(266 days)
Not Found
No
The document describes standard image processing and analysis functions without mentioning AI, ML, or related concepts like deep learning, neural networks, or training/test sets for model development.
No
The device is described as a Software as Medical Device (SaMD) for reviewing medical images and providing diagnostic information, not for applying therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The software provides diagnostic information". This indicates its role in the diagnostic process.
Yes
The device description explicitly states that both InterView XP and InterView FUSION are "designed as a software only product" and "a standalone software, i.e. Software as Medical Device (SaMD) product". They operate on standard Windows OS and process DICOM images, indicating no specialized hardware is included or required beyond a standard computer.
Based on the provided information, neither InterView XP nor InterView FUSION are IVD (In Vitro Diagnostic) devices.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The core function of an IVD is to analyze biological samples.
- InterView XP and InterView FUSION are described as Software as Medical Device (SaMD) for reviewing and processing medical images. Their input is medical images acquired by various imaging modalities (gamma cameras, SPECT, PET, CT, MRI), not biological specimens.
- The intended use and device descriptions clearly focus on image display, manipulation, analysis, and quantification of medical images. There is no mention of analyzing biological samples.
Therefore, these devices fall under the category of medical imaging software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
InterView XP is a Software as Medical Device (SaMD) aimed at reviewing medical images such as planar scans (Static, Whole Body, Dynamic, Multi-Gated) and tomographic scans (SPECT) acquired by gamma cameras. Review of other image modalities is also supported. Common Users for clinical purposes are trained medical professionals, including clinicians and technicians in hospitals or imaging centers. Software components provide functions for image display, manipulation, enhancements, analysis and quantification. This device is not indicated for mammography use or dental diagnostics. The software provides diagnostic information, however, diagnostic decision cannot be based solely on the software. InterView XP has no specific target population.
InterView FUSION is a Software as Medical Device (SaMD) aimed at reviewing medical images such as planar scans and tomographic scans from SPECT, PET, CT, and MRI modalities. Review of other image modalities is also supported. The common users for clinical purposes are trained medical professionals, including clinicians in hospitals or imaging centers. Software components provide functions for image display, manipulation, enhancements, analysis, and quantification. This device is not indicated for mammography use or dental diagnostics. The software provides diagnostic information - however, diagnostic decisions cannot be based solely on this software. InterView FUSION has no specific target population.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
InterView XP: InterView XP is a DICOM image visualization and post-processing Software as Medical Device (SaMD). It is a standalone medical device. Developed by Medical Imaging Systems, built on state-of-the-art technologies, providing evaluation method according to the international guidelines for planar, whole body and SPECT nuclear medicine applications. The product is designed as a software only product, operating on Windows based OS. The software inputs are images of nuclear medicine studies that are DICOM 3.0 compatible and uploaded into the user's computer and the Software will process the images in multiple ways to achieve the image analysis by the user's demands.
InterView FUSION: InterView FUSION is a multi-modal visualization and evaluation software. Developed by Mediso built on state-of-the-art technologies, novel image processing algorithms and tools for evaluating different medical imaging modalities. The product is designed as a standalone software, i.e. Software as Medical Device (SaMD) product, operating on Windows OS as a classical user application.
Multi-modal registration and fusion of SPECT, PET, CT and MRI studies is a core functionality of InterView FUSION. Evaluation can be performed with the help of several specialized viewers and automated algorithms. Statistical measurements by ROIs, VOIs are present just as well as SUV representation for PET and even SPECT images. A wide range of function-specialized tools provide a well-detailed, fast and easy evaluation of medical images combining with advanced visualizations and interactions with flexible workspaces. Special segmentation methods provide quick and easy extraction of organs/regions from images. Basic arithmetic operations as well as spatial and frequency domain filters are also available.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
InterView XP: planar scans (Static, Whole Body, Dynamic, Multi-Gated) and tomographic scans (SPECT, Gated SPECT) acquired by gamma cameras. Review of other image modalities is also supported.
InterView FUSION: planar scans and tomographic scans from SPECT, PET, CT, and MRI modalities. Review of other image modalities is also supported.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Common Users for clinical purposes are trained medical professionals, including clinicians and technicians in hospitals or imaging centers.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical testing consisted of a software validation that traced and tested all identified inputs and requirements. This testing consisted of the establishment of User Needs, Functional System Requirement, and Component Requirement Specifications. Test cases were executed to verify that these requirements were fulfilled. Clinical effectiveness was assessed through the completion of Functional Design Validations and Usability Validations. Acceptance criteria were fulfilled. No clinical testing was performed in association with this submission.
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 29, 2023
Mediso Medical Imaging Systems, Ltd. % William McLain Sr. Consultant CRO Group, Inc. 342 E. Main Street, Suite 207 Leola, Pennsylvania 17540
Re: K221984
Trade/Device Name: InterView XP; InterView FUSION Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: February 24, 2023 Received: February 27, 2023
Dear William Mclain:
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
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Dghx
Daniel M. Krainak, Ph.D. Assistant Director Magnetic Resonance and Nuclear Medicine Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221984
Device Name InterView XP
Indications for Use (Describe)
InterView XP is a Software as Medical Device (SaMD) aimed at reviewing medical images such as planar scans (Static, Whole Body, Dynamic, Multi-Gated) and tomographic scans (SPECT) acquired by gamma cameras. Review of other image modalities is also supported. Common Users for clinical purposes are trained medical professionals, including clinicians and technicians in hospitals or imaging centers. Software components provide functions for image display, manipulation, enhancements, analysis and quantification. This device is not indicated for mammography use or dental diagnostics. The software provides diagnostic information, however, diagnostic decision cannot be based solely on the software. InterView XP has no specific target population.
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
Indications for Use
510(k) Number (if known) K221984
Device Name InterView FUSION
Indications for Use (Describe)
InterView FUSION is a Software as Medical Device (SaMD) aimed at reviewing medical im- ages such as planar scans and tomographic scans from SPECT, PET, CT, and MRI modalities. Review of other image modalities is also supported. The common users for clinical purposes are trained medical professionals, including clinicians in hospitals or imaging centers. Software components provide functions for image display, manipulation, enhancements, analysis, and quantification. This device is not indicated for mammography use or dental diagnostics. The software provides diagnostic information - however, diagnostic decisions cannot be based solely on this software. InterView FUSION has no specific target population.
| 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."
4
510(k) Summary - InterView XP
Submission Owner and Correspondent
Submission Owner
Mediso Medical Imaging Systems, Ltd. Laborc utca 3. Budapest HUNGARY H-1037 Ph: +36-1-3993030 Email: info@mediso.hu
Submission Correspondent
CRO Group, Inc. 342 E. Main Street, Suite 207 Leola, PA 17540 Contact: William McLain Phone: 717-656-9656 E-Mail: bmclain@crogroup.com
Date Summary Prepared
February 23, 2023
Device Trade Name
InterView XP
Device Common Name
Medical Image Visualization And Post-processing Software As Medical Device (SaMD)
Device Classification Name
Medical Image Management and Processing System Classified as Class 2 at 21 CFR 892.2050, product code LLZ.
5
Legally Marketed Device To Which The Device Is Substantially Equivalent
The InterView XP is substantially equivalent to the Xeleris V Processing and Review Systems cleared under K201103.
Description of the Device
InterView XP is a DICOM image visualization and post-processing Software as Medical Device (SaMD). It is a standalone medical device. Developed by Medical Imaging Systems, built on state-of-the-art technologies, providing evaluation method according to the international guidelines for planar, whole body and SPECT nuclear medicine applications. The product is designed as a software only product, operating on Windows based OS. The software inputs are images of nuclear medicine studies that are DICOM 3.0 compatible and uploaded into the user's computer and the Software will process the images in multiple ways to achieve the image analysis by the user's demands.
General evaluation
General evaluation is a special procedure that has no predefined workflow steps. This procedure offers various tools that might be combined together to build a custom procedure. These tools are the same that are used in other procedures. Combined with user programming not only the workflow is customized but also the numerical results derived from processed data.
Indications for Use
InterView XP is a Software as Medical Device (SaMD) aimed at reviewing medical images such as planar scans (Static, Whole Body, Dynamic, Multi-Gated) and tomographic scans (SPECT, Gated SPECT) acquired by gamma cameras. Review of other image modalities is also supported. Common Users for clinical purposes are trained medical professionals, including clinicians and technicians in hospitals or imaging centers. Software components provide functions for image display, manipulation, enhancements, analysis and quantification. This device is not indicated for mammography use or dental diagnostics. The software provides diagnostic information, however, diagnostic decision cannot be based solely on the software. InterView XP has no specific target population.
6
Comparison Table with Predicate Device
The following Table compares the technological characteristics between the proposed InterView XP and the predicate Xeleris V Processing and Review Systems cleared under K201103.
7
| Feature | Subject device
InterView XP | Predicate device
Xeleris V Processing and Review Systems (K201103) | Comparison |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | InterView XP is an advanced medical image
visualization and post-processing Software as
Medical Device (SaMD) for clinical applications.
InterView XP is specialized for Nuclear Medicine
applications focusing on planar, whole body and
SPECT evaluations. InterView XP supports
SPECT reconstruction. The process of
quantitative evaluation is guided through
standardized evaluation steps and supported by
specialized viewers and automated algorithms. A
wide range of function-specialized tools enable
measurement, manipulation, enhancement and
analysis of medical images. Data from Mediso or
third party manufacturer's devices may be passed
to the application from the integrated database or
other PACS systems. Data handling includes
images transfer, storage and printing capabilities
of DICOM images. InterView XP is a stand-alone
medical software which can operate on dedicated
workstations provided by the manufacturer.
InterView XP is NOT intended to be used as a
replacement for visual interpretation nor as a
diagnostic tool without other clinical and
laboratory information. It is not intended to treat
the patient, to monitor vital signs or to give a
direct diagnosis of disease. | Intended use & Indications for use
The system is intended for use by Nuclear Medicine
(NM) or Radiology practitioners and referring
physicians. The intended use of the system is to
provide digital processing, review and reporting of
medical images, including data display, quality
control, image manipulation and quantification
analysis, transfer, storage and printing capabilities.
The system operates in a variety of configurations.
The hardware components may include computer
workstations, Communications devices, video
monitors, data storage and hardcopy devices.
Software components provide functions for
performing operations related to image display;
manipulation, enhancements, analysis and
quantification and can operate on dedicated
workstations and client-server architectures.
(....)* | Similarities:
Each software is intended to be
used for nuclear medicine
applications.
Processing, review and reporting
are the core functionalities.
Both are Software as Medical
Device (SaMD)
Workstation or client-server
architecture is supported.
Differences:
N/A
Intended use statement of InterView and
Xeleris software are substantially
equivalent. |
| Feature | Subject device
InterView XP | Predicate device
Xeleris V Processing and Review Systems
(K201103) | Comparison |
| Indications for use | InterView XP is a Software as Medical Device
(SaMD) aimed at reviewing medical images such
as planar scans (Static, Whole Body, Dynamic,
Multi-Gated) and tomographic scans (SPECT,
Gated SPECT) acquired by gamma cameras.
Review of other image modalities is also
supported. Common Users for clinical purposes
are trained medical professionals, including
clinicians and technicians in hospitals or imaging
centers. Software components provide functions
for image display, manipulation, enhancements,
analysis and quantification. This device is not
indicated for mammography use or dental
diagnostics. The software provides diagnostic
information; however, diagnostic decision cannot
be based solely on the software. InterView XP
has no specific target population. | The system is intended for use by Nuclear Medicine
(NM) or Radiology practitioners and referring
physicians for display, processing, archiving, printing,
reporting and networking of NMI data, including
planar scans (Static, Whole Body, Dynamic, Multi-
Gated) and tomographic scans (SPECT, Gated
SPECT, dedicated PET or Camera-Based-PET)
acquired by gamma cameras or PET scanners. The
system can run on dedicated workstation or in a
server-client configuration.
The NM or PET data can be coupled with registered
and/or fused CT or MR scans, and with physiological
signals in order to depict, localize, and/or quantify the
distribution of radionuclide tracers and anatomical
structures in scanned body tissue for clinical
diagnostic purposes. | Similarities:
- Intended users are the same.
- Software core functionalities are
the same. - Both software process similar
modalities. - Both software support stand-alone and client-server architecture.
Differences: - N/A
- Indications for use statement of InterView
and Xeleris software are substantially
equivalent. |
| Field of use | General nuclear medicine processing methods in
the field of Endocrinology, Cardiology,
Osteology, Neurology, Nephrology, Hepatology,
Gastroenterology, Pulmonology and other fields
of nuclear medicine. SPECT reconstruction
engine. | The system is intended for use by Nuclear Medicine
(NM) or Radiology practitioners. Tools for general
nuclear medicine including but not limited to
applications for bone and cardiac, lung, renal,
gallbladder, gastric brain, thyroid analysis. SPECT
reconstruction methods included. Dosimetry
applications. | Similarities: - Nuclear medicine applications.
Differences: - See detailed comparison below.
- The field of use of InterView and Xeleris
software is nuclear medicine. No impact
on substantial equivalence. |
| Target population | No specifics target population. | Specifics target population is not
defined.
Differences: - N/A | Similarities:
- No specific target population.
Differences: - N/A.
- Neither InterView nor Xeleris has a
specifics target population. No impact on
substantial equivalence. |
8
510(k) Summary - InterView X
9
| XP |
|---|
| iew |
| 11 |
| inter' |
| I |
| ry |
| a |
| imm |
| Su |
| 0(k) |
| 510 |
| Feature | Subject device
InterView XP | Predicate device
Xeleris V Processing and Review Systems
(K201103) | Technical Characteristics | Comparison |
|------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device design | Standalone Software with Graphical User
Interface (GUI) controlled by the peripherals of
the workstation.
InterView family are post-processing software,
and they have no control over the image
generating devices. | Standalone Software with Graphical User Interface
(GUI) controlled by the peripherals of the workstation.
Xeleris is a post-processing software and has no
control over the image generating devices. | | Similarities:
Both softwares are GUI based
software applications.
Basic operational principles are
similar.
Neither software has impact on
the Image generating device.
Differences:
N/A
Device design of InterView and Xeleris
software are substantially equivalent. |
| Host environment | Operates in a single user environment, on a
stand-alone workstation, or multi-user
environment, on a server using Windows Remote
Desktop Protocol.
Single user and client operation system are
Windows 10, server operation system is Windows
Server 2019. | The system can run on dedicated workstation or in a
server-client configuration deployed on a virtual
server.
Single user and client operation system are Windows
10, server operation system is Windows Server 2016. | | Similarities:
Normal workstation and server
configurations.
Each software is based on
Windows Operating System.
Differences:
Different version of server
operating system.
Xeleris support virtualization.
Different operating system version and
virtualization are not considered as a
significant technological difference. No |
10
| XP |
|---|
| ew |
| 19 |
| ntei |
| I |
| A |
| S |
| a |
| mm |
| C |
| SI |
| C |
| 0(k) |
| 51 |
11
| XP |
|---|
| iew |
| 11 |
| inter' |
| I |
| ry |
| a |
| imm |
| Su |
| 0(k) |
| 510 |
| Feature | Subject device
InterView XP | Predicate device
Xeleris V Processing and Review Systems
(K201103) | Clinical procedures -
Cardiology | Comparison |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SPECT
reconstruction | Detect and correct motion; preview result; | Sinogram and linogram images for QC analysis;
automatic gated and non-gated SPECT motion
correction; tools for manual adjustment and
correction | | Similarities:
Quality control before
reconstruction.
Conventional reconstruction
methods.
Reorientation methods.
Differences:
Iterative reconstruction
algorithm. |
| | Range; simultaneous reconstruction;
reconstruction algorithms; iterative reconstruction;
attenuation correction; material map for CT AC;
manual registration; automatic registration;
change AC; filters; reconstruction profiles; | Side-by-side reconstruction and auto reformat;
filtered back projection; iterative reconstruction
w/scatter correction and/or attenuation correction
(where relevant data is provided); 3D Post-Filter;
Chang Attenuation Correction; comprehensive review
of all slice planes, 3-plane spot collection and
triangulation to show image interrelationships; | | InterView and Xeleris has a different
implementation of 3D iterative OSEM
reconstruction that are based on the
modelling of the same physical principles
(attenuation, scatter correction); therefore
it can be considered as substantially
equivalent. |
| | Manual reorientation; automatic reorientation;
simultaneous reorientation; reoriented image
parameters | Supports reformat; oblique slices; | | Similarities:
Myocardial Perfusion SPECT
analysis.
First-pass radionuclide
angiography analysis.
Equilibrium gated planar
radionuclide ventriculography
analysis.
Differences: |
| | Myocardial Perfusion SPECT; Myocardial
Perfusion Gated SPECT; Gated blood pool
SPECT; Thallium-201 chloride or [99mTc]
labelled SESTAMIBI or Tetrofosmin; visual
assessment; perfusion, wall motion, and
thickening on polar maps; circumferential profile
curves; global and regional ejection fraction; end-
diastolic and end-systolic left ventricular volumes
and stroke volume; launch third-party software; | Cardiac SPECT, gated SPECT, and PET data
including Sestamibi, Thallium, Tetrofosmin, Dual
Isotope, FOG, and Rubidium; review beating heart
slices; Calculation of TID and lung heart ratio; Polar
Plots and Reversibility Polar Plots; ejection fraction;
masking; cardiac review screen; including 3D, Polar
Maps, four sets, five slices review, ED/ES review,
beating slices, EF, side-by-side perfusion and beating
gated review; Synchronized gated slice beating;
Direct linkage with optional 3rd party packages | | Gated blood pool SPECT
analysis.
Minor differences in the
processing methods. |
| | Gated blood pool SPECT; ventricle function on
phase, motion and amplitude polar maps; phase
histogram and volume curve; global and regional
ejection fraction | N/A (with third party cardiac SW) | | InterView and Xeleris provide clinical
procedures for cardiac analysis. Although |
| Feature | Subject device
InterView XP | Predicate device
Xeleris V Processing and Review Systems
(K201103) | Comparison | |
| Clinical
procedures -
Endocrinology | First-pass radionuclide angiography; visual
assessment; vena cava sup. transit time for
quality control; cardiac output; Stroke volume;
Mean Pulmonary Transit Time; Pulmonary
Circulation Time; left to right shunt ratio
Equilibrium gated planar radionuclide
ventriculography analysis; visual assessment;
global ejection fraction; ejection and filling time;
average heart cycle and heart rate, and the
lower/upper limit of the R-R interval
Thyroid [99mTc]-Pertechnetate uptake, weight,
and geometry; Thyroid lodine uptake, weight and
geometry; visual assessment; normalized uptake;
thyroid weight; estimation of activity to be
administered for the radioiodine therapy
Parathyroid dual label; [99mTc] MIBI, tetrofosmin,
or thallium-chloride, the other with [123I] Nal or
[99mTc] pertechnetate; visual assessment both the
thyroid and abnormal parathyroid tissue;
normalized difference image
Thyroid I-123 clearance; [123I] sodium-iodide;
visual assessment; clearance calculated from the
time activity curve | EF analysis with volume curve; left/right ventricle
selection; auto/manual ROIs for systole and diastole;
interactive beat selection; phase/Amplitude analysis;
quality control review screen including transit times;
pulmonary to system flow Used to determine the
existence and size of the inter-cardiac shunts
Peak Filling Rate protocol that includes the left
ventricle (LV) emptying index and determines several
timing, ejection fraction and rate parameters
Thyroid uptake index; 99mTc and I-131 static studies;
statistics on the entire thyroid per thyroid lobe, or by
region (cold or hot spot)
Parathyroid imaging analysis; dual isotope (99mTc &
201TI); dual phase MIBI
N/A | there might be some difference in the
processing methods and the derived
parameters (e.g. intermediate results are
also displayed) cardiac processing of both
software can be considered as
substantially equivalent.
For gated blood pool SPECT analysis see
reference device.
Similarities:
Thyroid uptake & geometry
analysis.
Differences:
Thyroid I-123 clearance.
Thyroid I-123 clearance analysis
procedure is based on general principles
for evaluating a series of static planar
studies, similar to dynamic planar
processing. Activity changes over time of
regions are visualized and parameters of
the time activity curves are calculated. No
specific clinical parameters are derived.
Although this procedure is not present in
Xeleris, this is not considered as a
significant difference between the two
products. No impact on substantial
equivalence. | |
12
13
14
| Feature | Subject device
InterView XP | Predicate device
Xeleris V Processing and Review Systems
(K201103) | Comparison |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical procedures -
Hepatology | Cholescintigraphy; [99mTc]-labeled IDA
derivatives; visual assessment; time activity
curves; parameters derived from curves;
gallbladder ejection fraction; | Gallbladder EF; ejection fraction; motion correction; | Similarities:
Gallbladder analysis.
Differences:
- Liver first pass
- Minor differences in the
processing methods |
| | Static liver and spleen; [99mTc] sulfur colloid;
visual assessment; descriptive statistics; | N/A | Static liver and spleen analysis procedure
is based on general principles for
evaluating a static planar study. Static
liver and spleen calculate a simple activity
ratio of the liver and spleen region. |
| | Liver first pass; [99mTc]-labeled IDA derivatives;
visual assessment; hepatic perfusion index; time
activity curves; parameters derived from curves | N/A | Liver first pass analysis procedure is
based on general principles for evaluating
a dynamic planar study. Activity changes
over time of regions are visualized and
parameters of the time activity curves are
calculated. No specific clinical parameters
are derived. |
| | | | Although these procedures are not
present in Xeleris, this is not considered
as a significant difference between the
two products. No impact on substantial
equivalence. |
15
| Feature | Subject device | Predicate device
(K201103) | Comparison |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical
procedures -
Nephrology | Dynamic Kidney; [Tc-99m] labeled DTPA, [Tc-
99m] labeled MAG3, Tc-99m] labeled EC, [I-131]
labeled OIH, [I-123] labeled OIH derivatives;
visual assessment; time activity curves;
parameters derived from curves; split renal
function (integral, Patlak-Rutland method);
transplanted kidney perfusion and function index;
Hilson index; residual and normalized residual
kidney activity (NORA); output efficiency; renal
blood flow (RBF/CO); diuretic response;
deconvolution and Patlak-Rutland plot analysis;
urine flow rate; residual urine volume; gravity-
assisted and post-void drainage parameters;
parametric images: time of maximum, maximal
counts, mean transit time
Static Kidney; [99mTc] labeled DMSA-derivatives;
visual assessment; split renal function; uptake of
the kidneys; different kidney depth estimation
methods | Xeleris V Processing and Review Systems
Renal analysis; renal perfusion; renal function;
automatically identify kidney ROIs with manual
adjustments; renogram for diuretic and captopril
acquisitions; DTPA, MAG3 and LASIX renography;
DMSA Renal; pediatric kidney depth calculation;
analysis methods include Gates GFR, QuantEM
(Option); modified Gates, modified Schlegal; single
sample clearance include Dubovsky (for Ortho lodo
hippuran and 99mTc-MAG3) and Bubeck (99mTc-
MAG3); perfusion methods include Hilson, Peter, and
Kirchner; relative uptake methods include Slope and
Integral methods; excretion index (20 min,30 min,
residual); Manchester with Rutland slope for relative
uptake support
Renogram DMSA; relative and absolute function
(%dose); three methods of entry of dose (camera,
well counter, and dose calibrator); five methods of
kidney depth estimation (manual, Raynaud, Taylor,
Tonnensen, and conjugate view) | Similarities:
Dynamic kidney analysis.
Static kidney analysis.
Differences:
Minor differences in the
processing methods.
InterView and Xeleris provide clinical
procedures for kidney analysis. Although
there might be some difference in the
processing methods and the derived
parameters (e.g. intermediate results are
also displayed) kidney processing of both
software can be considered as
substantially equivalent. |
| Clinical
procedures -
Neurology | Brain fist-pass; [99mTc] HMPAO, [99mTc] RBC;
visual assessment; mean transit time; perfusion;
time activity curves; parameters derived from
curves | N/A | Similarities:
Brain perfusion analysis.
DaTscan analysis.
Differences: |
16
| Feature | Subject device
InterView XP | Predicate device
Xeleris V Processing and Review Systems
(K201103) | Comparison |
|---------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Brain perfusion; [99mTc] HMPAO; visual
assessment; regional analysis | CBF Segmentation Protocol; Trans-axial slice
subdivided into equiangular sectors over 360
degrees; Brain oblique reformatting; OM line
definition with external marker; analysis of mean
count, total count, maximum pixel value and standard
deviation; Early/Late and Right/Left Mean ratios -
Quality control of reconstructed data; image slice
comparisons | Brain first-pass.
Normal database of age
matched reference values.
Minor differences in the
processing methods. |
| | DaTscan; I-123 DaTscan; visual assessment;
Statistics (mean counts, area...) of the striatal
regions; count ratios | DaTQUANT optional application; visual evaluation
and quantification of I-123-ioflupane images; elative
comparison of uptake ratios; pre-defined VOI
template; database of age matched reference values | InterView and Xeleris provide clinical
procedures for brain perfusion and
DaTscan analysis. Although there might
be some difference in the processing
methods and the derived parameters (e.g.
intermediate results are also displayed)
brain perfusion and DaTscan processing
of both software can be considered as
substantially equivalent. Normal database
of age matched reference values is not
available in InterView but supported in the
third-party software that are optionally
provided with InterView. This functionality
allows better interpretation of results but
processing of DaTscan brain images is
possible even without a normal database. |
| | | | Brain first pass analysis procedure is
based on general principles for evaluating
a dynamic planar study. Activity changes
over time of regions are visualized and
parameters of the time activity curves are
calculated. No specific clinical parameters
are derived. Although this procedure is not
present in Xeleris, this is not considered
as a significant difference between the
two products. No impact on substantial
equivalence. |
17
| Feature | Subject device
InterView XP | Predicate device
Xeleris V Processing and Review Systems
(K201103) | Comparison |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical
procedures -
Osteology | Whole body bone; visual assessment; basic
statistics; | Whole Body and Bone Spots Review; Review whole
body and spot images; dual zoom mode; predefined
automatic layouts; regional masking; ROI
comparison-based analysis; statistic and count
display; | Similarities:
• Whole body analysis.
• 3-Phase Bone Scintigraphy
analysis.
• Sacroiliac index analysis.
Differences:
• Minor differences in the
processing methods.
InterView and Xeleris provide clinical
procedures for bone analysis. Although
there might be some difference in the
processing methods and the derived
parameters (e.g. intermediate results are
also displayed) bone processing of both
software can be considered as
substantially equivalent. |
| | 3-Phase Bone Scintigraphy; [99mTc]-labelled
diphosphonates; visual assessment; uptake ratio Analysis of the perfusion and blood pool phases; ROI
comparison-based analysis; statistic and count
display; | | |
| | Sacroiliac Index; [99mTc]-labelled
diphosphonates; visual assessment; sacroiliac
joint-to-sacrum ratios; left-to-right (or right-to-left)
sacroiliac count ratio | Sacroiliac ratio with manual or auto edge detection | |
| Clinical
procedures -
Pulmonology | Lung Quantitative 6-Part; [99mTc] MAA, [99mTc]
DTPA, Kr-81, Xe-133, Xe-127; visual
assessment; basics statistics; | N/A | Similarities:
• Lung ventilation and perfusion
analysis.
Differences:
• Lung shunt fraction.
• Lung quantitative 6 part |
| | Combined Lung; Lung Quantitative 6-Part;
[99mTc] MAA, [99mTc] DTPA, Kr-81, Xe-133, Xe-
127; visual assessment; | Lung analysis; analysis of lung ventilation and
perfusion; ventilation index and quantitative perfusion
analysis including ratio; templates for lung segments
visualization; | Lung shunt fraction and lung quantitative
6-Part analysis procedure is based on
general principles for evaluating a static |
| | | N/A | |
18
| Feature | Subject device
InterView XP | Predicate device
Xeleris V Processing and Review Systems
(K201103) | Comparison |
|---------|---------------------------------------------------------------------------|--------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Lung shunt fraction; [99mTc] MAA; visual
assessment; lung shunt index; | | planar study. Lung shunt fraction
calculates a simple activity ratio of the
lung and liver region (total lung counts) /
(total lung counts + total liver counts).
Lung quantitative 6-Part simple calculates
activities in 6 regions of the lung.
Although these procedures are not
present in Xeleris, this is not considered
as a significant difference between the
two products. No impact on substantial
equivalence. |
ndication for use of the dedicated applications of GE Xeleris system is not included in the comparison, only the general part
19
Non-Clinical Testing
Nonclinical testing consisted of a software validation that traced and tested all identified inputs and requirements. This testing consisted of the establishment of User Needs, Functional System Requirement, and Component Requirement Specifications. Test cases were executed to verify that these requirements were fulfilled. Clinical effectiveness was assessed through the completion of Functional Design Validations and Usability Validations. Acceptance criteria were fulfilled. Testing was based on:
- . IEC 62304:2006 + A1/2015, Medical device software. Software life-cycle processes
- IEC 62366-1:2015, Medical devices. Part 1: Application of usability engineering to . medical devices
- ISO 12052:2017, Health informatics. Digital imaging and communication in medicine ● (DICOM) including workflow and data management
- NEMA PS3, DICOM PS 3.x standard-series ●
- General Principles of Software Validation; Final Guidance for Industry and FDA Staff, . Issued January 11, 2002
Clinical Testing
No clinical testing was performed in association with this submission.
Conclusions
In conclusion, the results of the comparison of design, materials, intended use and technological characteristics and the performance test demonstrate that the InterView XP is substantially equivalent to the predicate device.
20
510(k) Summary - InterView FUSION
Submission Owner and Correspondent
Submission Owner
Mediso Medical Imaging Systems, Ltd. Laborc utca 3. Budapest HUNGARY H-1037 Ph: +36-1-3993030 Email: info@mediso.hu
Submission Correspondent
CRO Group, Inc. 342 E. Main Street, Suite 207 Leola, PA 17540 Contact: William McLain Phone: 717-656-9656 E-Mail: bmclain@crogroup.com
Date Summary Prepared
February 23, 2023
Device Trade Name
InterView FUSION
Device Common Name
Medical Image Visualization And Post-processing Software As Medical Device (SaMD)
Device Classification Name
Medical Image Management and Processing System Classified as Class 2 at 21 CFR 892.2050. product code LLZ.
21
Legally Marketed Device To Which The Device Is Substantially Equivalent
The InterView FUSION is substantially equivalent to the Xeleris V Processing and Review Systems cleared under K201103.
Description of the Device
InterView FUSION is a multi-modal visualization and evaluation software. Developed by Mediso built on state-of-the-art technologies, novel image processing algorithms and tools for evaluating different medical imaging modalities. The product is designed as a standalone software, i.e. Software as Medical Device (SaMD) product, operating on Windows OS as a classical user application.
Multi-modal registration and fusion of SPECT, PET, CT and MRI studies is a core functionality of InterView FUSION. Evaluation can be performed with the help of several specialized viewers and automated algorithms. Statistical measurements by ROIs, VOIs are present just as well as SUV representation for PET and even SPECT images. A wide range of function-specialized tools provide a well-detailed, fast and easy evaluation of medical images combining with advanced visualizations and interactions with flexible workspaces. Special segmentation methods provide quick and easy extraction of organs/regions from images. Basic arithmetic operations as well as spatial and frequency domain filters are also available.
Indications for Use
InterView FUSION is a Software as Medical Device (SaMD) aimed at reviewing medical images such as planar scans and tomographic scans from SPECT, PET, CT, and MRI modalities. Review of other image modalities is also supported. The common users for clinical purposes are trained medical professionals, including clinicians and technicians in hospitals or imaging centers. Software components provide functions for image display, manipulation, enhancements, analysis, and quan- tification. This device is not indicated for mammography use or dental diagnostics. The software provides diagnostic information - however, diagnostic decisions cannot be based solely on this software. InterView FUSION has no specific target population.
22
Technological Characteristics
The following Table compares the technological characteristics between the proposed InterView FUSION and the predicate Xeleris V Processing and Review Systems cleared under K201103.
23
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| Feature | Subject device
InterView FUSION | Predicate device
Xeleris V Processing and Review Systems (K201103) | Comparison |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | InterView FUSION is an advanced multi-modality
medical image visualization and post-processing
Software as Medical Device (SaMD) for clinical
applications. Multi-modal registration and fusion of
functional - SPECT, PET - and anatomical - CT,
MRI - studies are a core functionality. Quantitative
evaluation can be performed with the help of
several specialized viewers, flexible workspaces
and automated algorithms. A wide range of
function-specialized tools enable measurement,
manipulation, enhancement and analysis of the
images. Data from Mediso or third-party
manufacturer's devices may be passed to the
application from the integrated database or other
PACS systems. InterView FUSION is a stand-alone
medical software. InterView FUSION is NOT
intended to be used as a replacement for visual
interpretation nor as a diagnostic tool without other
clinical and laboratory information. It is not intended
to treat the patient, to monitor vital signs or to give a
direct diagnosis of disease. | The system is intended for use by Nuclear
Medicine (NM) or Radiology practitioners
and referring physicians. The intended use
of the system is to provide digital processing,
review and reporting of medical images,
including data display, quality control, image
manipulation and quantification analysis,
transfer, storage and printing capabilities.
The system operates in a variety of
configurations. The hardware components
may include computer workstations,
Communications devices, video monitors,
data storage and hardcopy devices.
Software components provide functions for
performing operations related to image
display; manipulation, enhancements,
analysis and quantification and can operate
on dedicated workstations and client-server
architectures.
(....)* | Similarities:
Each software is intended to be used for
nuclear medicine applications.
Processing, review and reporting are the
core functionalities.
Both are Software as Medical Device
(SaMD)
Workstation or client-server architecture
is supported.
Differences:
N/A
Intended use statement of InterView and Xeleris
software are substantially equivalent. |
| Indications for
use | InterView FUSION is a Software as Medical Device
(SaMD) aimed at reviewing medical images such as
planar scans and tomographic scans from SPECT,
PET, CT and MRI modalities. Review of other image
modalities is also supported. Common Users for
clinical purposes are trained medical professionals,
including clinicians and technicians in hospitals or
imaging centers. Software components provide
functions for image display, manipulation, | The system is intended for use by Nuclear
Medicine (NM) or Radiology practitioners
and referring physicians for display,
processing, archiving, printing, reporting and
networking of NMI data, including planar
scans (Static, Whole Body, Dynamic,
Multi-Gated) and tomographic scans
(SPECT, Gated SPECT, dedicated PET or
Camera-Based-PET) acquired by gamma | Similarities:
Intended users are the same.
Software core functionalities are the
same.
Both software process similar
modalities.
Both software support stand-alone and
client-server architecture. |
24
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| Feature | Subject device
InterView FUSION | Predicate device
Xeleris V Processing and Review
Systems (K201103) | Comparison |
|------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | enhancements, analysis and quantification. This
device is not indicated for mammography use or
dental diagnostics. The software provides
diagnostic information, however diagnostic decision
cannot be based solely on the software. InterView
FUSION has no specific target population. | cameras or PET scanners. The system can
run on dedicated workstation or in a
server-client configuration.
The NM or PET data can be coupled with
registered and/or fused CT or MR scans,
and with physiological signals in order to
depict, localize, and/or quantify the
distribution of radionuclide tracers and
anatomical structures in scanned body tissue
for clinical diagnostic purposes. | Differences:
N/A
Indications for use statement of InterView and
Xeleris software are substantially equivalent. |
| Clinical
procedures
Lesion detection
method | Lesion detection method; detection range; mask
regions; global threshold method; local threshold
method; lymph node package method | Q. Volumetrix Al; quantitative SPECT/PET
results are further enhanced with advanced
segmentation tools providing 2D and 3D
organ and lesion characterization. | Similarities:
Lesion detection.
Differences:
Minor differences in the processing
methods.
InterView and Xeleris provide a clinical procedure
for lesion detection. Lesion detection is an
advanced segmentation method that facilitates
the segmentation of lesions (regions with higher
activity on NM images). Different manual and
automatic methods might be applied to find the
proper lesion contour. Although there are
differences in the applied techniques it shall be
considered as substantially equivalent. |
| Clinical
procedures
Follow-up
method | Follow-up method; quality control; register images;
compare images; copy baseline findings; propagate
findings; overview findings; display results; manage
follow-up finding | Q. Volumetrix Al; quantitative patient
follow-up; two instances of the same
application with two different studies of the
same patient | Similarities:
Follow-up analysis.
Differences:
Minor differences in the workflow
InterView and Xeleris provide a clinical procedure
for follow-up analysis that is comparing a patient
earlier studied with the current ones. The essence |
25
| Feature | Subject device | Predicate device | Comparison |
|---|---|---|---|
| InterView FUSION | Xeleris V Processing and Review | ||
| Systems (K201103) | of the procedure is to provide a simple workflow | ||
| that facilitates processing. Although there are | |||
| differences in the workflow, it shall be considered | |||
| as substantially equivalent. |
26
Non-Clinical Testing
Nonclinical testing consisted of a software validation that traced and tested all identified inputs and requirements. This testing consisted of the establishment of User Needs, Functional System Requirement, and Component Requirement Specifications. Test cases were executed to verify that these requirements were fulfilled. Clinical effectiveness was assessed through the completion of Functional Design Validations and Usability Validations. Acceptance criteria were fulfilled. Testing was based on:
- IEC 62304:2006 + A1/2015, Medical device software. Software life-cycle processes ●
- IEC 62366-1:2015, Medical devices. Part 1: Application of usability engineering to ● medical devices
- ISO 12052:2017, Health informatics. Digital imaging and communication in medicine . (DICOM) including workflow and data management
- NEMA PS3, DICOM PS 3.x standard-series
- General Principles of Software Validation; Final Guidance for Industry and FDA Staff, Issued January 11, 2002
Clinical Testing
No clinical testing was performed in association with this submission.
Conclusions
In conclusion, the results of the comparison of design, materials, intended use and technological characteristics and the performance test demonstrate that the InterView FUSION is substantially equivalent to the predicate device.