(189 days)
Not Found
Yes
The device description explicitly states that the software "utilizes AI algorithms for semi-automated liver segmentation".
No
The device is an image analysis software used for visualization, evaluation, and reporting of liver and lesions, aiding in assessment and treatment planning. It does not directly provide therapy or treatment.
No
The "Note" explicitly states: "DrAid™ for Liver Segmentation does not generate diagnoses or potential findings directly." Instead, it provides tools for visualization, evaluation, and reporting of liver and lesions, aiding in assessment and treatment planning, with the interpretation and clinical decision-making left to qualified healthcare professionals.
Yes
The device is explicitly described as "web-based software" and "software medical device" with "Software" listed as a device characteristic. While it processes images from CT scanners, the device itself is the software application.
Based on the provided information, DrAid™ for Liver Segmentation is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. This typically involves analyzing biological samples like blood, urine, or tissue.
- DrAid™ Functionality: DrAid™ for Liver Segmentation analyzes medical images (CT scans) of the liver. It processes and segments the liver and identified lesions within the body, not specimens taken from the body.
- Intended Use: The intended use is for visualization, evaluation, and reporting of liver and lesions using imaging data, aiding in evaluation and treatment planning. It explicitly states it "does not generate diagnoses or potential findings directly."
- Device Description: The description focuses on image processing, AI algorithms for segmentation, and measurement tools applied to CT images.
Therefore, DrAid™ for Liver Segmentation falls under the category of a medical image analysis software, not an In Vitro Diagnostic device.
No
The letter does not state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The "Control Plan Authorized (PCCP) and relevant text" section explicitly states "Not Found".
Intended Use / Indications for Use
DrAid™ for Liver Segmentation is a web-based software, non-invasive image analysis application designed for the visualization, evaluation, and reporting of liver and physician identified lesions using multiphase images (with slice thickness
§ 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).
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VinBrain Joint Stock Company Steven Quoc Hung Truong Chief Executive Officer No 7 Bang Lang 1 Street, Vinhomes Riverside Ecological Urban Area. Long Bien District Hanoi, 100000 Vietnam
December 6, 2024
Re: K241543
Trade/Device Name: DrAid™ for Liver Segmentation Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QIH Dated: November 7, 2024 Received: November 7, 2024
Dear Steven Quoc Hung Truong:
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.
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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 OS regulation reguires 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 Rue"). 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.
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For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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-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 DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K241543
Device Name DrAid™ for Liver Segmentation
Indications for Use (Describe)
DrAid™ for Liver Segmentation is a web-based software, non-invasive image analysis application designed for the visualization, evaluation, and reporting of liver and physician identified lesions using multiphase images (with slice thickness ❌ Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
DrAid™ for Liver Segmentation
| Name and Address of Applicant: | VinBrain Joint Stock Company
No 7 Bang Lang 1 Street,
Vinhomes Riverside Ecological Urban Area,
Viet Hung Ward, Long Bien District,
Hanoi, 100000, Vietnam |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Steven Quoc Hung Truong , Chief Executive Officer |
| Telephone No.: | 84 (981) 927-516 |
| Email Address: | anh3.pham@vinbrain.net |
| Date of Submission: | November 7, 2024 |
| Device Name: | DrAidTM for Liver Segmentation |
| Product Code: | QIH |
| Regulation Name: | Medical image management and processing system |
| Regulation Number: | 892.2050 |
| Classification: | Class II |
| Classification Name: | System, Image Processing, Radiological |
Identification of Predicate Device:
510(k) Number: K131498 Device Name: IQQA-LIVER MULTIMODALITY SOFTWARE Manufacturer: EDDA TECHNOLOGY, INC.
1. Device Description Summary
Device Identification:
Key device components:
- AI algorithm for liver segmentation ।
- Measurement algorithm -
- DICOM Processing Module for CT images -
- Liver Segmentation viewer -
- Results Export Module -
- Device Characteristics: -
- Software -
Environment of Use:
-
Healthcare facility/hospital -
Brief Written Description: -
Explanation of how the device works/principle of operation: DrAid™ for Liver Segmentation is a web-based software that processes and analyzes multiphase CT images in DICOM format. The software utilizes AI algorithms for semi-automated liver segmentation, combined with manual editing capabilities. Additionally, the device provides tools for manual segmentation
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with user input of seed points and boundary editing for physician-identified lesions within the liver.
- Key Features for SE/Performance: -
- Visualization modes: i
- Original DICOM 2D image viewing ।
- -MPR visualization
- -Manual correction tools:
- Seed point placement -
- Boundary editing for lesions -
- । Segmentation refinement
- Reporting tool. ।
- Visualization modes: i
- Energy Source: -
- -Web-based application running on standard hospital/clinic workstations
2. Indications for use
DrAid™ for Liver Segmentation is a web-based software, non-invasive image analysis application designed for the visualization, evaluation, and reporting of liver and physician identified lesions using multiphase images (with slice thickness