(25 days)
Not Found
Yes
The summary explicitly states that "The liver segmentation and liver vessel segmentation algorithms for CT processing are Al alqorithms" and "The liver segmentation for MR processing is an AI algorithm."
No.
VisAble.IO is an image processing software intended to assist physicians in planning and confirming ablation procedures. It does not directly perform a therapeutic function on a patient.
No
The "Intended Use / Indications for Use" section explicitly states, "The software is not intended for diagnosis." It is designed to assist physicians in planning and confirming liver ablation procedures, not for diagnostic purposes.
Yes
The device is explicitly described as a "stand-alone software application" and its functions are solely related to image processing, analysis, and display. While it runs on a dedicated computer, the device itself is the software, not the hardware it runs on.
Based on the provided information, VisAble.IO is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use explicitly states that the software is "not intended for diagnosis." IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. VisAble.IO's purpose is to assist physicians in planning and confirming liver ablation procedures based on medical images.
- Device Description: The description focuses on image processing, segmentation, planning, and confirmation of procedures using medical imaging data (CT and MR). It does not mention any interaction with biological samples or performing tests on such samples.
- Input: The input is medical imaging data (CT and MR images), not biological samples.
- Functionality: The core functionalities revolve around image manipulation, analysis, and quantification for procedural planning and confirmation, not diagnostic testing.
While the device uses AI algorithms and processes medical data, its intended use and functionality clearly place it outside the definition of an In Vitro Diagnostic device. It is a medical image processing software intended to aid in surgical planning and confirmation.
No
The letter does not state that the FDA has reviewed and approved or cleared a PCCP for this specific device. The section "Control Plan Authorized (PCCP) and relevant text" explicitly states "Not Found".
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
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
-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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Computed Tomography (CT), Magnetic Resonance (MR)
Anatomical Site
Liver
Indicated Patient Age Range
The system can be used on patient data for any patient demographic chosen to undergo the ablation treatment.
Intended User / Care Setting
Qualified trained physicians / Operating Room and hospital healthcare environment such as interventional radiology control room
Description of the training set, sample size, data source, and annotation protocol
Liver Segmentation Algorithm (CT):
- 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 (CT):
- 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
Liver Segmentation Algorithm (MR):
- 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
Description of the test set, sample size, data source, and annotation protocol
Segmentation post-processing Testing, Image Registration Testing, Measurement and Quantification Testing.
CT Processing:
- Liver Segmentation: N=50, M: 52% F: 48%, Mean Age: 60.6, US: 32 OUS: 18, GE Medical Systems, Siemens
- Ablation Target Segmentation: N=59, M: 54% F: 46%, Mean Age: 60.0, US: 30 OUS: 29, GE Medical Systems, Siemens, Philips
- Ablation Zone Segmentation: N=59, M:64% F: 36%, Mean Age: 66.0, US: 30 OUS: 29, GE Medical Systems, Siemens
- Liver Vessels Segmentation: N=100, M: 52% F: 48%, Mean Age: 58.5, US: 72 OUS: 28, GE Medical Systems, Siemens
MR Processing:
- Liver Segmentation: N=25, M: 76% F: 24%, Mean Age: 70.4, US: 25, GE Medical Systems, Philips, Siemens
- Ablation Target Segmentation: N=50, M: 70% F: 30%, Mean Age: 69, US: 46 OUS: 4, GE Medical Systems, Philips, Siemens
Image Registration:
- Pre-ablation CT to Post Ablation CT Image Registration: N=46, M: 59% F: 41%, Mean Age: 63.3, US: 13 OUS: 33, GE Medical Systems, Siemens, Philips
- Pre-ablation MR to Post-ablation CT Image Registration: N=25, M: 56% F: 28% Other: 16%, Mean Age: 68.4, US: 25, MR: GE Medical Systems, Philips, Siemens CT: GE Medical Systems, Philips, Siemens, Toshiba
- Pre-ablation MR to Pre-ablation CT Image Registration: N=18, M: 83% F: 17%, Mean Age: 71.5, US: 14 OUS: 4, MR: GE Medical Systems, Philips, Siemens, Toshiba CT: GE Medical Systems, Philips, Toshiba
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key results for segmentation algorithms (Mean DICE) and image registration (Mean Corresponding Distance - MCD):
CT Processing:
- Liver Segmentation: Performance = Mean DICE = 0.98 (Goal = 0.92)
- Ablation Target Segmentation: Performance = Mean DICE = 0.82 (Goal = 0.70)
- Ablation Zone Segmentation: Performance = Mean DICE = 0.88 (Goal = 0.70)
- Liver Vessels Segmentation: Performance = Mean DICE = 0.72 (Goal = 0.70)
MR Processing:
- Liver Segmentation: Performance = Mean DICE = 0.93 (Goal = 0.92)
- Ablation Target Segmentation: Performance = Mean DICE = 0.76 (Goal = 0.70)
Image Registration:
- Pre-ablation CT to Post Ablation CT Image Registration: Performance = MCD*=4.09 mm (Goal = 6.06 mm)
- Pre-ablation MR to Post-ablation CT Image Registration: Performance = MCD* = 4.72 mm (Goal = 6.06 mm)
- Pre-ablation MR to Pre-ablation CT Image Registration: Performance = MCD* = 5.10 mm (Goal = 7.90 mm)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Mean DICE, Mean Corresponding Distance (MCD)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Image /page/0/Picture/0 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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).
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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 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
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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) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------------- | ---------------------------------------------------------------------------- |
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K240773
510(K) SUMMARY
TechsoMed's VisAble.IO
Submitter
TechsoMed Medical Technologies. LTD.
Meir Weisgal 2 Rehovot Israel
Phone: +972545595951
Contact Person: Dalia Dickman, PhD.
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.
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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
VisAble.IO (Ver 1.4) | Predicate Device
VisAble.IO (Ver 1.0) |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | | K223639 |
| Classification | Class II 892.2050 QTZ, QIH,
LLZ | Class II 892.2050 QTZ, QIH,
LLZ |
| Intended Use | The intended patient
population is patients chosen
by interventional radiologists to | The intended patient population
is patients chosen by
interventional radiologists to |
| | undergo ablation treatment
(including patients with soft
tissue lesions) | undergo ablation treatment
(including patients with soft
tissue lesions) |
| 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. | VisAble.IO is a Computed
Tomography (CT) image
processing software package
available for use with liver
ablation procedures. |
| | VisAble.IO is controlled by the
user via a user interface. | 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 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. | 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. | The software is not intended for
diagnosis. The software is not
intended to predict ablation
volumes or predict ablation
success. |
| User Population | Qualified trained physicians | Qualified trained physicians |
| Where used | The application's use
environment is the Operation
Room and the hospital
healthcare environment such
as interventional radiology
control room | The application's use
environment is the Operation
Room and the hospital
healthcare environment such as
interventional radiology control
room |
| Energy Used | None - software only
application. The software
application does not deliver or
depend on energy delivered to
or from patients | None - software only application.
The software application does
not deliver or depend on energy
delivered to or from patients |
| Technological
Characteristics | VisAble.IO is a 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 the device is
the Operating Room and the | VisAble.IO is a 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 the device is the
Operating Room and the hospital |
| | hospital healthcare environment such as interventional radiology control room. VisAble.IO has 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) | healthcare environment such as interventional radiology control room. VisAble.IO has 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) |
| 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. |
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7
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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
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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% | |||||
| F: 48% | 60.6 | US: 32 | |||||
| OUS: 18 | GE Medical Systems, | ||||||
| Siemens | Mean DICE =0.92 | Mean DICE =0.98 | |||||
| Ablation Target Segmentation | 59 | M: 54% | |||||
| F: 46% | 60.0 | US: 30 | |||||
| OUS: 29 | GE Medical Systems, | ||||||
| Siemens, Philips | Mean DICE = 0.70 | Mean DICE = 0.82 | |||||
| Ablation Zone Segmentation | 59 | M:64% F: | |||||
| 36% | 66.0 | US: 30 | |||||
| OUS: 29 | GE Medical Systems, | ||||||
| Siemens | Mean DICE = 0.70 | Mean DICE = 0.88 | |||||
| Liver Vessels Segmentation | 100 | M: 52% | |||||
| F: 48% | 58.5 | US: 72 | |||||
| OUS: 28 | GE Medical Systems, | ||||||
| Siemens | Mean DICE = 0.70 | Mean DICE = 0.72 | |||||
| MR Processing | |||||||
| Liver Segmentation | 25 | M: 76% | |||||
| F: 24% | 70.4 | US: 25 | GE Medical Systems, Philips, | ||||
| Siemens | Mean DICE = 0.92 | Mean DICE = 0.93 | |||||
| Ablation Target Segmentation | 50 | M: 70% | |||||
| F: 30% | 69 | US: 46 | |||||
| OUS: 4 | GE Medical Systems, Philips, | ||||||
| Siemens | Mean DICE = 0.70 | Mean DICE = 0.76 | |||||
| Image Registration | |||||||
| Pre-ablation CT to Post Ablation CT | |||||||
| Image Registration | 46 | M: 59% | |||||
| F: 41% | 63.3 | US: 13 | |||||
| OUS: 33 | GE Medical Systems, | ||||||
| Siemens, | |||||||
| Philips | MCD*= 6.06 mm | MCD*=4.09 mm | |||||
| Pre-ablation MR to Post-ablation CT | |||||||
| Image Registration | 25 | M: 56% | |||||
| F: 28% | |||||||
| Other: 16% | 68.4 | US: 25 | MR: GE Medical Systems, Philips, Siemens | ||||
| CT: GE Medical Systems, Philips, Siemens, Toshiba | MCD* = 6.06 mm | MCD* = 4.72 mm | |||||
| Pre-ablation MR to | |||||||
| Pre-ablation CT | |||||||
| Image Registration | 18 | M: 83% | |||||
| F: 17% | 71.5 | US: 14 | |||||
| OUS: 4 | MR: GE Medical | ||||||
| Systems, Philips, | |||||||
| Siemens, | |||||||
| Toshiba |
CT: GE Medical
Systems, Philips,
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.