Ablation Confirmation

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October 3, 2019 NeuWave Medical, Inc. % Neda Chini Senior Regulatory Affairs Program Lead 3529 Anderson Street MADISON, WI 53704 Re: K192427 Trade/Device Name: Ablation Confirmation Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: September 4, 2019 Received: September 5, 2019 Dear Neda Chini: 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 (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 located 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. 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 {1}------------------------------------------------ statutes and regulations administered by other Federal agencies. 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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, Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) #### K192427 Device Name Ablation ConfirmationTM #### Indications for Use (Describe) Ablation Confirmation™ (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 NEUWA VE 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. **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}------------------------------------------------ K192427 | Date:<br>Subject: | 08/28/2019<br>510(k) Summary of Safety and Effectiveness Information for NeuWave<br>Medical's Ablation Confirmation™ image processing software | |---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------| | Company: | NeuWave Medical, Inc.<br>3529 Anderson Street<br>Madison, WI 53704 | | FDA Establishment# | 3008769756 | | Contact: | Neda Chini, Senior Regulatory Affairs Program Lead<br>P – 949-789-8656<br>F - 608-512-1509 | | Proprietary:<br>Classification: | Ablation Confirmation™ Common: Computed Tomography X-ray System<br>Radiology, JAK, 21 CFR 892.1750 | The 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 1992. ### Predicate Devices Ablation Confirmation™ is substantially equivalent to the following currently marketed device: - Ablation Confirmation Software Class II 21CFR892.1750, Radiology, JAK, which has . been the subject of a cleared 510(k) with the FDA log number K171022. ### Indications For Use Ablation Confirmation™ (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. ### Device Description AC 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. AC functions are controlled via a USB connected mouse. AC connects to a facility PACS system and CT scanner and receives and sends CT, fused PET and MR images via the DICOM protocol. AC 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) identification, segmentation and measurement - Automatic identification of ablation probes - . Registration of multiple images into a single view Ablation Confirmation 510(k) Submission Safety Summary Page 1 of 6 {4}------------------------------------------------ Prior to an ablation procedure, physicians can use AC to semi-automatically segment and visualize ablation target lesions in soft tissue including liver, lung and kidney. The physician initiates the segmentation with tools provided on the screen. AC then uses segmentation algorithms to construct a 2-D visualization of the target lesion selected. The physician can accept the initial segmentation results or use AC tools to manually adjust the defined target lesion. Once accepted, the identified target is rendered into a 3D image. Upon the placement of ablation probes, taking and importing the CT scan, AC can process the image and identify up to three ablation probes. AC can then perform a registration of the initial CT scan, containing the identified target with the second scan containing the ablation probe(s) in place. The resulting image allows the physician to visualize the ablation probe(s) in relation to the identified target. This enables physicians to ensure probe(s) placement prior to starting the ablation. Following the ablation procedure and a post-procedure CT scan, AC allows the physician to semiautomatically segment and visualize the ablation zone using the same process as in the initial target segmentation. AC then performs a registration of the initial CT scan, containing the identified target, with the final CECT scan containing the segmented ablation zone. The physician also has the option to evaluate the effect of potential tissue contraction to help determine the technical success (ablation zone covers target lesion with desired amount of margin) of the ablation procedure. All AC processing and viewing is accomplished at the NEUWAVE Microwave Ablation System without the physician having to leave the procedure area to utilize separate image processing tools. Additionally, AC allows for the images to be viewed by a remote physician for time-saving clinical consultation on the current procedure. ### Modifications This 510(k) was submitted to update the Ablation Confirmation software with the following modifications: - . Improved automatic probe detection feature - . New feature for manual probe definition available for users when the software cannot automatically detect the ablation probes. - . Network communication monitoring – a new convenience feature to aid in troubleshooting network connectivity issues. - Removed "Remote Viewing" feature based upon customer feedback - Improvements to the target/ablation zone edit tools to allow the user to select if they want to edit a single slice or multiple slices - An "undo/redo" capability for segmentation operations was added. - . Allow importation of a fused Positron Emission Tomography (PET) scan for use as a comparison scan. The fused images are created by another device and transmitted as a DICOM Secondary Capture image. Note that the fused PET/CT images are not able to be manipulated, processed or registered to another image using AC software. This feature addition simply allows fused PET/CT scans to be displayed as a "Comparison" scan within the existing AC construct. No measurements are allowed on the fused PET/CT scans. - . Allow the user to view the Set Up scan as a comparison scan when viewing the Evaluate Ablation screen. - Render targets, ablations and ablation probes as semi-transparent (as opposed to opaque) to allow for better visualization of the objects relative to each other. Ablation Confirmation 510(k) Submission Safety Summary Page 2 of 6 {5}------------------------------------------------ - Image registration improvements that include a "manual registration" process in place of ● the previous "Refine Registration" feature. Also, the addition of "undo" in the registration workflow as a user convenience feature. - . New function to measure the distance between probe tips when multiple probes are used. - . Displaying the diameter of the sphere when the user is placing/changing the size of a sphere to provide the user with additional information compared with previous software versions. | Feature/Specification | | Predicate: Ablation Confirmation Software<br>V2.3.0 (K171022) | | Same as<br>predicate | Comments/impact on<br>safety and effectiveness | |---------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Subject Device: Ablation<br>Confirmation Software<br>V3.1.0 | | | | | | Indication for Use | Ablation Confirmation™<br>(AC), is a Computed<br>Tomography (CT) image<br>processing software<br>package available as an<br>optional feature for use<br>with the NEUWAVE<br>Microwave Ablation<br>System. AC is controlled by<br>the user via an<br>independent user interface<br>on a second monitor<br>separate from the<br>NEUWAVE Microwave<br>Ablation System user<br>interface. AC imports<br>images from CT scanners<br>and facility PACS systems<br>for display and processing<br>during ablation<br>procedures. AC assists<br>physicians in identifying<br>ablation targets, assessing<br>proper ablation probe<br>placement and confirming<br>ablation zones. The<br>software is not intended<br>for diagnosis. | Ablation Confirmation™<br>(AC), is a Computed<br>Tomography (CT) image<br>processing software<br>package available as an<br>optional feature for use<br>with the Certus® 140 2.45<br>GHz Ablation System. AC is<br>controlled by the user via<br>an independent user<br>interface on a second<br>monitor separate from the<br>Certus 140 user interface.<br>AC imports images from CT<br>scanners and facility PACS<br>systems for display and<br>processing during ablation<br>procedures. AC assists<br>physicians in identifying<br>ablation targets, assessing<br>proper ablation probe<br>placement and confirming<br>ablation zones. The<br>software is not intended<br>for diagnosis. | | Yes | No changes to the<br>Indication For Use. The<br>product name of the<br>ablation system was<br>updated to reflect a<br>branding/name change. | | Image Acquisition | The system is capable of<br>retrieving CT image data,<br>conforming to the DICOM<br>standard. Additionally,<br>fused PET images and MR<br>images can be imported<br>for the comparison scan<br>feature. | The system is capable of<br>retrieving CT image data,<br>conforming to the DICOM<br>standard. Additionally, MR<br>images can be imported<br>for the comparison scan<br>feature. | | No | The fused PET<br>images are created<br>by another device<br>and transmitted as a<br>DICOM Secondary<br>Capture image.<br>Note that the fused<br>PET/CT images are<br>not able to be | | Feature/Specification | Subject Device: Ablation<br>Confirmation Software<br>V3.1.0 | Predicate: Ablation<br>Confirmation Software<br>V2.3.0 (K171022) | Same as<br>predicate | Comments/impact on<br>safety and effectiveness | | | | | | | processed or<br>registered to<br>another image using<br>AC software. This<br>feature addition<br>simply allows fused<br>PET/CT scans to be<br>displayed as a<br>"Comparison" scan<br>within the existing<br>AC construct. No<br>measurements are<br>allowed on the<br>fused PET/CT scans. | | | 3D Image<br>Manipulation | The system provides tools to<br>manipulate the 3D image<br>rendering. These tools<br>include:<br>• Rotation<br>• Pan/Zoom<br>• Window/Level<br>• Distance between<br>tips when multiple<br>probes are detected | The system provides tools to<br>manipulate the 3D image<br>rendering. These tools<br>include:<br>• Rotation<br>• Pan/Zoom<br>• Window/Level | No | Addition of distance<br>between probe tip<br>measurement as a<br>convenience feature for<br>users. No new risks or<br>required risk mitigations<br>were identified and no<br>impact on safety or<br>effectiveness. | | | Region of Interest<br>(ROI) Identification | The system allows the user to<br>semi-automatically define<br>regions of interest on CT<br>images. A single-step "undo"<br>function was added to this<br>feature. | The system allows the user to<br>semi-automatically define<br>regions of interest on CT<br>images. | No | "Undo" is a minor change<br>and convenience feature<br>for users. No new risks or<br>required risk mitigations<br>were identified and no<br>impact to safety or<br>effectiveness. | | | ROI Measurements | The system allows the user to<br>assess the volume of the<br>defined ROIs. | The system allows the user to<br>assess the volume of the<br>defined ROIs. | Yes | No changes in this<br>submission | | | Desired Margin<br>Identification | The system allows the users<br>to draw on the ROI images to<br>visualize a user-determined<br>desired margin for the<br>ablation procedure. | The system allows the users<br>to draw on the ROI images to<br>visualize a user-determined<br>desired margin for the<br>ablation procedure. | Yes | No changes in this<br>submission | | | Registration | The system can perform<br>deformable registration on<br>two distinct CT images. The<br>user can manually adjust the<br>results of the registration<br>process. Replaced 'Refine<br>Registration' capability with a<br>'Manual Registration'<br>capability. When using the<br>manual registration, the user | The system can perform<br>deformable registration on<br>two distinct CT images. The<br>user can manually adjust the<br>results of the registration<br>process. | No | Automatic registration<br>algorithms and mechanisms<br>remain unchanged. The<br>manual registration option<br>methodology has changed<br>and an "undo" feature was<br>added. No new risks were<br>identified, no new risk<br>mitigations were required | | | Feature/Specification | Subject Device: Ablation<br>Confirmation Software<br>V3.1.0 | Predicate: Ablation<br>Confirmation Software<br>V2.3.0 (K171022) | Same as<br>predicate | Comments/impact on<br>safety and effectiveness | | | | has the option of turning off<br>the deformations computed<br>by the deformable<br>registration. | | | and no impact to safety or<br>effectiveness. | | | Probe Identification | The system can automatically<br>identify ablation probes<br>within the scan. AC can detect<br>up to 3 probes.<br>The software also enables the<br>user to manually draw probes | The system can automatically<br>identify ablation probes<br>within the scan. AC can detect<br>up to 3 probes. | No | Continuous improvement<br>of existing probe detection<br>feature. Ability to manual<br>draw probes is a minor<br>feature addition to improve<br>feature set. | | | Probe placement<br>Assessment | The system, using the<br>deformable registration<br>process, can visualize the<br>position of the ablation<br>probe(s) in relation to the<br>ROI. | The system, using the<br>deformable registration<br>process, can visualize the<br>position of the ablation<br>probe(s) in relation to the<br>ROI. | Yes | No changes in this<br>submission | | | Ablation Zone<br>Assessment | Using the same process as<br>ROI identification, the system<br>allows the user to semi-<br>automatically identify the<br>ablation zone following an<br>ablation procedure. | Using the same process as<br>ROI identification, the system<br>allows the user to semi-<br>automatically identify the<br>ablation zone following an<br>ablation procedure. | Yes | No changes in this<br>submission | | | Allows User to<br>Account for Tissue<br>Contraction | Yes | Yes | Yes | No changes in this<br>submission | | | Assessing the<br>technical success of<br>the ablation<br>procedure. | Using the same deformable<br>registration process, image<br>set with ablation zone can be<br>overlaid onto the image set<br>with the initial ROI<br>segmentation to help<br>physicians determine the<br>technical success of an<br>ablation procedure.<br>Allow user to view the Set Up<br>scan next to the Evaluate<br>Ablation scan. | Using the same deformable<br>registration process, image<br>set with ablation zone can be<br>overlaid onto the image set<br>with the initial ROI<br>segmentation to help<br>physicians determine the<br>technical success of an<br>ablation procedure | No | This change is a minor<br>workflow enhancement<br>based upon user feedback.<br>No new risks or required<br>risk mitigations were<br>identified and no impact to<br>safety or effectiveness. | | {6}------------------------------------------------ {7}------------------------------------------------ ## Performance Data Ablation Confirmation™ was tested in accordance with a test plan that fully evaluated all functions performed by the software. The system passed all pre-determined acceptance criteria identified in the test plan. Verification and validation testing were completed 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". Potential risks arising from the new or updated features were analyzed and satisfactorily mitigated in the device design and labeling. {8}------------------------------------------------ ## Substantial Equivalence Discussion Ablation Confirmation™ is substantially equivalent in design concepts, technologies and materials to the identified predicate. This version of the AC software does not present any new questions of safety or effectiveness.