,DR, RF, RT, MG, SC,VL, as well ashospital/radiologyinformation systems andany other informationsystems that supportDICOM 3.0 standard.miPlatform also supportsmultidimensional imagevisualization,measurement andanalysis tools, andreporting algorithms. Theuser interface is designedto follow typical clinicalworkflow patterns toprocess, review,validate/edit and analyzedigital images. Thesoftware supports the	institutions/ siteswhich will archive,distribute, retrieveand display imagesand data from allhospital modalitiesand informationsystems.The systemcontains interactivetools in order toease the process ofanalyzing andcomparing threedimensional (3D)images. It is asingle system thatintegrates review,dictation andreporting tools tocreate a productivework environmentfor the radiologistsand physicians.TheCarestreamVuemotion softwareprogram is used forpatientmanagement byclinicians in orderto access anddisplay patientdata, medicalreports, andmedical images fordiagnosis fromdifferent modalitiesincluding CR, DR
miPlatform ZFP Viewer isoffered as extensionapplication to miPlatformmedical imaging suitesystem. This softwaretechnology uses HTML5which allows a browser-enabled device to run thesoftware application, andthus requires no installation(zero foot print). The user is
able to access patient images	following image analysis options:	CT, MR, NM and US.
and study reports from amobile device, such asiPad3, as well as personalcomputer using MicrosoftWindows System, anywherethrough a wireless and 3G,4G network. miPlatformZFP Viewer has a simpleGUI for viewing andincludes tools such as zoom,pan, windowing, basicmeasurement, and 3Dvisualization functions,including volume renderingand multi-planarreconstruction. Only FDAcleared monitors shall beused to review images fordiagnostic use.	Vessel Analysis is anoption intended fordetermining the presenceand extent of vascularobstructive disease byproviding a non-invasivesurvey of a patient'scoronary or peripheralarteries. Physicians canselect any artery to viewthe following anatomicalreferences: thehighlighted vessel in 3D,two rotate-able curvedMPR vessel viewsdisplayed at anglesorthogonal to each other,and cross sections of thevessel. Physicians canmanually measure thelumen width to obtainpercentage stenosiscalculations. In addition,clinicians can manuallymeasure vessel lengthalong the centerline instandard curved MPRviews and examineHounsfield unit or signalintensity statistics.	Carestream VueMotion provideswireless andportable access tomedical images forremote reading orreferral purposesfrom browsersincluding usagewith validatedmobile devices.This device is notintended to replacefull workstationsand should be usedonly when there isno access to aworkstation. Forprimaryinterpretation andreview ofmammographyimages, only usedisplay hardwarethat is specificallydesigned for andcleared by the FDAfor mammography.
miPlatform ZFP Viewerprovides wireless andportable access to medicalimages, addition to standardintranet or internet access.This device is not intended toreplace full workstations andshould be used only whenthere is no access to aworkstation. When usedon a mobile device, themiPlatform ZFP Viewer isnot for diagnostic use.	Coronary CalciumScoring is an optionintended for cardiacscoring from CT imagederived measurements,including non-invasivedetection and
For primary interpretationand review	of mammography images, onlyuse display hardware that isspecifically designed for andcleared by the FDA for

	mammography. MIP/MRPtools are not supported formammography images fordiagnostic use.	quantification ofatherosclerotic plaque.Physicians can use semi-automatic tools inCoronary CalciumScoring to mark calcifiedlesions of coronaryarteries, and automatedcomputation of Agatstonscoring will beperformed and presentedin a report.miPlatform supports areal-time image-basedconference option withintegrated audio/videocapability. Multiple usersmay log into the systemand participate in theconference from differentlocations via internetconnection.
GraphicalUI	Yes	Yes	Yes
WindowO.S. -Client	Yes	Yes	Yes
ImageinputDICOM3.0	Yes	Yes	Yes
Imagesstored onremoteserver	Yes	Yes	Yes
NetworkProtocol:TCP-IP	Yes	Yes	Yes
Query,retrieve	Yes	Yes	Yes

display, store and process digital medical images
Display of patient data	Yes	Yes	Yes
Multi-Planar reconstruction(MPR)	Yes (Not supported for Mammography image)	Yes	Yes
View Image	Yes	Yes	Yes
Zoom in/out Image	Yes	Yes	Yes
Pan Image	Yes	Yes	Yes
Set Window Width/Level	Yes	Yes	Yes
Length Measurement	Yes	Yes	Yes
Angle Measurement	Yes	Yes	Yes
cine Modalities	Yes CT, MR, NM, US, XA, DX, RF, VL, CR/DR, ES, OP, XC, PT, OT, MG	Yes CT, MR, NM, US, XA, PET, DX, DR, RF, RT, MG, SC, VL	Yes CR,DR,CT,MR,N M,US
Remote view	Yes	Yes	Yes
Communication standard	DICOM, HL7	DICOM, HL7	DICOM, HL7
authorized users	Yes	Yes	Yes
Timeline	Yes	Yes	No
ScrollThroughImages	Yes	Yes	No
ResetImage	Yes	Yes	No
Text Label	Yes	Yes	No
Text-ArrowLabels	Yes	Yes	No
Annotation	Yes	Yes	No
ROI(Region of Interest)	Yes	Yes	No
Inverse/Rotate/Flip	Yes	Yes	No
Magnifying Glass	Yes	Yes	No
Display Point by Point	Yes	Yes	No
DeleteAnnotationandMeasurement	Yes	Yes	No
Show/Hide PatientInformation	Yes	Yes	No
Technological differences between miPlatform v3.0 and miPlatform ZFP Viewer
MobileDeviceSupport forDiagnostic Viewing	miPlatform v3.0: PC1. miPlatform ZFP Viewer:2. PC, Only when used with FDA cleared monitors	PC	PC,Tablet Computer
OperationPlatform	miPlatform v3.0:1. Recommended	CPU: Intel I5 3.1 or higher	iPad 2, iPhone 4S,Galaxy S3 and
Hardware Configuration	Memory: 4GB or higher	Galaxy Note 10. 1
of miPlatform server:	Hard Drives: 250GB or higher	or newer
CPU: Intel Xeon Processor2GHz or higher	NIC: Gigabit Ethernet Card	Version with equal or better performance.
Memory: 4GB or higher	Operating system: Window w XP or above
Graphics: NVIDIA GeForceGTS 250 or higher	Browser: MS Internet Explorer 7 or above.
Hard Disk: 1TB or higher
NIC: 10/100/1000 Base TX
Network environment: alocal or wide area network;Network bandwidth 10M or higher.
Operation system: WindowSQL Server 2008 or 2012
Note: Please only use FDAcleared display monitors andworkstations to displayMammograms for diagnosis.
Recommended HardwareConfiguration ofmiPlatform viewer
CPU: Intel Core i3 orhigher
Memory: 2GB or higher
Hard Drives: 100GB orhigher
Operation System:Windows 7 or Windows 10
Display Device: UseFDA cleared diagnosticdisplay. Recommendeddiagnostic display withminimum resolution1366x768; The highestresolution 1680x1050 orhigher
NIC: 10/100/1000 Base

7.6. Identified technological characteristics with predicate device:

{6}------------------------------------------------

{7}------------------------------------------------

{8}------------------------------------------------

{9}------------------------------------------------

{10}------------------------------------------------

{11}------------------------------------------------

{12}------------------------------------------------

TX
Network environment:• a local or wide area network; Network bandwidth greater than 2M
• HD Camera
• Headset
2. miPlatform ZFP Viewer:Recommended Hardware Configuration of miPlatform ZFP viewer
• Mobile Terminal:iPad3; (Not for Diagnostic Use)
• Network Environment:Wifi/4G/3G, network bandwidth 2M or higher.
• Operating System: iOS 8.0
PC:
• CPU: Intel Core i3 or higher
• Memory: 2GB or higher
• Hard Drives: 100GB or higher
• Operation System: Windows 7 or Windows 10
• Display Device: Use FDA cleared diagnostic display.
• NIC: 10/100/1000 Base TX
• Network environment:a local or wide area network; Network bandwidth greater than 2M

{13}------------------------------------------------

MaximumIntensityprojection(MIP)	1. miPlatform v3.0: Yes2. miPlatform ZFP Viewer:Not supported	Yes	Yes
HTML 5	1. miPlatform v3.0: No2. miPlatform ZFP Viewer:Yes	No	Yes
IOS	1. miPlatform v3.0: No2. miPlatform ZFP Viewer:Yes	No	Yes
Mammographic Use	1. miPlatform v3.0: Yes, with FDA cleared monitors.2. miPlatform ZFP Viewer:Not for diagnostic use	Yes	No

Functions performed on image modalities including OP, XC, OT, ES are the same as on radiological images. These modalities are not for diagnostic use.

Technological Characteristics:

The miPlatform v3.0 and miPlatform ZFP Viewer has similar technological characteristics and is similar in overall design, principal of operation and configuration compared to the Predicate Devices.

Performance

Support of the substantial equivalence of the miPlatform v3.0 and miPlatform ZFP Viewer device was provided as a result of software validation, which confirms all features of the miPlatform v3.0 and miPlatform ZFP Viewer device were compliant with the software requirements.

Basis for Determination of Substantial Equivalence:

Upon reviewing and comparing intended use, design, principle of operation and overall technological characteristics, the miPlatform v3.0 and miPlatform ZFP Viewer, when used on PC, is determined by Hinacom Software and Technology, Ltd. to be substantially equivalent to existing legally marketed devices.

The difference is that when used on a mobile device, the miPlatform ZFP Viewer is not for diagnostic use, which is specified in the Indications for Use and the labeling.

Testing

{14}------------------------------------------------

miPlatform v3.0 and miPlatform ZFP Viewer are tested successfully with reference to its Software Requirements Specification, as well as design verification and validation documents and Traceability Matrix document. Verification, and testing activities establish the performance, functionality, and reliability characteristics of the miPlatform v3.0 and miPlatform ZFP Viewer, which is found to be safe and effective and substantially equivalent to the currently-cleared predication devices.

Testing involved system level functionality test, segmentation accuracy test, measurement accuracy test, interfacing test, usability test, serviceability test, labeling test, as well as the test for risk mitigation method analyzed and implemented in the risk management process. In addition, we conducted the performance comparison testing on retrospective images to help demonstrate that the proposed device is substantially equivalent to the predicate devices.

Pass/Fail criteria were based on the requirements and intended use of the product. Test results showed that all tests successfully passed.

7.7.Determination of Substantial equivalence:

Summary of Non-Clinical Tests:

The miPlatform v3.0 and miPlatform ZFP Viewer and their components comply with the following voluntary standards: NEMA PS3.1-3.18(2008) Digital Imaging and Communication in Medicine (DICOM) Set.

The performance of the software is tested in accordance with Hinacom's design control procedures to demonstrate intended performance. Potential hazards are controlled via risk management processes and verification and validation testing. Instructions for use are provided to facilitate intended operation.

miPlatform v3.0 and miPlatform ZFP Viewer were designed in compliance with the following Process Standards:

DICOM PS 3.2. Digital Imaging and Communications in Medicine – Conformance Standard
The following quality assurance measures were applied to the development of the device:
Risk Analysis
Requirements Reviews

{15}------------------------------------------------

Design Reviews
Performance testing (verification)
Safety testing (verification)
Final acceptance testing (validation)

7.8.Performance Data from nonclinical Testing:

Designated individuals performed all verification and validation activities and results demonstrated that the predetermined acceptance criteria were met. The system passed all testing criteria.

Extensive performance tests had been conducted regarding the technological characteristics aspects. All tests had been passed successfully.

Applicable Standards:

DICOM standard for image data format and communication

7.9.Safety and Effectiveness

General Safety and Effectiveness Concerns:

The device labeling contains instructions for use and any necessary cautions and warnings, to provide for safe and effective use of the device. The hardware components specified are all "off the shelf" computer components.

7.10. Comparison with Predicate Devices

miPlatform v3.0 and miPlatform ZFP Viewer are substantially equivalent to several software applications that display, visualize, analyze and measure images and regions of interest. The predicate devices are miPlatform Medical Imaging Suite (K131424) and CARESTREAM Vue PACS v11.4 Vue Motion (K132824) which have been classified under 21 CFR 892.2050 as Class II medical device.

miPlatform v3.0 and miPlatform ZFP Viewer, when used on PC, are substantially equivalent to the identified predicate devices. All of these devices offer the visualization techniques, measurement and analysis tools which can be applied for more effective and accurate display, interpretation, and communication.

{16}------------------------------------------------

miPlatform v3.0 and miPlatform ZFP Viewer, when used on PC, are similar in characteristics, materials, and features, and have similar technological features, intended use and indications for use as the predicates, and do not pose any new issue of safety and effectiveness.

7.11. Conclusions

In summary, HINACOM software and technology, Ltd. is of the opinion that miPlatform v3.0 and miPlatform ZFP Viewer, when used on PC, do not introduce any new potential safety risk, is as effective and performs as well as devices currently on the market, and thus concludes that miPlatform v3.0 and miPlatform ZFP Viewer software, when used on PC, are substantially equivalent to the predicate devices.

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).