(88 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the technology as a "proprietary computational algorithm" and "algorithmic testing," without mentioning AI/ML specific terms or methodologies.
No
The device is a software application intended to provide physicians with adjunctive information for assessing the ablation zone; it does not directly perform or facilitate therapeutic intervention.
No
The "Intended Use / Indications for Use" section explicitly states, "BioTracelO Precision is not intended for standalone prediction or for diagnostic purposes."
Yes
The device description explicitly states that BioTraceIO Precision is a "stand-alone software application" and a "software application". While it processes images from ultrasound and CECT, it does not include or rely on any specific hardware components for its core functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- BioTraceIO Precision's Function: BioTraceIO Precision is a software application that analyzes ultrasound images captured during and after a liver ablation procedure. It provides visual information (maps) related to the ablation zone. It does not analyze biological samples from the patient.
- Intended Use: The intended use explicitly states that it provides "adjunctive information in their clinical assessment of ablation zone" and is "not intended for standalone prediction or for diagnostic purposes." This further reinforces that it's a tool to assist in the interpretation of imaging, not a diagnostic test performed on biological samples.
Therefore, BioTraceIO Precision falls under the category of medical imaging software or a medical device that processes imaging data, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
BioTraceIO Precision is intended to provide physicians with adjunctive information in their clinical assessment of ablation zone created by liver tissue ablation, as part of their overall post-procedure clinical assessment. BioTraceIO Precision generates and depicts a map (BioTrace Map or BTM) post-procedure, that correlates with image findings seen with Contrast-enhanced Computed Tomography (CECT) obtained at 24hours post treatment. The information is provided in the 2D ultrasound plane. This is the only plane and location displayed. No imaging of other portions of the ablation zone is available.
During the ablation procedure BioTraceIO Precision overlays the reference ablation zone (RAZ) provided by the ablation device manufacturer on the ultrasound image. BioTraceIO Precision is indicated for use in patients undergoing radiofrequency (RF) or microwave (MW) liver ablation procedures.
BioTraceIO Precision is not intended for standalone prediction or for diagnostic purposes. BioTraceIO Precision does not support the use of multiple needles, either simultaneously or consecutively.
Manual ablation target contours and margins as defined by the user are not intended for diagnosis, to predict ablation volumes or predict ablation success.
The physician should not rely on BioTraceIO Precision BTM alone in decisions about patient management post treatment nor should BioTraceIO Precision serve as a substitute for any other assessment method, e.g., CT scans.
Product codes (comma separated list FDA assigned to the subject device)
QZL
Device Description
BioTraceIO Precision is a stand-alone software application with tools and features designed to assist users in their clinical assessment of ablation zone created by liver tissue ablation, as part of their overall post-procedure clinical assessment.
BioTraceIO Precision is a software application that uses a proprietary computational algorithm to analyze ultrasound images captured during liver ablation treatment (microwave ablation [MWA] or radiofrequency ablation [RFA]), as depicted in standard abdominal ultrasound imaging.
The streamed ultrasound images are captured and analyzed by the BioTraceIO algorithm. providing a visual display of the expected ablation zone, namely the Reference Ablation Zone (RAZ), calculated based on technical parameters provided by the ablation manufacturer datasheet. The RAZ is displayed during the procedure (Online Mode). BioTraceIO Precision also provides a visual display of the estimated ablation zone correlative to the 24-hour CECT, namely the BioTrace Map (BTM), after the completion of the procedure (Offline Mode).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound images, Contrast-enhanced Computed Tomography (CECT)
Anatomical Site
Liver tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified trained operators; Clinical operating environment
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
Algorithmic testing was performed on the BTM algorithm, to ensure that performance and accuracy was as expected. The validation analysis resulted in a mean DICE coefficient of 84.7 [95% C1: 83.07, 86.49] and 85.5 [95% Cl: 83.63, 87.43] for the optimized BTM and predicate BTM, respectively, as compared to ablation zone visualized on the 24-hour post ablation CECT (T=24 CECT). This result was tested using both paired t-test (p = 0.2408), as well as Wilcoxon Signed-Rank test (p = 0.11).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
BioTraceIO Precision 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 functional and algorithmic testing demonstrate that BioTraceIO Precision meets the user needs and requirements of the device, which are considered to be substantially equivalent to those of the listed predicate device.
Algorithmic testing was performed on the BTM algorithm, to ensure that performance and accuracy was as expected. The validation analysis resulted in a mean DICE coefficient of 84.7 [95% C1: 83.07, 86.49] and 85.5 [95% Cl: 83.63, 87.43] for the optimized BTM and predicate BTM, respectively, as compared to ablation zone visualized on the 24-hour post ablation CECT (T=24 CECT). This result was tested using both paired t-test (p = 0.2408), as well as Wilcoxon Signed-Rank test (p = 0.11). Both methodologies yielded similar non-significant p-values, indicating no significant differences in measurement of mean dice coefficients between the two algorithms. The optimized BTM also demonstrated a significantly (paired t-test p
N/A
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 USA 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.
December 27, 2024
TechsoMed Medical Technologies Ltd. Dalia Dickman Head of Regulatory Affairs Meir Weisgal 2 REHOVOT, 7654055 ISRAEL
Re: K243084
Trade/Device Name: BioTraceIO Precision (2.0) Regulation Number: 21 CFR 892.2052 Regulation Name: Post-Ablation Tissue Response Prediction Software Regulatory Class: Class II Product Code: QZL Dated: December 2, 2024 Received: December 2, 2024
Dear Dalia Dickman:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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.
2
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Digitally signed by Shahram for Shahram Vaezy -S Vaezy -S Date: 2024.12.27 13:58:03 -05'00'
Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological
Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K243084
Device Name BioTraceIO Precision (2.0)
Indications for Use (Describe)
BioTraceIO Precision is intended to provide physicians with adjunctive information in their clinical assessment of ablation zone created by liver tissue ablation, as part of their overall post-procedure clinical assessment. BioTracelO Precision generates and depicts a map (BioTrace Map or BTM) post-procedure, that correlates with image findings seen with Contrast-enhanced Computed Tomography (CECT) obtained at 24hours post treatment. The information is provided in the 2D ultrasound plane. This is the only plane and location displayed. No imaging of other portions of the ablation zone is available.
During the ablation procedure BioTraceIO Precision overlays the reference ablation zone (RAZ) provided by the ablation device manufacturer on the ultrasound image.
BioTracelO Precision is indicated for use in patients undergoing radiofrequency (RF) or microwave (MW) liver ablation procedures.
BioTraceIO Precision is not intended for standalone prediction or for diagnostic purposes. BioTraceIO Precision does not support the use of multiple needles, either simultaneously or consecutively.
Manual ablation target contours and margins as defined by the user are not intended for diagnosis, to predict ablation volumes or predict ablation success.
The physician should not rely on BioTraceIO Precisions about patient management post treatment nor should BioTraceIO Precision serve as a substitute for any other assessment method, e.g., CT scans.
| 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) | ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ||
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
510(K) SUMMARY
K243084
TechsoMed's BioTracelO Precision
Submitter
TechsoMed Medical Technologies. LTD. Meir Weisgal 2 Rehovot Israel
Phone: +972545595951
Contact Person: Dalia Dickman, PhD.
Date Prepared: September 26, 2024
Name of Device: BioTraceIO Precision (2.0)
Common or Usual Name: BioTracelO Precision
Classification Name: Post-Ablation Tissue Response Prediction Software (CFR 892.2052)
Regulatory Class: Class II
Product Code: QZL
Predicate Device
| 510(k) Number | DEN230020 |
|---|---|
| Trade Name | BioTraceIO Precision |
| Manufacturer | TechsoMed Medical Technologies. LTD. |
| Device Name | BioTraceIO Lite |
| Regulation Number | 892.2052 |
| Regulation Name | Post-Ablation Tissue Response Prediction Software |
| Regulatory Class | Class II |
| Primary Product Code | QZL |
Reference Device
| 510(k) Number | K240773 |
|---|---|
| Trade Name | BioTraceIO Vision |
| 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 |
| Product Code | QTZ, QIH, LLZ |
5
Device Description
BioTracelO Precision is a stand-alone software application with tools and features designed to assist users in their clinical assessment of ablation zone created by liver tissue ablation, as part of their overall post-procedure clinical assessment.
BioTracelO Precision is a software application that uses a proprietary computational algorithm to analyze ultrasound images captured during liver ablation treatment (microwave ablation [MWA] or radiofrequency ablation [RFA]), as depicted in standard abdominal ultrasound imaging.
The streamed ultrasound images are captured and analyzed by the BioTracelO algorithm. providing a visual display of the expected ablation zone, namely the Reference Ablation Zone (RAZ), calculated based on technical parameters provided by the ablation manufacturer datasheet. The RAZ is displayed during the procedure (Online Mode). BioTracelO Precision also provides a
visual display of the estimated ablation zone correlative to the 24-hour CECT, namely the BioTrace Map (BTM), after the completion of the procedure (Offline Mode).
Intended Use / Indications for Use
BioTracelO Precision is intended to provide physicians with adjunctive information in their clinical assessment of ablation zone created by liver tissue ablation, as part of their overall post-procedure clinical assessment.
BioTraceIO Precision generates and depicts a map (BioTrace Map or BTM) post-procedure, that correlates with image findings seen with Centrast-enhanced Computed Tomography (CECT) obtained at 24hours post treatment. The information is provided in the 2D ultrasound plane. This is the only plane and location displayed. No imaging of other portions of the ablation zone is available.
During the ablation procedure BioTracelO Precision overlays the reference ablation zone (RAZ) provided by the ablation device manufacturer on the ultrasound image. BioTraceIO Precision is indicated for use in patients undergoing radiofrequency (RF) or microwave (MW) liver ablation procedures.
BioTracelO Precision is not intended for standalone prediction or for diagnostic purposes. BioTracelO Precision does not support the use of multiple needles, either simultaneously or consecutively.
Manual ablation target contours and margins as defined by the user are not intended for diagnosis, to predict ablation volumes or predict ablation success.
The physician should not rely on BioTraceIO Precision BTM alone in decisions about patient management post treatment nor should BioTracelO Precision serve as a substitute for any other assessment method, e.g., CT scans.
Summary of Technological Characteristics
Both the subject and predicate device are stand-alone software applications that use a proprietary computational algorithm to analyze ultrasound images captured during liver ablation treatment (microwave ablation [MWA] or radiofrequency ablation [RFA]), as depicted in standard abdominal ultrasound imaging.
The streamed ultrasound images are captured and analyzed by the BioTracelO algorithm, providing a visual display of the expected ablation zone, namely the Reference Ablation Zone (RAZ), calculated based on technical parameters provided by the ablation manufacturer datasheet. The RAZ is displayed during the procedure (Online Mode). BioTracelO Precision also provides a visual display of the estimated ablation zone correlative to the 24-hour CECT, namely the BioTrace
6
Map (BTM), after the completion of the procedure (Offline Mode).
The following technological differences exist between the subject and the predicate device:
The primary differences between devices are: (1) BTM algorithm processing time has been optimized to reduce delay for the user, and in turn is displayed in the offline mode 15 minutes after the ablation procedure has been completed (2) the RAZ algorithm has been adapted to have the same implementation used for BTM processing for the purpose of algorithm optimization and easier maintenance (3) user interface (UI) modifications have been made to improve the user experience
(4) cybersecurity improvements have been made (5) technical modifications have been made such as name change, file configuration change and architecture change.
A table comparing the key features of the subject and predicate devices is provided below.
7
Substantial Equivalence Comparison Table
| Subject Device | Predicate Device | |
|---|---|---|
| BioTraceIO Precision (Ver 2.0) | BioTraceIO Precision | |
| (previously commercially named | ||
| BioTraceIO Lite) | ||
| DeNovo/510(k) | ||
| number | K243084 | DEN230020 |
| Classification | Class II QZL | Class II QZL |
| Intended Use | A stand-alone software application | |
| with tools and features designed to | ||
| assist users in their clinical | ||
| assessment of ablation zone | ||
| created by liver tissue ablation, as | ||
| part of their overall post-procedure | ||
| clinical assessment. | A stand-alone software application | |
| with tools and features designed to | ||
| assist users in their clinical | ||
| assessment of ablation zone | ||
| created by liver tissue ablation, as | ||
| part of their overall post-procedure | ||
| clinical assessment. | ||
| Indications | ||
| for | ||
| Use | BioTraceIO Precision is intended | |
| to provide physicians with | ||
| adjunctive information in their | ||
| clinical | ||
| assessment of ablation zone | ||
| created by liver tissue ablation, as | ||
| part of their overall post-procedure | ||
| clinical assessment. | ||
| BioTraceIO Precision generates | ||
| and depicts a map (BioTrace Map | ||
| or BTM) post-procedure, that | ||
| correlates with image findings | ||
| seen with Contrast-enhanced | ||
| Computed Tomography (CECT) | ||
| obtained at 24 hours post | ||
| treatment. The information is | ||
| provided in the 2D ultrasound | ||
| plane. This is the only plane | ||
| and location displayed. No imaging | ||
| of other portions of the ablation | ||
| zone is available. | ||
| During the ablation procedure | ||
| BioTraceIO Precision overlays the | ||
| reference ablation zone (RAZ) | ||
| provided by the ablation device | ||
| manufacturer on the ultrasound | ||
| image. | ||
| BioTraceIO Precision is indicated | ||
| for use in patients undergoing | ||
| radiofrequency (RF) or microwave | ||
| (MW) liver ablation procedures. | ||
| BioTraceIO Precision is not | ||
| intended for standalone prediction | ||
| or for diagnostic purposes. | ||
| BioTraceIO Precision does not | ||
| support the use of multiple | BioTraceIO Lite is intended to | |
| provide physicians with adjunctive | ||
| information in their clinical | ||
| assessment of ablation zone | ||
| created by liver tissue ablation, as | ||
| part of their overall post-procedure | ||
| clinical assessment. | ||
| BioTraceIO Lite generates and | ||
| depicts a map (BioTrace Map or | ||
| BTM) post-procedure, that | ||
| correlates with image findings seen with | ||
| Contrast-enhanced Computed | ||
| Tomography (CECT) obtained at 24 | ||
| hours post treatment. The | ||
| information is provided in the 2D | ||
| ultrasound plane. This is the only | ||
| plane | ||
| and location displayed. No imaging | ||
| of other portions of the ablation | ||
| zone is available. | ||
| During the ablation procedure | ||
| BioTraceIO Lite overlays the | ||
| reference ablation zone (RAZ) | ||
| provided | ||
| by the ablation device manufacturer | ||
| on the ultrasound image. | ||
| BioTraceIO Lite is indicated for use | ||
| in patients undergoing | ||
| radiofrequency (RF) or microwave | ||
| (MW) | ||
| liver ablation procedures. | ||
| BioTraceIO Lite is not intended for | ||
| standalone prediction or for | ||
| diagnostic purposes. | ||
| needles, either simultaneously or | ||
| consecutively. | ||
| Manual ablation target contours | ||
| and margins as defined by the user | ||
| are not intended for diagnosis, to | ||
| predict ablation volumes or predict | ||
| ablation success. |
The physician should not rely on
BioTraceIO Precision BTM alone
in decisions about patient
management
post treatment nor should
BioTraceIO Precision serve as a
substitute for any other
assessment method,
e.g., CT scans. | BioTraceIO Lite does not support
the use of multiple needles, either
simultaneously or consecutively.
The physician should not rely on
BioTraceIO Lite BTM alone in
decisions about patient
management
post treatment nor should
BioTraceIO Lite serve as a
substitute for any other assessment
method,
e.g., CT scans. |
| Primary
Differences | (1) the BTM algorithm processing
time has been optimized through
enhancements in algorithm
architecture to reduce delay for the
user, and in turn is displayed in the
offline mode 15 minutes after the
ablation procedure has been
completed (2) the RAZ algorithm
has been updated to utilize the
same architectural framework as
the BTM algorithm. This adaptation
facilitates optimization and
simplifies maintenance (3) user
interface (UI) modifications have
been made to improve the user
experience such as button layout
improvements and allow for
selection of a reference US frame
for needle marking (4)
cybersecurity improvements have
been made such as encryption of
PHI and installation responsibilities
(5) technical modifications have
been made such as name change,
report viewer file configuration
change and software framework
architecture change. | NA |
| User Population | Qualified trained operators | Qualified trained operators |
| Where used | BioTraceIO Precision is
designated for use in a clinical
operating environment with
compatible ultrasound and liver
tissue ablation devices. | BioTraceIO Precision is designated
for use in a clinical operating
environment with
compatible
ultrasound and liver tissue ablation
devices. |
| 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 | BioTraceIO Precision is a software
application that uses a proprietary
computational algorithm to analyze
ultrasound images captured during | BioTraceIO Precision is a software
application that uses a proprietary
computational algorithm to analyze
ultrasound images captured during |
| | liver ablation treatment
(microwave ablation [MWA] or
radiofrequency ablation [RFA]), as depicted in
standard abdominal ultrasound
imaging.
The streamed ultrasound images
are captured and analyzed by the
BioTraceIO algorithm, providing a
visual display of the expected
ablation zone, namely the
Reference Ablation Zone (RAZ),
calculated based on technical
parameters provided by the
ablation manufacturer datasheet.
The RAZ is displayed, during the
procedure (Online Mode).
BioTracelO Precision also
provides a visual display of the
estimated ablation zone correlative
to the 24-hour CECT, namely the
BioTrace Map (BTM)
fifteen (15) minutes after the
completion of the procedure
(Offline Mode).
Color-coded display of scores
reflecting image quality and
reliability of the RAZ motion
compensation displayed in the UI
using a color-coded 5-point scale.
These scores are computed based
on objective metrics, and their
purpose is to ensure the correct
execution of the algorithms in the
BioTraceIO Precision system.
Manual contouring of ablation
target on the reference US frame
and display of the ablation margin
as defined by the user around the
contour. This feature was cleared in
K240773. | liver ablation treatment (microwave
ablation [MWA] or radiofrequency
ablation [RFA]), as depicted in
standard abdominal ultrasound
imaging.
The streamed ultrasound images
are captured and analyzed by the
BioTraceIO algorithm, providing a
visual display of the expected
ablation zone, namely the
Reference Ablation Zone (RAZ),
calculated based on technical
parameters provided by the ablation
manufacturer datasheet. The RAZ
is displayed, during the procedure
(Online Mode). BioTracelO
Precision also provides a visual
display of the estimated ablation
zone correlative to the 24-hour
CECT, namely the BioTrace Map
(BTM), thirty (30) minutes after the
completion of the procedure (Offline
Mode).
Generation of scores reflecting image
quality and reliability of the RAZ
motion compensation which runs as
background calculations within the
software and is not visible to the user.
These scores are computed based
on objective metrics, and their
purpose is to ensure the correct
execution of the algorithms in the
BioTraceIO Precision system.
NA |
| Design:
Data
Visualization | BTM on offline mode; RAZ on
online mode | BTM on offline mode; RAZ on
online mode |
| Design;
Data
Input | Used with a hardware streaming
device that is connected to an
ultrasound machine output, to
capture input ultrasound images. | Used with a hardware streaming
device that is connected to an
ultrasound machine output, to
capture input ultrasound images. |
| Design:
Online
Mode | In online mode, the BioTracelO
algorithm analyses the ultrasound
images, and calculates a
transformation matrix per frame.
The transformation matrix defines
the movement and orientation
change between two frames and is
used to transform the RAZ and
register it to the ultrasound image. | In online mode, the BioTracelO
algorithm analyses the ultrasound
images, and calculates a
transformation matrix per frame.
The transformation matrix defines
the movement and orientation
change between two frames and is
used to transform the RAZ and
register it to the ultrasound image. |
| | In offline mode, the BioTraceIO
algorithm calculates the BTM as it
is generated during the procedure. | In offline mode, the BioTraceIO
algorithm calculates the BTM as it is
generated during the procedure. |
| | BTM calculations are based on the
biological response of the tissue to
heating and its appearance on
ultrasound imaging. | BTM calculations are based on the
biological response of the tissue to
heating and its appearance on
ultrasound imaging. |
| Design: | In offline mode, the BioTraceIO
algorithm calculates the BTM as it
is generated during the procedure. | In offline mode, the BioTraceIO
algorithm calculates the BTM as it is
generated during the procedure. |
| Mode | BTM calculations are based on the
biological response of the tissue to
heating and its appearance on
ultrasound imaging. | BTM calculations are based on the
biological response of the tissue to
heating and its appearance on
ultrasound imaging. |
| Offline | | |
8
9
10
Performance Data
BioTraceIO Precision 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 functional and algorithmic testing demonstrate that BioTracelO Precision meets the user needs and requirements of the device, which are considered to be substantially equivalent to those of the listed predicate device.
Alqorithmic testing was performed on the BTM alqorithm, to ensure that performance and accuracy was as expected. The validation analysis resulted in a mean DICE coefficient of 84.7 [95% C1: 83.07, 86.49] and 85.5 [95% Cl: 83.63, 87.43] for the optimized BTM and predicate BTM, respectively, as compared to ablation zone visualized on the 24-hour post ablation CECT (T=24 CECT). This result was tested using both paired t-test (p = 0.2408), as well as Wilcoxon Signed-Rank test (p = 0.11). Both methodologies yielded similar non-significant p-values, indicating no
significant differences in measurement of mean dice coefficients between the two algorithms. The optimized BTM also demonstrated a significantly (paired t-test p