(28 days)
Not Found
No
The summary describes standard image processing and measurement tools without mentioning AI or ML. The "automatic" features likely refer to rule-based algorithms, not learned models.
No
The device is a software solution that assists cardiologists and clinical specialists with visualization and measurements for pre-operative planning and post-operative evaluation and does not perform active therapy or treatment.
Yes
The device assists Cardiologists and Clinical Specialists with visualization and measurements of the heart and vessels for pre-operative planning, sizing for cardiovascular interventions, and post-operative evaluation, which are activities directly related to diagnosis and treatment planning. The ability to identify calcifications, aneurysms, and other anomalies further supports its role in diagnosis.
Yes
The device description explicitly states that the iNtuition-Structural Heart Module is an "optional image post-processing software module" and a "software device generally used with off-the-shelf hardware." It also details various software features and functionalities without mentioning any proprietary hardware components included with 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 tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The iNtuition-Structural Heart Module is a software solution that processes medical images (CT, MR, etc.) of the heart and vessels. It assists clinicians with visualization, measurement, and analysis of these structures for pre- and post-operative planning and evaluation.
- Lack of Biological Sample Analysis: The device does not analyze biological samples from the patient. Its input is medical imaging data, not biological specimens.
- Focus on Image Processing and Analysis: The description clearly outlines the software's capabilities in image processing, segmentation, measurement, and visualization of anatomical structures. This is distinct from the analysis of biological markers in a sample.
Therefore, the iNtuition-Structural Heart Module falls under the category of medical image processing and analysis software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
iNtuition-Structural Heart Module is a software solution that is intended to assist Cardiologists, Radiologists and Clinical Specialists with the visualization and measurements of structures of the heart and vessels.
iNtuition-Structural Heart Module enables the user to:
- Visualize and measure (diameters, lengths, angles, areas and volumes) structures of . the heart and vessels for pre-operative planning and sizing for cardiovascular interventions and surgery, and for post-operative evaluation.
- Quantify calcium (volume, density). .
iNtuition-Structural Heart Module has the following tools and features that facilitate:
- Automatic and manual centerline detection. .
- Segmentation of cardiovascular structures. .
- Measurement tools (diameters, lengths, areas, volumes, angles) for the dimensions . of vessels and structures.
- . Calcium quantification and scoring.
- Various visualization techniques: 2D/3D/4D visualization, MPR, Curved MPR, . Stretched MPR, MIP, MinIP, Raysum and MAR.
- . Capture and Report.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
iNtuition-Structural Heart Module is an optional image post-processing software module using iNtuition (K121916) standard features and part of its optional features. It is a software device generally used with the off-the-shelf hardware, offered in various configurations, with the simplest configuration being a stand-alone workstation capable of image review, communications, archiving, database maintenance, remote review, reporting and basic 3D capabilities. It can also be configured as a server with some, or with all, or none of its optional features.
Whether provided as a workstation or a server, the iNtuition-Structural Heart Module software is designed to provide access by a local user physically sitting at the computer hosting the iNtuition server software, and/or by one or more remote users who concurrently connect to the server using a freely-downloadable thin client application or through a zero-footprint web viewer (with conference capabilities) over local network or internet.
iNtuition-Structural Heart Module is iNtuition (K121916) based optional feature and employs all standard features offered by iNtuition such as convenient image manipulation tools like drawing of region of interests, manual and automatic segmentation of structures, image assessment and measurement tools - linear, diameter, angle, area and volume and tools that support the creation of reports, transmitting and storing this report in digital form and tracking historical information about the studies analyzed by the software. iNtuition Vessel analysis and calcium scoring features are utilized to support automatic and manual centerline extraction and analysis and calcium quantification.
iNtuition-Structural Heart Module:
- . Supports the visualization and quantification of coronary vessels and cardiac structures for anatomic and pre- or post-operative evaluations through guided clinical workflows.
- . Enables the assessment and measurement of different structures of the heart, e.g. aorta, aortic valves, mitral valve, pulmonic valve, atria and atrial appendages, and ventricles.
- . Provides analysis of the feasibility of a transapical, transfemoral or subclavian approach to structures for replacement or repair procedures via 3D measurements.
- Uses the same iNtuition (K121916) Vessel Analysis and Calcium modules.Enables . assessment and measurement of vessels and can help identify calcifications, aneurysms and other anomalies to quickly and reliably prepare for various types of vascular procedures.Supports the creation, transmission and storage of a report in digital form. It can also track historical information about the studies analyzed by the software.Displays results analysis, that can be printed as hardcopy or saved in a variety of formats to a hard disk, network, PACS system or CD/DVD/USB.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
- CT, MR, Nuc, PET,
- Angio, US/Echo,
- SPECT,
- CR/DR Review
- 2D, 3D, 4D Medical
- Image review including
- cine play
Anatomical Site
heart and vessels
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Cardiologists, Radiologists and Clinical Specialists
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)
iNtuition-Structural Heart Module did not require clinical studies to demonstrate its safety and effectiveness.
The verification and Validation tests have been performed to address the indication for use, the technological characteristics claims, requirement specifications and risk management results.
Software testing and validation were done according to written test protocols established before testing was conducted. Test results were reviewed by designated technical professionals before being formalized and after ensuring that the software fully satisfies all expected and previously defined system requirements and features. Test results support the conclusion that iNtuition- Structural Heart Module performance satisfies the design intent and is equivalent to its predicate devices.
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 for the U.S. Food & Drug Administration (FDA). The logo includes a stylized depiction of the Rod of Asclepius, a symbol associated with medicine and healing. The text "U.S. FOOD & DRUG" is prominently displayed, followed by "ADMINISTRATION" in a smaller font size. The logo is clean and professional, reflecting the FDA's role in regulating and overseeing food and drug safety.
July 12, 2019
TeraRecon, Inc. % Megha Jain QARA Manager 4000 East, 3rd Ave, Suite 200 FOSTER CITY CA 94402
Re: K191585
Trade/Device Name: iNtuition-Structural Heart Module Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: June 11, 2019 Received: June 14, 2019
Dear Megha Jain:
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/cfpmp/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
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,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K 191585
Device Name
iNtuition - Structural Heart Module 4.4
Indications for Use (Describe)
iNtuition-Structural Heart Module is a software solution that is intended to assist Cardiologists, and Clinical Specialists with the visualization and measurements of the heart and vessels.
iNtuition-Structural Heart Module enables the user to:
- · Visualize and measure (diameters, lengths, angles, areas and volumes) structures of the heart and vessels for pre-operative planning and sizing for cardiovascular interventions and for post-operative evaluation.
- · Quantify calcium (volume, density)
iNtuition-Structural Heart Module has the following tools and features that facilitate:
- · Automatic and manual centerline detection.
- · Segmentation of cardiovascular structures.
- · Measurement tools (diameters, lengths, areas, volumes, angles) for the dimensions of vessels and structures.
- · Calcium quantification and scoring.
- · Various visualization techniques: 2D/3D/4D visualization, MPR, Stretched MPR, MIP, MinlP, Raysum and MAR.
- · Capture and Report.
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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3
K191585
Date of Summary: 09 July 2019
| 510(k) Summary of Safety and Effectiveness
| (As required by 21 CFR 807.92(c)) | iNtuition-Structural Heart Module |
|---|---|
| --------------------------------------------------------------------------------- | ----------------------------------- |
Submitter: TeraRecon, Inc. Applicant: 4000 E 3rd Ave, Suite 200 Sponsor: Foster City, CA 94402 Establishment: Registration#: 2954793
Contact erson: Magha Jain QARA Manager Ph: 650 -372-1100 Fax: 650 -372-1101 Email: mjain@terarecon.com
Device Information:
| Name of Device: | iNtuition-Structural Heart Module |
|---|---|
| Common Name: | Medical Imaging System |
| Classification Name: | § 892.2050, Picture Archiving and Communications System |
| Product Code: | LLZ |
| Classification Panel: | Radiology |
| Device Classification: | Class II |
Predicate Devices::
- 3mensio Workstation (K153736) (Primary predicate device) -
- iNtuition (K121916) (Secondary predicate device) -
Indications for Use:
iNtuition-Structural Heart Module is a software solution that is intended to assist Cardiologists, Radiologists and Clinical Specialists with the visualization and measurements of structures of the heart and vessels.
iNtuition-Structural Heart Module enables the user to:
- Visualize and measure (diameters, lengths, angles, areas and volumes) structures of . the heart and vessels for pre-operative planning and sizing for cardiovascular interventions and surgery, and for post-operative evaluation.
- Quantify calcium (volume, density). .
iNtuition-Structural Heart Module has the following tools and features that facilitate:
- Automatic and manual centerline detection. .
- Segmentation of cardiovascular structures. .
- Measurement tools (diameters, lengths, areas, volumes, angles) for the dimensions . of vessels and structures.
4
- . Calcium quantification and scoring.
- Various visualization techniques: 2D/3D/4D visualization, MPR, Curved MPR, . Stretched MPR, MIP, MinIP, Raysum and MAR.
- . Capture and Report.
Device Description:
iNtuition-Structural Heart Module is an optional image post-processing software module using iNtuition (K121916) standard features and part of its optional features. It is a software device generally used with the off-the-shelf hardware, offered in various configurations, with the simplest configuration being a stand-alone workstation capable of image review, communications, archiving, database maintenance, remote review, reporting and basic 3D capabilities. It can also be configured as a server with some, or with all, or none of its optional features.
Whether provided as a workstation or a server, the iNtuition-Structural Heart Module software is designed to provide access by a local user physically sitting at the computer hosting the iNtuition server software, and/or by one or more remote users who concurrently connect to the server using a freely-downloadable thin client application or through a zero-footprint web viewer (with conference capabilities) over local network or internet.
iNtuition-Structural Heart Module is iNtuition (K121916) based optional feature and employs all standard features offered by iNtuition such as convenient image manipulation tools like drawing of region of interests, manual and automatic segmentation of structures, image assessment and measurement tools - linear, diameter, angle, area and volume and tools that support the creation of reports, transmitting and storing this report in digital form and tracking historical information about the studies analyzed by the software. iNtuition Vessel analysis and calcium scoring features are utilized to support automatic and manual centerline extraction and analysis and calcium quantification.
iNtuition-Structural Heart Module:
- . Supports the visualization and quantification of coronary vessels and cardiac structures for anatomic and pre- or post-operative evaluations through guided clinical workflows.
- . Enables the assessment and measurement of different structures of the heart, e.g. aorta, aortic valves, mitral valve, pulmonic valve, atria and atrial appendages, and ventricles.
- . Provides analysis of the feasibility of a transapical, transfemoral or subclavian approach to structures for replacement or repair procedures via 3D measurements.
- Uses the same iNtuition (K121916) Vessel Analysis and Calcium modules.Enables .
5
assessment and measurement of vessels and can help identify calcifications, aneurysms and other anomalies to quickly and reliably prepare for various types of vascular procedures.Supports the creation, transmission and storage of a report in digital form. It can also track historical information about the studies analyzed by the software.Displays results analysis, that can be printed as hardcopy or saved in a variety of formats to a hard disk, network, PACS system or CD/DVD/USB.
Comparison Technological Characteristics:
A comparison of the technological characteristics of the predicates and subject device is given in the table below:
| | New Device | Predicate Device
(Secondary) | Predicate Device
(Primary) |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | iNtuition-Structural Heart
Module | iNtuition | 3mensio Workstation |
| Manufacturer | Terarecon, Inc. | Terarecon, Inc. | Pie Medical Imaging |
| 510(k) Number | K191585 | K121916 | K153736 |
| | Indication for Use | | |
| Indications for Use | iNtuition-Structural Heart
Module is a software solution
that is intended to assist
Cardiologists, Radiologists and
Clinical Specialists with the
visualization and measurements
of structures of the heart and
vessels.
iNtuition-Structural Heart
Module enables the user to:
- Visualize and measure
(diameters, lengths, angles,
areas and volumes)
structures of the heart and
vessels for pre- operative
planning and sizing for
cardiovascular
interventions and surgery,
and for post- operative
evaluation. - Quantify calcium (volume,
density)
iNtuition-Structural Heart
Module has the following tools
and features that facilitate: - Automatic and manual
centerline detection. - Segmentation of cardiovascular
structures. | - To receive, store, transmit,
post- process, display and
allow manipulation of
reports and medical images
from acquisition devices,
including optical or other
non-DICOM format images,
DICOM images with
modality type XA, US, CR,
DR, SPECT, NM and MG,
and images from volumetric
medical scanning devices
such as EBT, CT, PET or
MRI. To provide access to
images derived data and
derived images via client-
server software, web
browser and mobile
technology. - Visualization in 2D/3D and
4D are supported for single
or multiple datasets. or
combinations thereof. Tools
are provided to define and
edit paths through structures
such as center lines, which
may be used to analyze
cross- sections of structures,
or to provide flythrough
visualizations rendered
along such a centerline. | 3mensio Workstation enables
visualization and measurement
of structures of the heart and
vessels for: - Pre-operational planning
and sizing for
cardiovascular
interventions and surgery - Postoperative evaluation
- Support of clinical
diagnosis by quantifying
dimensions in coronary
arteries - Support of clinical
diagnosis by quantifying
calcifications (calcium
scoring) in the coronary
arteries
To facilitate the above, the
3mensio Workstation provides
general functionality such as: - Segmentation of
cardiovascular structures - Automatic and manual
centerline detection - Visualization and image-
reconstruction techniques:
2D review, Volume
Rendering, MPR, Curved
MPR, Stretched CMRP, |
6
| Measurement tools (diameters, lengths, areas, volumes, angles) | Segmentation of regions of interest and quantitative analysis tools are provided, for images of vasculature, pathology and morphology, including distance, angle, volume, histogram, ratios thereof, and tracking of quantities over time. A database is provided to track and compare results using published comparison techniques such as RECIST and WHO. Calcium scoring for quantification of atherosclerotic plaque is supported. | Slabbing, MIP, AIP, MinIP |
|---|---|---|
| ---------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------- |
7
| New Device | Predicate Device
(Secondary) | Predicate Device
(Primary) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| for the dimensions of vessels
and structures. | Support is provided for digital
image processing to derive | Measurement and annotation
tools |
| Calcium quantification and
scoring. | metadata or new images from input
image sets, for internal use or for | Reporting tools |
| Various visualization
techniques: 2D/3D/4D
visualization, MPR, Curved
MPR, Stretched MPR, MIP,
MinIP, Raysum and MAR.
Capture and Report. | forwarding to other devices using
the DICOM protocol. Image
processing tools are provided to
extract metadata to derive
parametric images from
combinations of multiple input
images, such as temporal phases, or
images co-located in space but
acquired with different imaging
parameters, such as different MR
pulse sequences, or different CT
image parameters (e.g. dual
energy). | |
| | iNtuition is designed for use by
healthcare professionals and is
intended to assist the physician in
diagnosis, who is responsible for
making all final patient
management decisions. | |
| | Interpretation of mammographic
images or digitized film screen
images is supported only when the
software is used without
compression and with an FDA-
Approved monitor that offers at
least 5Mpixel resolution and meets
other technical specifications
reviewed and accepted by the FDA. | |
| | iNtuitionMOBILE provides
wireless and portable access to
medical images. This device is not
intended to replace full
workstations and should be used
only when there is no access to a
workstation. Not intended for
diagnostic use when used via a web | |
| Technical Characteristics | |||
|---|---|---|---|
| Data Type | - CT, MR, Nuc, PET, |
- Angio, US/Echo,
- SPECT,
- CR/DR Review
- 2D, 3D, 4D Medical
- Image review including
- cine play | - CT, MR, Nuc, PET, Angio,
- US/Echo, SPECT, CR/DR
- Review
- 2D, 3D, 4D Medical Image
- review including cine play | - CT data in DICOM
- format (vendor
- independent) |
| Input Patient Data | - Manual through - keyboard/mouse
- Command line interface | - Manual through
- keyboard/mouse
- Command line interface | - Manual through
- keyboard/mouse
- Command line interface |
| Study list
functionality | Importing
Exporting
Deleting
Search
Anonymization | Importing
Exporting
Deleting
Search
Anonymization | Exporting
Deleting
Anonymizing (no
automatic deletion of
original patient data)
Search |
| Centerline
Extraction and | Automatic and manual
centerlines
Centerline edits and
refinements.
Vessel Analysis
Automatic and manual
segmentation of
structures
Segmentation editing | Automatic and manual
centerlines
Centerline edits and
refinements.
Vessel Analysis
Automatic and manual
segmentation of structures
Segmentation editing | Realign orthogonal
MPR's
Segmentation toolset:
Automatic segmentation
Automatic centerline
Manual centerline
Centerline editing
Undo/Redo operations
Volume sculpting |
| Image Assessment | Linear (length, diameter,
perimeter), distance pair,
angular and ROI
measurements
Area measurements
Volume measurements
including volumetric
histogram, VOI and TVA
for Time Volume
Analysis for heart
chamber segmentation
and analysis
C-arm angulation
calculation
Text and arrow
annotations
Anatomy ID (Landmark
Label Selection)
Calcium scoring for
assessment of calcium in
the aortic root
Calcium scoring for
assessment of calcium in
the coronary arteries
Segmentation and
analysis of coronary
artery tree centerline
Synchronized side-by-
side review
Synchronized center of
rotation viewing
Findings workflow for
temporal correlative
analysis
2D/3D Batch movie tool | Linear (length, diameter,
perimeter), distance pair,
angular and ROI
measurements
Area measurements
Volume measurements
including volumetric
histogram, VOI and TVA for
Time Volume Analysis for
heart chamber segmentation
and analysis
C-arm angulation calculation
Text and arrow annotations
Anatomy ID (Landmark Label
Selection)
Calcium scoring for
assessment of calcium in the
aortic root
Calcium scoring for
assessment of calcium in the
coronary arteries
Segmentation and analysis of
coronary artery tree centerline
Synchronized side-by- side
review
Synchronized center of
rotation viewing
Findings workflow for
temporal correlative analysis
2D/3D Batch movie tool and
export | Linear (length and
diameter), angular and
ROI measurements
Volume measurements
C-arm angulation
calculation
Text and arrow
annotations
Calcium scoring for
assessment of calcium in
the aortic root
Calcium scoring for
assessment of calcium in
the coronary arteries
Segmentation and
analysis of coronary
artery tree centerline |
| | New Device | Predicate Device
(Secondary) | Predicate Device
(Primary) |
| Image Assessment
Rendering | Volume rendering, MIP,
MPR, MinIP, Raysum
(ThickMPR)
3D triangulation
Perspective endoluminal
view
Medial Axial Reformat
(MAR)
Curved Planar Reformat
(CPR)
Double-oblique MIP and
MPR
Image enhancement
filters
Synchronized side-by-
side viewing
Synchronized center of
rotation viewing
Cube View
Workflow templates
Multi-Mask Display
(multi- object display)
User-defined
measurement protocols
Editing tools: crop, cut,
free- hand | Volume rendering,
MIP, MPR, MinIP,
Raysum (ThickMPR)
3D triangulation
Perspective endoluminal view
Medial Axial Reformat (MAR)
Curved Planar Reformat
(CPR)
Double-oblique MIP and MPR
Image enhancement filters
Synchronized side-by-side
viewing
Synchronized center of
rotation viewing
Cube View
Workflow templates
Multi-Mask Display (multi-
object display)
User-defined measurement
protocols
Editing tools: crop, cut, free-
hand | Orthogonal, oblique,
double oblique, curved,
cross-curved, stretched
MPR rendering
MIP, AveIP, MinIP and
color volume slabs
MIP volume rendering
Color volume rendering
Grayscale volume
rendering
2D slice review and stack
comparison
4D cine
Interactive VOI clipping
Multi-tissue color and
opacity control
Active presets
User-defined presets |
| Storage of Results | Structured reporting with
xml, text, xls output
Word and html report
DICOM SC
Workflow scenes: restore
saved state | Structured reporting with xml,
text, xls output
Word and html report
DICOM SC
Workflow scenes: restore
saved state | Printout
Session state
PDF format
DICOM PDF report |
| Conferencing and
Collaboration | Conferencing and
Collaboration | Conferencing and Collaboration | N/A |
| Operating System | Microsoft Windows | Microsoft Windows | Microsoft Windows |
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Summary of Clinical Performance Tests:
iNtuition-Structural Heart Module did not require clinical studies to demonstrate its safety and effectiveness.
General Safety and Effectiveness Concerns:
iNtuition-Structural Heart Module doesn't present any safety concerns or effectiveness. iNtuition- Structural Heart Module has the same standard and part of optional features, technological characteristics, and similar indications for use than its predicates.
10
iNtuition-Structural Heart Module instructions for use are included within the device labeling provided in Volume 013 and in Appendix A, and the information provided in the labeling will enable the user to operate the device in a safe and effective manner.
Risk management is ensured via risk analysis, which is used to identify and mitigate potential hazards from early design phase till design software validation and release. These potential hazards are controlled during software development by verification and validation testing. Furthermore, the software operators are healthcare professionals who are responsible for making all final patient management decisions.
Conformance Standards:
There are no applicable FDA mandated performance standards for this device. However, voluntary standards such as DICOM, various in-house standard operating procedures are in place and have been utilized in the production of the software.
The device complies with the following conformance standards:
- ISO 14971:2007- Medical devices Application of risk management to medical devices.
- IEC 62304:2006/A1:2015 Medical device software Software life cycle processes. -
- -IEC 62366-1:2015 - Medical Devices - Application of usability engineering to medical devices.
- NEMA PS 3.1-3.20 (2016) Digital Imaging and Communications in Medicine -(DICOM) set.
Performance Data
The verification and Validation tests have been performed to address the indication for use, the technological characteristics claims, requirement specifications and risk management results.
Substantial Equivalence:
In all material aspects, iNtuition-Structural Heart Module is substantially equivalent to the predicate devices. Performance testing was carried out according to internal company procedures. Software testing and validation were done according to written test protocols established before testing was conducted. Test results were reviewed by designated technical professionals before being formalized and after ensuring that the software fully satisfies all expected and previously defined system requirements and features. Test results support the conclusion that iNtuition- Structural Heart Module performance satisfies the design intent and is equivalent to its predicate devices.
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Conclusion:
iNtuition-Structural Heart Module, as described in this premarket notification, has similar indication for use and same technical characteristics as the predicate devices, and therefore, is substantially equivalent in terms of basic design, features and intended use to those predicates.
In summary, TeraRecon, Inc., believes that iNtuition-Structural Heart Module is an optional feature of iNtuition (K121916) and doesn't present any new safety or effectiveness risks to users and is substantially equivalent to and performs as well as the predicate devices.