Who is the manufacturer of ABLATE-IQ?

Neuwave Medical, Inc. filed the 510(k) submission for ABLATE-IQ (K232227).

What is the FDA product code for ABLATE-IQ?

JAK. It is classified under 21 CFR 892.1750 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for ABLATE-IQ?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like ABLATE-IQ?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ABLATE-IQ

Q: What are the predicate devices for ABLATE-IQ?

Ablation Confirmation (K192427).

K232227 · Neuwave Medical, Inc. · JAK · Apr 4, 2024 · Radiology

Device Facts

Record ID	K232227
Device Name	ABLATE-IQ
Applicant	Neuwave Medical, Inc.
Product Code	JAK · Radiology
Decision Date	Apr 4, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1750
Device Class	Class 2

Indications for Use

ABLATE-IQ™ assists physicians in identifying ablation targets, assessing proper ablation probe placement and visualizing treatment zones when used with the NEUWAVE Microwave Ablation System (NEUWAVE System). The software is not intended for diagnosis, to predict ablation volume, or to predict ablation success.

Device Story

ABLATE-IQ is CT image processing software resident on the NEUWAVE Microwave Ablation System. It connects to hospital PACS and CT scanners via DICOM to receive/send CT, PET, and MR images. Operated by physicians via a dedicated monitor and USB mouse, it provides 2D/3D image manipulation, ROI segmentation, probe detection, and image registration. New features in v3.2.0 include probe insertion path planning, proposed ablation zone visualization (based on ex-vivo animal data), and electronic reporting. The device assists in procedural planning and technical assessment of ablation probe placement relative to targets. It does not control the ablation system or probe output. By providing visual feedback and registration of pre- and post-ablation scans, it aids physicians in determining technical success of the ablation procedure.

Clinical Evidence

Bench testing only. Verification and validation testing performed per 21 CFR 820.30, including unit, integration, system-level, regression, and information security testing. Software passed all pre-determined acceptance criteria. No clinical data presented.

Technological Characteristics

Software-only device resident on the NEUWAVE Microwave Ablation System. Connectivity via DICOM protocol for PACS/CT/PET/MR integration. Features include 2D/3D image processing, deformable registration, and semi-automated ROI/probe identification. Cybersecurity controls include whitelisting, shell lockdown, firewall rules, Bitlocker, and remote code removal. Operates on a dedicated monitor with independent user interface.

Indications for Use

Indicated for physicians to identify ablation targets, assess ablation probe placement, and visualize treatment zones during procedures using the NEUWAVE Microwave Ablation System. Not for diagnosis, predicting ablation volume, or predicting ablation success.

Regulatory Classification

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.

Predicate Devices

Ablation Confirmation (K192427)

Submission Summary (Full Text)

{0}------------------------------------------------ April 4, 2024 Image /page/0/Picture/1 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. NeuWave Medical, Inc. % Allison Francis Regulatory Affairs Specialist 3529 Anderson Street MADISON, WI 53704 #### Re: K232227 Trade/Device Name: ABLATE-IQTM Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: March 4, 2024 Received: March 4, 2024 Dear Allison Francis: 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. 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-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-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 {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K232227 Device Name ABLATE-IOTM Indications for Use (Describe) ABLATE-IO™ assists physicians in identifying ablation targets, assessing proper ablation probe placement and visualizing treatment zones when used with the NEUWAVE Microwave Ablation System (NEUWAVE System). The software is not intended for diagnosis, to predict ablation volume, or to predict ablation success. | 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. 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." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the text 'K232227'. The text is in a simple, sans-serif font. The letters and numbers are all the same size and are evenly spaced. The 'K' is the only letter, and the rest of the text is numbers. Image /page/3/Picture/1 description: The image shows the logo for NeuWave Medical. The logo consists of a green sphere with a white wave design on the left, followed by the text "NeuWave Medical" in a simple, sans-serif font. Below the company name, in smaller letters, it says "PART OF THE ETHICON™ FAMILY OF COMPANIES". ### 510(k) Summary This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. Submission Sponsor: NeuWave Medical Inc. 3529 Anderson Street Madison, WI 53704 April 3, 2024 FDA Establishment# 3008769756 Date: Submission Contact: Allison Francis Regulatory Affairs Specialist Phone: 508-728-7585 Email: afranc52@its.jnj.com > Mohamed Shariff Director of Regulatory Affairs Phone: 856-449-9609 Email: msharif3@its.jnj.com #### Device Identification | Device Trade Name: | ABLATE-IQ TM | |----------------------|-------------------------------------| | Common Name: | System, X-Ray, Tomography, Computed | | Classification Name: | Computed tomography x-ray system | | Device Class: | Class II | | Product Code: | JAK | | CFR Section: | 21 CFR 892.1750 | #### Predicate Device ABLATE-IQ™ is substantially equivalent to the following currently marketed device: Predicate Device - Ablation Confirmation (K192427) NeuWave Medical, Inc. #### Indications for Use ABLATE-IQ™ assists physicians in identifying ablation targets, assessing proper ablation probe placement and visualizing treatment zones when used with the NEUWAVE Microwave Ablation System (NEUWA VE System). The software is not intended for diagnosis, to predict ablation volume, or to predict ablation success. ABLATE-IQTM 510(k) Summary Page 1 of 10 {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows a logo with a green sphere on the left and the letter 'N' on the right. Inside the sphere is a white, stylized wave-like design. Below the 'N' is the word 'PARTNERS' in a smaller font size. A black line is at the bottom of the image. ### Device Description ABLATE-IQ™ formally known as Ablation Confirmation, is a Computed Tomography (CT) image processing software package available as an optional feature for use with the NEUWAVE System. ABLATE-IQ™ is resident on the NEUWAVE Microwave Ablation System and is accessible to the physicians via a second, dedicated monitor with its own user interface separate from the ablation user interface. ABLATE-IO™ functions are controlled via a USB connected mouse. ABLATE-IQ™ connects to a facility PACS system and CT scanner and receives and sends CT, fused PET and MR images via the DICOM protocol over the hospital network. DICOM enables the integration of scanners, servers, workstations, printers, and network hardware from multiple manufacturers into an electronic PACS. ABLATE-IQTM contains a wide range of image processing tools, including: - · 2D image manipulation - · 3D image generation (from 2D images) - · 3D image manipulation - · Region of interest (ROI)/target identification, segmentation, and measurement - · Image-based detection of ablation probes manually placed by the user (physician) - · Registration of multiple images into a single view ### Modifications This 510(k) was submitted to update the Ablation Confirmation software with the following modifications: - · Planning (New Premium Feature that is optionally licensed for 3.2.0): Probe Insertion Path Planning is an optional feature that allows the user to pre-plan the location and trajectory of the probe(s) relative to a pre-defined target(s). Proposed Ablation Zone Display allows the user to try different combinations of time and power derived from ex-vivo animal tissue data to help users visualize proposed ablation zones with targets and does not provide a clinical representation of tissue to be ablated. - · Reporting (New Premium Feature that is optionally licensed for 3.2.0): Generation of an electronic report containing procedural information (e.g., ablation time and power used), data related to the target, and the treatment zone dimensions is also a new optional software feature available. The resulting report can be stored to the Hospital PACS. - · Workflow Updates (page combinations): Prior to 3.2.0, the software had ten steps the user was required to step through. In 3.2.0, the ABLATE-IQ™ navigation groups similar workflow steps together under 3 major workflow pages. - · Profiles: The system can apply default settings for procedure selectable features and recall those in a procedure selectable way. The default settings do not control the NEUWAVE system nor probe output in any way. - · Cybersecurity: New cybersecurity features were added for additional protection and compliance {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows a circular, glossy button or icon. The button is a muted green color, resembling a sage or olive green. A stylized, white design is overlaid on the button. The design appears to be an abstract representation of a wave or a stylized plant. The white design has a flowing, organic shape that contrasts with the solid green background. #### Comparison of Subject Device and Predicate Device ABLATE-IQ™ software version 3.2.0 has the same or similar technological characteristics as the predicate device and therefore is substantially equivalent to the predicate device. | Attribute | Subject Device ABLATE-IQTM K232227 | Predicate Device Ablation Confirmation K192427 | Comparison | |--------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | NeuWave Medical | NeuWave Medical | Same | | Product Code | JAK | JAK | Same | | Regulation Number | 892.1750 | 892.1750 | Same | | Indications for Use | ABLATE-IQTM assists physicians in identifying ablation targets, assessing proper ablation probe placement and visualizing treatment zones when used with the NEUWAVE Microwave Ablation System (NEUWAVE System). The software is not intended for diagnosis, to predict ablation volume, or to predict ablation success. | Ablation ConfirmationTM (AC), is a Computed Tomography (CT) image processing software package available as an optional feature for use with the NEUWAVE Microwave Ablation System. AC is controlled by the user via an independent user interface on a second monitor separate from the NEUWAVE Microwave Ablation System user interface. AC imports images from CT scanners and facility PACS systems for display and processing during ablation procedures. AC assists physicians in identifying ablation targets, assessing proper ablation probe placement and confirming ablation zones. The software is not intended for diagnosis. | Same, the subject device indications for use is the same as the underlined text from the predicate device. The verbiage of the Indications for Use of the subject device is slightly different than the declared predicate as the text is being reduced for clarity. The change in verbiage does not alter the intended use of the device as compared to the predicate device. | | Attribute | Subject Device ABLATE-IQTM K232227 | Predicate Device Ablation Confirmation K192427 | Comparison | | Image Acquisition | The system is capable of retrieving CT image data, conforming to the DICOM standard. Additionally, fused PET images and MR images can be imported for the comparison scan feature. | The system is capable of retrieving CT image data, conforming to the DICOM standard. Additionally, fused PET images and MR images can be imported for the comparison scan feature. | Same | | 2D Image Manipulation | The system provides tools to manipulate the 2D image data. The tool set includes: Window/LevelPan/ZoomImage ScrollingPoint measurement (HU and coordinate)Distance measurementRotation | The system provides tools to manipulate the 2D image data. The tool set includes: Window/LevelPan/ZoomImage ScrollingPoint measurement (HU and coordinate)Distance measurementRotation | Same | | 3D Image Generation | The system is able to generate a 3D image based upon the 2D image series. | The system is able to generate a 3D image based upon the 2D image series. | Same | | 3D Image Manipulation | The system provides tools to manipulate the 3D image rendering. These tools include: RotationPan/ZoomWindow/LevelDistance between tips when multiple probes are detected | The system provides tools to manipulate the 3D image rendering. These tools include: RotationPan/ZoomWindow/LevelDistance between tips when multiple probes are detected | Same | | Attribute | Subject Device ABLATE-IQTM | Predicate Device Ablation Confirmation | Comparison | | | K232227 | K192427 | | | Region of Interest (ROI) Identification | The system allows the user to semi- automatically define regions of interest on CT images. A single- step "undo" function was added to this feature. | The system allows the user to semi- automatically define regions of interest on CT images. A single- step "undo" function was added to this feature. | Same | | ROI Measurements | The system allows the user to assess the volume of the defined ROIs. | The system allows the user to assess the volume of the defined ROIs. | Same | | Desired Margin Identification | The system allows the users to draw on the ROI images to visualize a user- determined desired margin for the ablation procedure. | The system allows the users to draw on the ROI images to visualize a user- determined desired margin for the ablation procedure. | Same | | Registration | The system can perform deformable registration on two distinct CT images. The user can manually adjust the results of the registration process. Replaced 'Refine Registration' capability with a 'Manual Registration' capability. When using the manual registration, the user has the option of turning off the deformations computed by the deformable registration. | The system can perform deformable registration on two distinct CT images. The user can manually adjust the results of the registration process. Replaced 'Refine Registration' capability with a 'Manual Registration' capability. When using the manual registration, the user has the option of turning off the deformations computed by the deformable registration. | Same | | Attribute | Subject Device ABLATE-IQTM K232227 | Predicate Device Ablation Confirmation K192427 | Comparison | | Probe Identification | The system can automatically identify ablation probes within the scan. ABLATE-IQTM can detect up to 3 probes. The software also enables the user to manually draw probes. | The system can automatically identify ablation probes within the scan. AC can detect up to 3 probes. The software also enables the user to manually draw probes. | Same | | Probe Placement Assessment | The system, using the deformable registration process, can visualize the position of the ablation probe(s) in relation to the ROI. | The system, using the deformable registration process, can visualize the position of the ablation probe(s) in relation to the ROI. | Same | | Ablation Zone Assessment | Using the same process as ROI identification, the system allows the user to semi- automatically identify the ablation zone following an ablation procedure. | Using the same process as ROI identification, the system allows the user to semi- automatically identify the ablation zone following an ablation procedure. | Same | | Allows User to Account for Tissue Contraction | Yes | Yes | Same | | Tissue Contraction Ranges - Liver | ABLATE-IQTM with V3.2.0 SW allows users to apply 0%, 10%, 15%, 20% or 30% tissue contraction to identified target during the "Evaluate Ablation Zone" step in the workflow or automatically based upon default settings. | Ablation Confirmation with V3.1.0 SW allows users to apply 0%, 10%, 15%, 20% or 30% tissue contraction to identified target during the "Evaluate Ablation Zone" step in the workflow or automatically based upon default settings. | Same | | Attribute | Subject Device ABLATE-IQTM K232227 | Predicate Device Ablation Confirmation K192427 | Comparison | | Tissue Contraction Ranges - Kidney | ABLATE-IQTM with V3.2.0 SW allows users to apply 0%, 10%, 15%, 20% or 30% tissue contraction to identified target during the "Evaluate Ablation Zone" step in the workflow or automatically based upon default settings. | Ablation Confirmation with V3.1.0 SW allows users to apply 0%, 10%, 15%, 20% or 30% tissue contraction to identified target during the "Evaluate Ablation Zone" step in the workflow or automatically based upon default settings. | Same | | Tissue Contraction Ranges - Lung | ABLATE-IQTM with V3.2.0 SW allows users to apply 0%, 10%, 20%, 30%, 40% or 50% tissue contraction to identified target during the "Evaluate Ablation Zone" step in the workflow or automatically based upon default settings | Ablation Confirmation with V3.1.0 SW allows users to apply 0%, 10%, 20%, 30%, 40% or 50% tissue contraction to identified target during the "Evaluate Ablation Zone" step in the workflow or automatically based upon default settings. | Same | | Assessing the technical success of the ablation procedure | Using the same deformable registration process, image set with ablation zone can be overlaid onto the image set with the initial ROI segmentation to help physicians determine the technical success of an ablation procedure. Allow user to view the Set Up scan next to the Evaluate Ablation scan. | Using the same deformable registration process, image set with ablation zone can be overlaid onto the image set with the initial ROI segmentation to help physicians determine the technical success of an ablation procedure. Allow user to view the Set Up scan next to the Evaluate Ablation scan. | Same | | Attribute | Subject Device ABLATE-IQ™ K232227 | Predicate Device Ablation Confirmation K192427 | Comparison | | Snapshots | User can take snapshots of any view and send to the facility PACS for achieving, if desired. | User can take snapshots of any view and send to the facility PACS for achieving, if desired. | Same | | Remote Viewing | No remote viewing capability | No remote viewing capability | Same | | Orthogonal 2D Viewing | Axial, Sagittal, Coronal, "Needle" and "Periscope" presentation options. | Axial, Sagittal, Coronal, "Needle" and "Periscope" presentation options. | Same | | Workflow | 3 workflow pages Prior to 3.2.0, the software had ten steps the user was required to step through. In 3.2.0, the ABLATE-IQ™ navigation groups similar workflow steps together under 3 major workflow pages. | 10 workflow pages | Different | | Reporting | New optional reporting feature added for version 3.2.0 software. | No reporting feature available. | Different | | Profiles | The system can apply default settings for procedure selectable features and recall those in a procedure selectable way. The default settings do not control the NEUWAVE system nor probe output in any way. | No profile feature available. | Different | | Planning | New optional feature added for software version 3.2.0. | No planning feature available. | Different | | Attribute | Subject Device ABLATE-IQ™ | Predicate Device Ablation Confirmation | Comparison | | | K232227 | K192427 | | | Cybersecurity | ABLATE-IQ™ V3.2.0 is a software only device resident on the NEUWAVE Microwave Ablation System. Cybersecurity updates were made to software V3.2.0 on the NEUWAVE Microwave Ablation System. Cybersecurity updates in V3.2.0 software on the NEUWAVE Microwave Ablation System include: ● Whitelisting Amendments ● Shell Lockdown Amendments ● Firewall Rule Amendments ● Bitlocker ● Remove Remote Code ● Component Removal Cleanup | Ablation Confirmation V3.1.0 is a software only device resident on the NEUWAVE Microwave Ablation System. Cybersecurity controls in V3.1.0 software on the NEUWAVE Microwave Ablation System include: ● Whitelisting ● Shell Lockdown ● Firewall | Similar. The NEUWAVE Microwave Ablation System software V3.2.0 includes new cybersecurity features for additional protection and compliance. | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows a circular logo with a light green background. A white, stylized wave-like design is prominently displayed in the center of the circle. The logo has a glossy appearance, suggesting a three-dimensional effect. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows a green sphere with a white, stylized wave design on its surface. The sphere has a glossy appearance, suggesting it may be made of glass or a similar material. The wave design is abstract and appears to be a single, continuous line that curves and flows across the sphere's surface. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image is a logo that features a green sphere with a white, stylized wave-like design on its surface. The sphere has a glossy appearance, suggesting a three-dimensional effect. The white design is abstract and could be interpreted as a stylized wave or a flowing shape. The overall design is simple and modern, with a focus on the contrast between the green sphere and the white design. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image is a circular logo with a light green background. A stylized white wave design is in the center of the circle. The wave appears to be a single, continuous line that curves and tapers to create a dynamic, flowing shape. The logo has a simple and clean design. {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows a circular logo with a light green background. A stylized white wave-like design is prominently displayed in the center…

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