(398 days)
Not Found
No
The summary describes a standard medical imaging management system with viewing and processing capabilities, but there is no mention of AI or ML technologies being used for image analysis, diagnosis, or any other function. The focus is on image acquisition, storage, distribution, processing (basic tools like zoom, pan, windowing, 3D visualization), and display.
No
The device is described as an internet-based image management system and viewer, intended for acquiring, storing, distributing, processing, and displaying medical images and associated patient data. It is not depicted as delivering any form of therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that for "radiology modalities, only FDA cleared monitors shall be used to review images for diagnostic use." Additionally, the "Device Description" mentions "Processing, diagnosing and sharing images in real time." These statements indicate that the device is intended to be used for diagnostic purposes under certain conditions.
Yes
The device is explicitly described as a "software package" and "extension application software" that is used with "general purpose computing hardware" and "browser-enabled device". It does not include or require specific, dedicated hardware components for its core functionality.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an "internet-based image management system" used to "acquire, store, distribute, process and display images and associated patient data" from various medical imaging modalities.
- Nature of the Device: The device is a software package for managing and viewing medical images. It does not involve the examination of specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
- Focus on Imaging: The entire description revolves around the handling and display of medical images from modalities like CT, MR, X-ray, etc.
IVD devices are specifically designed to perform tests on biological samples to provide diagnostic information. This device's function is centered on the management and visualization of medical images, which falls under the category of medical imaging software or PACS (Picture Archiving and Communication System).
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR, NM, US, XA, PET, DX, CR/DR, RF, RT, MG, SC, VL, ES, OP, XC, PT, OT
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained professionals, including but not limited to physicians, nurses and medical technicians.
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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
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)
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.
| 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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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.
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.
7.4.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.
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 for
510(k) | Predicate device | Predicate device |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | miPlatform Medical
Imaging Suite v3.0,
miPlatform ZFP Viewer | miPlatform Medical
Imaging Suite v2.0 | CARESTREAM
Vue PACS v11.4
Vue Motion |
| 510(k)
number | K171977 | K131424 | K132824 |
| Manufact
urer | Hinacom Software and
Technology, Ltd | Hinacom Software and
Technology, Ltd | Carestream
Health, Inc. |
| Class | Class II | Class II | Class II |
| Product
code | LLZ | LLZ | LLZ |
| 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 | miPlatform 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 | The
CarestreamVue
PACS is an image
management
system whose
intended use is to
provide completely
scalable local and
wide area PACS
solution for
hospital and related |
| 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. | general purpose
computing hardware to
acquire, store, distribute,
process and display
images and associated
data. The software
performs digital image
processing, analysis,
reviewing,
communication and
storage.
miPlatform supports
receiving, sending,
printing, storing and
displaying studies
received from the
following modality types
via DICOM: CT, MR,
NM, US, XA, PET, DX,
DR, RF, RT, MG, SC,
VL, as well as
hospital/radiology
information systems and
any other information
systems that support
DICOM 3.0 standard.
miPlatform also supports
multidimensional image
visualization,
measurement and
analysis tools, and
reporting algorithms. The
user interface is designed
to follow typical clinical
workflow patterns to
process, review,
validate/edit and analyze
digital images. The
software supports the | institutions/ sites
which will archive,
distribute, retrieve
and display images
and data from all
hospital modalities
and information
systems.
The system
contains interactive
tools in order to
ease the process of
analyzing and
comparing three
dimensional (3D)
images. It is a
single system that
integrates review,
dictation and
reporting tools to
create a productive
work environment
for the radiologists
and physicians.
The
CarestreamVue
motion software
program is used for
patient
management by
clinicians in order
to access and
display patient
data, medical
reports, and
medical images for
diagnosis from
different modalities
including CR, DR | |
| 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 | following image analysis options: | CT, MR, NM and US. | |
| 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. | Vessel Analysis is an
option intended for
determining the presence
and extent of vascular
obstructive disease by
providing a non-invasive
survey of a patient's
coronary or peripheral
arteries. Physicians can
select any artery to view
the following anatomical
references: the
highlighted vessel in 3D,
two rotate-able curved
MPR vessel views
displayed at angles
orthogonal to each other,
and cross sections of the
vessel. Physicians can
manually measure the
lumen width to obtain
percentage stenosis
calculations. In addition,
clinicians can manually
measure vessel length
along the centerline in
standard curved MPR
views and examine
Hounsfield unit or signal
intensity statistics. | Carestream Vue
Motion provides
wireless and
portable access to
medical images for
remote reading or
referral purposes
from browsers
including usage
with validated
mobile devices.
This device is not
intended to replace
full workstations
and should be used
only when there is
no access to a
workstation. For
primary
interpretation and
review of
mammography
images, only use
display hardware
that is specifically
designed for and
cleared by the FDA
for mammography. | |
| miPlatform ZFP Viewer
provides wireless and
portable access to medical
images, 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. | Coronary Calcium
Scoring is an option
intended for cardiac
scoring from CT image
derived measurements,
including non-invasive
detection and | | |
| 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. | quantification of
atherosclerotic plaque.
Physicians can use semi-
automatic tools in
Coronary Calcium
Scoring to mark calcified
lesions of coronary
arteries, and automated
computation of Agatston
scoring will be
performed and presented
in a report.
miPlatform supports a
real-time image-based
conference option with
integrated audio/video
capability. Multiple users
may log into the system
and participate in the
conference from different
locations via internet
connection. | |
| Graphical
UI | Yes | Yes | Yes |
| Window
O.S. -
Client | Yes | Yes | Yes |
| Image
input
DICOM
3.0 | Yes | Yes | Yes |
| Images
stored on
remote
server | Yes | Yes | Yes |
| Network
Protocol:
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 |
| Scroll
Through
Images | Yes | Yes | No |
| Reset
Image | Yes | Yes | No |
| Text Label | Yes | Yes | No |
| Text-
Arrow
Labels | 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 |
| Delete
Annotation
and
Measurement | Yes | Yes | No |
| Show/Hide Patient
Information | Yes | Yes | No |
| Technological differences between miPlatform v3.0 and miPlatform ZFP Viewer | | | |
| Mobile
Device
Support for
Diagnostic Viewing | miPlatform v3.0: PC
- miPlatform ZFP Viewer:
- PC, Only when used with FDA cleared monitors | PC | PC,
Tablet Computer |
| Operation
Platform | miPlatform v3.0: - 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 Processor
2GHz 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 GeForce
GTS 250 or higher | Browser: MS Internet Explorer 7 or above. | | |
| Hard Disk: 1TB or higher | | | |
| NIC: 10/100/1000 Base TX | | | |
| Network environment: a
local or wide area network;
Network bandwidth 10M or higher. | | | |
| Operation system: Window
SQL Server 2008 or 2012 | | | |
| Note: Please only use FDA
cleared display monitors and
workstations to display
Mammograms for diagnosis. | | | |
| Recommended Hardware
Configuration of
miPlatform viewer | | | |
| 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. Recommended
diagnostic display with
minimum resolution
1366x768; The highest
resolution 1680x1050 or
higher | | | |
| NIC: 10/100/1000 Base | | | |
7.6. Identified technological characteristics with predicate device:
6
7
8
9
10
11
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| 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 |
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| Maximum
Intensity
projection
(MIP) | 1. miPlatform v3.0: Yes
2. miPlatform ZFP Viewer:
Not supported | Yes | Yes |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------|-----|-----|
| HTML 5 | 1. miPlatform v3.0: No
2. miPlatform ZFP Viewer:
Yes | No | Yes |
| IOS | 1. miPlatform v3.0: No
2. 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
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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
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- 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.
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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.