(42 days)
Not Found
No
The document describes standard image review and manipulation tools, anatomical mapping based on user-identified landmarks, and basic measurement functions. There is no mention of AI, ML, or any learning algorithms. The testing described focuses on registration accuracy and functional requirements, not performance metrics typically associated with AI/ML models.
No
The device is described as an image review, manipulation, and analysis tool to assist users in screening, diagnosis, and planning, and does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section states that the device tool is used to assist users in "screening, diagnosis, planning and performing image-guided interventional procedures." Additionally, the "Device Description" states that the device software allows the user to measure the size of a region of interest, which is a diagnostic function.
Yes
The device description explicitly states it is an "electronic image review and reporting software program intended to operate on a Windows Operating System (OS) computer." It receives images and data from external sources (ultrasound systems and spatial positioning devices) and provides software-based tools for review, manipulation, and analysis. There is no indication of proprietary hardware being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of disease. This examination is performed outside of the living body.
- Device Function: The Tractus TissueMapper Reviewer Application is a software program that processes and displays medical images (specifically Ultrasound) obtained from within the human body. It assists skilled medical professionals in reviewing, manipulating, and analyzing these images for screening, diagnosis, planning, and performing image-guided procedures.
- Lack of Specimen Analysis: The device does not analyze biological specimens. Its input is image data, not biological samples.
Therefore, while it is a medical device used in the diagnostic and interventional process, its function falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Tractus TissueMapper Reviewer Application provides two and three-dimensional image review, manipulation, and analysis tools to assist users in screening, diagnosis, planning and performing image-guided interventional procedures. The supported imaging modality is Ultrasound (US). Images and data are received from various imaging systems and other sources such as calibrated spatial positioning devices.
This device provides the capability to overlay annotations on 2D or 3D medical image displays. These annotations may represent the position of instruments including but not limited to imaging probes or other tracked devices.
This device is intended to assist skilled medical professionals in clinical screening and interventions, for anatomical structures where imaging is currently used for visualizing such structures, including head and neck, breast, thoracic, and abdominal applications.
Product codes
LLZ
Device Description
The TissueMapper Reviewer Application consists of: the Tractus TissueMapper Reviewer Application software. The TissueMapper Reviewer Application is an electronic image review and reporting software program intended to operate on a Windows Operating System (OS) computer. The device allows the review of previously recorded ultrasound examinations which are performed using standard ultrasound systems and other sources such as calibrated spatial positioning devices, the images of which were recorded digitally.
The images are displayed on a computer monitor. The images may be reviewed individually or as a self-playing sequence (video clip). Certain image functions may be adjusted by the software, such as image brightness, image contrast and image size magnification or reduction. The speed of the video presentation may be adjusted by the software.
The device software presents sequences of mapped ultrasound images to review previously-recorded hand-held ultrasound examinations, which can be transferred to a computer using a media storage device (USB). Each image is mapped anatomically with respect to a user-identified anatomical landmark, such as the nipple or navel. The image mapping information allows anatomic location of useridentified regions of interest for comparison with other imaging techniques or for procedure planning purposes.
The device software allows the user to measure the size, on two user-defined axes, of the region of interest. The device software allows the user to create and store electronic reports on each region of interest.
The TissueMapper Reviewer Application requires two off-the-shelf accessories:
- Off-the-shelf computer (PC) to run the Tractus TissueMapper Reviewer Application software, which meets the following requirements:
- Display ≥140 DPI ± 5%
- Minimum Resolution of 1920x1080
- Keyboard and Pointing device
- Processor speed of ≥ 2.5 GHz
- Hard drive ≥750 GB
- RAM≥6GB
- Ethernet
- ≥4 USB 2.0 ports or better
- UL60950 ITE Compliant
- Operating System: Windows 7
- Off-the-shelf media storage (USB) to move image files from standard legally marketed ultrasound machines to the off-the-shelf computer noted above
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound (US)
Anatomical Site
head and neck, breast, thoracic, and abdominal applications
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Skilled medical professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Testing was conducted in-house by trained personnel in a simulated work-environment using phantoms to obtain the functional and accuracy test results. Registration accuracy tests were performed to ensure that the registration and correspondence between ultrasound meets or exceeds specified criteria. The test methodology employed was identical to that of the Aegis predicate device, conducted by targeting locations within a phantom and confirming that the selected target location based on the registration calculation is within the same tolerance range or better than the Aegis predicate device. System Validation Testing of the Tractus TissueMapper Reviewer Application was performed on a two breast phantoms with 11 masses total randomly positioned.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Data: Testing for TissueMapper Reviewer Application was performed to ensure that all functional requirements have been met, and that core functions execute as expected. Testing was conducted in-house by trained personnel in a simulated work-environment using phantoms to obtain the functional and accuracy test results. Registration accuracy tests were performed to ensure that the registration and correspondence between ultrasound meets or exceeds specified criteria. The test methodology employed was identical to that of the Aegis predicate device, conducted by targeting locations within a phantom and confirming that the selected target location based on the registration calculation is within the same tolerance range or better than the Aegis predicate device. System Validation Testing of the Tractus TissueMapper Reviewer Application was performed on a two breast phantoms with 11 masses total randomly positioned. All 11 of the masses were successfully identified.
Key results: The results of these tests demonstrate that the TissueMapper Reviewer Application validation is within specification. In all instances, the TissueMapper Reviewer Application functioned as intended and the operation observed was as expected.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Sentinelle Medical Aegis Navigation Application (K093672)
Reference Device(s)
Not Found
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).
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510(k) SUMMARY
Tractus TissueMapper Reviewer Application
JAN 2 9 2013
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Tractus Corporation
981 El Cajon Drive, Danville, CA 94526
Phone: (503) 758-4964 Facsimile: (866) 397-4732
Contact Person: Eric A. Eggers.
Date Prepared: January 23, 2013
Name of Device and Name/Address of Sponsor
TissueMapper Reviewer Application
Tractus Corporation
981 El Cajon Drive
Danville, CA 94526
Common or Usual Name: Picture Archiving and Communications System
Regulation Number: 21 CFR 892.2050
Product Code: LLZ
Device Class: Class II
Predicate Devices
Sentinelle Medical Aegis Navigation Application (K093672)
Intended Use / Indications for Use:
The Tractus TissueMapper Reviewer Application provides two and threedimensional image review, manipulation, and analysis tools to assist users in screening, diagnosis, planning and performing image-guided interventional procedures. The supported imaging modality is Ultrasound (US). Images and data are received from various imaging systems and other sources such as calibrated spatial positioning devices.
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This device provides the capability to overlay annotations on 2D or 3D medical image displays. These annotations may represent the position of instruments including but not limited to imaging probes or other tracked devices.
This device is intended to assist skilled medical professionals in clinical screening and interventions, for anatomical structures where imaging is currently used for visualizing such structures, including head and neck, breast, thoracic, and abdominal applications.
Technological Characteristics
The TissueMapper Reviewer Application consists of:
- . the Tractus TissueMapper Reviewer Application software
The TissueMapper Reviewer Application is an electronic image review and reporting software program intended to operate on a Windows Operating System (OS) computer. The device allows the review of previously recorded ultrasound examinations which are performed using standard ultrasound systems and other sources such as calibrated spatial positioning devices, the images of which were recorded digitally.
The images are displayed on a computer monitor. The images may be reviewed individually or as a self-playing sequence (video clip). Certain image functions may be adjusted by the software, such as image brightness, image contrast and image size magnification or reduction. The speed of the video presentation may be adjusted by the software.
The device software presents sequences of mapped ultrasound images to review previously-recorded hand-held ultrasound examinations, which can be transferred to a computer using a media storage device (USB). Each image is mapped anatomically with respect to a user-identified anatomical landmark, such as the nipple or navel. The image mapping information allows anatomic location of useridentified regions of interest for comparison with other imaging techniques or for procedure planning purposes.
The device software allows the user to measure the size, on two user-defined axes, of the region of interest. The device software allows the user to create and store electronic reports on each region of interest.
The TissueMapper Reviewer Application requires two off-the-shelf accessories:
- . Off-the-shelf computer (PC) to run the Tractus TissueMapper Reviewer Application software, which meets the following requirements: o Display
■≥140 DPI ± 5%
2
· Minimum Resolution of 1920x1080
- o Keyboard and Pointing device
- o Processor speed of ≥ 2.5 GHz
- o Hard drive ≥750 GB
- o RAM≥6GB
- o Ethernet
- o ≥4 USB 2.0 ports or better
- o UL60950 ITE Compliant
- o Operating System: Windows 7
- Off-the-shelf media storage (USB) to move image files from standard legally marketed ultrasound machines to the off-the-shelf computer noted above
Pursuant to 809.92(a)(6), basically, both the applicant's device ("Tractus TissueMapper Reviewer Application") and the predicate device ("Sentinelle Medical Aegis Navigation Application"), present previously recorded images that are spatially mapped with calibrated spatial positioning devices for subsequent review, employ electromagnetic sensors to detect the location of an ultrasound transducer for a registration of transducer location with respect to the region of body scanned with ultrasound, allow for review of ultrasound images collected in the course an ultrasound scan and are software products that run on accessory PC computers. The only technological differences between the Tractus TissueMapper Reviewer Application and its predicate ("Sentinelle Medical Aegis Navigation Application") are: (1) the TissueMapper Reviewer Application is only
used with the imaging modality of Ultrasound; (2) the TissueMapper Reviewer Application is used to identify and map regions of interest for planning subsequent non-invasive diagnostic examinations, such as a diagnostic X-Rav, diagnostic ultrasound, or MRI, where the Sentinelle Medical Aegis Navigation Application may be also used to overlay instrument templates for planning interventional procedures. such as biopsy. Both the applicant's device ("Tractus TissueMapper Reviewer Application") and the predicate device ("Sentinelle Medical Aegis Navigation Application") are software devices that have a Moderate Level of Concern.
The Tractus TissueMapper Reviewer Application software is Safety Class B according to ANSI/AAMI/IEC 62304:2006. Determination of the LOC and Safety Class is the result of risk assessment activities per ISO 14971.
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Tractus corporation
Tissuemapper Reviewer application
Substantial Equivalence Chart
| | [Tractus TissueMapper Reviewer
Application, K123901] | [Sentinelle Medical Aegis
Navigation Application,
K093672] |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Tractus TissueMapper Application
Software provides two and three-
dimensional image review, manipulation,
and analysis tools to assist users in
screening, diagnosis, planning and
performing image-guided interventional
procedures. The supported
imaging modality is Ultrasound
(US). Images and data are received from
various imaging systems and other
sources such as calibrated spatial
positioning devices.
This device provides the capability to
overlay annotations on 2D or 3D medical
image displays. These annotations may
represent the position of instruments
including but not limited
to imaging probes or other tracked
devices.
This device is intended to assist skilled
medical professionals in clinical screening
and interventions, for anatomical
structures where imaging is currently
used for visualizing such structures,
including head and neck, breast, thoracic,
and abdominal applications. | This device provides two and
three-dimensional image review,
manipulation, and analysis tools to
assist users in screening,
diagnosis, planning and
performing image-guided
interventional
procedures. Supported imaging
modalities include Magnetic
Resonance (MR), Ultrasound
(US),
Single Photon Emission Computed
Tomography (SPECT), Computed
Tomography (CT), Positron
Emission Tomography (PET),
Fluoroscopy and Endoscopy.
Images and data are received from
various imaging systems and other
sources such as calibrated spatial
positioning devices.
This device provides the capability
to overlay annotations on 2D or 3D
medical image displays.
These annotations may represent
the position of instruments
including but not limited to biopsy
needles, guidance wires, imaging
probes or other tracked devices.
This device is intended to assist
skilled medical professionals in
clinical screening and
interventions, for anatomical
structures where imaging is
currently used for visualizing such
structures, including head and
neck, breast, thoracic, and
abdominal applications (including
pelvis).
Lossy compressed mammographic
images and digitized film screen
images must not be
reviewed for primary image |
| | | interpretations. Mammographic
images may only be interpreted
using a FDA approved monitor that
offers at least 5 MPixel resolution
and meets other technical
specifications reviewed and
accepted by the FDA. |
| Indications for Use | Same as above | Same as above |
| User Population | Skilled medical professionals | Skilled medical professionals |
| Technological
Characteristics | System, Image Processing,
Radiological; Picture Archiving and
Communications System | System, Image Processing,
Radiological; Picture Archiving
and Communications System |
| Primary
component(s) | Software: TissueMapper Reviewer
Application | Software: Aegis Navigation
Application |
| Accessories (if
any) | Computer (PC) and storage media
(USB) | Not specified in 510(k), assumed
to include computer to run
software and some type of media
or method to transmit files to
computer |
| Safety Features | Software risk analysis developed in
accordance with ISO 14971 | Not available in 510(k) |
| Software | Yes | Yes |
| 3-D Rendering | Yes | Yes |
| Regions of Interest
- Location | Yes | Yes |
| Regions of Interest - Annotation | Yes | Yes |
| Supported Imaging
Modalities | Ultrasound | MRI, Ultrasound, SPECT, CT,
Fluoroscopy, and Endoscopy. |
| Software level of
concern | Moderate level of concern | Moderate level of concern |
| Standards with
which the Device
Complies | None required | Not available in 510(k) |
.
4
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5
Performance Data
Testing for TissueMapper Reviewer Application was performed to ensure that all functional requirements have been met, and that core functions execute as expected. Testing was conducted in-house by trained personnel in a simulated work-environment using phantoms to obtain the functional and accuracy test results. Registration accuracy tests were performed to ensure that the registration and correspondence between ultrasound meets or exceeds specified criteria. The test methodology employed was identical to that of the Aegis predicate device, conducted by targeting locations within a phantom and confirming that the selected target location based on the registration calculation is within the same tolerance range or better than the Aegis predicate device. System Validation Testing of the Tractus TissueMapper Reviewer Application was performed on a two breast phantoms with 11 masses total randomly positioned. All 11 of the masses were successfully identified.
The results of these tests demonstrate that the TissueMapper Reviewer Application validation is within specification.
As such, TissueMapper Reviewer is as safe and effective as the predicate devices and is substantially equivalent to existing products on the market today. The software performs as well as, or better than legally marketed predicate devices.
Tractus' TissueMapper Reviewer Applications for use are drawn from the indications for use of a legally marketed predicate device: Sentinelle's Aegis Navigation Application. Tractus TissueMapper Reviewer Application draws from features of this predicate device and does not provide novel functionality. As such, the features provided by Tractus TissueMapper Reviewer Application do not in themselves raise new concerns of safety or effectiveness.
In all instances, the TissueMapper Reviewer Application functioned as intended and the operation observed was as expected.
Substantial Equivalence
The TissueMapper Reviewer Application is as safe and effective as the Sentinelle Medical Aegis Navigation Application. The TissueMapper Reviewer Application has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the TissueMapper Reviewer Application and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the TissueMapper Reviewer is as safe and effective as Sentinelle Medical Aegis Navigation Application Thus, the TissueMapper Reviewer Application is substantially equivalent.
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Image /page/6/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS) in the USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an abstract symbol, possibly representing a human figure or a flame.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 29, 2013
Tractus Corporation %Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K123901
Trade/Device Name: Tractus TissueMapper Reviewer Application Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 14, 2013 Received: January 15, 2013
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
7
Page 2-Mr. Job
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. ·
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sean MyBoyd -S for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
8
Indications for Use
510(k) Number (if known): . K123901
Tractus TissueMapper Reviewer Application Device Name:
Indications for Use:
The Tractus TissueMapper Reviewer Application provides two and three-dimensional image review, manipulation, and analysis tools to assist users in screening, diagnosis, planning and performing image-guided interventional procedures. The supported imaging modality is Ultrasound (US). Images and data are received from various imaging systems and other sources such as calibrated spatial positioning devices.
This device provides the capability to overlay annotations on 2D or 3D medical image displays. These annotations may represent the position of instruments including but not limited to imaging probes or other tracked devices.
This device is intended to assist skilled medical professionals in clinical screening and interventions, for anatomical structures where imaging is currently used for visualizing such structures; including head and neck, breast, thoracic, and abdominal applications
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Sean M. Boyd -S
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
K123901 510(k)
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