ABLATE-IQ

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

Intended 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)

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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).

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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 ([e-mail]) or phone [phone] 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

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### 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) | |
|----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: DejaVu Sans, sans-serif">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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### 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: [phone] Email: [e-mail]

> Mohamed Shariff Director of Regulatory Affairs Phone: [phone] Email: [e-mail]

#### 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

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### 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

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#### 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<br>ABLATE-IQTM<br>K232227 | Predicate Device<br>Ablation Confirmation<br>K192427 | Comparison |
|--------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | NeuWave Medical | NeuWave Medical | Same |
| Product Code | JAK | JAK | Same |
| Regulation<br>Number | 892.1750 | 892.1750 | Same |
| Indications<br>for Use | ABLATE-IQTM assists<br>physicians in<br>identifying ablation<br>targets, assessing<br>proper ablation probe<br>placement and<br>visualizing treatment<br>zones when used with<br>the NEUWAVE<br>Microwave Ablation<br>System (NEUWAVE<br>System). The software<br>is not intended for<br>diagnosis, to predict<br>ablation volume, or to<br>predict ablation<br>success. | Ablation ConfirmationTM<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<br>by the user via an<br>independent user<br>interface on a second<br>monitor separate from<br>the NEUWAVE<br>Microwave Ablation<br>System user interface.<br>AC imports images from<br>CT scanners and facility<br>PACS systems for<br>display and processing<br>during ablation<br>procedures. AC assists<br>physicians in identifying<br>ablation targets,<br>assessing proper ablation<br>probe placement and<br>confirming ablation<br>zones. The software is<br>not intended for<br>diagnosis. | Same, the subject device<br>indications for use is the<br>same as the underlined text<br>from the predicate device.<br>The verbiage of the<br>Indications for Use of the<br>subject device is slightly<br>different than the declared<br>predicate as the text is<br>being reduced for clarity.<br>The change in verbiage<br>does not alter the intended<br>use of the device as<br>compared to the predicate<br>device. |
| Attribute | Subject Device<br>ABLATE-IQTM<br>K232227 | Predicate Device<br>Ablation Confirmation<br>K192427 | Comparison |
| Image<br>Acquisition | The system is capable<br>of retrieving CT image<br>data, conforming to the<br>DICOM standard.<br>Additionally, fused PET<br>images and MR images can<br>be imported for the<br>comparison scan feature. | The system is capable<br>of retrieving CT image<br>data, conforming to the<br>DICOM standard.<br>Additionally, fused PET<br>images and MR images can<br>be imported for the<br>comparison scan feature. | Same |
| 2D Image<br>Manipulation | The system provides tools<br>to manipulate the 2D<br>image data. The tool set<br>includes:<br>Window/LevelPan/ZoomImage ScrollingPoint<br>measurement<br>(HU and<br>coordinate)Distance<br>measurementRotation | The system provides tools<br>to manipulate the 2D<br>image data. The tool set<br>includes:<br>Window/LevelPan/ZoomImage ScrollingPoint<br>measurement<br>(HU and<br>coordinate)Distance<br>measurementRotation | Same |
| 3D Image<br>Generation | The system is able to<br>generate a 3D image<br>based upon the 2D<br>image series. | The system is able to<br>generate a 3D image<br>based upon the 2D<br>image series. | Same |
| 3D Image<br>Manipulation | The system provides tools<br>to manipulate the 3D<br>image rendering.<br>These tools include:<br>RotationPan/ZoomWindow/LevelDistance between tips<br>when multiple probes<br>are detected | The system provides tools<br>to manipulate the 3D<br>image rendering.<br>These tools include:<br>RotationPan/ZoomWindow/LevelDistance between tips<br>when multiple probes<br>are detected | Same |
| Attribute | Subject Device<br>ABLATE-IQTM | Predicate Device<br>Ablation Confirmation | Comparison |
| | K232227 | K192427 | |
| Region of<br>Interest (ROI)<br>Identification | The system allows the<br>user to semi-<br>automatically define<br>regions of interest on CT<br>images. A single- step<br>"undo" function was<br>added to this feature. | The system allows the<br>user to semi-<br>automatically define<br>regions of interest on CT<br>images. A single- step<br>"undo" function was<br>added to this feature. | Same |
| ROI<br>Measurements | The system allows the<br>user to assess the volume<br>of the defined ROIs. | The system allows the<br>user to assess the volume<br>of the defined ROIs. | Same |
| Desired Margin<br>Identification | The system allows the users<br>to draw on the ROI images<br>to visualize a user-<br>determined desired margin<br>for the ablation procedure. | The system allows the<br>users to draw on the ROI<br>images to visualize a user-<br>determined desired margin<br>for the ablation procedure. | Same |
| Registration | The system can perform<br>deformable registration on<br>two distinct CT images.<br>The user can manually<br>adjust the results of the<br>registration process.<br>Replaced 'Refine<br>Registration' capability<br>with a 'Manual<br>Registration' capability.<br>When using the manual<br>registration, the user has<br>the option of turning off<br>the deformations computed<br>by the deformable<br>registration. | The system can perform<br>deformable registration on<br>two distinct CT images.<br>The user can manually<br>adjust the results of the<br>registration process.<br>Replaced 'Refine<br>Registration' capability<br>with a 'Manual<br>Registration' capability.<br>When using the manual<br>registration, the user has<br>the option of turning off<br>the deformations computed<br>by the deformable<br>registration. | Same |
| Attribute | Subject Device<br>ABLATE-IQTM<br>K232227 | Predicate Device<br>Ablation Confirmation<br>K192427 | Comparison |
| Probe<br>Identification | The system can<br>automatically identify<br>ablation probes within the<br>scan. ABLATE-IQTM can<br>detect up to 3 probes.<br><br>The software also enables<br>the user to manually draw<br>probes. | The system can<br>automatically identify<br>ablation probes within the<br>scan. AC can detect up to<br>3 probes.<br><br>The software also enables<br>the user to manually draw<br>probes. | Same |
| 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. | Same |
| Ablation Zone<br>Assessment | Using the same process as<br>ROI identification, the<br>system allows the user to<br>semi- automatically<br>identify the ablation zone<br>following an ablation<br>procedure. | Using the same process as<br>ROI identification, the<br>system allows the user to<br>semi- automatically<br>identify the ablation zone<br>following an ablation<br>procedure. | Same |
| Allows User to<br>Account for<br>Tissue<br>Contraction | Yes | Yes | Same |
| Tissue<br>Contraction<br>Ranges - Liver | ABLATE-IQTM with<br>V3.2.0 SW allows users<br>to apply 0%, 10%, 15%,<br>20% or 30% tissue<br>contraction to identified<br>target during the<br>"Evaluate Ablation<br>Zone" step in the<br>workflow or<br>automatically based<br>upon default settings. | Ablation Confirmation<br>with V3.1.0 SW allows<br>users to apply 0%, 10%,<br>15%, 20% or 30%<br>tissue contraction to<br>identified target during<br>the "Evaluate Ablation<br>Zone" step in the<br>workflow or<br>automatically based<br>upon default settings. | Same |
| Attribute | Subject Device<br>ABLATE-IQTM<br>K232227 | Predicate Device<br>Ablation Confirmation<br>K192427 | Comparison |
| Tissue<br>Contraction<br>Ranges - Kidney | ABLATE-IQTM with<br>V3.2.0 SW allows users to<br>apply 0%, 10%, 15%,<br>20% or 30% tissue<br>contraction to identified<br>target during the<br>"Evaluate Ablation Zone"<br>step in the workflow or<br>automatically based upon<br>default settings. | Ablation Confirmation<br>with V3.1.0 SW allows<br>users to apply 0%, 10%,<br>15%, 20% or 30% tissue<br>contraction to identified<br>target during the<br>"Evaluate Ablation Zone"<br>step in the workflow or<br>automatically based upon<br>default settings. | Same |
| Tissue<br>Contraction<br>Ranges - Lung | ABLATE-IQTM with<br>V3.2.0 SW allows users to<br>apply 0%, 10%, 20%,<br>30%, 40% or 50%<br>tissue contraction to<br>identified target during<br>the "Evaluate Ablation<br>Zone" step in the<br>workflow or<br>automatically based<br>upon default settings | Ablation Confirmation<br>with V3.1.0 SW allows<br>users to apply 0%, 10%,<br>20%, 30%, 40% or 50%<br>tissue contraction to<br>identified target during<br>the "Evaluate Ablation<br>Zone" step in the<br>workflow or<br>automatically based<br>upon default settings. | Same |
| Assessing the<br>technical success<br>of the ablation<br>procedure | Using the same<br>deformable registration<br>process, image set with<br>ablation zone can be<br>overlaid onto the image<br>set 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<br>Set Up scan next to the<br>Evaluate Ablation scan. | Using the same<br>deformable registration<br>process, image set with<br>ablation zone can be<br>overlaid onto the image<br>set 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<br>Set Up scan next to the<br>Evaluate Ablation scan. | Same |
| Attribute | Subject Device<br>ABLATE-IQ™<br>K232227 | Predicate Device<br>Ablation Confirmation<br>K192427 | Comparison |
| Snapshots | User can take<br>snapshots of any view<br>and send to the facility<br>PACS for achieving, if<br>desired. | User can take snapshots<br>of any view and send to<br>the facility PACS for<br>achieving, if desired. | Same |
| Remote Viewing | No remote viewing<br>capability | No remote viewing<br>capability | Same |
| Orthogonal 2D<br>Viewing | Axial, Sagittal,<br>Coronal, "Needle" and<br>"Periscope"<br>presentation options. | Axial, Sagittal, Coronal,<br>"Needle" and<br>"Periscope" presentation<br>options. | Same |
| Workflow | 3 workflow pages<br>Prior to 3.2.0, the<br>software had ten steps<br>the user was required<br>to step through. In<br>3.2.0, the ABLATE-IQ™ navigation<br>groups similar<br>workflow steps<br>together under 3 major<br>workflow pages. | 10 workflow pages | Different |
| Reporting | New optional<br>reporting feature<br>added for version 3.2.0<br>software. | No reporting feature<br>available. | Different |
| Profiles | The system can apply<br>default settings for<br>procedure selectable<br>features and recall<br>those in a procedure<br>selectable way.<br>The default settings do<br>not control the<br>NEUWAVE system<br>nor probe output in<br>any way. | No profile feature<br>available. | Different |
| Planning | New optional feature<br>added for software<br>version 3.2.0. | No planning feature<br>available. | Different |
| Attribute | Subject Device<br>ABLATE-IQ™ | Predicate Device<br>Ablation Confirmation | Comparison |
| | K232227 | K192427 | |
| Cybersecurity | ABLATE-IQ™ V3.2.0<br>is a software only<br>device resident on the<br>NEUWAVE<br>Microwave Ablation<br>System. Cybersecurity<br>updates were made to<br>software V3.2.0 on the<br>NEUWAVE<br>Microwave Ablation<br>System. Cybersecurity<br>updates in V3.2.0<br>software on the<br>NEUWAVE<br>Microwave Ablation<br>System include:<br>● Whitelisting<br>Amendments<br>● Shell Lockdown<br>Amendments<br>● Firewall Rule<br>Amendments<br>● Bitlocker<br>● Remove Remote<br>Code<br>● Component<br>Removal<br>Cleanup | Ablation Confirmation<br>V3.1.0 is a software only<br>device resident on the<br>NEUWAVE Microwave<br>Ablation System.<br>Cybersecurity controls in<br>V3.1.0 software on the<br>NEUWAVE Microwave<br>Ablation System include:<br>● Whitelisting<br>● Shell Lockdown<br>● Firewall | Similar.<br>The NEUWAVE<br>Microwave Ablation<br>System software V3.2.0<br>includes new<br>cybersecurity features for<br>additional protection and<br>compliance. |

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