(158 days)
Not Found
No
The document explicitly states that a "(non-Al) image processing approach is applied to CT imaging data".
No.
The device is described as a workflow enhancement and a tool to support physicians in evaluating radiological findings and forming diagnoses; it does not directly treat or prevent a disease.
No
The device is described as a "workflow enhancement" tool that provides "quantitative support in the examination of radiological findings" and helps physicians "form a potential diagnosis or list of likely diagnoses." However, it explicitly states, "The software does not perform any function which cannot be accomplished by a trained user utilizing manual tracing methods" and its "intent... is to enhance the workflow by saving time and automating potential error prone manual tasks." This indicates it aids in the diagnostic process but does not independently make a diagnosis, thus it is not a diagnostic device itself.
Yes
The device is explicitly described as a "stand-alone software device" and runs on off-the-shelf hardware. Its function is image processing and analysis of CT data, with no mention of integrated or proprietary hardware components.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: IVDs are designed to examine specimens derived from the human body, such as blood, urine, tissue, etc., to provide information about a person's health.
- This device analyzes medical images: The e-Lung software processes CT thoracic datasets, which are medical images, not biological samples.
- The intended use is image analysis and workflow enhancement: The description clearly states the software provides quantitative support for evaluating radiological findings from CT scans and enhances the workflow for physicians examining these images. It does not analyze biological markers or substances from a patient sample.
While the software provides quantitative data that can support a physician in forming a diagnosis, the data itself is derived from image analysis, not from an in vitro examination of a biological specimen.
N/A
Intended Use / Indications for Use
The e-Lung software provides reproducible CT values for pulmonary tissue, which is essential for providing quantitative support in the examination of radiological findings. These radiological findings can then be evaluated by the physician in conjunction with a range of ancillary information to form a potential diagnosis or list of likely diagnoses. The e-Lung software package is intended to be a workflow enhancement and visualization tool for the assessment of CT thoracic datasets. e-Lung can be used to support the physician when examining the pulmonary and thoracic tissue (i.e. lung parenchyma) in CT thoracic datasets. 3D segmentation, volumetric measurements, density evaluations, and reporting tools are combined with a dedicated workflow.
Product codes
JAK
Device Description
Brainomix 360 e-Lung is a software package compliant with the DICOM standard and running on an off-the-shelf physical or virtual server. e-Lung is a CT processing module which operates within the integrated Brainomix 360 platform.
Brainomix 360 e-Lung is a stand-alone software device which uses a set of image processing algorithms to perform evaluation (3D segmentation and isolation of sub-compartments, volumetric measurements, and density evaluations), editing, and reporting tools which are combined with a dedicated workflow.
e-Lung can be used to support the physician in the examination of radiological findings that may be indicative of chest diseases e.g. when examining the pulmonary and thoracic tissue (i.e. lung parenchyma) in CT thoracic datasets. These radiological findings can then be evaluated by the physician in conjunction with a range of ancillary information to form a potential diagnosis or list of likely diagnoses.
e-Lung is designed to analyze pulmonary CT slice data and display analysis results. Each voxel of the scan is measured by Hounsfield units (HU), a measurement of x-ray attenuation that is applied to each volume element in three dimensional space. The HU are utilized to distinguish between air, water, tissue and bone, such distinction is common in the industry.
e-Lung provides computed tomography (CT) viewing, and parenchymal density analysis in one application. e-Lung provides quantitative measurements and tabulates quantitative properties.
e-Lung focuses on what is visible to the eye and applies volumetric methods that might otherwise be too time consuming to use.
The software does not perform any function which cannot be accomplished by a trained user utilizing manual tracing methods; the software does not reconstruct a 3D rendering image of the lung; the intent of the software is to enhance the workflow by saving time and automating potential error prone manual tasks.
e-Lung has functions for loading, and saving datasets, and will generate screen displays, computations and aggregate statistics. e-Lung data output may be exported to a CSV, Excel or PDF file.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found. The device states "A (non-Al) image processing approach is applied to CT imaging data to automatically segment lung mask". The predicate device uses "A non-adaptive deep learning-based algorithm is applied to the CT imaging data to automatically segment lung regions."
Input Imaging Modality
CT
Anatomical Site
pulmonary and thoracic tissue (i.e. lung parenchyma)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Dataset for lung segmentation validation:
- Sample Size: 100 cases (N=38 from a research registry at Boston Medical Center, N=62 from a commercial database of clinical imaging data).
- Data Source: Retrospective study of tomography (CT) chest studies from Boston Medical Center and a commercial database.
- Annotation Protocol: Ground truth lung masks were generated from the consensus of three experienced US board certified radiologists who segmented the lungs following their usual standard of care.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Study Type: Clinical Study (lung segmentation), retrospective.
- Sample Size: 100 cases.
- Standalone Performance: The e-Lung software's lung mask generation was compared to ground truth masks.
- Key Results: The similarity was evaluated using Dice Similarity Coefficients (DSC). The acceptability criterion was an average DSC across all cases of over 0.95 (lower bound of confidence interval). All cases showed a DSC above 0.95. The median DSC was 0.978 (IQR: 0.974-0.980). Performance was consistent for left (median DSC=0.976, IQR: 0.972-0.978) and right lungs (median DSC=0.979, IQR: 0.976-0.981). Performance was also consistent across various demographic, clinical, and imaging subgroups.
- Study Type: Digital Phantom (Density Evaluations)
- Standalone Performance: Tested density analysis output (structural density filtering and density histogram evaluation).
- Key Results: Validated by ensuring a good Dice score (min 0.80) between e-Lung structural densities and histogram densities and predefined parameters in the digital phantom dataset.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Dice Similarity Coefficients (DSC): All cases showed a DSC of above the acceptability criterion (DSC=0.95). The median DSC was 0.978 (IQR: 0.974-0.980).
For density evaluations: Dice score (min 0.80).
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
May 13, 2024
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Brainomix Limited % Thais Sala Senior Quality Assurance and Regulatory Affairs Manager First Floor, Seacourt Tower West Way OXFORD. OX2JJ UNITED KINGDON
Re: K233875
Trade/Device Name: Brainomix 360 e-Lung Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: December 7, 2023 Received: April 15, 2024
Dear Thais Sala:
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 (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/cdrb/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-devices/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,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Rav Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K233875
Device Name Brainomix 360 e-Lung
Indications for Use (Describe)
The e-Lung software provides reproducible CT values for pulmonary tissue, which is essential for providing quantitative support in the examination of radiological findings. These radiological findings can then be evaluated by the physician in conjunction with a range of ancillary information to form a potential diagnosis or list of likely diagnoses. The e-Lung software package is intended to be a workflow enhancement and for the assessment of CT thoracic datasets. e-Lung can be used to support the physician when examining the pulmonary and thoracic tissue (i.e. lung parenchyma) in CT thoracic datasets. 3D segmentation, volumetric measurements, density evaluations, and reporting tools are combined with a dedicated workflow.
| 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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3
Image /page/3/Picture/0 description: The image shows the logo for BRAINOMIX. The logo consists of a stylized brain icon on the left, followed by the word "BRAINOMIX" in a sans-serif font. The brain icon is a gradient of light blue to dark blue. The letters "B", "R", "N", "O", "M", "X" are dark gray, while the letters "A" and "I" are a gradient of light blue to dark blue.
K233875
510(K) Summary Brainomix Limited – Brainomix 360 e-Lung
| Date Prepared: | 07Dec2023 |
|---|---|
| Applicant's Name: | Brainomix Limited |
| Applicant's Address: | First Floor, Seacourt Tower, West Way |
| Oxford, OX2 0JJ | |
| United Kingdom | |
| Official Contact: | Thais Sala |
| +44 (0) 7375 967 695 | |
| tsala@brainomix.com | |
| Device Proprietary Name: | Brainomix 360 e-Lung |
| Regulation Name: | Computed tomography x-ray system |
| Regulatory Class: | Class II |
| Product Code: | JAK |
| Regulation Number: | 21 C.F.R. §892.1750 |
1. Predicate Device
Brainomix 360 e-Lung is Substantially Equivalent to the following Legally Marketed device:
Trade Name: Vida | Vision Manufacturer: VIDA Diagnostics Inc. Regulation Number: 21 C.F.R. §892.1750 Regulatory Class: Class II Regulation Name: Computed tomography x-ray system Product Code: JAK Submission Number: K200990
2. Device Description
Brainomix 360 e-Lung is a software package compliant with the DICOM standard and running on an off-the-shelf physical or virtual server. e-Lung is a CT processing module which operates within the integrated Brainomix 360 platform.
Brainomix 360 e-Lung is a stand-alone software device which uses a set of image processing algorithms to perform evaluation (3D segmentation and isolation of sub-compartments, volumetric measurements, and density evaluations), editing, and reporting tools which are combined with a dedicated workflow.
e-Lung can be used to support the physician in the examination of radiological findings that may be indicative of chest diseases e.g. when examining the pulmonary and thoracic tissue (i.e. lung parenchyma) in CT thoracic datasets. These radiological findings can then be evaluated by the
4
Image /page/4/Picture/0 description: The image shows the logo for BRAINOMIX. The logo consists of a stylized brain icon on the left, followed by the word "BRAINOMIX" in a sans-serif font. The brain icon is a gradient of light blue, while the letters "AI" in "BRAINOMIX" are also in the same light blue gradient, contrasting with the rest of the word which is in a dark gray color.
physician in conjunction with a range of ancillary information to form a potential diagnosis or list of likely diagnoses.
e-Lung is designed to analyze pulmonary CT slice data and display analysis results. Each voxel of the scan is measured by Hounsfield units (HU), a measurement of x-ray attenuation that is applied to each volume element in three dimensional space. The HU are utilized to distinguish between air, water, tissue and bone, such distinction is common in the industry.
e-Lung provides computed tomography (CT) viewing, and parenchymal density analysis in one application. e-Lung provides quantitative measurements and tabulates quantitative properties.
e-Lung focuses on what is visible to the eye and applies volumetric methods that might otherwise be too time consuming to use.
The software does not perform any function which cannot be accomplished by a trained user utilizing manual tracing methods; the software does not reconstruct a 3D rendering image of the lung; the intent of the software is to enhance the workflow by saving time and automating potential error prone manual tasks.
e-Lung has functions for loading, and saving datasets, and will generate screen displays, computations and aggregate statistics. e-Lung data output may be exported to a CSV, Excel or PDF file.
3. Intended Use / Indications for Use
The e-Lung software provides reproducible CT values for pulmonary tissue, which is essential for providing quantitative support in the examination of radiological findings. These radiological findings can then be evaluated by the physician in conjunction with a range of ancillary information to form a potential diagnosis or list of likely diagnoses. The e-Lung software package is intended to be a workflow enhancement and visualization tool for the assessment of CT thoracic datasets. e-Lung can be used to support the physician when examining the pulmonary and thoracic tissue (i.e. lung parenchyma) in CT thoracic datasets. 3D segmentation, volumetric measurements, density evaluations, and reporting tools are combined with a dedicated workflow.
4. Performance Data
4.1 Clinical Study (lung segmentation)
A retrospective study has been carried out to validate the lung segmentation functionality of e-Lung. The study evaluated the accuracy of the e-Lung lung mask generation compared to a ground truth mask generated from the consensus of three experienced US board certified radiologists, who segmented the lungs following their usual standard of care. The similarity between the device lung masks and the ground truth lung masks was evaluated using Dice Similarity Coefficients (DSC), which index the amount of overlap between the two masks. The acceptability criterion for the study was an average DSC across all cases of over 0.95 (defined by the lower bound of the confidence interval).
The dataset for this validation study comprised tomography (CT) chest studies performed in the clinical context of evaluation of lung disease. Cases were selected from two sources: from a research registry held at Boston Medical Center (N=38) and from a commercial database of clinical imaging data (N=62). The number of cases from different scanner manufacturers and models
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Image /page/5/Picture/0 description: The image shows the logo for BRAINOMIX. The logo consists of a stylized brain icon on the left, followed by the word "BRAINOMIX" in a sans-serif font. The "A" in "BRAINOMIX" is designed with a gradient fill, transitioning from blue to green.
is shown in Table 1. A range of convolution kernels and acquisition parameters were included in the dataset, including 24 cases acquired with contrast.
The dataset was enriched to ensure a distribution of clinical and demographic variables (e.g. age, gender, race/ethnicity, clinical site, BMI, smoking history and radiological findings) that allows generalizability to the patient population for whom use is intended. The median age was 61 years (inter-quartile range [IQR]: 52.5-70, total range: 23-100). The number of cases in relevant demographic or clinical subgroups is shown in Table 2.
All cases were successfully processed by the device. All cases showed a DSC of above the acceptability criterion (DSC=0.95). The distribution of DSC is shown in Figure 1. The median DSC was 0.978 (IQR: 0.974-0.980). Hence, the study met the acceptability criterion. Performance was consistent for the left and right lungs (left: median DSC=0.976, IQR: 0.972-0.978; right: median DSC=0.979, IQR: 0.976-0.981). Table 3 reports the median (and IQR) DSC for clinically-relevant subgroups, including age, gender, race/ethnicity, BMI, smoking status, radiological findings, hospital location, scanner manufacturer, slice thickness, KvP and contrast. Lung segmentation performance of the device was consistent across all subgroups.
| Manufacturer | Model | N |
|---|---|---|
| SIEMENS | All | 36 |
| SOMATOM Perspective | 22 | |
| SOMATOM go.Up | 6 | |
| SOMATOM Definition AS+ | 3 | |
| SOMATOM Definition AS | 2 | |
| Sensation 16 | 2 | |
| SOMATOM go.Top | 1 | |
| GE | All | 28 |
| Revolution Apex | 9 | |
| Revolution Frontier | 8 | |
| Revolution CT | 7 | |
| LightSpeed VCT | 2 | |
| BrightSpeed S | 1 | |
| Discovery STE | 1 | |
| Philips | All | 23 |
| IQon - Spectral CT | 12 | |
| Brilliance 16 | 4 | |
| Brilliance 64 | 4 | |
| Brilliance 6 | 2 | |
| Gemini | 1 | |
| Toshiba | All | 13 |
| Aquilion | 9 |
Table 1. Table showing the number of cases in the lung segmentation different scanner manufacturers and models.
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Image /page/6/Picture/0 description: The image shows the logo for BRAINOMIX. The logo consists of a stylized brain image on the left, followed by the word "BRAINOMIX" in a sans-serif font. The "A" and "I" in "BRAINOMIX" are in a lighter blue color, while the rest of the letters are in a darker gray color. The brain image is also in the lighter blue color.
Aquilion ONE 4
Distribution of DSC, Ground Truth vs Device
Image /page/6/Figure/4 description: This image is a histogram showing the distribution of DSC values. The x-axis represents the DSC values, ranging from 0.95 to 0.99, while the y-axis represents the frequency, ranging from 0 to 40. The histogram shows a distribution that is skewed to the left, with the highest frequency of DSC values around 0.97 to 0.98. The image also includes the text 'W = 0.913, p