Ceevra Reveal 3+

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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 logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Ceevra, Inc. Ken Koster CTO 149 New Montgomery St. 4th Floor San Francisco, California 94105 March 4, 2025 Re: K243933 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: OIH Dated: January 10, 2025 Received: January 10, 2025 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 (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. {1}------------------------------------------------ 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. 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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory {2}------------------------------------------------ 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 Jessica Lamb, Ph.D. Assistant Director 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 {3}------------------------------------------------ ## Indications for Use Submission Number (if known) K243933 Device Name Ceevra Reveal 3+ Indications for Use (Describe) 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. 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. 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The overall impression is that of a company logo or identifier. # 510(k) Summary #### General Information 1. | 510(k) Sponsor | Ceevra, Inc. | |-----------------------|------------------------------------------------------------| | Address | 149 New Montgomery St, 4th Floor<br>San Francisco CA 94105 | | Correspondence Person | Ken Koster<br>CTO, Ceevra, Inc. | | Contact Information | Email: kkoster@ceevra.com<br>Phone: 415-305-5326 | | Date Prepared | March 2, 2025 | #### 2. Updated 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. Originally Cleared Device | Proprietary Name | Ceevra Reveal 3+ | |------------------------|--------------------------------------------------| | Common Name | Reveal 3+ | | Premarket Notification | K233568 | | Classification Name | Automated Radiological Image Processing Software | | Regulation Number | 21 CFR 892.2050 | Ceevra, Inc., Traditional 510(k) Page 1 {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for CEEVRA. The logo features a stylized, curved design in shades of blue, resembling a wave or a network of interconnected points. Below the graphic is the text "CEEVRA" in a simple, sans-serif font, also in blue. | Product Code | QIH | |------------------|-----| | Regulatory Class | II | #### Device Description 4. Ceevra Reveal 3+, as modified, ("Modified 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 Mobile Image Viewer software application which runs on compatible mobile devices, and the 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. Modified Reveal 3+ includes features that enable clinicians to interact with the 3D images including rotating, zooming, panning, selectively showing or hiding individual anatomical structures, and viewing measurements of or between anatomical structures. #### ನ. 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 indications for use and technological characteristics of the updated device are substantially equivalent to the originally cleared device. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image contains the logo for CEEVRA. The logo features a stylized letter 'C' formed by a series of blue arcs that transition from solid to dotted, suggesting movement or connectivity. Below the symbol, the word 'CEEVRA' is written in a sans-serif font, with a gradient effect that mirrors the color scheme of the arc above. | | | | Table 6.1: Comparison of Indications for Use Statements | |--|--|--|---------------------------------------------------------| |--|--|--|---------------------------------------------------------| | Updated Device: | Originally Cleared Device: | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Modified Ceevra Reveal 3+ | Ceevra Reveal 3+ (K233568) | | Ceevra Reveal 3+ is intended as a medical imaging<br>system that allows the processing, review, analysis,<br>communication and media interchange of multi-<br>dimensional digital images acquired from CT or MR<br>imaging devices and that such processing may include<br>the generation of preliminary segmentations of normal<br>anatomy using software that employs machine learning<br>and other computer vision algorithms. It is also intended<br>as software for preoperative surgical planning, and as<br>software for the intraoperative display of the<br>aforementioned multi-dimensional digital<br>images.<br>Ceevra Reveal 3+ is designed for use by health care<br>professionals and is intended to assist the clinician who<br>is responsible for making all final patient management<br>decisions. | Ceevra Reveal 3+ is intended as a medical imaging<br>system that allows the processing, review, analysis,<br>communication and media interchange of multi-<br>dimensional digital images acquired from CT or MR<br>imaging devices and that such processing may include<br>the generation of preliminary segmentations of normal<br>anatomy using software that employs machine learning<br>and other computer vision algorithms. It is also intended<br>as software for preoperative surgical planning, and as<br>software for the intraoperative display<br>of the<br>aforementioned multi-dimensional digital<br>images.<br>Ceevra Reveal 3+ is designed for use by health care<br>professionals and is intended to assist the clinician who<br>is responsible for making all final patient management<br>decisions. | | The machine learning algorithms in use by Ceevra | The machine learning algorithms in use by Ceevra | | Reveal 3+ are for use only for adult patients (22 and | Reveal 3+ are for use only for adult patients (22 and | | over). Three-dimensional images for patients under the | over). Three-dimensional images for patients under the | | age of 22 or of unknown age will be generated without | age of 22 or of unknown age will be generated without | | the use of any machine learning algorithms. | the use of any machine learning algorithms. | | Feature/<br>Function | Updated Device:<br>Modified Ceevra Reveal 3+ | Originally Cleared Device:<br>Ceevra Reveal 3+ (K233568) | |----------------------------|--------------------------------------------------------|----------------------------------------------------------| | Supported image Modalities | CT and MR | CT and MR | | Intended users | Healthcare Professionals | Healthcare Professionals | | Intended environment | Healthcare facilities such as<br>hospitals and clinics | Healthcare facilities such as<br>hospitals and clinics | | Device Class | Class II | Class II | | Image analysis features | Interactive manipulation and<br>3D visualization | Interactive manipulation and<br>3D visualization | | Preoperative use | Yes | Yes | | Intraoperative use | Yes | Yes | Table 6.2: Comparison of Technological Characteristics {7}------------------------------------------------ Image /page/7/Picture/0 description: The image features a logo with a stylized, abstract design above the word "CEEVRA." The design consists of curved, blue lines that appear to emanate from a central point, creating a sense of movement or flow. The lines gradually transition into a series of blue dots, adding a gradient effect to the overall shape. The word "CEEVRA" is written in a modern, sans-serif font, with the letters also rendered in a gradient blue color, complementing the design above. | Feature/<br>Function | Updated Device:<br>Modified Ceevra Reveal 3+ | Originally Cleared Device:<br>Ceevra Reveal 3+ (K233568) | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------| | 3D images used intraoperatively<br>for real-time guidance, navigation<br>or otherwise integrated with<br>surgical instruments | No | No | | Segmentation work performed by | Internal Operators | Internal Operators | | Built-in features for end-user to<br>compare CT/MR to device output | No | No | | Quantitative measurements<br>calculated by device | Volume of structure, diameter<br>of structure, distance between<br>two points | Volume of structure, diameter<br>of structure, distance between<br>two points | | Software generates semi-<br>automated segmentations of<br>abnormal anatomy | No | No | | Software generates semi-<br>automated segmentations of<br>certain normal anatomy | Yes | Yes | | Technology used to generate semi-<br>automated segmentations of<br>pulmonary arteries within the<br>lung, pulmonary veins within the<br>lung, pulmonary airways, and<br>bronchopulmonary segments | Machine Learning | Computer vision algorithms<br>not utilizing Machine Learning | #### 7. Performance Data Safety and performance of Modified 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 documents, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. " Four machine learning models are included in Modified Ceevra Reveal 3+. These models were verified with datasets of actual CT or MR imaging studies of patients. A total of 133 imaging studies were used to evaluate the device. No dataset contained more than one imaging study from any particular patient. No Ceevra, Inc., Traditional 510(k) Page 4 {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for CEEVRA. The logo consists of a blue circular design made up of smaller curved lines that resemble a stylized letter 'C'. Below the circular design, the word "CEEVRA" is written in a blue sans-serif font. The overall design is clean and modern. 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 included 48% female patients and 52% male patients. Across all datasets, 31% of patients were under 60 years old, 36% were 60 to 70 years old, 27% were over 70 years old, and 6% were of unknown age. Scanner manufacturers included GE Medical Systems, Toshiba, Hitachi, 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 (from MR prostate imaging) 0.90 DSC; bladder (from MR prostate imaging) 0.93 DSC; neurovascular bundles (from MR prostate imaging) 6.6 mm HD-95; kidney (from CT abdomen imaging) 0.92 DSC; kidney (from MR abdomen imaging) 0.89 DSC; artery (from CT abdomen imaging) 0.90 DSC; artery (from MR abdomen imaging) 0.87 DSC; vein (from CT abdomen imaging) 0.88 DSC; vein (from MR abdomen imaging) 0.82 DSC; pulmonary attery (from CT chest imaging) 0.82 DSC; pulmonary vein (from CT chest imaging) 0.83 DSC, airways (from CT chest imaging) 0.82 DSC; bronchopulmonary segments (from CT chest imaging) 0.86 DSC. The accuracy of measurement features has been validated on phantom data and on datasets of actual CT or MR imaging studies of patients, including CT and MR imaging studies processed with machine learning models. #### Conclusion 8. Based on the intended use, indications for use, technological characteristics, and performance comparison to the originally cleared Reveal 3+ device (K233568), Modified Ceevra Reveal 3+ device is deemed to not raise new questions of safety and effectiveness and is substantially equivalent to the originally cleared device in terms of safety, efficacy, and performance.