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.

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.

AI/ML Overview

The provided text is a 510(k) Premarket Notification submission for the TeraRecon iNtuition-Structural Heart Module. It is a regulatory document declaring substantial equivalence to predicate devices, rather than a detailed study report proving the device meets specific acceptance criteria based on performance metrics.

The document explicitly states: "iNtuition-Structural Heart Module did not require clinical studies to demonstrate its safety and effectiveness." This means that the information you've requested regarding performance data, sample sizes, ground truth establishment, expert adjudication, and MRMC studies for demonstrating the device meets acceptance criteria via a pre-defined study is not present in this regulatory filing.

Therefore, I cannot extract structured information about specific acceptance criteria and a study proving the device meets them from this document. The FDA clearance is based on a claim of substantial equivalence to existing predicate devices, meaning it has similar indications for use and technological characteristics, and therefore does not raise new questions of safety or effectiveness.

The "Performance Data" section (Page 10) only mentions:

"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."

This describes internal software verification and validation activities, which are typically for functional correctness and adherence to design specifications, not a comparative clinical performance study against specific, quantified acceptance criteria for diagnostic accuracy or clinical outcomes that would usually involve human readers or external ground truth.

In summary, the document states that a clinical performance study was not required. Thus, I cannot provide the details you requested in the structured format, as the information is not available in the provided text.

Summary

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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

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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

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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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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.

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. 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:

. 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 .

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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 HeartModule	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 HeartModule is a software solutionthat is intended to assistCardiologists, Radiologists andClinical Specialists with thevisualization and measurementsof structures of the heart andvessels.iNtuition-Structural HeartModule enables the user to:- Visualize and measure(diameters, lengths, angles,areas and volumes)structures of the heart andvessels for pre- operativeplanning and sizing forcardiovascularinterventions and surgery,and for post- operativeevaluation.- Quantify calcium (volume,density)iNtuition-Structural HeartModule has the following toolsand features that facilitate:- Automatic and manualcenterline detection.- Segmentation of cardiovascularstructures.	- To receive, store, transmit,post- process, display andallow manipulation ofreports and medical imagesfrom acquisition devices,including optical or othernon-DICOM format images,DICOM images withmodality type XA, US, CR,DR, SPECT, NM and MG,and images from volumetricmedical scanning devicessuch as EBT, CT, PET orMRI. To provide access toimages derived data andderived images via client-server software, webbrowser and mobiletechnology.- Visualization in 2D/3D and4D are supported for singleor multiple datasets. orcombinations thereof. Toolsare provided to define andedit paths through structuressuch as center lines, whichmay be used to analyzecross- sections of structures,or to provide flythroughvisualizations renderedalong such a centerline.	3mensio Workstation enablesvisualization and measurementof structures of the heart andvessels for:- Pre-operational planningand sizing forcardiovascularinterventions and surgery- Postoperative evaluation- Support of clinicaldiagnosis by quantifyingdimensions in coronaryarteries- Support of clinicaldiagnosis by quantifyingcalcifications (calciumscoring) in the coronaryarteriesTo facilitate the above, the3mensio Workstation providesgeneral functionality such as:- Segmentation ofcardiovascular structures- Automatic and manualcenterline detection- Visualization and image-reconstruction techniques:2D review, VolumeRendering, MPR, CurvedMPR, Stretched CMRP,

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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
----------------------------------------------------------------	-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	---------------------------

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New Device	Predicate Device(Secondary)	Predicate Device(Primary)
for the dimensions of vesselsand structures.	Support is provided for digitalimage processing to derive	Measurement and annotationtools
Calcium quantification andscoring.	metadata or new images from inputimage sets, for internal use or for	Reporting tools
Various visualizationtechniques: 2D/3D/4Dvisualization, MPR, CurvedMPR, Stretched MPR, MIP,MinIP, Raysum and MAR.Capture and Report.	forwarding to other devices usingthe DICOM protocol. Imageprocessing tools are provided toextract metadata to deriveparametric images fromcombinations of multiple inputimages, such as temporal phases, orimages co-located in space butacquired with different imagingparameters, such as different MRpulse sequences, or different CTimage parameters (e.g. dualenergy).
	iNtuition is designed for use byhealthcare professionals and isintended to assist the physician indiagnosis, who is responsible formaking all final patientmanagement decisions.
	Interpretation of mammographicimages or digitized film screenimages is supported only when thesoftware is used withoutcompression and with an FDA-Approved monitor that offers atleast 5Mpixel resolution and meetsother technical specificationsreviewed and accepted by the FDA.
	iNtuitionMOBILE provideswireless and portable access tomedical images. This device is notintended to replace fullworkstations and should be usedonly when there is no access to aworkstation. Not intended fordiagnostic 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 listfunctionality	ImportingExportingDeletingSearchAnonymization	ImportingExportingDeletingSearchAnonymization	ExportingDeletingAnonymizing (noautomatic deletion oforiginal patient data)Search
CenterlineExtraction and	Automatic and manualcenterlinesCenterline edits andrefinements.Vessel AnalysisAutomatic and manualsegmentation ofstructuresSegmentation editing	Automatic and manualcenterlinesCenterline edits andrefinements.Vessel AnalysisAutomatic and manualsegmentation of structuresSegmentation editing	Realign orthogonalMPR'sSegmentation toolset:Automatic segmentationAutomatic centerlineManual centerlineCenterline editingUndo/Redo operationsVolume sculpting
Image Assessment	Linear (length, diameter,perimeter), distance pair,angular and ROImeasurementsArea measurementsVolume measurementsincluding volumetrichistogram, VOI and TVAfor Time VolumeAnalysis for heartchamber segmentationand analysisC-arm angulationcalculationText and arrowannotationsAnatomy ID (LandmarkLabel Selection)Calcium scoring forassessment of calcium inthe aortic rootCalcium scoring forassessment of calcium inthe coronary arteriesSegmentation andanalysis of coronaryartery tree centerlineSynchronized side-by-side reviewSynchronized center ofrotation viewingFindings workflow fortemporal correlativeanalysis2D/3D Batch movie tool	Linear (length, diameter,perimeter), distance pair,angular and ROImeasurementsArea measurementsVolume measurementsincluding volumetrichistogram, VOI and TVA forTime Volume Analysis forheart chamber segmentationand analysisC-arm angulation calculationText and arrow annotationsAnatomy ID (Landmark LabelSelection)Calcium scoring forassessment of calcium in theaortic rootCalcium scoring forassessment of calcium in thecoronary arteriesSegmentation and analysis ofcoronary artery tree centerlineSynchronized side-by- sidereviewSynchronized center ofrotation viewingFindings workflow fortemporal correlative analysis2D/3D Batch movie tool andexport	Linear (length anddiameter), angular andROI measurementsVolume measurementsC-arm angulationcalculationText and arrowannotationsCalcium scoring forassessment of calcium inthe aortic rootCalcium scoring forassessment of calcium inthe coronary arteriesSegmentation andanalysis of coronaryartery tree centerline
	New Device	Predicate Device(Secondary)	Predicate Device(Primary)
Image AssessmentRendering	Volume rendering, MIP,MPR, MinIP, Raysum(ThickMPR)3D triangulationPerspective endoluminalviewMedial Axial Reformat(MAR)Curved Planar Reformat(CPR)Double-oblique MIP andMPRImage enhancementfiltersSynchronized side-by-side viewingSynchronized center ofrotation viewingCube ViewWorkflow templatesMulti-Mask Display(multi- object display)User-definedmeasurement protocolsEditing tools: crop, cut,free- hand	Volume rendering,MIP, MPR, MinIP,Raysum (ThickMPR)3D triangulationPerspective endoluminal viewMedial Axial Reformat (MAR)Curved Planar Reformat(CPR)Double-oblique MIP and MPRImage enhancement filtersSynchronized side-by-sideviewingSynchronized center ofrotation viewingCube ViewWorkflow templatesMulti-Mask Display (multi-object display)User-defined measurementprotocolsEditing tools: crop, cut, free-hand	Orthogonal, oblique,double oblique, curved,cross-curved, stretchedMPR renderingMIP, AveIP, MinIP andcolor volume slabsMIP volume renderingColor volume renderingGrayscale volumerendering2D slice review and stackcomparison4D cineInteractive VOI clippingMulti-tissue color andopacity controlActive presetsUser-defined presets
Storage of Results	Structured reporting withxml, text, xls outputWord and html reportDICOM SCWorkflow scenes: restoresaved state	Structured reporting with xml,text, xls outputWord and html reportDICOM SCWorkflow scenes: restoresaved state	PrintoutSession statePDF formatDICOM PDF report
Conferencing andCollaboration	Conferencing andCollaboration	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.

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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.

Regulation Number and Section

§ 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).