(29 days)
Not Found
Yes
The intended use statement explicitly mentions "software that employs machine learning and other computer vision algorithms" for generating preliminary segmentations. The device description and performance studies also detail the use and validation of "machine learning models".
No
The device is described as a medical imaging system and software for surgical planning and display, not for providing direct treatment.
Yes
The device is described 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 is intended to "assist the clinician who is responsible for making all final patient management decisions." The preliminary segmentations of normal anatomy, particularly with the aid of machine learning, are used for "preoperative surgical planning" and "intraoperative display" which are critical steps in diagnosis and treatment planning.
Yes
The device description explicitly states "Ceevra Reveal 3+ ("Reveal 3+"), manufactured by Ceevra, Inc. (the "Company"), is a software as a medical device". It also describes the device as software applications running on compatible mobile devices and computers, and mentions display on external displays or off-the-shelf VR headsets, none of which are part of the device itself.
Based on the provided information, Ceevra Reveal 3+ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Ceevra Reveal 3+ Function: Ceevra Reveal 3+ processes and displays medical images acquired from CT or MR imaging devices. These images are generated from the patient's body, not from specimens taken from the body. The device's purpose is to aid in surgical planning and intraoperative display based on these images.
- No Specimen Analysis: The description of Ceevra Reveal 3+ does not mention any analysis of biological specimens. Its inputs are digital images from imaging modalities.
Therefore, Ceevra Reveal 3+ falls under the category of medical imaging software or surgical planning software, not an In Vitro Diagnostic device.
No
The clearance letter does not explicitly state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / 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 seqmentations 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
Product codes (comma separated list FDA assigned to the subject device)
QIH
Device Description
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 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
CT, MR
Anatomical Site
Not Found
Indicated Patient Age Range
Adult patients (22 and over) for machine learning algorithms. 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.
Intended User / Care Setting
Healthcare professionals / Healthcare facilities such as hospitals and clinics
Description of the training set, sample size, data source, and annotation protocol
No imaging study used to verify performance was used for training; independence of training and testing data were enforced at the level of the scaming 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 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.
Description of the test set, sample size, data source, and annotation protocol
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 than one 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 scaming 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 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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) 0.87 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 (from CT chest imaging) 0.85 DSC; vein (from CT chest imaging) 0.81 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. The types of measurements verified were: volumes of structures, and distances between two points. All three types of measurements produced by Ceevra Reveal 3+ were verified to be accurate within a mean difference of +/- 10%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sørensen-Dice coefficient (DSC), Hausdorff distance metric at the 95th percentile (HD-95)
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 & Drug Administration (FDA). On the left is the Department of Health & 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.
Ceevra, Inc. Ken Koster Cto 149 New Montgomery St. 4th Floor San Francisco, CA 94105
Re: K233568
December 5, 2023
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: November 6, 2023 Received: November 6, 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 (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.
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).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
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-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 Assistant Director DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
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 seqmentations 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)
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
Image /page/3/Picture/0 description: The image shows the logo for CEEVRA, which is a blue, stylized wave-like design above the company name in blue. Below the company name is the alphanumeric code "K233568" in a large, bold font. The logo is simple and modern, with a focus on the company name and the unique identifier.
510(k) Summary
General Information 1.
| 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 | December 4, 2023 |
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 | K222676 |
| Classification Name | Automated Radiological Image Processing Software |
| Regulation Number | 21 CFR 892.2050 |
| Product Code | QIH |
| Regulatory Class | II |
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 features that enable clinicians to interact with the 3D images including rotating,
4
Image /page/4/Picture/0 description: The image shows the logo for CEEVRA. The logo consists of a blue, stylized wave-like design above the word "CEEVRA" in a gradient blue font. The wave design is made up of several curved lines that resemble a crescent shape, with the lines gradually decreasing in size from left to right, giving the impression of movement or flow. The word "CEEVRA" is written in a sans-serif font, with the color transitioning from a darker blue at the top to a lighter blue at the bottom.
zooming, panning, selectively showing or hiding individual anatomical structures, and viewing measurements of or between anatomical structures.
ડ. 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.
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 device.
| Updated Device: | Originally Cleared Device: |
|---|---|
| Ceevra Reveal 3+ | Ceevra Reveal 3 (K222676) |
| Ceevra Reveal 3+ is intended as a medical imaging | Ceevra Reveal 3 is intended as a medical imaging |
| system that allows the processing, review, analysis, | system that allows the processing, review, analysis, |
| communication and media interchange of multi- | communication and media interchange of multi- |
| dimensional digital images acquired from CT or MR | dimensional digital images acquired from CT or MR |
| imaging devices and that such processing may include | imaging devices and that such processing may include |
| the generation of preliminary segmentations of normal | the generation of preliminary segmentations of normal |
| anatomy using software that employs machine learning | anatomy using software that employs machine learning |
| and other computer vision algorithms. It is also intended | and other computer vision algorithms. It is also intended |
| as software for preoperative surgical planning, and as | as software for preoperative surgical planning, and as |
| software for the intraoperative display | software for the intraoperative display |
| of the | of the |
| aforementioned multi-dimensional digital | aforementioned multi-dimensional digital |
| images. | images. |
| Ceevra Reveal 3+ is designed for use by health care | Ceevra Reveal 3 is designed for use by health care |
| professionals and is intended to assist the clinician who | professionals and is intended to assist the clinician who |
| is responsible for making all final patient management | is responsible for making all final patient management |
| decisions. | 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). |
| over). Three-dimensional images for patients under the | Three-dimensional images for patients under the age of |
| age of 22 or of unknown age will be generated without | 22 or of unknown age will be generated without the use |
| the use of any machine learning algorithms. | of any machine learning algorithms. |
Table 6.1: Comparison of Intended Use Statements
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Image /page/5/Picture/0 description: The image shows the logo for CEEVRA. The logo consists of a blue, semi-circular design made up of small squares that gradually decrease in size as they extend outward. Below the design, the word "CEEVRA" is written in a blue, sans-serif font. The overall design is clean and modern.
| Feature/
Function | Updated Device:
Ceevra Reveal 3+ | Originally Cleared Device:
Ceevra Reveal 3 (K222676) |
|-------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|---------------------------------------------------------|
| 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 use | Yes | Yes |
| Intraoperative use | 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 measurements
calculated by device | Volume of structure,
diameter of structure,
distance between two points | None |
| Software generates semi-automated
segmentations of abnormal anatomy | No | No |
| Software generates semi-automated
segmentations of certain normal
anatomy | Yes | Yes |
Table 6.2: Comparison of Technological 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 life cycle processes, in addition to the FDA Guidance documents, "Guidance for the Content of Premarket Submissions for Software in Medical Devices" and "Content of Premarket Submission for Management of Cybersecurity in Medical Devices."
Machine Learning Models
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 than one 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 scaming 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 40% female patients and 60% male patients. Across all datasets, 32% of patients were under 60 years old,
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Image /page/6/Picture/0 description: The image shows the logo for CEEVRA. The logo consists of a blue, stylized letter C formed by a series of curved lines that resemble a wave or a digital signal. Below the symbol, the word "CEEVRA" is written in a simple, sans-serif font, also in blue.
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 (from MR 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 (from CT chest imaging) 0.85 DSC; vein (from CT chest imaging) 0.81 DSC.
Measurement Features
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. The types of measurements verified were: volumes of structures, and distances between two points. All three types of measurements produced by Ceevra Reveal 3+ were verified to be accurate within a mean difference of +/- 10%.
8. Conclusion
Based on the intended use, indications for use, technological characteristics, and performance comparison to the originally cleared Reveal 3 device (K222676), the updated Ceevra Reveal 3+ device is deemed to not rasse new questions of safety and effectiveness and is substantially equivalent to the originally cleared device in terms of safety, efficacy, and performance.