(165 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on image viewing, manipulation, and 3D visualization tools, not AI/ML-driven analysis or diagnosis.
No.
The device is a software solution for viewing, manipulating, and comparing medical images, not for providing direct therapy or treatment. Its intended use is to aid in the interpretation of examinations and follow-up documentation, complementing the standard practices of trained professionals.
No
The device is described as a "viewer" that allows medical professionals to interpret images, but it explicitly states that it "does not directly generate any diagnosis or potential findings" and that "The medical professional retains the ultimate responsibility for making the diagnosis."
Yes
The device is explicitly described as a "stand-alone software package" and its function is focused on viewing, manipulating, and visualizing medical images, which are software-based operations. While it can be used in Virtual Reality, the core device is the software itself.
Based on the provided information, Clarus Viewer® Version 1.0 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. This typically involves tests performed on blood, urine, tissue, etc.
- Clarus Viewer's Intended Use: The intended use of Clarus Viewer® is for viewing, manipulating, storing, visualizing, and comparing medical images (CT and MR) from within the body. It works with images already acquired from the patient, not with specimens taken from the patient.
- No Specimen Analysis: The device description clearly states it imports and visualizes medical data (DICOM images) and models. There is no mention of analyzing biological specimens.
- Focus on Image Interpretation: The intended use emphasizes that the software supports the interpretation of examinations by a trained professional and does not directly generate diagnoses. This aligns with image viewing and manipulation tools, not IVDs which provide diagnostic information based on specimen analysis.
Therefore, Clarus Viewer® falls under the category of medical image viewing and processing software, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Clarus Viewer® Version 1.0 is a software solution intended to be used for viewing, manipulation, storage, 3D-visualization, and comparison of medical images from multiple imaging modalities and/or multiple timepoints. The application supports images and anatomical datasets, limited to CT and MR.
Clarus Viewer® supports the interpretation of examinations and follow-up documentation of findings within healthcare institutions, for example, in Radiology and other Medical Imaging environments. It is intended to provide image and related information that is interpreted by a trained professional but does not directly generate any diagnosis or potential findings.
Note: The medical professional retains the ultimate responsibility for making the perfinent diagnosis based on their standard practices. Clarus Viewer is a complement to these standard procedures. Clarus Viewer® is not intended for the displaying of digital mammography images for diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
Clarus Viewer® is a stand-alone software package that imports medical data in the Digital Imaging and Communications and Medicine (DICOM) standard, stored on local or remote PACS sources. Clarus Viewer® is intended to allow users to visualize and manipulate 2D and 3D images and models of CT and MRI datasets and visualize and manipulate 3D volumetric models. Clarus Viewer® can present the 2D and 3D images in either a desktop mode or in Virtual Reality.
Within Clarus Viewer®, users can strip away layers of bone and tissue, revealing the relevant images for evaluation. Users can view and evaluate the 3D model from any angle. In the same way a doctor may hold and rotate a physical anatomical model in the real world, within Clarus Viewer® the image can be rotated and examined, or sliced away or apart to examine interior structures, tissues, and fluids.
The Clarus Viewer® system is intended to be used as a supplemental viewer by trained medical professionals. It allows the user to view images, models, and related medical information that can then be interpreted by a trained professional. Clarus Viewer® does not directly generate any diagnosis. The medical professional retains the ultimate responsibility for making the diagnosis.
Clarus Viewer is not intended for the displaying of digital mammography images for diagnosis.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT and MR
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained professional within healthcare institutions, for example, in Radiology and other Medical Imaging environments.
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)
The following information is provided in support of substantial equivalence.
- Clinical evaluation, including:
- Valid Clinical Association Assessment
- Clinical Validation
- Artifacts Analysis of the VIVE Pro 2
- Image Display Quality Analysis of the VIVE Pro 2- contrast, resolution, luminance, distortion
- Risk Management activities
- Software testing, including unit testing, integration testing and system level testing of:
- Virtual environment
- User interface
- Scan deck
- Clarus data
- Voxel model
- Volumetric model
- Clarus Viewer® tools
- Off-the-Shelf software validation
- Human Factors / Usability testing
- Cybersecurity assessment
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 of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Clarus Viewer Corporation % Carolyn Guthrie VP of Regulatory Kapstone Medical, LLC 520 Elliot Street CHARLOTTE NC 28202
Re: K222757
February 24, 2023
Trade/Device Name: Clarus Viewer® Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: January 25, 2023 Received: January 25, 2023
Dear Carolyn Guthrie:
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/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.
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
1
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 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.
Jessica Lamb
Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222757
Device Name Clarus Viewer®
Indications for Use (Describe)
Clarus Viewer® Version 1.0 is a software solution intended to be used for viewing, manipulation, storage, 3D-visualization, and comparison of medical images from multiple imaging modalities and/or multiple timepoints. The application supports images and anatomical datasets, limited to CT and MR.
Clarus Viewer® supports the interpretation of examinations and follow-up documentation of findings within healthcare institutions, for example, in Radiology and other Medical Imaging environments. It is intended to provide image and related information that is interpreted by a trained professional but does not directly generate any diagnosis or potential findings.
Note: The medical professional retains the ultimate responsibility for making the perfinent diagnosis based on their standard practices. Clarus Viewer is a complement to these standard procedures. Clarus Viewer® is not intended for the displaying of digital mammography images for diagnosis.
| 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
Image /page/3/Picture/0 description: The image shows the logo for Clarus Viewer. On the left side of the logo is a 3D geometric shape with a cube inside. To the right of the geometric shape is the word "CLARUS" in all caps, with the word "VIEWER" underneath in a smaller font size.
Clarus Viewer® 510(k) Summary
In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR 807.92, the following summary of information is provided.
1. Date of Preparation:
February 7, 2023
2. Applicant
Clarus Viewer Corporation 5030 Bradford Drive NW; Building 2, Suite 104 Huntsville, AL 35805
3. Official Correspondent
Carolyn Guthrie Email: cquthrie@kapstonemedical.com Phone: (704) 737-2866 Kapstone Medical LLC 520 Elliot St. Charlotte, NC 28202
4. Device Name
Trade Name: Clarus Viewer®
Common Name: Picture archiving and communications system Classification Name: Medical Image Management and Processing System Regulation Number: 21 CFR 892.2050 Product Code: LLZ Classification: Class II Panel: Radiology
4
Image /page/4/Picture/0 description: The image is a logo for Clarus Viewer. The logo consists of two parts: a geometric shape on the left and the text "CLARUS VIEWER" on the right. The geometric shape is a hexagon with a cube inside, and the text is in a bold, sans-serif font. The word "CLARUS" is above the word "VIEWER", and there is a registered trademark symbol to the right of the word "CLARUS".
5. Predicate Devices
Clarus Viewer®is substantially equivalent to the predicate device shown in Table 5.1.
| Trade Name | Clearance | Claim of Equivalence for: | 510(k) holder |
|---|---|---|---|
| ImmersiveTouch | K210726 | Predicate Device | ImmersiveTouch |
6. Intended Use (Intended Purpose and Conditions of Use):
Clarus Viewer® Version 1.0 is a software solution intended to be used for viewing, manipulation, communication, storage, 3D-visualization, and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports images and anatomical datasets, limited to CT and MR.
Clarus Viewer® supports the interpretation and evaluation of examinations and follow-up documentation of findings within healthcare institutions, for example, in Radiology and other Medical Imaging environments. It is intended to provide image and related information that is interpreted by a trained professional but does not directly generate any diagnosis or potential findings.
Note: The medical professional retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices. Clarus Viewer is a complement to these standard procedures. Clarus Viewer® is not intended for the displaying of digital mammography images for diagnosis.
7. Device Description
Clarus Viewer® is a stand-alone software package that imports medical data in the Digital Imaging and Communications and Medicine (DICOM) standard, stored on local or remote PACS sources. Clarus Viewer® is intended to allow users to visualize and manipulate 2D and 3D images and models of CT and MRI datasets and visualize and manipulate 3D volumetric models. Clarus Viewer® can present the 2D and 3D images in either a desktop mode or in Virtual Reality.
Within Clarus Viewer®, users can strip away layers of bone and tissue, revealing the relevant images for evaluation. Users can view and evaluate the 3D model from any angle. In the same way a doctor may hold and rotate a physical anatomical model in the real world, within Clarus Viewer® the image can be rotated and examined, or sliced away or apart to examine interior structures, tissues, and fluids.
The Clarus Viewer® system is intended to be used as a supplemental viewer by trained medical professionals. It allows the user to view images, models, and related medical information that can then be interpreted by a trained professional. Clarus Viewer® does not directly generate any diagnosis. The medical professional retains the ultimate responsibility for making the diagnosis.
5
Image /page/5/Picture/0 description: The image shows the logo for Clarus Viewer. The logo consists of a geometric shape on the left and the word "CLARUS" in bold, black letters on the right. Below "CLARUS" is the word "VIEWER" in a smaller font, also in black. The geometric shape appears to be a cube inside of a hexagon.
Clarus Viewer is not intended for the displaying of digital mammography images for diagnosis.
8. Substantial Equivalence
8.1 Comparison of Intended Use
Clarus Viewer® and the predicate device are both stand-alone software intended for transfer of 2D medical imaging information to generate 3D representations for visualization, analysis, measuring and treatment planning. Thus, there is no difference between the subject device and the predicate device with respect to intended use.
8.2 Comparison of Operating Principle
Both Clarus Viewer® and the predicate device use 3D Generated Anatomical Representations in a 3D Space using the same VR hardware.
8.3 Comparison of Similar Technological Characteristics
Clarus Viewer® and the predicate device are both based on the following same technological characteristics:
- Both input DICOM medical data input.
- . Both allow viewing in the Axial, Coronal and Sagittal planes.
- Both have MR and CT imaging modalities. ●
- . Both utilize commercial VR hardware, namely VIVE Pro 2.
- . Both utilize tracking with 6 degrees of freedom.
- . Both have evaluation tools including annotation, measurement, and slicing.
- Both allow the increase and decrease of the model volumetric tissue densities. .
8.4 Discussion of Technological Differences
There are new or different implementations of similar technological characteristics between Clarus Viewer® and the predicate device, with minor changes that do not affect the safety and effectiveness of the device. Clarus Viewer® and the predicate device have differences in the following technological characteristics:
- . The imaging modalities of Clarus Viewer®, namely CT and MR, fall within that of the predicate, with the predicate also offering CBCT and 3D angiography.
- The VR Hardware Compatibility of the predicate includes the Oculus Quest 2 and VIVE . Pro 2. Clarus Viewer® is only compatible with the VIVE Pro 2 and not compatible with the Oculus Quest 2.
- . Both devices include Annotation, Measurement, Slice and Control Tools, and allow the modification of the transparency of the 3D representation which increases or decreases the volumetric model tissue densities for dynamic evaluation. Clarus Viewer® allows multiple methods for adjustment of transparency within the entire 3D representation or within specific portions only, while the predicate device adjusts the transparency for specific portions of the 3D representation only.
6
Image /page/6/Picture/1 description: The image contains the logo for Clarus Viewer. The logo consists of an orange hexagon with a gray cube inside of it. To the right of the hexagon is the word "CLARUS" in black, with the word "VIEWER" in a smaller font below it.
9. Performance Data
The following information is provided in support of substantial equivalence.
- Clinical evaluation, including: .
- Valid Clinical Association Assessment O
- Clinical Validation O
- Artifacts Analysis of the VIVE Pro 2 O
- Image Display Quality Analysis of the VIVE Pro 2- contrast, resolution, luminance, O distortion
- Risk Management activities
- Software testing, including unit testing, integration testing and system level testing of: ●
- Virtual environment o
- O User interface
- Scan deck O
- Clarus data O
- Voxel model O
- Volumetric model O
- Clarus Viewer® tools o
- Virtual environment o
- . Off-the-Shelf software validation
- Human Factors / Usability testing
- . Cybersecurity assessment
11 Conclusion
Clarus Viewer® and the predicate device ImmersiveTouch (K210726) have the same intended use and are available by prescription only. Any technical differences identified do not result in new questions of safety or effectiveness.
Through assessment of technological characteristics, intended use and performance data, it can be concluded that Clarus Viewer is substantially equivalent to the ImmersiveTouch device.