Who is the manufacturer of CariCloud?

Caristo Diagnostics filed the 510(k) submission for CariCloud (K200274).

What is the FDA product code for CariCloud?

LLZ. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for CariCloud?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like CariCloud?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CariCloud

K200274 · Caristo Diagnostics · LLZ · May 21, 2020 · Radiology

Device Facts

Record ID	K200274
Device Name	CariCloud
Applicant	Caristo Diagnostics
Product Code	LLZ · Radiology
Decision Date	May 21, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device

Intended Use

CariCloud is a software device used by operators to evaluate attenuation in the coronary arteries and surrounding tissue in CCTA images. CariCloud is to be used by trained operators. CariCloud analysis results are to be used by Healthcare Professionals and may assist in diagnosis. CariCloud analysis results are indicated for use for all patients referred for CCTA imaging.

Device Story

CariCloud v1.0 is a prescription software device for display, manipulation, and quantification of previously acquired CCTA images. Trained operators download datasets from remote systems; initiate and oversee image analysis; intervene to correct processing errors. Device performs automatic and manual centerline extraction; vessel analysis; automatic and manual segmentation of structures; linear, area, and volume measurements. Output includes a summary report with qualitative and quantitative analysis for healthcare professionals to assist in diagnosis. Used in clinical settings; operates on any system supporting Chrome browser. Benefits include standardized assessment of coronary artery attenuation.

Clinical Evidence

Bench testing only. Performance evaluated via inter-operator and intra-operator variability studies comparing CariCloud to the predicate device. ICC values for all measures (PFA, TVOI-A, TVOI-V, TROI-A) were excellent (ICC > 0.96) for both devices, with a maximum difference in ICC of 0.017. No significant difference in variability between devices.

Technological Characteristics

Software-only device; operates via Chrome browser. Features include automatic/manual centerline extraction, segmentation, and image assessment tools (MPR, 3D triangulation, CPR). Data input via manual keyboard/mouse/command line. Output stored as DICOM SC. Cybersecurity and data security measures implemented. Software level of concern: Moderate.

Indications for Use

Indicated for all patients referred for CCTA imaging to evaluate attenuation in coronary arteries and surrounding tissue. For use by trained operators; results intended for healthcare professionals to assist in diagnosis.

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

TeraRecon iNtuition (K121916)

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Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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 in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION". Caristo Diagnostics % Mr. James Davis Head of Quality and Regulatory Affairs New Barclay House, 234 Botley Road Oxford, Oxfordshire OX20HP UNITED KINGDOM Re: K200274 Trade/Device Name: CariCloud v1.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: May 1, 2020 Received: May 4, 2020 Dear Mr. Davis: 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for May 21, 2020 {1}------------------------------------------------ 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. For Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K200274 Device Name CariCloud v1.0 Indications for Use (Describe) The indications for use, are as follows: CariCloud is a software device used by operators to evaluate attenuation in the coronary arteries and surrounding tissue in CCTA images. CariCloud is to be used by trained operators. CariCloud analysis results are to be used by Healthcare Professionals and may assist in diagnosis. CariCloud analysis results are indicated for use for all patients referred for CCTA imaging. 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." FORM FDA 3881 (7/17) {3}------------------------------------------------ Image /page/3/Picture/1 description: The image is a logo for Caristo diagnostics. The logo features the word "Caristo" in a bold, dark gray font, with the word "diagnostics" in a smaller, light gray font underneath. To the left of the word "Caristo" is a circular graphic made up of three concentric arcs in dark gray, red, and orange. #### SUBMITTER l. Caristo Diagnostics New Barclay House 234 Botley Road Oxford OX2 0HP Phone: +44 (0) 1865 950720 Contact Person: James Davis Date Prepared: May 01, 2020 ## DEVICE ll. Name of Device: CariCloud v1.0 Common or Usual Name: CariCloud Classification Name: Picture archiving and communications (21 CFR§ 892.2050) Regulatory Class: II Product Code: LLZ ## PREDICATE DEVICE lll. TeraRecon iNtuition, K121916 This predicate has not been subject to a design-related recall. ## DEVICE DESCRIPTION IV. CariCloud is an image processing prescription software device intended to be used to display, manipulate and quantify previously acquired CT images. Datasets are downloaded from remote systems for clinical interpretation. Trained users will initiate and oversee image analysis and intervene when necessary to correct processing errors. The outcome of analysis will be used to create a summary report that includes qualitative and quantitative analysis. K200274 {4}------------------------------------------------ Image /page/4/Picture/1 description: The image is a logo for Caristo diagnostics. The logo features the word "Caristo" in a bold, sans-serif font, with the word "diagnostics" in a smaller, lighter font underneath. To the left of the word "Caristo" is a stylized "C" made up of three concentric arcs in red, orange, and yellow. The logo is simple and modern, and the colors are bright and eye-catching. # INDICATIONS FOR USE The Indications for use are as follows: - . CariCloud is a software device used by operators to evaluate attenuation in the coronary arteries and surrounding tissue in CCTA images. - . CariCloud is to be used by trained operators. CariCloud analysis results are to be used by Healthcare Professionals and may assist in diagnosis. - . CariCloud analysis results are indicated for use for all patients referred for CCTA imaging. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image is a logo for Caristo diagnostics. The logo features the word "Caristo" in a bold, dark gray font, with the letter "C" stylized with concentric circles in black, red, and orange. Below "Caristo" is the word "diagnostics" in a smaller, light gray font. ## COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE V. PREDICATE DEVICE The following table compares CariCloud v1.0 to the predicate device with respect to indications for use, principles of operation, technological characteristics, and performance, forming the basis for the determination of substantial equivalence. | Attribute | CariCloud | iNtuition | Comparison | |------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Caristo Diagnostics | TeraRecon. INC | Not Applicable | | 510(k) Number | K200274 | K121916 | Not Applicable | | Product Code | LLZ | LLZ | Same | | Regulation Number | 21 CFR 892.2050 | 21 CFR 892.2050 | Same | | Intended Use / Indications for Use | CariCloud is a software device used by operators to evaluate attenuation in the coronary arteries and surrounding tissue in CCTA images. CariCloud is to be used by trained operators. CariCloud analysis results are to be used by Healthcare Professionals and may assist in diagnosis. CariCloud analysis results are indicated for use for all patients referred for CCTA imaging. | To receive, store, transmit, post-process, display and allow manipulation of reports and medical images from acquisition devices, including optical or other non-DICOM format images, DICOM images with modality type XA, US, CR, DR, SPECT, NM and MG, and images from volumetric medical scanning devices such as EBT, CT, PET or MRI. To provide access to images derived data and derived images via client-server software, web browser and mobile technology. Visualization in 2D, 3D and 4D are supported for single or multiple datasets, or combinations thereof Tools are provided to define and edit paths through structures such as centerlines, which may be used to analyze cross-sections of structures, or to provide flythrough visualizations rendered along such a centerline | CariCloud and TeraRecon's iNtuition device can both be used to evaluate attenuation in the coronary arteries and surrounding tissue in CT images. CariCloud and TeraRecon's iNtuition device differ in that iNtuition has additional features and supports use in evaluating images from other modalities and diagnostic areas such as oncology and neurology. The fact that TeraRecon's iNtuition device supports additional modalities and diagnostic areas does not affect the safety and effectiveness of CariCloud because the additional functionality offered by iNtuition is unrelated to the safety and effectiveness of CCTA image analysis. | {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for Caristo diagnostics. The logo features the word "Caristo" in a bold, dark gray font, with the word "diagnostics" in a smaller, lighter gray font underneath. To the left of the word "Caristo" is a graphic element consisting of concentric arcs in red, orange, and yellow, creating a circular design. {7}------------------------------------------------ Image /page/7/Picture/1 description: The image is a logo for Caristo diagnostics. The logo features the word "Caristo" in a dark gray, sans-serif font, with the word "diagnostics" in a smaller, lighter gray font underneath. To the left of the word "Caristo" is a stylized "C" made up of concentric arcs in red, dark gray, orange, and yellow. | Attribute | CariCloud | iNtuition | Comparison | | | | |-----------------------------|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|---------------------------------------------------------------|--------------------------------------------------------------------------------------------------| | | | Interpretation of mammographic images or digitized film screen images is supported only when the software is used without compression and with an FDA- Approved monitor that offers at least SMpixel resolution and meets other technical specifications reviewed and accepted by the FDA. iNtuitionMOBILE provides wireless and portable access to medical images. This device is not intended to replace full workstations and should be used only when there is no access to a workstation. Not intended for diagnostic use when used via a web browser or mobile device. iNtuition will be marketed as a software only solution for the end-user (with recommended hardware requirements) or as a complete workstation for the end user (software package with harware kit). | | | | | | | | | | | Technical Characteristics | | | | | Data Type | | - CT - 3D Medical Image Review | - CT, MR, Nuc, PET, Angio, US/Echo, SPECT, CR/DR Review | CariCloud supports CT review. This difference does not affect the safety of the device. | | | | | | | - 2D, 3D, 4D Medical Image review including cine play | | | Input Patient Data | - Manual through keyboard/mouse | - Manual through keyboard/mouse | The same as the predicate device. | | | | | | - Command line interface. | - Command line interface | | | | | | Study list functionality | - Search | - Importing - Exporting - Deleting - Search | CariCloud does not support import, export, delete and anonymization. This difference does not affect the safety of the device. | | | | | | | | | | | | | | | - Anonymization | | | | | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image is a logo for Caristo diagnostics. The logo features the word "Caristo" in a bold, sans-serif font, with the "C" stylized as a series of concentric arcs in red, orange, and yellow. Below "Caristo" is the word "diagnostics" in a smaller, lighter gray font. The overall design is modern and professional. | Attribute | CariCloud | iNtuition | Comparison | |--------------------------|--------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------| | Centerline Extraction | - Automatic and manual centerlines | - Automatic and manual centerlines | The same as the predicate device. | | | - Centerline edits and refinements. | - Centerline edits and refinements. | | | | - Vessel Analysis | - Vessel Analysis | | | | - Automatic and manual segmentation of structures - Segmentation editing | - Automatic and manual segmentation of structures - Segmentation editing | | | Image Assessment | - Linear (length, diameter), distance and ROI measurements | - Linear (length, diameter, perimeter), distance pair, angular and ROI measurements | CariCloud supports a sub- set of the image assessment tools that are in the predicate device. This does not affect the safety of the device. | | | - Area measurements | - Area measurements | | | | - Volume measurements including VOI and thresholding | - Volume measurements including volumetric histogram, VOI and TVA for Time Volume Analysis for heart chamber segmentation and analysis | | | | - Segmentation and analysis of coronary artery tree centerline | - C-arm angulation calculation | | | | - Synchronized side-by-side review | - Text and arrow annotations | | | | - Synchronized center of rotation viewing | - Anatomy ID (Landmark Label Selection) | | | | | - Calcium scoring for assessment of calcium in the aortic root | | | | | - Calcium scoring for assessment of calcium in the coronary arteries - Segmentation and analysis of coronary artery tree centerline - Synchronized side-by-side review - Synchronized center of rotation viewing | | {9}------------------------------------------------ Image /page/9/Picture/1 description: The image shows the logo for Caristo diagnostics. The logo features the word "Caristo" in a bold, dark gray font. Below "Caristo" is the word "diagnostics" in a smaller, light gray font. To the left of the word "Caristo" is a graphic of three partial circles in yellow, orange, and red. | Attribute | CariCloud | iNtuition | Comparison | |----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | - Findings workflow for temporal correlative analysis 2D/3D Batch movie tool and export - 2D/3D Batch movie tool and export | | | Image Assessment Rendering | - MPR - 3D triangulation - Curved Planar Reformat (CPR) - Synchronized side-by- side viewing - Synchronized center of rotation viewing - Multi-Mask Display (multi- object display) - Editing tools: free- hand | - 2D/3D Batch movie tool and export - MIP , MPR, MinIP , - Raysum (ThickMPR) - 3D triangulation - Perspective endoluminal view - Medial Axial Reformat (MAR) - Curved Planar Reformat (CPR) - Double-oblique MIP and MPR - Image enhancement filters - Synchronized side-by- side viewing - Synchronized center of | CariCloud supports a sub- set of the image assessment rendering tools that are in the predicate device. This does not affect the safety of the device. | | | | rotation viewing - Cube View | | {10}------------------------------------------------ Image /page/10/Picture/1 description: The image is a logo for Caristo diagnostics. The logo has the word "Caristo" in a dark gray font, with the word "diagnostics" in a light gray font underneath. To the left of the word "Caristo" is a graphic of three concentric arcs in red, orange, and yellow. | Attribute | CariCloud | iNtuition | Comparison | |--------------------------------------|--------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------| | | | - Workflow templates - Multi-Mask Display (multi-object display) - User-defined measurement protocols - Editing tools: crop, cut, free-hand | | | Storage of results | DICOM SC | - Structured reporting with xml, text, xls output - Word and html report - DICOM SC - Workflow scenes: restore saved state | CariCloud supports a sub- set of the result storage tools that are in the predicate device. This does not affect the safety of the device. | | Conferencing and Collaboration | Not supported. | Conferencing and Collaboration | Not supported. This does not affect the safety of the device. | | Operating System | Any operating system that supports the Chrome Browser. | Microsoft Windows | CariCloud is supported on the Chrome Browser. This does not affect the safety of the device. | The agreement in results, inter-operator variability and intra-operator variability attained using both the new device and the predicate device was excellent. CariCloud v1.0 does not raise any new questions of safety or effectiveness as compared to the predicate device. {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the logo for Caristo diagnostics. The logo features the word "Caristo" in a bold, dark gray font, with a stylized "C" that incorporates segments of red, orange, and yellow. Below "Caristo" is the word "diagnostics" in a lighter gray font. The logo is clean and modern, suggesting a company focused on medical diagnostics. ### PERFORMANCE DATA VI. # Software Verification and Validation Testing Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff: "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices." The software level of concern for CariCloud v1.0 is Moderate, as per FDA's quidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". This device does not control a life supporting or life-sustaining device, does not control the delivery of a potentially harmful energy, does not control the delivery of treatment, does not provide diagnostic information, and does not provide any vital signs monitoring. The hazard analysis identifies the potential software-related risks of using the device, and the mitigations implemented. ## Performance Testing CariCloud v1.0 software has been developed and tested in accordance with the Caristo Diagnostics Design Control processes and has been subject to extensive safety and performance testing. Nonclinical verification and validation testing has been performed to demonstrate that CariCloud v1.0 meets its design requirements and intended use. Software verification has been conducted at unit and system integration levels. A risk analysis was performed to document the risks associated with the use of the CariCloud v1.0 software product with all identified risks being mitigated. Cybersecurity and data security testing has been conducted to verify that data and patient protected health information security measures are included in the design of the software. Based on the Verification and Validation testing that has been conducted. CariCloud v1.0 is substantially equivalent to the predicate device. {12}------------------------------------------------ Image /page/12/Picture/1 description: The image shows the logo for Caristo diagnostics. The logo features the word "Caristo" in a bold, dark gray font. Below "Caristo" is the word "diagnostics" in a smaller, light gray font. To the left of the word "Caristo" is a stylized graphic consisting of three concentric arcs in different colors: yellow, orange, and red. # Performance Testing - Inter-operator and Intra-operator Variability For each device, ICC values were calculated between individual results of each read by each operator on each device for each measure based on an average-rating, absolute-agreement, 2-way mixedeffects model. Theses are shown in the table below. | | PFA | | | TVOI-A | | | TVOI-V | | | TROI-A | | | |---------------------|-------------|-------------|-------------|-------------|-------------|-------------|-------------|-------------|-------------|-------------|-------------|-------------| | ICC | Reader 1 | Reader 2 | Reader 3 | Reader 1 | Reader 2 | Reader 3 | Reader 1 | Reader 2 | Reader 3 | Reader 1 | Reader 2 | Reader 3 | | Predicate Device | 0.999 | 0.998 | 0.999 | 0.986 | 0.983 | 0.985 | 0.988 | 0.991 | 0.973 | 1.0 | 1.0 | 1.0 | | New Device | 0.997 | 0.997 | 0.994 | 0.987 | 0.971 | 0.982 | 0.971 | 0.986 | 0.969 | 1.0 | 0.998 | 1.0 | # Comparison of Intra-Operator Agreement achieved for Each Measure on Each Device: For all measures, the intra-operator agreement achieved on both the predicate device and the new device for each operator was excellent (ICC greater than 0.96) with a maximum difference in ICC between the two devices was 0.017. There was no significant difference between the inter-operator variability and intra-operator variability results attained on the two devices. ### CONCLUSIONS VII. CariCloud v1.0 has the same intended use and the same or similar technological characteristics as the predicate device, TeraRecon iNtuition. The minor differences in the indications do not alter the intended use of CariCloud v1.0 and do not raise any new questions of safety or effectiveness. For this reason, CariCloud v1.0 is substantially equivalent to the predicate device.