Salix Central

K243038 · Artrya Limited · QIH · Mar 27, 2025 · Radiology

Device Facts

• Record ID: K243038
• Device Name: Salix Central
• Applicant: Artrya Limited
• Product Code: QIH · Radiology
• Decision Date: Mar 27, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device

Intended Use

Salix Central is a web-based software application that is intended to be used for viewing, post-processing, and analyzing cardiac computed tomography (CT) images acquired from a CT scanner in a Digital Imaging and Communications in Medicine (DICOM) Standard format. This software provides tools that can be used for the qualitative and quantitative assessment of physician-identified coronary plaques and stenosis in coronary computed tomography angiography (CCTA) and to perform calcium scoring in non-contrast cardiac CT. Salix Central is intended to complement standard care as an adjunctive tool and is not intended as a replacement to a medical professional's comprehensive diagnostic decision-making process. The software's semi-automated features are intended for an adult population and should only be used by qualified medical professionals experienced in examining and evaluating cardiac CT images.

Device Story

Salix Central is a web-based, cloud-hosted (AWS) SaaS application for cardiac CT image analysis. It ingests DICOM-formatted cardiac CT images from scanners. Using machine learning (ML) algorithms, it performs semi-automated tasks including centerline extraction, vessel labeling, lumen/vessel wall segmentation, and calcium scoring. Physicians use the software to review these outputs, identify coronary plaques and stenosis, and generate reports. It serves as an adjunctive tool to complement standard clinical care. It is operated by radiologists, cardiologists, or clinical specialists in a clinical setting. The device aids in the qualitative and quantitative assessment of CAD, supporting the physician's diagnostic decision-making process.

Clinical Evidence

Bench-only validation using 363 de-identified cardiac CT studies from 6 US centers. Testing evaluated calcium scoring (Pearson correlation 0.958), centerline extraction (90.4% true placement), vessel labeling (78.4% F1 score), and lumen/vessel wall segmentation (Dice scores 0.8996/0.9016). Reference ground truth established by board-certified cardiologists. Validation dataset included diverse scanner manufacturers and CAD-RADS disease severity levels. All performance metrics exceeded pre-defined acceptance criteria.

Technological Characteristics

Web-based SaaS application hosted on AWS. DICOM 3.0 compliant. Employs ML-enabled algorithms for image processing. Features include 2D/3D imaging, multiplanar reformatting (MPR), and manual/semi-automatic centerline extraction and wall segmentation. Connectivity via secure network server integration. Software development follows IEC 62304:2015 and ISO 13485:2016 standards.

Indications for Use

Indicated for adult patients undergoing CCTA or non-contrast cardiac CT for evaluation of coronary artery disease (CAD) or suspected CAD. Used by qualified medical professionals (cardiologists, radiologists, clinical specialists) for viewing, post-processing, and analyzing cardiac CT images.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• cvi42 Auto Imaging Software Application (K213998)

Reference Devices

• iNtuition-Structural Heart Module (K191585)

Submission Summary (Full Text)

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Artrya Limited Gabriela Quijada Quality and Regulatory Manager 1257 Hay Street West Perth PERTH. WA 6005 AUSTRALIA

March 27, 2025

Re: K243038 Trade/Device Name: Salix Central Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: OIH Dated: February 27, 2025 Received: February 27, 2025

Dear Gabriela Quijada:

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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 ([e-mail]) or phone [phone] or 301-796-7100).

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Sincerely,

Jessica Lamb

Jessica Lamb, Ph.D. Assistant Director Imaging Software DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

Submission Number (if known)

#### K243038

Device Name

Salix Central

#### Indications for Use (Describe)

Salix Central is a web-based software application that is intended to be used for viewing, post-processing, and analyzing cardiac computed tomography (CT) images acquired from a CT scanner in a Digital Imaging and Communications in Medicine (DICOM) Standard format.

This software provides tools that can be used for the qualitative assessment of physicianidentified coronary plaques and stenosis in coronary computed tomography angiography (CCTA) and to perform calcium scoring in non-contrast cardiac CT.

Salix Central is intended to complement standard care as an adjunctive tool and is not intended as a replacement to a medical professional's comprehensive diagnostic decision-making process. The software's semi-automated features are intended for an adult population and should only be used by qualified medical professionals experienced in examining cardiac CT images.

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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## K243038

## 510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| Date Prepared: | February 25, 2025 |
|------------------------|-----------------------------------------------------------------------------------------------|
| Submitter: | Artrya Ltd. |
| Official Contact: | Gabriela Quijada<br>1257 Hay Street<br>West Perth, 6005, Australia<br>Phone: [phone] |
| Proprietary Name: | Salix Central |
| Common Name: | System, Image Processing, Radiological |
| Classification: | Class II Medical Device<br>Requlation Number: 21 CFR 892.2050<br>Product Code: QIH |
| Predicate Device: | cvi42 Auto Imaging Software Application (K213998) |
| Reason For Submission: | New Traditional 510(k) |

#### Indications for Use

Salix Central is a web-based software application that is intended to be used for viewing, postprocessing, and analyzing cardiac computed tomography (CT) images acquired from a CT scanner in a Digital Imaging and Communications in Medicine (DICOM) Standard format.

This software provides tools that can be used for the qualitative and quantitative assessment of physician-identified coronary plaques and stenosis in coronary computed tomography angiography (CCTA) and to perform calcium scoring in non-contrast cardiac CT.

Salix Central is intended to complement standard care as an adjunctive tool and is not intended as a replacement to a medical professional's comprehensive diagnostic decision-making process. The software's semi-automated features are intended for an adult population and should only be used by qualified medical professionals experienced in examining and evaluating cardiac CT images.

## Device Description

Salix Central is a web-based software application, hosted on AWS cloud services, delivered using a SaaS model. The software provides interactive, post-processing tools for trained radiologists or cardiologists for viewing, and characterizing cardiac computed tomography (CT)

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image data obtained from a CT scanner. The physician-driven coronary analysis is used to review CT image data to prepare a standard coronary report that may include the presence and extent of physician-identified coronary plaques (i.e., atherosclerosis) and stenosis, and assessment of calcified plaque (calcium scoring). The Cardiac CT image data are physicianordered and typically obtained from patients who underwent CCTA or CAC CT for evaluation of CAD or suspected CAD.

A reference standard was created to train the machine (ML) enabled algorithms in Salix Central. Data for training and validation sampled from our database based on pre-defined exclusion criteria. Data were also selected to ensure no site was shared by training and validation cohorts. The training dataset included 3835 unique patient cases from 6 unique sites from the USA, Canada, Australia and Japan.

## Substantial Equivalence Discussion

Salix Central is substantially equivalent to the predicate, cvi42 Auto Imaging Software Application (K213998). Both devices and the reference device, iNtuition-Structural Heart Module (K191585), have the same Intended Use/Indications for Use and are similar with respect to key features and performance characteristics. The Predicate Device & Reference Device Comparison Table below provides a comparison between the Salix Central and the predicate device cvi42 Auto Imaging Software Application (K213998) and reference device, iNtuition-Structural Heart Module (K191585):

| Predicate Device & Reference Device Comparison | | | |
|------------------------------------------------|-------------------------|--------------------------------------------|--------------------------------------|
| Topic | Proposed Device | Predicate Device | Reference Device |
| Manufacturer | Artrya Ltd. | Circle Cardiovascular<br>Imaging Inc. | TeraRecon, Inc. |
| Model Name | Salix Central | cvi42 Auto Imaging<br>Software Application | iNtuition-Structural Heart<br>Module |
| 510(k) Number | Subject Device: K243038 | K213998 | K191585 |

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| Predicate Device & Reference Device Comparison | | | |
|------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Topic | Proposed Device | Predicate Device | Reference Device |
| Manufacturer | Artrya Ltd. | Circle Cardiovascular<br>Imaging Inc. | TeraRecon, Inc. |
| Model Name | Salix Central | cvi42 Auto Imaging<br>Software Application | iNtuition-Structural Heart<br>Module |
| 510(k) Number | Subject Device: K243038 | K213998 | K191585 |
| Intended Use /<br>Indications for<br>Use | Salix Central is a web-<br>based software application<br>that is intended to be used<br>for viewing, post-<br>processing, and analyzing<br>cardiac computed<br>tomography (CT) images<br>acquired from a CT<br>scanner in a Digital Imaging<br>and Communications in<br>Medicine (DICOM)<br>Standard format.<br>This software provides<br>tools that can be used for<br>the qualitative and<br>quantitative assessment of<br>physician-identified<br>coronary plaques and<br>stenosis in coronary<br>computed tomography<br>angiography (CCTA) and to<br>perform calcium scoring in<br>non-contrast cardiac CT. | cvi42 Auto is intended to<br>be used for viewing, post-<br>processing, qualitative<br>and quantitative<br>evaluation of<br>cardiovascular magnetic<br>resonance (MR) and<br>computed tomography<br>(CT) images in a Digital<br>Imaging and<br>Communications in<br>Medicine (DICOM)<br>Standard format. It<br>enables a set of tools to<br>assist physicians in<br>qualitative assessment of<br>cardiac images and<br>quantitative<br>measurements of the<br>heart and adjacent<br>vessels; perform calcium<br>scoring; and to confirm<br>the presence or absence<br>of physician-identified<br>lesion in blood vessels. | iNtuition-Structural Heart<br>Module is a software<br>solution that is intended to<br>assist Cardiologists,<br>Radiologists and Clinical<br>Specialists with the<br>visualization and<br>measurements of<br>structures of the heart and<br>vessels. iNtuition-<br>Structural Heart Module<br>enables the user to: -<br>Visualize and measure<br>(diameters, lengths,<br>angles, areas and<br>volumes) structures of the<br>heart and vessels for pre-<br>operative planning and<br>sizing for cardiovascular<br>interventions and surgery,<br>and for post- operative<br>evaluation. - Quantify<br>calcium (volume, density)<br>- iNtuition-Structural Heart<br>Module has the following |
| Predicate Device & Reference Device Comparison | | | |
| Topic | Proposed Device | Predicate Device | Reference Device |
| Manufacturer | Artrya Ltd. | Circle Cardiovascular<br>Imaging Inc. | TeraRecon, Inc. |
| Model Name | Salix Central | cvi42 Auto Imaging<br>Software Application | iNtuition-Structural Heart<br>Module |
| 510(k) Number | Subject Device: TBD | K213998 | K191585 |
| | Salix Central is intended to<br>complement standard care<br>as an adjunctive tool and is<br>not intended as a<br>replacement to a medical<br>professional's<br>comprehensive diagnostic<br>decision-making process.<br>The software's semi-<br>automated features are<br>intended for an adult<br>population and should only<br>be used by qualified<br>medical professionals<br>experienced in examining<br>and evaluating cardiac CT<br>images. | The target population for<br>cvi42 Auto's manual<br>workflows is not<br>restricted; however, Salix<br>Central's semi-automated<br>machine learning<br>algorithms are intended<br>for an adult population.<br>cvi42 Auto shall be used<br>only for cardiac images<br>acquired from an MR or<br>CT scanner. It shall be<br>used by qualified medical<br>professionals,<br>experienced in examining<br>and evaluating<br>cardiovascular MR or CT<br>images, for the purpose of<br>obtaining diagnostic<br>information as part of a<br>comprehensive diagnostic<br>decision-making process. | tools and features that<br>facilitate: - Automatic and<br>manual centerline<br>detection. - Segmentation<br>of cardiovascular<br>structures |
| Device Class | II | II | II |
| Device<br>Classification | QIH | LLZ, QIH | LLZ |
| Intended Users | Cardiologists, Radiologists<br>and Clinical Specialists | Qualified Medical<br>Professionals | Cardiologists,<br>Radiologists and Clinical<br>Specialists |
| Operating<br>Platform | Client-Server Google<br>Chrome Application | macOS, Microsoft<br>Windows | Microsoft Windows |
| DICOM<br>Compliant | Yes; DICOM 3.0 or higher | Yes | Yes |
| Image<br>Acquisition | CT | MR and CT | CT, MR, Nuc, PET, Angio,<br>US/Echo, SPECT |
| Secured<br>Network Server<br>Integration | Yes | Yes | Yes |
| Store Images | Yes | Yes | Yes |
| 2D Imaging | Yes | Yes | Yes |
| 3D Imaging | Yes | Yes | Yes |
| Multiplanar<br>Reformat<br>(MPR) | Yes | Yes | Yes |
| Study Analysis<br>- Navigation<br>Tools | Panning<br>Windowing<br>Zooming | Panning<br>Windowing<br>Zooming | Yes |
| Predicate Device & Reference Device Comparison | | | |
| Topic | Proposed Device | Predicate Device | Reference Device |
| Manufacturer | Artrya Ltd. | Circle Cardiovascular<br>Imaging Inc. | TeraRecon, Inc. |
| Model Name | Salix Central | cvi42 Auto Imaging<br>Software Application | iNtuition-Structural Heart<br>Module |
| 510(k) Number | Subject Device: TBD | K213998 | K191585 |
| | Series, slices, and phases | Series, slices, and phases | Series, slices, and phases |
| Study Analysis<br>- Visualization<br>and Editing | Centerline<br>Wall<br>Signal Intensity Overlay | Yes | Yes |
| Measurements | Distance<br>Diameter<br>Area<br>Hounsfield Unit (HU)<br>Lumen % diameter<br>reduction | Distance<br>Perimeter<br>Area<br>Hounsfield Unit (HU)<br>Volume | Yes |
| Centerline<br>Extraction and<br>Wall<br>Segmentation | Manual and semi-automatic<br>/ user-editable | Manual and semi-<br>automatic using Machine<br>Learning technique | Semi-automatic |
| Calcium<br>Scoring | Yes…