(172 days)
No reference devices were used in this submission.
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the device as a "post-processing tool" that uses "user segmentation" for measurements, indicating a rule-based or manually-assisted system rather than an AI model.
No
The device is described as "a medical image analysis system" and "a post-processing tool" that assists medical professionals in the stratification of patients and analysis of arterial diseases. It explicitly states it is "not intended to provide a diagnosis or clinical recommendation" and is "not intended to be used as a sole source of clinical data to determine diagnosis and/or treatment pathways." This indicates it is for diagnostic support, not direct therapy.
No
The device description explicitly states: "Mosaic V1.0.1 is intended to complement standard of care but is not intended to provide a diagnosis or clinical recommendation" and "Mosaic is not intended to be used as a sole source of clinical data to determine diagnosis and/or treatment pathways." While it assists in analysis and stratification, it does not make a diagnosis.
Yes
The device is described as "Mosaic V1.0.1 is a medical image analysis system that allows the viewing, processing, and analysis of multi-dimensional digital images acquired with contrast from CT imaging devices." and "Mosaic V1.0.1 is a post-processing tool used to analyse arterial diseases. It reads in computed tomography angiography (CTA) scans and users can process the scans...". The language consistently refers to it as software for processing and analyzing existing images, without mention of any associated hardware that would constitute a physical medical device.
No
This device analyzes medical images (CT scans) and provides measurements and visualizations. It does not analyze specimens derived from the human body (e.g., blood, tissue, urine) to provide information for diagnosis or treatment.
N/A
Intended Use / Indications for Use
Mosaic V1.0.1 is a medical image analysis system that allows the viewing, processing, and analysis of multi-dimensional digital images acquired with contrast from CT imaging devices.
Mosaic V1.0.1 is intended to assist trained medical professionals in the stratification of patients suspected or identified to have atherosclerosis as well as stratification of patients suspected or identified to have aneurysmal disease of the aorta or carotid, iliac, femoral and popliteal arteries.
The software enables post processing of images obtained using a multidetector CT and provides tools for the measurement and visualisation of arterial vessels and any disease present, including editing of contrasted lumen and artery boundaries.
Any processed artery can be selected to view: the vessel in 3D; color-coded interactive data maps displayed on the 3D vessel; curved, straightened and cross-sectional MPR views of the vessel; and quantitative data from regions of interest. Data includes standard 2D distance measurements as well as stenosis, Hounsfield unit statistics, and tissue volumes.
Typical users of Mosaic V1.0.1 outputs are trained medical professionals, including radiologists and clinicians. Typical operators of Mosaic V1.0.1 are those suitably trained in the use of the software.
Mosaic V1.0.1 is intended to complement standard of care but is not intended to provide a diagnosis or clinical recommendation.
Product codes
LLZ
Device Description
Mosaic V1.0.1 is a post-processing tool used to analyse arterial diseases. It reads in computed tomography angiography (CTA) scans and users can process the scans to aid clinicians in their analysis of anatomy and pathology. Processing CTA with Mosaic enables the creation of vessel centrelines from which measurements and image reformatting is possible. The outputs of the software include visual images, measures of diameter, distance, volume, including plaque volumes, positive remodelling of the arterial wall, and stenosis. These measurements are based on user segmentation. Outputs from Mosaic, including the saved analysis file and PDF report, can be used to assist with the decision-making process and clinical management of the patient, but Mosaic is not intended to be used as a sole source of clinical data to determine diagnosis and/or treatment pathways.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT imaging devices, multidetector CT, computed tomography angiography (CTA)
Anatomical Site
Aorta or carotid, iliac, femoral and popliteal arteries.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Typical users of Mosaic V1.0.1 outputs are trained medical professionals, including radiologists and clinicians. Typical operators of Mosaic V1.0.1 are those suitably trained in the use of the software.
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
Validation testing using phantom and clinical images was conducted to address performance qualification of the subject device under typical operating conditions. Clinical images with 0.54 x 0.54 mm pixel resolution were evaluated using Mosaic relative to ground truth measurements.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software verification and validation activities were consistent with FDA guidance on "General Principles of Software Validation", "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submission for Management of Cybersecurity in Medical Devices." Verification testing demonstrated that the product meets defined system requirements and features. Performance testing: Validation testing using phantom and clinical images was conducted to address performance qualification of the subject device under typical operating conditions. Clinical images with 0.54 x 0.54 mm pixel resolution were evaluated using Mosaic relative to ground truth measurements. Measurements included calculations of vessel diameter, length, tissue volumes, stenosis and positive remodelling index over ranges that reflect the intended use of the software. Measurements from Mosaic were shown to be substantially equivalent to ElucidVivo.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Diameter was tested over 2.0 mm to 60.0 mm with bias of ranging from 0.015 [-0.039, 0.070] to 0.100 [-0.121, 0.123] and RMSE from 0.079 [0.044, 0.113] to 0.239 [0.142, 0.335]. Bias and RMSE are in mm.
- Tissue volume was tested over 0.65 cm³ to 226.19 cm³ with bias ranging from -0.012 [-0.032, 0.009] to -3.120 [-4.819, -1.420] and RMSE from 0.039 [0.022, 0.055] to 4.331 [2.995, 5.666]. Bias and RMSE are in cm³.
- Stenosis was tested over 33% to 85% with bias ranging from 0.2 [-1.0, 1.5] to 7.8 [4.5, 11.0] and RMSE from 2.0 [1.0, 3.1] to 9.3 [2.4, 16.3]. Bias and RMSE are in %.
- Positive remodelling index was tested from 1.17 to 1.57 with bias ranging from -0.010 [-0.015, -0.005] to -0.073 [-0.102, -0.044] and RMSE from 0.013 [0.009, 0.017] to 0.089 [0.066, 0.112]. Bias and RMSE are unitless.
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.
No reference devices were used in this submission.
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).
FDA 510(k) Clearance Letter - Mosaic V1.0.1
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
Navier Medical
Aastha Chaudhary
Quality and Regulatory Manager
Level 13, Office 1
256 Adelaide Tce
Perth, WA 6000
Australia
Re: K244012
Trade/Device Name: Mosaic (V1.0.1)
Regulation Number: 21 CFR 892.2050
Regulation Name: Medical Image Management And Processing System
Regulatory Class: Class II
Product Code: LLZ
Dated: May 16, 2025
Received: May 19, 2025
June 16, 2025
Dear Aastha Chaudhary:
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.
Page 2
K244012 - Aastha Chaudhary Page 2
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" (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 QS 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 (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-reporting-combination-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 Rule"). 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-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
Page 3
K244012 - Aastha Chaudhary Page 3
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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,
Jessica Lamb
Assistant Director
Imaging Software Team
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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
Submission Number (if known)
K244012
Device Name
Mosaic (V1.0.1)
Indications for Use (Describe)
Mosaic V1.0.1 is a medical image analysis system that allows the viewing, processing, and analysis of multi-dimensional digital images acquired with contrast from CT imaging devices.
Mosaic V1.0.1 is intended to assist trained medical professionals in the stratification of patients suspected or identified to have atherosclerosis as well as stratification of patients suspected or identified to have aneurysmal disease of the aorta or carotid, iliac, femoral and popliteal arteries.
The software enables post processing of images obtained using a multidetector CT and provides tools for the measurement and visualisation of arterial vessels and any disease present, including editing of contrasted lumen and artery boundaries.
Any processed artery can be selected to view: the vessel in 3D; color-coded interactive data maps displayed on the 3D vessel; curved, straightened and cross-sectional MPR views of the vessel; and quantitative data from regions of interest. Data includes standard 2D distance measurements as well as stenosis, Hounsfield unit statistics, and tissue volumes.
Typical users of Mosaic V1.0.1 outputs are trained medical professionals, including radiologists and clinicians. Typical operators of Mosaic V1.0.1 are those suitably trained in the use of the software.
Mosaic V1.0.1 is intended to complement standard of care but is not intended to provide a diagnosis or clinical recommendation.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Page 5
Mosaic V1.0.1 510(k) Summary Statement
Page 1 of 3
1 Company and Product Details
1.1 510(k) Submitter
| Field | Details |
|---|---|
| Company Name | Navier Medical Ltd |
| Address | Office 1, Level 13, 256 Adelaide Terrace, Perth WA 6000, Australia |
| Phone Number | +61 0450 215 141 |
| Contact Person | Aastha Chaudhary, QA and RA Manager |
| Date Prepared | 16-June-2025 |
1.2 Subject Device
| Field | Details |
|---|---|
| Manufacturer Name | Navier Medical Ltd |
| Device Name | Mosaic V1.0.1 |
| Common or usual name | Image processing system |
| Classification Name | Medical image management and processing system |
| Regulatory Class | II |
| Product Code | LLZ |
| Classification Regulation | 21 C.F.R. § 892.2050 |
1.3 Predicate Device
| Field | Details |
|---|---|
| Manufacturer Name | Elucid Bioimaging Inc. |
| Device Name | ElucidVivo A.3 |
| 510(k) reference | K221463 |
| Classification Name | Medical image management and processing system |
| Regulatory Class | II |
| Product Code | LLZ |
| Classification Regulation | 21 C.F.R. § 892.2050 |
No reference devices were used in this submission.
2 Device Description
Mosaic V1.0.1 is a post-processing tool used to analyse arterial diseases. It reads in computed tomography angiography (CTA) scans and users can process the scans to aid clinicians in their analysis of anatomy and pathology. Processing CTA with Mosaic enables the creation of vessel centrelines from which measurements and image reformatting is possible. The outputs of the software include visual images, measures of diameter, distance, volume, including plaque volumes, positive remodelling of the arterial wall, and stenosis. These measurements are based on user segmentation. Outputs from Mosaic, including the saved analysis file and PDF report, can be used to assist with the decision-making process and clinical management of the patient, but Mosaic is not intended to be used as a sole source of clinical data to determine diagnosis and/or treatment pathways.
3 Indications for Use
Mosaic V1.0.1 is a medical image analysis system that allows the viewing, processing, and analysis of multi-dimensional digital images acquired with contrast from CT imaging devices.
Page 6
Mosaic V1.0.1 510(k) Summary Statement
Page 2 of 3
Mosaic V1.0.1 is intended to assist trained medical professionals in the stratification of patients suspected or identified to have atherosclerosis as well as stratification of patients suspected or identified to have aneurysmal disease of the aorta or carotid, iliac, femoral and popliteal arteries.
The software enables post processing of images obtained using a multidetector CT and provides tools for the measurement and visualisation of arterial vessels and any disease present, including editing of contrasted lumen and artery boundaries.
Any processed artery can be selected to view: the vessel in 3D; color-coded interactive data maps displayed on the 3D vessel; curved, straightened and cross-sectional MPR views of the vessel; and quantitative data from regions of interest. Data includes standard 2D distance measurements as well as stenosis, Hounsfield unit statistics, and tissue volumes.
Typical users of Mosaic V1.0.1 outputs are trained medical professionals, including radiologists and clinicians. Typical operators of Mosaic V1.0.1 are those suitably trained in the use of the software.
Mosaic V1.0.1 is intended to complement standard of care but is not intended to provide a diagnosis or clinical recommendation.
4 Intended Use
Mosaic V1.0.1 is intended to assist trained medical professionals in the stratification of patients suspected or identified to have atherosclerosis as well as stratification of patients suspected or identified to have aneurysmal disease of the aorta or carotid, iliac, femoral and popliteal arteries. The software post processes images obtained using a multidetector CT and provides tools for the measurement and visualisation of arterial vessels and any disease present.
The software is not intended to replace the skill and judgment of a qualified medical practitioner and should only be used by people who have been appropriately trained in the software's functions, capabilities and limitations.
5 Technological Characteristics Compared to the Predicate
Mosaic V1.0.1 has all the same technological characteristics and features as ElucidVivo.
| Characteristic | Mosaic V1.0.1 (Subject) | ElucidVivo™ A.3 (Predicate) | Comparison Assessment |
|---|---|---|---|
| Computer Operating System | Windows OS | Windows OS and Mac OS | Similar to predicate. |
| Image Input Format | DICOM | DICOM | Same as predicate. |
| Image Acquisition | CT | CT | Same as predicate. |
| Hounsfield Unit (HU)-based Segmentation | YES | YES | Same as predicate. |
| 2D Imaging | YES | YES | Same as predicate. |
| 3D Imaging | YES | YES | Same as predicate. |
| Multiplanar Reformatting (MPR) | YES | YES | Same as predicate. |
| 2D Measurements | YES | YES | Same as predicate. |
| Vessel Stenosis | YES | YES | Same as predicate. |
| Volumetric Measurements | YES | YES | Same as predicate. |
| Features of Arterial Disease (based on HU) | Calcified tissue (> 350 HU) | ||
| Low-attenuating plaque (Adaptive algorithm) | |||
| Custom | Calcified tissue (>250 HU) | ||
| Low-attenuating plaque (called Lipid Rich Necrotic Core; |