V5med Lung AI

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March 27, 2025 V5med Inc. % Ining Cheng Consultant 7F., No. 36, Chenggong 12th St., Zhubei City Hsinchu County, 302050 TAIWAN Re: K242919 Trade/Device Name: V5med Lung AI Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: OEB, LLZ Dated: February 24, 2025 Received: February 24, 2025 Dear Ining Cheng: 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. 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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 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-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 Radiological 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) #### K242919 Device Name V5med Lung Al #### Indications for Use (Describe) V5med Lung AI is a Computer-Aided Detection (CAD) software designed to assist radiologists in detecting pulmonary nodules (with diameter of 4-30 mm) during CT examinations of the chest for asymptomatic populations. This software provides adjunctive information to alert radiologists to regions of interest with suspected lung nodules that may otherwise be overlooked. It can be used in a concurrent read mode, where the Al analysis results are displayed alongside the original CT images during either the initial review or any subsequent reviews by the radiologist. V5med Lung Al does not replace the radiologist's critical judgment or diagnostic processes and should not be used in isolation from the original CT series. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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The word "med" is written in lowercase letters to the right of the "V5" symbol, also in blue. # 510(k) Summary This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.87(h). | The assigned 510(k) number is | K242919 | |----------------------------------------------------|------------------------------------------------| | Submitter: | V5med Inc. | | | 7F., No. 36, Chenggong 12th St., Zhubei City, | | | Hsinchu County, Taiwan | | | Phone: +886-3-623-3089 | | Contact Person | JONI CHENG | | | Email: Joni.Cheng@v5.com.tw | | | Phone: +886-3-623-3089 | | Date Prepared | March 26, 2025 | | Device Name | V5med Lung AI | | Regulation Name: | Medical image management and processing system | | CFR Classification: | 21 CFR 892.2050 | | Device Class | II | | Product Code: | OEB, LLZ | | Panel: | Radiology | | Primary Predicate device: | AVIEW Lung Nodule CAD (K221592) | | Secondary Predicate device: ClearRead CT (K161201) | | {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for V5med. The logo is written in a sans-serif font and is blue. The number 5 in the logo has a curved line extending from the bottom of the number. The text "med" is written to the right of the number 5. ## Indications for use V5med Lung AI is a Computer-Aided Detection (CAD) software designed to assist radiologists in detecting pulmonary nodules (with diameter of 4-30 mm) during chest CT examinations of asymptomatic populations. This software provides adjunctive information to alert radiologists to regions of interest with suspected lung nodules that may otherwise be overlooked. It can be used in a concurrent read mode, where the AI analysis results are displayed alongside the original CT images during either the initial review or any subsequent reviews by the radiologist. V5med Lung AI does not replace the radiologist's clinical judgment or diagnostic processes and should not be used in isolation from the original CT series. # Device Description The V5med Lung AI is a software product designed to detect nodules in the lungs. The detection model is trained using a Deep Convolutional Neural Network (CNN) based algorithm, enabling automatic detection of lung nodules ranging from 4 to 30 mm in chest CT images. The system integrates algorithm logic and database on the same server, ensuring simplicity and ease of maintenance. It accepts chest CT images from a PACS system, Radiological Information System (RIS), or directly from a CT scanner, analyzes the images, and provides output annotations regarding lung nodules. ## Summary of the technological characteristics V5med Lung AI is functionally equivalent to the following predicate device: AVIEW Lung Nodule CAD (K221592) cleared February 24, 2023. The following table demonstrates that the intended uses and technical characteristics of V5med Lung AI are substantially equivalent to the predicate devices. Any differences between the subject device and the predicated device has no negative impact on safety or efficacy of the subject device and does not raise any new potential safety risks and is equivalent in performance to existing legally marketed devices. {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for V5med. The logo is blue and features the text "V5med" in a stylized font. The "V" and "5" are connected, and the "5" has a curved line extending from its bottom, resembling a smile. The word "med" is written in a smaller font size compared to "V5". # Functional Specification Comparison Table for the V5med Lung AI and AVIEW Lung Nodule CAD (K221592): | Specification | Subject Device | Primary Predicate Device<br>K221592 | Secondary Predicate Device<br>K161201 | Comparison | |---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | V5med Lung AI | AVIEW Lung Nodule CAD | ClearRead CTTM | N/A | | Classification Name | Medical Image Management and<br>Processing System | Medical Image Management and<br>Processing System | Medical image management and<br>processing system | Same | | Device Class | Class II | Class II | Class II | Same | | Regulation Number | 21 CFR 892.2050 | 21 CFR 892.2050 | 21 CFR 892.2050 | Same | | Product Code | OEB/LLZ | OEB/LLZ | OEB/LLZ | Same | | Review Panel | Radiology | Radiology | Radiology | Same | | 510(k) Number | K242919 | K221592 | K161201 | N/A | | Indications for Use | V5med Lung AI is a Computer-Aided<br>Detection (CAD) software designed to<br>assist radiologists in detecting<br>pulmonary nodules (with diameter of<br>4-30 mm) during CT examinations of<br>the chest for asymptomatic<br>populations. This software provides<br>adjunctive information to alert<br>radiologists to regions of interest with<br>suspected lung nodules that may<br>otherwise be overlooked. It can be<br>used in a concurrent read mode, where<br>the AI analysis results are displayed<br>alongside the original CT images<br>during both the initial review and any<br>subsequent reviews by the radiologist.<br>V5med Lung AI does not replace the<br>radiologist's critical judgment or<br>diagnostic processes and should not<br>be used in isolation from the original<br>CT series. | AVIEW Lung Nodule CAD is a<br>Computer-Aided Detection (CAD)<br>software designed to assist<br>radiologists in the detection of<br>pulmonary nodules (with diameter 3-<br>20 mm) during the review of<br>CT examinations of the chest for<br>asymptomatic populations. AVIEW<br>Lung Nodule CAD provides<br>adjunctive information to alert the<br>radiologists to regions of interest<br>with suspected lung nodules that may<br>otherwise be overlooked. AVIEW<br>Lung Nodule CAD may be used as a<br>second reader after the radiologist<br>has completed their initial read. The<br>algorithm has been validated using<br>non-contrast CT images, the majority<br>of which were acquired on Siemens<br>SOMATOM CT series scanners;<br>therefore, limiting device use to use<br>with Siemens SOMATOM CT series<br>is recommended. | ClearRead CTTM is comprised of<br>computer assisted reading tools<br>designed to aid the radiologist in the<br>detection of pulmonary nodules<br>during review of CT examinations of<br>the chest on an asymptomatic<br>population. The ClearRead CT<br>requires both lungs be in the field of<br>view. ClearRead CT provides<br>adjunctive information and is not<br>intended to be used without the<br>original CT series. | V5med Lung AI and AVIEW Lung<br>Nodule CAD (predicate device) are<br>both Computer-Aided Detection (CAD)<br>software designed to assist radiologists<br>in detecting pulmonary nodules during<br>CT examinations of the chest for<br>asymptomatic populations. Both<br>provide adjunctive information to alert<br>radiologists to regions of interest with<br>suspected lung nodules that may<br>otherwise be overlooked.<br>However, V5med Lung AI supports a<br>broader nodule diameter range (4-30<br>mm), compared to AVIEW's range of<br>3-20 mm, making it similar to<br>ClearRead CTTM, which also covers<br>nodules from 5-20 mm. Additionally,<br>V5med Lung AI does not restrict the<br>use to non-contrast images, unlike<br>AVIEW, aligning it more closely with<br>ClearRead CTTM. Furthermore, V5med<br>Lung AI does not limit the scanner<br>source, while AVIEW is validated | {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the logo for V5med. The logo is in blue and features a stylized "V" and "5" connected together. The word "med" is written in lowercase letters to the right of the "V5". | General Description | | | | | |------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | The V5med Lung AI is a software product designed to detect nodules in the lungs. The detection model is trained using a Deep Convolutional Neural Network (CNN) based algorithm, enabling automatic detection of lung nodules ranging from 4 to 30 mm in chest CT images. The system integrates algorithm logic and database on the same server, ensuring simplicity and ease of maintenance. It accepts chest CT images from a Picture Archiving and Communication System (PACS), Radiological Information System (RIS), or directly from a CT scanner, analyzes the images, and provides output annotations regarding lung nodules. | The AVIEW Lung Nodule CAD is a software product that detects nodules in the lung. The lung nodule detection model was trained by Deep Convolution Neural Network (CNN) based algorithm from the chest CT image. Automatic detection of lung nodules of 3 to 20mm in chest CT images. By complying with DICOM standards, this product can be linked with the Picture Archiving and Communication System (PACS) and provides a separate user interface to provide functions such as analyzing, identifying, storing, and transmitting quantified values related to lung nodules. The CAD's results could be displayed after the user's first read, and the user could select or de-select the mark provided by the CAD. The device's performance was validated with SIEMENS' SOMATOM series manufacturing. The device is intended to be used with a cleared AVIEW platform. | ClearRead CT is a dedicated post-processing application that generates a secondary vessel suppressed Lung CT series with CADe marks and associated region descriptors intended to aid the radiologist in the detection of pulmonary nodules. | primarily with Siemens SOMATOM CT series scanners, making V5med Lung AI more flexible like ClearRead CTTM. These differences do not impact the safety and effectiveness of V5med Lung AI.<br>V5med Lung AI and AVIEW Lung Nodule CAD both utilize Deep Convolutional Neural Network (CNN) based algorithms for lung nodule detection in chest CT images. However V5med Lung AI supports a broader nodule detection range of 4 to 30 mm, compared to AVIEW's 3 to 20 mm, making it similar to ClearRead CT™™, which also covers nodules from 5 - 20 mm. Unlike AVIEW, which is validated with SIEMENS' SOMATOM series and intended to be used with a cleared AVIEW platform, V5med Lung AI does not restrict the scanner source or the use of non-contrast images, aligning it more closely with ClearReac CT™™ in terms of flexibility. These differences do not impact the safety and effectiveness of V5med Lung AI. | | Detection target(s) | Pulmonary nodules in screening and diagnostic chest CT acquisitions. | Pulmonary nodules in non-contrast chest CT acquisitions | Pulmonary nodules in chest CT acquisitions. | The detection targets of V5med Lung AI are similar to the detection targets of the predicate devices. | | Nodule Characteristics | Diameter: | Diameter: | Diameter: | Diameter: | | | • Pulmonary nodules 4 – 30 mm | • Pulmonary nodules 3 – 20 mm | • Pulmonary nodules 5 – 20 mm | The diameter range of V5med<br>Lung AI is similar to the<br>predicate devices | | | Locations:<br>• Full range: central, peripheral | Locations:<br>• Full range: central, peripheral<br>Contours:<br>• Round, irregular | | Locations:<br>• Same as primary predicate | | Nodule Marking | A bounding box is provided around<br>nodules | A bounding box is provided around<br>nodules | A bounding box is provided around<br>nodules | Same | | Automatically locate<br>and identify lung<br>nodules | Yes | Yes | Yes | Same | | Modifies the Original<br>CT scan | No | No | Yes | Same as AVIEW Lung Nodule CAD. | | Image format | DICOM | DICOM | DICOM | Same | | Hosting Platform | - | AVIEW | - | No specific hosting platform. Same as<br>cleared ClearRead CT. | | Hosting Application | - | AVIEW LCS | - | No specific hosting application. Same<br>as cleared ClearRead CT. | | Outputs | DICOM GSPS (Grayscale Softcopy<br>Presentation State) | DICOM GSPS (Grayscale Softcopy<br>Presentation State)<br>XML (Coordinate of detected<br>nodules)<br>Able to view results<br>on AVIEW, AVIEW<br>LCS viewer page | DICOM GSPS (Grayscale Softcopy<br>Presentation State) | Similar to AVIEW Lung Nodule CAD<br>but lacks XML output and specific<br>viewer capabilities of AVIEW.<br>The outputs of V5med Lung AI are<br>similar to the outputs of the predicate<br>devices.…