(189 days)
Not Found
Yes
The "Summary of Performance Studies" section explicitly states that the study evaluated the "AI/ML segmentation algorithm method (proposed device)".
No
The device is described as a "workflow enhancement and visualization tool" for assessing CT thoracic datasets, providing quantitative measurements and analysis to support diagnosis, not to provide therapy.
No
The e-Lung software is described as a "workflow enhancement and visualization tool" that provides "quantitative support in the examination of radiological findings." It processes CT data to provide measurements and evaluations (3D segmentation, volumetric measurements, density evaluations) that "support the physician when examining the pulmonary and thoracic tissue." While these findings can "form a potential diagnosis or list of likely diagnoses" when evaluated by a physician in conjunction with ancillary information, the software itself "does not perform any function which cannot be accomplished by a trained user utilizing manual tracing methods." It is stated that it "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." This indicates it's an aid for the physician's diagnostic process, primarily for visualization and quantification, rather than making a diagnosis itself or providing diagnostic conclusions.
Yes
The device description explicitly states "Brainomix 360 e-Lung is a stand-alone software device". It runs on off-the-shelf hardware and processes existing CT data.
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 taken 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 examining radiological findings, enhances workflow, and visualizes CT data. It does not mention analyzing biological samples.
- The output is image-based measurements and reports: The software provides segmentations, volumetric measurements, density evaluations, and reports based on the CT images.
While the software provides quantitative data that can support a physician in forming a diagnosis, it does so by analyzing images, not biological samples. Therefore, it falls under the category of medical imaging software or a medical device software, not an In Vitro Diagnostic.
No
The provided text does not contain any explicit statement that the FDA has reviewed, approved, or cleared a PCCP for this specific device.
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 (comma separated list FDA assigned to the subject device)
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 documentation of radiological findings that may be indicative of chest diseases when examining the pulmonary and thoracic tissue (i.e. lung parenchyma) in CT thoracic datasets. These radiological findings are then evaluated 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
Yes
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The lung segmentation performance of the updated algorithm was validated through a head-to-head comparison between proposed and predicate devices. 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. It was demonstrated that the Dice Similarity Coefficient (DSC) values were significantly higher for the AI/ML segmentation algorithm method (proposed device) than the segmentation method of the predicate device (V=11628, p
§ 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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and 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.
February 19, 2025
Brainomix Limited % Zsolt Szrnka Regulatory Affairs Manager First Floor, Seacourt Tower West Way OXFORD. OX2 0JJ UNITED KINGDOM
Re: K242411
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: August 14, 2024 Received: January 16, 2025
Dear Zsolt Szrnka:
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. 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-ray Systems Team 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
Enclosure
3
Indications for Use
Submission Number (if known)
K242411
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 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.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
K242411
Image /page/4/Picture/1 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 blue and teal, while the word "BRAINOMIX" is mostly gray, with the "AI" portion in a matching blue and teal gradient.
510(k) Summary Brainomix Limited – Brainomix 360 e-Lung
| Date Prepared: | 16Jan2025 |
|---|---|
| Applicant's Name: | Brainomix Limited |
| Applicant's Address: | First Floor, Seacourt Tower, West Way |
| Oxford, OX 0JJ | |
| United Kingdom | |
| Official Contact: | Zsolt Szrnka |
| +44 (0) 1865 582730 | |
| regulatory@brainomix.com | |
| Device Proprietary Name: | Brainomix 360 e-Lung |
| Device Classification Name: | System, X-Ray, Tomography, Computed |
| Regulatory Class: | Class II |
| Product Code: | JAK |
| Regulation Number: | 21 C.F.R. §892.1750 |
| Regulation Name: | Computed tomography x-ray system |
1. Predicate Device
Brainomix 360 e-Lung is Substantially Equivalent to the following Legally Marketed device:
Trade Name: Brainomix 360 e-Lung Manufacturer: Brainomix Ltd. Regulation Number: 21 C.F.R. §892.1750 Regulatory Class: Class II Regulation Name: Computed tomography x-ray system Product Code: JAK Submission Number: K233875
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.
5
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 bold, sans-serif font. The brain icon and the "AI" in the word "BRAINOMIX" are in a gradient of light blue to teal, while the rest of the word is in dark gray.
e-Lung can be used to support the physician in the documentation of radiological findings that may be indicative of chest diseases when examining the pulmonary and thoracic tissue (i.e. lung parenchyma) in CT thoracic datasets. These radiological findings are then evaluated 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
e-Lung complies with DICOM (Digital Imaging and Communications in Medicine) – developed by the American College of Radiology and the National electrical Manufacturers Association. NEMA PS 3.1 – 3.20.
The lung segmentation performance of the updated algorithm was validated through a head-to-head comparison between proposed and predicate devices. 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. It was demonstrated that the Dice Similarity Coefficient (DSC) values were significantly higher
6
Image /page/6/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 blue and green, while the letters "AI" in the word "BRAINOMIX" are also in the same gradient of blue and green, while the rest of the letters are in a dark gray color.
for the AI/ML segmentation algorithm method (proposed device) than the segmentation method of the predicate device (V=11628, p