(28 days)
Not Found
No
The summary describes standard image processing techniques and does not mention AI, ML, or related concepts.
No
The device is an image processing software that assists physicians in identifying ablation targets and confirming ablation zones, but it does not directly perform a therapeutic function. It is explicitly stated that the software is "not intended for diagnosis" and is an "image processing software package."
No
The "Intended Use / Indications for Use" section explicitly states, "The software is not intended for diagnosis."
No
The device is described as an optional feature for use with a hardware system (NEUWAVE Microwave Ablation System) and is resident on that system, even though it has a separate user interface. It also interacts with external hardware like CT scanners and PACS systems. While it is primarily software, its function is intrinsically tied to and dependent on the hardware of the ablation system and imaging modalities.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" explicitly states: "The software is not intended for diagnosis." IVD devices are specifically intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.
- Function: The software's function is to assist physicians in identifying ablation targets, assessing probe placement, and confirming ablation zones during a procedure. This is a procedural aid, not a diagnostic tool that analyzes samples from the human body to provide diagnostic information.
- Input: While it uses medical images (CT, PET, MR), it's processing these images to guide and confirm a medical procedure, not to perform a diagnostic test on a biological sample.
Therefore, based on the definition and intended use of IVD devices, this software does not fit that classification.
N/A
Intended Use / 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.
Product codes
JAK
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
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT), fused PET images, MR images
Anatomical Site
soft tissue including liver, lung and kidney
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians / NEUWAVE Microwave Ablation System procedure area
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
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.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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. 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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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,
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)
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3
| Date:
Subject: | 08/28/2019
510(k) Summary of Safety and Effectiveness Information for NeuWave
Medical's Ablation Confirmation™ image processing software |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Company: | NeuWave Medical, Inc.
3529 Anderson Street
Madison, WI 53704 |
| FDA Establishment# | 3008769756 |
| Contact: | Neda Chini, Senior Regulatory Affairs Program Lead
P – 949-789-8656
F - 608-512-1509 |
| Proprietary:
Classification: | Ablation Confirmation™ Common: Computed Tomography X-ray System
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
V2.3.0 (K171022) | | Same as
predicate | Comments/impact on
safety and effectiveness |
|---------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject Device: Ablation
Confirmation Software
V3.1.0 | | | | |
| Indication 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. | Ablation Confirmation™
(AC), is a Computed
Tomography (CT) image
processing software
package available as an
optional feature for use
with the Certus® 140 2.45
GHz Ablation System. AC is
controlled by the user via
an independent user
interface on a second
monitor separate from the
Certus 140 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. | | Yes | No changes to the
Indication For Use. The
product name of the
ablation system was
updated to reflect a
branding/name change. |
| 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, MR
images can be imported
for the comparison scan
feature. | | No | The fused PET
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 |
| Feature/Specification | Subject Device: Ablation
Confirmation Software
V3.1.0 | Predicate: Ablation
Confirmation Software
V2.3.0 (K171022) | Same as
predicate | Comments/impact on
safety and effectiveness | |
| | | | | 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. | |
| 3D Image
Manipulation | The system provides tools to
manipulate the 3D image
rendering. These tools
include:
• Rotation
• Pan/Zoom
• Window/Level
• Distance between
tips when multiple
probes are detected | The system provides tools to
manipulate the 3D image
rendering. These tools
include:
• Rotation
• Pan/Zoom
• Window/Level | No | Addition of distance
between probe tip
measurement as a
convenience feature for
users. No new risks or
required risk mitigations
were identified and no
impact on safety or
effectiveness. | |
| 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. | No | "Undo" is a minor change
and convenience feature
for users. No new risks or
required risk mitigations
were identified and no
impact to safety or
effectiveness. | |
| 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. | Yes | No changes in this
submission | |
| 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. | Yes | No changes in this
submission | |
| 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 | The system can perform
deformable registration on
two distinct CT images. The
user can manually adjust the
results of the registration
process. | No | Automatic registration
algorithms and mechanisms
remain unchanged. The
manual registration option
methodology has changed
and an "undo" feature was
added. No new risks were
identified, no new risk
mitigations were required | |
| Feature/Specification | Subject Device: Ablation
Confirmation Software
V3.1.0 | Predicate: Ablation
Confirmation Software
V2.3.0 (K171022) | Same as
predicate | Comments/impact on
safety and effectiveness | |
| | has the option of turning off
the deformations computed
by the deformable
registration. | | | and no impact to safety or
effectiveness. | |
| Probe Identification | 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 | The system can automatically
identify ablation probes
within the scan. AC can detect
up to 3 probes. | No | Continuous improvement
of existing probe detection
feature. Ability to manual
draw probes is a minor
feature addition to improve
feature set. | |
| 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. | Yes | No changes in this
submission | |
| 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. | Yes | No changes in this
submission | |
| Allows User to
Account for Tissue
Contraction | Yes | Yes | Yes | No changes in this
submission | |
| 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 | No | This change is a minor
workflow enhancement
based upon user feedback.
No new risks or required
risk mitigations were
identified and no impact to
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.