(259 days)
No
The summary describes image processing, registration, fusion, ROI identification, and quantitative analysis, but does not mention AI or ML. The "automatic quantification of ROIs" could potentially involve ML, but the description doesn't explicitly state this, and the lack of mention of training/test sets further suggests the absence of ML.
No
The device is a software tool for evaluating and managing digital medical images, focusing on display, processing, and quantitative analysis, not on directly treating or diagnosing medical conditions.
Yes
The device "aids in evaluation and information management of digital medical images by trained medical professionals" and assists in tasks such as "quantitative/statistical analysis of full or partial body scans" and "evaluating quantitative change in ROIs." These functions contribute to diagnostic processes rather than directly providing a diagnosis.
Yes
The device description explicitly states that QTxI is "stand-alone software" and operates on standard operating systems (Windows 7 and 10). The description focuses entirely on software functionalities for image processing, analysis, and PACS features, with no mention of accompanying or required hardware components beyond a standard computer.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The description of QTxI clearly states its purpose is to process and analyze digital medical images (DICOM CT and PET scans) of the human body, not biological specimens like blood, urine, or tissue.
- The intended use and device description focus on image processing, analysis, and management. The functions described are related to displaying, registering, fusing, contouring, and quantifying features within medical images. These are typical functions of medical image analysis software, not IVDs.
- The device description mentions a module for identifying and measuring "hot-spots on PET scans." While this involves analyzing data from a medical imaging procedure, it's still an analysis of the image data itself, not a test performed on a biological sample.
In summary, QTxI is a software tool for analyzing and managing medical images, which falls under the category of medical imaging software or PACS (Picture Archive and Communications System) functionality, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Quantitative Total Extensible Imaging (QTxI) is a software tool used to aid in evaluation and information management of digital medical images by trained medical professionals including, but not limited to, radiologists, nuclear medicine physicians, medical imaging technologists, dosimetrists and physicists. The medical modical images include DICOM CT and PET as supported by ACR/NEMA DICOM 3.0.
QTxI assists in the following indications:
· Receive, store, retrieve, display and process digital medical images.
- · Create, display and print reports from those images.
· Provide medical professionals with the ability to display, register, and fuse medical images.
· Identify Regions of Interest (ROIs) and perform ROI contouring allowing quantitative/statistical analysis of full or partial body scans.
· Evaluate quantitative change in ROIs (total or partial body; individual) with 3D interactive rendering of images with highlighted ROIs.
Product codes
LLZ
Device Description
Quantitative Total Extensible Imaging (QTxl) is a software tool designed for use in medical imaging. It is stand-alone software which operates on Windows 7 and Windows 10. Its intended function and use is to provide medical professionals with the means to display, register and fuse medical images from multiple modalities including DICOM PET and CT. Additionally, it identifies Regions of Interest (ROIs) and performs ROI contouring allowing quantitative/statistical analysis of full or partial-body scans through registration to template space.
QTxl is designed to support multiple image analysis modules. Each module is designed for a specific image analysis purpose. Currently QTxl includes only the Quantitative Total Bone Imaging (QTBI) module, which is designed to identify and measure hot-spots on PET scans. QTBI aids the efficiency of medical professionals through automatic quantification of ROIs and changes in those ROIs, including 3D interactive rendering of the patient skeleton with highlighted Regions of Interest.
QTxI also functions as a Picture Archive and Communications System (PACS) intended to receive, store, retrieve, display and process digital medical images, as well as create, display and print reports from those images. It also provides platform features for security, workflow and integration.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM CT and PET
Anatomical Site
Full or partial body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained medical professionals including, but not limited to, radiologists, nuclear medicine physicians, medical imaging technologists, dosimetrists and physicists.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance bench tests and simulated clinical performance tests have been performed on the Quantitative Total Extensible Imaging (QTxl) in order to verify the device characteristics. Testing conducted to demonstrate substantial equivalence included:
- . Software verification testing that demonstrates the device meets product performance and functional specifications.
- . Software verification testing demonstrating that DICOM information collected with medical imaging systems and transmitted through manual or virtual input are captured, transmitted, and stored properly to maintain data integrity (e.g., no loss of data).
QTxl met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, and test protocols.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 23rd, 2018
AIQ Solutions, Inc. % Mr. Mitch Lewandowski Principal/Consultant EpiReg LLC 3428 John Muir Drive MIDDLETON WI 53562
Re: K173444
Trade/Device Name: Quantitative Total Extensible Imaging (QTxI) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 8, 2018 Received: June 12, 2018
Dear Mr. Lewandowski:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jeff Bridges
Digitally signed by Jeffrey J.
Ballyns -S
ON: C=US, o=U.S. Government,
Du=HHS, ou=FDA, ou=People,
0.9.2342.19200300.100.1.1=200
0569725, cn=Jeffrey J. Ballyns -S
Date: 2018.07.23 10:41:24 -04'00'
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) K173444
Device Name
Quantitative Total Extensible Imaging (QTxI)
Indications for Use (Describe)
Quantitative Total Extensible Imaging (QTxI) is a software tool used to aid in evaluation and information management of digital medical images by trained medical professionals including, but not limited to, radiologists, nuclear medicine physicians, medical imaging technologists, dosimetrists and physicists. The medical modical images include DICOM CT and PET as supported by ACR/NEMA DICOM 3.0.
QTxI assists in the following indications:
· Receive, store, retrieve, display and process digital medical images.
- · Create, display and print reports from those images.
· Provide medical professionals with the ability to display, register, and fuse medical images.
· Identify Regions of Interest (ROIs) and perform ROI contouring allowing quantitative/statistical analysis of full or partial body scans.
· Evaluate quantitative change in ROIs (total or partial body; individual) with 3D interactive rendering of images with highlighted ROIs.
| 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) |
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510(k) Summary
1. 510(k) Owner:
AIQ Solutions Inc.
2. Address:
8025 Excelsior Drive Madison, WI 53717
Contact Person: 3.
Mitch Lewandowski, M.S./ M.P.H; Principal Consultant Email: info@epireq.com Tel: 608 712-8585 Direct: 608 695-9333
Date 510(k) Summary Prepared: 4.
05 October 2017
5. Trade Name:
Quantitative Total Extensible Imaging (QTxl) Medical Image and Information Management System
6. Common Name:
Picture archiving and communication system
Classification Name: 7.
21 CFR 892.2050, Picture archiving and communication system (LLZ)
8. Predicate Device(s):
Exini Diagnostics AB; EXINI, K122205
Device Description: 9.
Quantitative Total Extensible Imaging (QTxl) is a software tool designed for use in medical imaging. It is stand-alone software which operates on Windows 7 and Windows 10. Its intended function and use is to provide medical professionals with the means to display, register and fuse medical images from multiple modalities including DICOM PET and CT. Additionally, it identifies Regions of Interest (ROIs) and performs ROI contouring allowing quantitative/statistical analysis of full or partial-body scans through registration to template space.
QTxl is designed to support multiple image analysis modules. Each module is designed for a specific image analysis purpose. Currently QTxl includes only the Quantitative Total Bone Imaging (QTBI) module, which is designed to identify and measure hot-spots on PET scans. QTBI aids the efficiency of medical professionals through automatic quantification of ROIs and changes in those
4
ROIs, including 3D interactive rendering of the patient skeleton with highlighted Regions of Interest.
QTxI also functions as a Picture Archive and Communications System (PACS) intended to receive, store, retrieve, display and process digital medical images, as well as create, display and print reports from those images. It also provides platform features for security, workflow and integration.
10. Indications for Use and Intended Use
Quantitative Total Extensible Imaging (QTxl) is a software tool used to aid in evaluation and information management of digital medical images by trained medical professionals including, but not limited to, radiologists, nuclear medicine physicians, medical imaging technologists, dosimetrists and physicists. The medical modalities of these medical images include DICOM CT and PET as supported by ACR/NEMA DICOM 3.0.
QTxl assists in the following indications:
- . Receive, store, retrieve, display and process digital medical images.
- . Create, display and print reports from those images.
- Provide medical professionals with the ability to display, register, and fuse ● medical images.
- . Identify Regions of Interest (ROls) and perform ROI contouring allowing quantitative/statistical analysis of full or partial body scans.
- . Evaluate quantitative change in ROIs (total or partial body; individual ROI within individual) with 3D interactive rendering of images with highlighted ROIs.
11. Technological Characteristics
QTxl has substantially equivalent indications for use, principle of operation, and technological characteristics as the Exini Diagnostics AB; EXINI, K122205.
The following table summarizes and compares data on the Exini Diagnostics AB; EXINI, K122205, and supporting predicate device MIMvista Corp. MIM4.1 (Seastar), K071964.
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| Specification /
Characteristic | Quantitative Total
Extensible Imaging (QTxl) | Exini Diagnostics AB;
EXINI, K122205 | MIMvista Corp.
MIM4.1 (Seastar), K071964 | Comparison to
Predicate(s) |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject Device | Predicate Device | Supporting Predicate Device | |
| Product Code | LLZ | LLZ | LLZ | No difference |
| Regulation
Number | 892.2050 | 892.2050 | 892.2050 | No difference |
| Regulatory
Class | II | II | II | No difference |
| Review Panel | Radiology | Radiology | Radiology | No difference |
| Predicate
Device | Exini Diagnostics AB;
EXINI (K122205) | MEQIA, IBIS Explorer and Markup
Software (K111319) | MIM4.0 (K060816); IKOEngelo
(K061006); Centricity PACS
(K043415) | N/A |
| 510(k)/ Type | K173444, Traditional | K122205, Traditional | K071964, Traditional | No difference |
| Features | Receive, store, retrieve, display
and process digital medical
images, as well as create,
display and print reports from
those images | Software tool set for acceptance, transfer,
storage, image display, manipulation and
quantification of digital medical images. | Receive, transmit, store, retrieve,
display, print and process digital
medical images, as well as create,
display and print reports from those
images | No difference |
| Medical
Modalities | DICOM CT and PET as
supported by
ACR/NEMA DICOM 3.0 | Nuclear imaging (NM) and computed
tomography (CT) as supported by
DICOM 3.0 standard. | CT, MRI, CR, DX, MG, US,
SPECT, PET and XA as supported
by ACR/NEMA DICOM 3.0. | QTXI does not utilize
as many medical
modalities as
predicate, but does
utilize equivalent
modalities in those
used by both systems. |
| Operating
System | Window 7 or Windows 10 | Microsoft Windows operating system | Windows 2000/XP | QTxl uses newer
versions of MicroSoft
Windows software |
| Methodology | Identifies Regions of Interest
(ROI) and performs ROI
contouring allowing
quantitative/statistical analysis
of full or partial-body scans
through registration to template
space | The device uses image processing
techniques for segmentation of skeletal
regions, normalization and hotspot
contouring/ segmentation. This device is
semi-automatic in that it requires a
manual step (hotspot verification step)
where the user reviews and edits the
selection of hotspots that are used as
input for quantitative analysis. The device
performs quantitative analysis based on
2D ROI (regions of interests)
measurements in whole body bone scans. | Generates contours using a
deformable registration technique
which registers pre-contoured
patients to target patients.
Registrations are either between a
serial pair of intra-patient volumes
or between a pre-existing atlas of
contoured patients and a patient
volume | All devices perform
centering analyses
utilizing a template
model. QTXI also
registers regions of the
patient. |
| Specification / Characteristic | Quantitative Total Extensible Imaging (QTxI)
Subject Device | Exini Diagnostics AB; EXINI, K122205
Predicate Device | MIMvista Corp.
MIM4.1 (Seastar), K071964
Supporting Predicate Device | Comparison to Predicate(s) |
| Indications for Use | Quantitative Total Extensible
Imaging (QTxI) is a software
tool used to aid in evaluation
and information management of
digital medical images by
trained medical professionals
including, but not limited to,
radiologists, oncologists,
nuclear medicine physicians,
medical imaging technologists,
dosimetrists and physicists. The
medical modalities of these
medical images include DICOM
CT and PET as supported by
ACR/NEMA DICOM 3.0.
QTxl assists in the following
indications:
Receive, store, retrieve,
display and process digital
medical images Create, display and print
reports from those images Provide medical
professionals with the
ability to display, register,
and fuse medical images | EXINI is intended to be used by trained
healthcare professionals and researchers
for acceptance, transfer, storage, image
display, manipulation, quantification and
reporting of digital medical images. The
system is intended to be used with images
acquired using nuclear imaging (NM) and
computed tomography (CT). The software
provides general
Picture Archiving and Communications
System (PACS) tools and a clinical
application for oncology including lesion
marking and analysis. | MIM 4.1 (SEASTAR) software is
used by trained medical
professionals as a tool to aid in
evaluation and information
management of digital medical
images. The medical image
modalities include, but are not
limited to, CT, MRI, CR, DX, MG,
US, SPECT, PET and XA as
supported by ACR/NEMA DICOM
3.0. MIM 4.1
(SEASTAR) assists in the following
indications:
Receive, transmit, store,
retrieve, display, print, and
process medical images and
DICOM objects. Create, display and print
reports from medical images. Registration, fusion display,
and review of medical images
for diagnosis, treatment,
evaluation, and treatment
planning. Evaluation of cardiac left
ventricular function and
perfusion, including left
ventricular end-diastolic
volume, end-systolic volume,
and ejection fraction. | All systems are used to
receive, store, retrieve,
display, and process
medical images and
DICOM objects.
This is accomplished
via registration to a
template space and
subsequent analysis of
the image data.
The predicate device
has multiple uses in
the therapeutic space,
which is not specific to
any device. |
| Specification /
Characteristic | Quantitative Total
Extensible Imaging (QTxI)
Subject Device | Exini Diagnostics AB;
EXINI, K122205
Predicate Device | MIMvista Corp.
MIM4.1 (Seastar), K071964
Supporting Predicate Device | Comparison to
Predicate(s) |
| Indications for
Use
(continued) | Identify Regions of
Interest (ROIs) and
perform ROI contouring
allowing quantitative/
statistical analysis of full or
partial body scans Evaluate quantitative
change in ROIs (total or
partial body; individual
ROI within individual) with
3D interactive rendering of
images with highlighted
ROIs. | | Localization and definition of
objects such as tumors and
normal tissues in medical
images. Creation, transformation, and
modification of contours for
applications including, but not
limited to, quantitative analysis,
aiding adaptive therapy,
transferring contours to
radiation therapy treatment
planning systems, and
archiving contours for patient
follow-up and management Quantitative and statistical
analysis of PET/SPECT brain
scans by comparing to other
registered PET/SPECT brainscans. | |
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7
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12. Performance Data (Nonclinical)
QTxl is a software tool. Non-clinical performance bench tests and simulated clinical performance tests have been performed on the Quantitative Total Extensible Imaging (QTxl) in order to verify the device characteristics. Testing conducted to demonstrate substantial equivalence included:
- . Software verification testing that demonstrates the device meets product performance and functional specifications.
- . Software verification testing demonstrating that DICOM information collected with medical imaging systems and transmitted through manual or virtual input are captured, transmitted, and stored properly to maintain data integrity (e.g., no loss of data).
13. Conclusion
QTxl met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, and test protocols.
The Quantitative Total Extensible Imaging (QTxl) software tool is substantially equivalent with respect to product performance, indications for use, intended use, scientific principles, technological characteristics, and materials, as the predicate device, Exini Diagnostics AB; EXINI, K122205.