(479 days)
CerebralGo Plus is an image processing software package to be used by trained professionals, including, but not limited to physicians and medical technicians. The software runs on standard "off-the-shel" hardware and can be used for image viewing and processing. Data and images are acquired through DICOM compliant imaging devices.
CerebralGo Plus provides viewing and processing capabilities for imaging datasets acquired with adult's CTA (CT Angiography).
CerebralGo Plus is not intended for primary diagnostic use.
CerebralGo Plus is a medical image management and processing software package to be used by trained professionals, including, but not limited to physicians and medical technicians.
The software runs on standard "off-the-shelf" hardware and can be used for image viewing, and processing images of DICOM compliant CTA imaging which, when interpreted by a trained clinician, may yield information useful in clinical decision making.
CerebralGo Plus system provides a wide range of basic image viewing, processing, and manipulation functions, through multiple output formats. The software is used to visualize large vessels from head and neck CTA imaging.
Here's a detailed breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria & Reported Device Performance
The document does not explicitly state formal acceptance criteria in a table format with pass/fail thresholds. Instead, it reports performance metrics (Dice Coefficient and 95% Hausdorff Distance) from a verification study. The implied "acceptance" is that these metrics demonstrate the device's efficacy for its intended use, particularly for segmentation tasks (implied by Dice and Hausdorff metrics which are common in image segmentation validation).
| Metric / Parameter | Unit of Measurement | Reported Device Performance |
|---|---|---|
| Dice Coefficient | N/A (unitless, a similarity measure) | 0.942 |
| 95% Hausdorff Distance | Millimeters (implied for medical imaging) | 3.692 |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 141 images.
- Data Provenance: The images were collected from the US and are described as covering different genders, ages, ethnicities, equipment, and CT protocols. It is a retrospective dataset as it was collected for verification of a pre-existing algorithm.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: 3 radiologists.
- Qualifications of Experts: All 3 radiologists were from the US. Their specific experience level (e.g., years of experience, subspecialty) is not explicitly stated in the provided text.
4. Adjudication Method for the Test Set
- Adjudication Method: When the first two radiologists conflicted (presumably in their independent assessments), a third radiologist would arbitrate to generate the reference standard (ground truth). This can be described as a 2+1 adjudication model.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done? No, a human-in-the-loop MRMC study comparing human readers with AI assistance versus without AI assistance was not done. The study described is a standalone (algorithm-only) performance evaluation against a consensus ground truth.
- Effect Size of Human Improvement (if applicable): Not applicable, as no MRMC study was conducted.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study Done? Yes. The performance data section explicitly states "Stand-alone software performance testing" and the results are presented for the algorithm itself (Dice Coefficient and Hausdorff Distance).
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the test set was established through expert consensus among 3 radiologists, using a 2+1 adjudication method.
8. Sample Size for the Training Set
- Training Set Sample Size: The exact sample size for the training set is not specified. The document only states that "Algorithm training of CerebralGo Plus has been conducted on images collected from China as training dataset."
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: The document does not provide details on how the ground truth for the training set (images collected from China) was established. It only mentions that these images were used for algorithm training.
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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 is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration" in a larger font and the word "Administration" in a smaller font.
Yukun (Beijing) Technology Co., Ltd. % Wang Qi Regulatory Affairs Manager Room 313/315, Building 3, No.11 Chuangxin Road, Science Park Beijing, Beijing 102200 CHINA
Re: K213986
April 13, 2023
Trade/Device Name: CerebralGo Plus Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QIH, LLZ Dated: March 12, 2023 Received: March 13, 2023
Dear Wang Qi:
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
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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 DHT 8B: Division of Radiological Imaging Devices and Electronic Products OHT 8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213986
Device Name CerebralGo Plus
Indications for Use (Describe)
CerebralGo Plus is an image processing software package to be used by trained professionals, including, but not limited to physicians and medical technicians. The software runs on standard "off-the-shel" hardware and can be used for image viewing and processing. Data and images are acquired through DICOM compliant imaging devices.
CerebralGo Plus provides viewing and processing capabilities for imaging datasets acquired with adult's CTA (CT Angiography).
CerebralGo Plus is not intended for primary diagnostic use.
| 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)
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Image /page/3/Picture/0 description: The image contains a logo and a number. The logo is a stylized letter 'M' composed of overlapping lines in shades of blue and purple. To the right of the logo is the number 'K213986' in a clear, sans-serif font. The number is likely an identification or tracking code.
This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.
| A. SUBMITTER | Yukun (Beijing) Technology Co., LtdRoom 313/315, Building 3, No.11 Chuangxin Road,Science Park, Chuangxin Road, Science Park, ChangpingDistrict, Beijing, China 102200Phone: +86 10-8973-5152 | |
|---|---|---|
| Contact Person: | Wang Qi, Regulatory Affairs ManagerEmail: wangqi@shukun.netContact Phone: +86 10-89735152 | |
| Date Summary Prepared: | Mar. 21, 2023 | |
| B. DEVICE | ||
| Trade or Proprietary Name: | CerebralGo Plus | |
| Version: | 1.0 | |
| Common Name: | Picture Archiving and Communications System | |
| Regulation Name: | Medical Image Management and Processing System | |
| Regulation Number: | 21 CFR 892.2050 | |
| Regulatory Class: | Class II | |
| Product Code: | QIH, LLZ |
C. LEGALLY MARKETED PREDICATE DEVICE
| 510(k) Number | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| K192692 | LLZ | Brainomix 360° e-CTA | Brainomix Limited |
This predicate device has not been subject to a design-related recall.
There are no reference devices in this submission.
D. DEVICE DESCRIPTION
CerebralGo Plus is a medical image management and processing software package to be used by trained professionals, including, but not limited to physicians and medical technicians.
The software runs on standard "off-the-shelf" hardware and can be used for image viewing, and processing images of DICOM compliant CTA imaging which, when interpreted by a trained clinician, may yield information useful in clinical decision making.
CerebralGo Plus system provides a wide range of basic image viewing, processing, and manipulation functions, through multiple output formats. The software is used to visualize large vessels from head and neck CTA imaging.
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Image /page/4/Picture/0 description: The image shows a logo with an abstract design. The logo features a stylized letter "M" composed of several overlapping geometric shapes in shades of pink, purple, and blue. To the right of the "M" is a small, solid blue circle, which serves as a visual anchor and balances the composition.
CerebralGo Plus can connect with other DICOM-compliant devices (e.g., Picture Archiving and Communication System (PACS), Workstations, CT Scanners) to receive CTA scans. After processing, results and images can be sent to a PACS via DICOM transfer and can be viewed on a PACS workstation or via a web user interface contained and accessed within a hospital network and firewall.
Algorithm training of CerebralGo Plus has been conducted on images collected from China as training dataset. Algorithm verification has been conducted on US images.
E. INDICATIONS FOR USE
The proposed indications for use for CerebralGo Plus are as follows:
CerebralGo Plus is an image processing software package to be used by trained professionals, including, but not limited to physicians and medical technicians. The software runs on standard "off-the-shelf" hardware and can be used for image viewing, and processing. Data and images are acquired through DICOM compliant imaging devices.
CerebralGo Plus provides viewing and processing capabilities for imaging datasets acquired with adult's CTA (CT Angiography).
CerebralGo Plus is not intended for primary diagnostic use.
F. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The technological design features of CerebralGo Plus have been compared to the predicate in intended use, indications for use, design, function, and technology and it is demonstrated that they are substantially equivalent.
| Table 2 Technological Characteristics Comparison Table | ||
|---|---|---|
| Characteristics | Predicate Device | Subject Device |
| Brainomix 360° e-CTA(K192692) | CerebralGo Plus(K213986) | |
| Brainomix Limited | Yukun (Beijing) Technology Co.,Ltd | |
| Regulatory Class | Class II | Class II |
| Product Code | LLZ | QIH, LLZ |
| Regulation | 21 CFR 892.2050 | 21 CFR 892.2050 |
| Device Description | Brainomix 360° e-CTA is asoftware package that providesfor the study of changes oftissue in digital imagescaptured by CT. Brainomix360° e-CTA provides viewingand quantification for CTAimages. | CerebralGo Plus is a softwarepackage that provides for thevisualization digital imagescapture byCTA. |
| IntendedUse/Indications forUse | Brainomix 360° e-CTA is animage processing softwarepackage to be used by trainedprofessionals, including, butnotlimited to physicians andmedical technicians. Thesoftware runs on standard "off-the-shelf" hardware (physicalor virtualized) and can be usedto perform image viewing,processing and analysis ofimages. Data and images areacquired through DICOMcompliant imaging devices.Brainomix 360° e-CTAprovides viewing and analysiscapabilities for imagingdatasets acquired with CTA(CT Angiography).Brainomix 360° e-CTA is notintended for mobile diagnosticuse. | CerebralGo Plus is an imageprocessing software package to beused by trained professionals,including, but not limited tophysiciansandmedicaltechnicians. The software runs onstandard "off-the-shelf" hardwareand can be used for imageviewing and processing. Data andimages are acquired throughcompliantDICOMimagingdevices.CerebralGoPlusprovidesprocessingandviewingcapabilities for imaging datasetsacquired with adult's CTA (CTAngiography).CerebralGo Plus is not intendedfor primary diagnostic use. |
| Environment of Use | Clinical/Hospital Environment | Clinical/Hospital Environment |
| Energy used an/ordelivered | None—software onlyapplication. The softwareapplication does not deliver ordepend on energy delivered toor from patients | None—software onlyapplication. The softwareapplication does not deliver ordepend on energy delivered to orfrom patients |
| End User | Trained clinicians | Trained clinicians |
Table 2 Technological Characteristics Comparison Table
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Image /page/5/Picture/0 description: The image shows a stylized logo with an abstract design. The logo features a series of connected shapes in varying shades of purple, blue, and teal. The shapes are arranged to resemble a stylized letter 'M' or a mountain range, with a small dot to the right of the main structure.
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Image /page/6/Picture/0 description: The image shows a logo with two stylized, connected shapes that resemble the letter 'M'. The shapes are formed by rounded, parallel lines in a gradient of colors, transitioning from pink and purple on the left to blue and teal on the right. A small, solid teal circle is positioned to the right of the shapes, adding a subtle accent to the overall design. The logo has a modern and abstract appearance.
| Supported Modalitiesfor image processingand visualization | CTA | CTA |
|---|---|---|
| PACS Functionality | View process and analyzemedical images. Performsstandard PACS functions withrespect to querying and listing | View process and analyzemedical images. Performsstandard PACS functions withrespect to querying and listing |
| DICOM Compliance | Yes | Yes |
| Computer Platform | Standard Physical and Virtualoff-the shelf Server | Standard off-the shelf server |
| Data Acquisition | Acquires medical image datafrom DICOM compliantimaging devices andmodalities | Acquires medical image datafrom DICOM compliant imagingdevices and modalities |
| CTA modality | CTA large vessel | CTA large vessel |
| Performance Data | Stand-alone softwareperformance testing | Stand-alone softwareperformance testing |
G. PERFORMANCE DATA
The results of software performance testing demonstrate that CerebralGo Plus has met all design requirements and specifications associated with the intended use of the software. All testing has been carried out in compliance with the requirements of 21 CFR 820 and in adherence to the DICOM standard.
Regarding the validation of the algorithm, the test data was used independently from training dataset.
The algorithm testing of CerebralGo Plus has been performed using 141 images collected from US, which covered different gender, age, ethnicity, equipment and CT protocol used to collect images. The information of demographic and equipment distribution was as follows:
| Demographic information | Quantity | |
|---|---|---|
| Gender | Male | 68 |
| Female | 73 | |
| Age | <40 | 6 |
| 40~70 | 58 | |
| >70 | 54 |
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Image /page/7/Picture/0 description: The image shows a logo with a stylized letter 'M' formed by overlapping geometric shapes in shades of purple, blue, and teal. The shapes create a sense of depth and movement, with the colors blending together to form a gradient effect. A small teal circle is positioned to the right of the 'M', possibly serving as a period or a design element to balance the composition.
| Unknown | 23 | |
|---|---|---|
| Ethnicity | Black or African American | 1 |
| Hispanic/Latino | 2 | |
| Non-Hispanic/Latino | 82 | |
| White | 5 | |
| Unknown | 51 | |
| Equipment information | Quantity |
| Equipment information | Quantity | |
|---|---|---|
| Equipment | GE | 4 |
| Siemens | 6 | |
| Philips | 101 | |
| Toshiba | 30 |
The reference standard of 141 images was created by 3 radiologists from US. When the two radiologists conflicted, the third radiologist would arbitrate and generate the reference standard. The results output by algorithm were compared with the reference standard, the value of Dice coefficient was 0.942, the value of 95% Hausdorff Distance was 3.692. The subgroups analysis was conducted based on scanning equipment, gender and age, and the results were shown in the table below:
| Parameter | Dice | HD95 | |
|---|---|---|---|
| Equipment | TOSHIBA | 0.936 | 3.979 |
| Philips | 0.945 | 3.494 | |
| SIEMENS | 0.942 | 1.328 | |
| GE | 0.924 | 10.098 | |
| Gender | Female | 0.941 | 3.702 |
| Male | 0.944 | 3.682 | |
| Age | <40 | 0.955 | 1.000 |
| 40-70 | 0.946 | 2.426 |
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Image /page/8/Picture/0 description: The image shows a logo with a stylized letter 'M'. The 'M' is formed by three overlapping shapes in shades of blue, purple, and pink, creating a gradient effect. To the right of the 'M' is a small, solid blue circle, which appears to be a dot. The logo has a modern and abstract design.
| >=70 | 0.940 | 4.846 | |
|---|---|---|---|
| -- | ------ | ------- | ------- |
Clinical Information
Not applicable; determination of substantial equivalence is not based on assessment of clinical performance data.
H. CONCLUSION
Based upon the information provided in this 510(k) submission, it has been determined that the subject device is substantially equivalent to the predicate device in regards to indications for use, intended use, design, technology, and performance.
§ 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).