Who is the manufacturer of Ceevra Reveal 3?

Ceevra, Inc. filed the 510(k) submission for Ceevra Reveal 3 (K222676).

What is the FDA product code for Ceevra Reveal 3?

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

What is the regulatory pathway for Ceevra Reveal 3?

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

Does Ceevra Reveal 3 use AI or machine learning?

Yes. Ceevra Reveal 3 (K222676) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Who can help prepare an FDA 510(k) submission like Ceevra Reveal 3?

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.

Can an AI/ML device like Ceevra Reveal 3 get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

Ceevra Reveal 3

K222676 · Ceevra, Inc. · QIH · Apr 25, 2023 · Radiology

Device Facts

Record ID	K222676
Device Name	Ceevra Reveal 3
Applicant	Ceevra, Inc.
Product Code	QIH · Radiology
Decision Date	Apr 25, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

Intended Use

Ceevra Reveal 3 is intended as a medical imaging system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from CT or MR imaging devices and that such processing may include the generation of preliminary segmentations of normal anatomy using software that employs machine learning and other computer vision algorithms. It is also intended as software for preoperative surgical planning, and as software for the intraoperative display of the aforementioned multi-dimensional digital images. Ceevra Reveal 3 is designed for use by health care professionals and is intended to assist the clinician who is responsible for making all final patient management decisions.

Device Story

Ceevra Reveal 3 is a software-as-a-medical-device (SaMD) system for 3D visualization of CT and MR images. Company personnel use the software to generate 3D models from patient scans; clinicians use the Reveal 3 Mobile Image Viewer or Desktop Image Viewer to interact with these models (rotate, zoom, pan, toggle anatomical structures) during preoperative planning and intraoperative procedures. The system employs machine learning and computer vision algorithms to generate preliminary segmentations of normal anatomy. Output is displayed on mobile devices, computers, external monitors, or VR headsets. The device assists clinicians in surgical planning and intraoperative visualization; it does not provide real-time surgical guidance or navigation. Clinicians retain responsibility for all final patient management decisions.

Clinical Evidence

Bench testing only. Performance verified using 141 imaging studies (CT/MR) from diverse scanner manufacturers (GE, Siemens, Toshiba, Philips). Models validated against manual segmentations by medical professionals. Metrics reported: Sørensen-Dice coefficient (DSC) for prostate (0.87), bladder (0.90), kidney (0.87-0.89), artery (0.83-0.87), and vein (0.81-0.86); Hausdorff distance (HD-95) for neurovascular bundles (7.8 mm). Subgroup analysis performed for age, sex, and scanner type.

Technological Characteristics

Software-as-a-medical-device (SaMD). Features machine learning and computer vision algorithms for automated segmentation of normal anatomy. Compatible with CT and MR modalities. Supports mobile, desktop, and VR display platforms. Developed in accordance with IEC 62304:2006/Amd 1:2015. Cybersecurity and software life cycle processes implemented per FDA guidance.

Indications for Use

Indicated for adult patients (22 and over) for processing, review, and 3D visualization of CT/MR images for preoperative planning and intraoperative display. Machine learning algorithms are restricted to adult patients; patients under 22 or of unknown age are processed without machine learning.

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

Ceevra Reveal 2.0 (K173274)

Related Devices

K233568 — Ceevra Reveal 3+ · Ceevra, Inc. · Dec 5, 2023
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K171356 — Clarity Reveal · Ceevra, Inc. · Aug 3, 2017
K201365 — True 3D Viewer · Echopixel, Inc. · Jul 17, 2020
K193149 — True 3D Viewer Software · Echopixel, Inc. · Dec 27, 2019

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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square. Ceevra, Inc. % Ken Koster CTO 149 New Montgomery Street, 4th Fl. SAN FRANCISCO CA 94105 April 25, 2023 Re: K222676 Trade/Device Name: Ceevra Reveal 3 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QIH Dated: March 20, 2023 Received: March 21, 2023 Dear Ken Koster: 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 {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. Jessica Lamb Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products 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) K222676 Device Name Ceevra Reveal 3 ## Indications for Use (Describe) Ceevra Reveal 3 is intended as a medical imaging system that allows the processing, review, and media interchange of multi-dimensional digital images acquired from CT or MR imaging devices and that such processing may include the generation of preliminary segmentations of normal anatomy using software that employs machine learning and other computer vision algorithms. It is also intended as software for preoperative surgical planning, and as software for the intraoperative display of the aforementioned multi-dimensional digital images. Ceevra Reveal 3 is designed for use by health care professionals and is intended to assist the clinician who is responsible for making all final patient management decisions. The machine learning algorithms in use by Ceevra Reveal 3 are for use only for adult patients (22 and over). Threedimensional images for patients under the age of 22 or of unknown age will be generated without the use of any machine learning algorithms. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X 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." {3}------------------------------------------------ # 510(k) Summary ## 1. General Information | 510(k) Sponsor | Ceevra, Inc. | |-----------------------|-------------------------------------------------------------| | Address | 149 New Montgomery St, 4th Floor San Francisco, CA 94105 | | Correspondence Person | Ken Koster CTO, Ceevra, Inc. | | Contact Information | Email: kkoster@ceevra.com Phone: 415-305-5326 | | Date Prepared | April 18, 2023 | ## 2. Subject Device | Proprietary Name | Ceevra Reveal 3 | |---------------------|--------------------------------------------------| | Common Name | Reveal 3 | | Classification Name | Automated Radiological Image Processing Software | | Regulation Number | 21 CFR 892.2050 | | Product Code | QIH | | Regulatory Class | II | ## 3. Predicate Device | Proprietary Name | Ceevra Reveal 2.0 | |------------------------|----------------------------------------| | Premarket Notification | K173274 | | Classification Name | System, Image Processing, Radiological | | Regulation Number | 21 CFR 892.2050 | | Product Code | LLZ | | Regulatory Class | II | {4}------------------------------------------------ #### Device Description 4. Ceevra Reveal 3 ("Reveal 3"), manufactured by Ceevra, Inc. (the "Company"), is a software as a medical device with two main functions: (1) it is used by Company personnel to generate three-dimensional (3D) images from existing patient CT and MR imaging, and (2) it is used by clinicians to view and interact with the 3D images during preoperative planning and intraoperatively. Clinicians view 3D images via the Reveal 3 Mobile Image Viewer software application which runs on compatible mobile devices, and the Reveal 3 Desktop Image Viewer software application which runs on compatible computers. The 3D images may also be displayed on compatible external displays, or in virtual reality (VR) format with a compatible off-the-shelf VR headset. Reveal 3 includes additional features that enable clinicians to interact with the 3D images including rotating, zooming, panning, and selectively showing or hiding individual anatomical structures. ## ર. Indications for Use Ceevra Reveal 3 is intended as a medical imaging system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from CT or MR imaging devices and that such processing may include the generation of preliminary segmentations of normal anatomy using software that employs machine learning and other computer vision algorithms. It is also intended as software for preoperative surgical planning, and as software for the intraoperative display of the aforementioned multi-dimensional digital images. Ceevra Reveal 3 is designed for use by health care professionals and is intended to assist the clinician who is responsible for making all final patient management decisions. The machine learning algorithms in use by Ceevra Reveal 3 are for use only for adult patients (22 and over). Three-dimensional images for patients under the age of 22 or of unknown age will be generated without the use of any machine learning algorithms. ## Substantial Equivalence 6. As detailed in the following tables, the intended use and technological characteristics of the subject device are substantially equivalent to the predicate devices. Table 6.1: Comparison of Indications for Use Statements | Subject Device: Ceevra Reveal 3 (K222676) | Primary Predicate: Ceevra Reveal 2.0 (K173274) | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Ceevra Reveal 3 is intended as a medical imaging system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from CT or MR imaging devices and that such processing may include the generation of preliminary segmentations of normal anatomy using software that employs machine | Ceevra Reveal 2.0 is intended as a medical imaging system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from CT or MR imaging devices. It is also intended as software for preoperative surgical planning, and as software for the intraoperative display of the aforementioned | {5}------------------------------------------------ | learning and other computer vision algorithms. It is also intended as software for preoperative surgical planning, and as software for the intraoperative display of the aforementioned multi-dimensional digital images. Ceevra Reveal 3 is designed for use by health care professionals and is intended to assist the clinician who is responsible for making all final patient management decisions. | multi-dimensional digital images. Ceevra Reveal 2.0 is designed for use by health care professionals and is intended to assist the clinician who is responsible for making all final patient management decisions. | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | The machine learning algorithms in use by Ceevra Reveal 3 are for use only for adult patients (22 and over). Three-dimensional images for patients under the age of 22 or of unknown age will be generated without the use of any machine learning algorithms. | | | Feature/ Function | Subject Device Ceevra Reveal 3 (K222676) | Primary Predicate Ceevra Reveal 2.0 (K173274) | |----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|--------------------------------------------------------| | Supported image Modalities | CT and MR | CT and MR | | Intended users | Healthcare Professionals | Healthcare Professionals | | Intended environment | Healthcare facilities such as hospitals and clinics | Healthcare facilities such as hospitals and clinics | | Device Class | Class II | Class II | | Image analysis features | Interactive manipulation and 3D visualization | Interactive manipulation and 3D visualization | | Preoperative viewing of 3D images | Yes | Yes | | Intraoperative viewing of 3D images | Yes | Yes | | 3D images used intraoperatively for real-time guidance, navigation or otherwise integrated with surgical instruments | No | No | | Segmentation work performed by | Internal Operators | Internal Operators | | Built-in features for end-user to compare CT/MR to device output | No | No | | Quantitative outputs calculated by device | No | No | | Software generates semi-automated segmentations of abnormal anatomy | No | No | | Software generates semi-automated segmentations of certain normal anatomy | Yes | No | # Table 7.2: Comparison of Device Characteristics #### 7. Performance Data Safety and performance of Ceevra Reveal 3 has been evaluated and verified in accordance with software specifications and applicable performance standards through software verification and validation testing. Additionally, the software validation activities were performed in accordance with IEC 62304:2006/Amd 1: 2015- Medical device software - Software life cycle processes, in addition to the FDA Guidance {6}------------------------------------------------ documents, "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." Four machine learning models are included in Ceevra Reveal 3. These models were verified with datasets of actual CT or MR imaging studies of patients. A total of 141 imaging studies were used to evaluate the device. No dataset contained more imaging study from any particular patient. No imaging study used to verify performance was used for training; independence of training and testing data were enforced at the level of the scanning institution, namely, studies sourced from a specific institution were used for either training or testing but could not be used for both. The data used in the device validation ensured diversity in patient population and scanner manufacturers. Subgroup analysis was performed for patient age, patient sex, and scanner manufacturers. For non-prostate related datasets, verification datasets included 40% female patients and 60% male patients. Across all datasets, 32% of patients were under 60 years old, 32% were 60 to 70 years old, 30% were over 70 years old, and 6% were of unknown age. Scanner manufacturers included GE Medical Systems, Siemens, Toshiba, and Philips Medical Systems. Ethnicity of patients in the datasets was reasonably correlated to the overall US population. Performance was verified by comparing segmentations generated by the machine learning models against segmentations generated by medical professionals from the same imaging study. The performance of the machine learning models, characterized by the Sørensen-Dice coefficient (DSC) or the Hausdorff distance metric at the 95th percentile (HD-95), was as follows: prostate imaging) 0.87 DSC; bladder (from MR prostate imaging) 0.90 DSC; neurovascular bundles (from MR prostate imaging) 7.8 mm HD-95; kidney (from CT abdomen imaging) 0.89 DSC; kidney (from MR abdomen imaging) 0.87 DSC; artery (from CT abdomen imaging) 0.87 DSC; artery (from MR abdomen imaging) 0.83 DSC; vein (from CT abdomen imaging) 0.86 DSC: vein (from MR abdomen imaging) 0.81 DSC: artery ffrom CT chest imaging) 0.85 DSC; vein (from CT chest imaging) 0.81 DSC. #### 8. Conclusion Ceevra Reveal 3 is deemed to be substantially equivalent to its predicate device based on indications for use, technological characteristics and performance testing. Ceevra Reveal 3 raises no new questions related to safety or effectiveness.