VisAble.IO

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Techsomed Dalia Dickman Head of Regulatory Affairs Meir Weisgal 2 REHOVOT, 7654055 ISRAEL April 15, 2024 Re: K240773 Trade/Device Name: VisAble.IO Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QTZ, QIH, LLZ Dated: March 20, 2024 Received: March 21, 2024 Dear Dalia Dickman: 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 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-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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K240773 Device Name VisAble.IO #### Indications for Use (Describe) VisAble.IO is a Computed Tomography (CT) and Magnetic Resonance (MR) image processing software package available for use with liver ablation procedures. VisAble.IO is controlled by the user via a user interface. VisAble.IO imports images from CT and MR scanners and facility PACS systems for display and processing during liver ablation procedures. VisAble.IO is used to assist physicians in planning ablation procedures, including identifying ablation targets and virtual ablation needle placement. VisAble.IO is used to assist physicians in confirming ablation zones. The software is not intended for diagnosis. The software is not intended to predict ablation volumes or predict ablation success. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | <span> <span></span>Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> <span></span>Over-The-Counter Use (21 CFR 801 Subpart C) </span> | |-----------------------------------------------------------------------------|----------------------------------------------------------------------------| |-----------------------------------------------------------------------------|----------------------------------------------------------------------------| #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Date Prepared: March 19, 2024 Name of Device: VisAble.IO Common or Usual Name: VisAble.IO Classification Name: Medical Image Management and Processing System (21 CFR 892.2050) Regulatory Class: Class II Product Code: QTZ, QIH, LLZ ### Predicate Devices | 510(K) Number | K223639 | |----------------------|------------------------------------------------| | Trade Name | VisAble.IO | | Manufacturer | TechsoMed Medical Technologies. LTD. | | Device Name | VisAble.IO | | Regulation Number | 892.2050 | | Regulation Name | Medical Image Management and Processing System | | Regulatory Class | Class II | | Primary Product Code | QTZ, QIH, LLZ | ### Device Description VisAble.IO is a stand-alone software application with tools and features designed to assist users in planning ablation procedures as well as tools for treatment confirmation. The use environment for VisAble.IO is the Operating Room and the hospital healthcare environment such as interventional radiology control room. VisAble.IO has five distinct workflow steps: - Data Import - . Anatomic Structures Segmentation (Liver, Hepatic Vein, Portal Vein, Ablation Target) - . Instrument Placement (Needle Planning) - Ablation Zone Segmentation {4}------------------------------------------------ - . Treatment Confirmation (Registration of Pre- and Post-Interventional Images; Quantitative Analysis) Of these workflow steps, two (Anatomic Segmentation, and Instrument Placement) make use of the planning image. These workflow steps contain features and tools designed to support the planning of ablation procedures. The other two (Ablation Zone Segmentation, and Treatment Confirmation) make use of the confirmation image volume. These workflow steps contain features and tools designed to support the evaluation of the ablation procedure's technical performance in the confirmation image volume. Key features of the VisAble.IO Software include: - . Workflow steps availability - Manual and automated tools for anatomic structures and ablation zone segmentation - Overlaying and positioning virtual instruments (ablation needles) and user-selected estimates of the ablation regions onto the medical images - . Image fusion and registration - . Compute achieved margins and missed volumes to help the user assess the coverage of the ablation target by the ablation zone - . Data saving and secondary capture generation The software components provide functions for performing operations related to image display, manipulation, analysis, and quantification, including features designed to facilitate segmentation of the ablation target and ablation zones. The software system runs on a dedicated computer and is intended for display and processing, of a Computed Tomography (CT) and Magnetic Resonance (MR), including contrast enhanced images. The system can be used on patient data for any patient demographic chosen to undergo the ablation treatment. VisAble.IO uses several algorithms to perform operations to present information to the user in order for them to evaluate the planned and post ablation zones. These include: - . Segmentation - . Image Registration - . Measurement and Quantification VisAble.IO is intended to be used for ablations with the following ablation instruments: For needle planning, the software currently supports the following needle models: - Medtronic: Emprint Antenna 15CM, 20CM, 30CM - - -NeuWave Medical: PR Probe 15CM, 20CM; PR XT Probe 15CM, 20CM; LK Probe 15CM, 20CM; LK XT Probe 15CM, 20CM - -H.S. Hospital Service: AMICA Probe 15 CM, 20 CM, 27 CM. For treatment confirmation (including segmentation and registration), the software is compatible with all ablation devices as these functions are independent from probes/power settings. ### Intended Use / Indications for Use VisAble.IO is a Computed Tomography (CT) and Magnetic Resonance (MR) image processing software package available for use with liver ablation procedures. {5}------------------------------------------------ VisAble. IO is controlled by the user via a user interface. VisAble.IO imports images from CT and MR scanners and facility PACS systems for display and processing during liver ablation procedures. VisAble.IO is used to assist physicians in planning ablation procedures, including identifying ablation targets and virtual ablation needle placement. VisAble.IO is used to assist physicians in confirming ablation zones. The software is not intended for diagnosis. The software is not intended to predict ablation volumes or predict ablation success. ### Summary of Technological Characteristics Both the subject and predicate device are stand-alone software application with tools and features designed to assist users in planning liver ablation procedures as well as tools for treatment confirmation. The use environment for both the subject and predicate device is the Operating Room and the hospital healthcare environment such as interventional radiology control room. The software components of the subject and predicate device provide functions for performing operations related to image display, manipulation, analysis, and quantification, including features designed to facilitate segmentation of the ablation target and ablation zones. Both the subject and predicate device have the same five distinct workflow steps: - Data Import . - . Anatomic Structures Segmentation - Instrument Placement (Needle Planning) ● - . Ablation Zone Segmentation - . Treatment Confirmation (Registration of Pre- and Post-Interventional Images; Quantitative Analysis) The following technological differences exist between the subject and the predicate device: The primary difference between devices is that, while the predicate device supports image processing of CT only, the subject device supports image processing of both Computed Tomography (CT) as well as Magnetic Resonance (MR). These differences do not raise additional concerns of safety or effectiveness as performance data demonstrates that the VisAble.IO is as safe and effective as the predicate device. A table comparing the key features of the subject and predicate devices is provided below. #### SUBSTANTIAL EQUIVALENCE COMPARISON TABLE | | Subject Device<br>VisAble.IO (Ver 1.4) | Predicate Device<br>VisAble.IO (Ver 1.0) | |------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) number | | K223639 | | Classification | Class II 892.2050 QTZ, QIH,<br>LLZ | Class II 892.2050 QTZ, QIH,<br>LLZ | | Intended Use | The intended patient<br>population is patients chosen<br>by interventional radiologists to | The intended patient population<br>is patients chosen by<br>interventional radiologists to | | | undergo ablation treatment<br>(including patients with soft<br>tissue lesions) | undergo ablation treatment<br>(including patients with soft<br>tissue lesions) | | Indications for Use | VisAble.IO is a Computed<br>Tomography (CT) and<br>Magnetic Resonance (MR)<br>image processing software<br>package available for use with<br>liver ablation procedures. | VisAble.IO is a Computed<br>Tomography (CT) image<br>processing software package<br>available for use with liver<br>ablation procedures. | | | VisAble.IO is controlled by the<br>user via a user interface. | VisAble.IO is controlled by the<br>user via a user interface. | | | VisAble.IO imports images<br>from CT and MR scanners and<br>facility PACS systems for<br>display and processing during<br>liver ablation procedures. | VisAble.IO imports images from<br>CT and MR scanners and facility<br>PACS systems for display and<br>processing during liver ablation<br>procedures. | | | VisAble.IO is used to assist<br>physicians in planning ablation<br>procedures, including<br>identifying ablation targets and<br>virtual ablation needle<br>placement. VisAble.IO is used<br>to assist physicians in<br>confirming ablation zones. | VisAble.IO is used to assist<br>physicians in planning ablation<br>procedures, including identifying<br>ablation targets and<br>virtual ablation needle<br>placement. VisAble.IO is used to<br>assist physicians in confirming<br>ablation zones. | | | The software is not intended<br>for diagnosis. The software is<br>not intended to predict ablation<br>volumes or predict ablation<br>success. | The software is not intended for<br>diagnosis. The software is not<br>intended to predict ablation<br>volumes or predict ablation<br>success. | | User Population | Qualified trained physicians | Qualified trained physicians | | Where used | The application's use<br>environment is the Operation<br>Room and the hospital<br>healthcare environment such<br>as interventional radiology<br>control room | The application's use<br>environment is the Operation<br>Room and the hospital<br>healthcare environment such as<br>interventional radiology control<br>room | | Energy Used | None - software only<br>application. The software<br>application does not deliver or<br>depend on energy delivered to<br>or from patients | None - software only application.<br>The software application does<br>not deliver or depend on energy<br>delivered to or from patients | | Technological<br>Characteristics | VisAble.IO is a stand-alone<br>software application with tools<br>and features designed to assist<br>users in planning liver ablation<br>procedures as well as tools for<br>treatment confirmation. The<br>use environment the device is<br>the Operating Room and the | VisAble.IO is a stand-alone<br>software application with tools<br>and features designed to assist<br>users in planning liver ablation<br>procedures as well as tools for<br>treatment confirmation. The use<br>environment the device is the<br>Operating Room and the hospital | | | hospital healthcare environment such as interventional radiology control room. VisAble.IO has five distinct workflow steps:<br>Data Import Anatomic Structures Segmentation Instrument Placement (Needle Planning) Ablation Zone Segmentation Treatment Confirmation (Registration of Pre- and Post-Interventional Images; Quantitative Analysis) | healthcare environment such as interventional radiology control room. VisAble.IO has five distinct workflow steps:<br>Data Import Anatomic Structures Segmentation Instrument Placement (Needle Planning) Ablation Zone Segmentation Treatment Confirmation (Registration of Pre- and Post-Interventional Images; Quantitative Analysis) | | Design: Supported modalities | CT, MR | CT | | Design: Data Visualization | Window and level, pan, zoom, cross- hairs, slice navigation | Window and level, pan, zoom, cross- hairs, slice navigation | | Design; Image Segmentation | Tools for segmenting 3D VOIs, including target tissues, ablation zones, vessels and liver. | Tools for segmenting 3D VOIs, including target tissues, ablation zones, vessels and liver. | | Design: Image registration | Registration of multiple images and imaging modalities into a single view. | Registration of multiple images and imaging modalities into a single view. | | Design: Ablation zone confirmation | Registration of the planning scan, containing the identified target tissue, with the confirmation scan showing the ablation zone. The delineated target tissue on the planning scan is then projected onto the confirmation scan and overlaid onto the delineated ablation zone segmentation. This helps the user in analysing if the ablation zone covers the target tissue with the desired amount of margin. | Registration of the planning scan, containing the identified target tissue, with the confirmation scan showing the ablation zone. The delineated target tissue on the planning scan is then projected onto the confirmation scan and overlaid onto the delineated ablation zone segmentation. This helps the user in analysing if the ablation zone covers the target tissue with the desired amount of margin. | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ # Performance Data VisAble.IO is validated and verified against its user needs and intended use by the successful execution of planned performance, functional and algorithmic testing included in this submission. The results of performance, functional and algorithmic testing demonstrate that VisAble.IO meets the user needs and requirements of the device, which are considered to be substantially equivalent to those of the listed predicate device. Performance testing (Bench) was performed on the following features, to ensure that performance and accuracy was as expected: - . Segmentation post-processing Testing - Image Registration Testing - . Measurement and Quantification Testing The liver segmentation and liver vessel segmentation algorithms for CT processing are Al alqorithms. The training and model validation dataset characteristics are as follows: Liver Segmentation Algorithm: - Patients - 1091 contrast-enhanced CT images from arterial or venous phases in axial orientation - · Age distribution: 50.70 ± 24.14 - · Sex distribution: 34.58% female, 65.42% male - Location of clinical sites: Germany, France, Turkey, Japan, Israel, Netherlands, Canada, USA, UK - · Imaging procedure: Contrast-enhanced CT images taken for diagnostic reading - · Number of clinical sites: 38 Liver Vessel Segmentation Algorithm: - Patients . - · N=393 contrast-enhanced CT images from the portal-venous or late venous phases in axial orientation - · Age distribution: 51.40 ± 22.81 - · Sex distribution: 37.43% female, 62.57% male - · Location of clinical sites: Central Europe, North America, East Asia - · Imaging procedure: Contrast-enhanced CT images taken for diagnostic reading in liver diagnosis - · Number of clinical sites: 36 The liver segmentation for MR processing is an AI algorithm. The training and model validation dataset characteristics are as follows: - . Patients - 418 MR images from arterial and venous phase • - Age distribution: 64.30 ± 13.99 - . Sex distribution: 26.86% female, 73.14% male - Location of clinical sites: Central Europe - Imaging procedure: MR images taken for diagnostic reading - Number of clinical sites: 3 {9}------------------------------------------------ The following table provides a summary of the validation results: | Algorithm | N | Gender | Mean Age | N per Region | MR /CT Brand | Performance Goal | Performance | |-------------------------------------------------------------|-----|--------------------------------|----------|-------------------|------------------------------------------------------------------------------------------------------------------|------------------|------------------| | CT Processing | | | | | | | | | Liver Segmentation | 50 | M: 52%<br>F: 48% | 60.6 | US: 32<br>OUS: 18 | GE Medical Systems,<br>Siemens | Mean DICE =0.92 | Mean DICE =0.98 | | Ablation Target Segmentation | 59 | M: 54%<br>F: 46% | 60.0 | US: 30<br>OUS: 29 | GE Medical Systems,<br>Siemens, Philips | Mean DICE = 0.70 | Mean DICE = 0.82 | | Ablation Zone Segmentation | 59 | M:64% F:<br>36% | 66.0 | US: 30<br>OUS: 29 | GE Medical Systems,<br>Siemens | Mean DICE = 0.70 | Mean DICE = 0.88 | | Liver Vessels Segmentation | 100 | M: 52%<br>F: 48% | 58.5 | US: 72<br>OUS: 28 | GE Medical Systems,<br>Siemens | Mean DICE = 0.70 | Mean DICE = 0.72 | | MR Processing | | | | | | | | | Liver Segmentation | 25 | M: 76%<br>F: 24% | 70.4 | US: 25 | GE Medical Systems, Philips,<br>Siemens | Mean DICE = 0.92 | Mean DICE = 0.93 | | Ablation Target Segmentation | 50 | M: 70%<br>F: 30% | 69 | US: 46<br>OUS: 4 | GE Medical Systems, Philips,<br>Siemens | Mean DICE = 0.70 | Mean DICE = 0.76 | | Image Registration | | | | | | | | | Pre-ablation CT to Post Ablation CT<br>Image Registration | 46 | M: 59%<br>F: 41% | 63.3 | US: 13<br>OUS: 33 | GE Medical Systems,<br>Siemens,<br>Philips | MCD*= 6.06 mm | MCD*=4.09 mm | | Pre-ablation MR to Post-ablation CT<br>Image Registration | 25 | M: 56%<br>F: 28%<br>Other: 16% | 68.4 | US: 25 | MR: GE Medical Systems, Philips, Siemens<br>CT: GE Medical Systems, Philips, Siemens, Toshiba | MCD* = 6.06 mm | MCD* = 4.72 mm | | Pre-ablation MR to<br>Pre-ablation CT<br>Image Registration | 18 | M: 83%<br>F: 17% | 71.5 | US: 14<br>OUS: 4 | MR: GE Medical<br>Systems, Philips,<br>Siemens,<br>Toshiba<br><br>CT: GE Medical<br>Systems, Philips,<br>Toshiba | MCD* = 7.90 mm | MCD* = 5.10 mm | {10}------------------------------------------------ *MCD = Mean Corresponding Distance VisAble.IO provides functions including linear distance measurements and volumetric measurements. The resolution of the medical image data directly affects the ability of the user to make definitive measurements, especially when the sizes of structures to identify, segment or measure are near the resolution of the image data. The software's functions are dependent on the user actions as well as on the available information in the provided medical image data. Segmentation tools provided within VisAble.IO include manual and semiautomated segmentation, and system post-processing of segmentations to remove 2D-holes and/or disconnected 3D regions present. The use of the segmentation tools to achieve a satisfactory delineation of ablation target or ablation zone is a user operation and the clinical accuracy of segmentation is the responsibility of the user and not a VisAble.IO function. Registration tools provided within VisAble.IO include automated local rigid registration within a region of interest around user-segmentations of ablation targets and ablation zones. Final accuracy of registration is dependent on user assessment and manual modification of the registration prior to acceptance, and not a VisAble.IO function. Measurements of the achieved margins and missed volumes, calculated by comparing the segmentations, are presented by the system following user acceptance of segmentations and registration as clinically accurate. Accuracy of linear distance measures calculated by VisAble.IO are dependent on the image resolution. Test planning was performed in accordance with standard testing procedures and guidelines as listed in internal development processes. Verification and validation testing were carried out as per planned arrangements in the Project Test Plan and Phase Test Plan(s) to ensure that design outputs meet design inputs and that this edition of VisAble.IO meets the product acceptance criteria. These are in accordance with the company's Design Control process in compliance with 21 CFR Part 820.30, which included testing that fulfills the requirements of FDA "Guidance on Software Contained in Medical Devices" and adherence to the DICOM standard. Potential risks were analyzed and satisfactorily mitigated in the device design. # Conclusions The VisAble.IO (V1.4) is as safe and effective as the cleared VisAble.IO (K223693). The VisAble.IO has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor differences in indications do not alter the intended use of the device and do not affect its safety and effectiveness when used as labeled. In addition, the minor technological differences between the VisAble.IO and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the VisAble.IO (V 1.4) is as safe and effective as the cleared VisAble.IO (K223693). Thus, the VisAble.IO is substantially equivalent to the predicate device.