BioTraceIO Vision is a Computed Tomography (CT) and Magnetic Resonance (MR) image processing software package available for use with ablation procedures.

BioTraceIO Vision is controlled by the user via a user interface.

BioTraceIO Vision imports images from CT and MR scanners and facility PACS systems for display and processing during ablation procedures.

BioTraceIO Vision is used to assist physicians in planning ablation procedures, including identifying ablation targets and virtual ablation needle placement. BioTraceIO Vision 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.

Device Description

BioTraceIO Vision 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 BioTraceIO Vision is the Operating Room and the hospital healthcare environment such as interventional radiology control room.

BioTraceIO Vision has six distinct workflow steps:

Data Import
Anatomic Structures Segmentation (Liver, Kidney, Hepatic Vein, Portal Vein, Ablation Target)
Instrument Placement (Needle Planning) for Microwave Ablation (MWA) or Cryoablation (Cryo) Procedures
Ablation Zone/Ice ball Segmentation
Registration of Pre-Procedure Images
Treatment Confirmation (Registration of Pre- and Post-Interventional Images; Quantitative Analysis)

Of these workflow steps, four (Anatomic Segmentation, Ablation Target Segmentation, Registration of Pre-Procedure Images 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 BioTraceIO Vision Software include:

Workflow steps availability
Manual and automated tools for anatomic structures and ablation target/zone segmentation
Overlaying and positioning virtual instruments (ablation needles) and user-selected estimates of the ablation regions onto the medical images
Image 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.

BioTraceIO Vision 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

BioTraceIO Vision is intended to be used for ablations with the following ablation instruments:

For needle planning, the software currently supports the following needle models:

Microwave ablation
- AngioDynamics: Solero Probe 14CM, 19CM, 29CM
- HS HOSPITAL SERVICE: Amica Probe (16G) 15CM, 20CM, 27CM; Amica Probe (14G) 15CM, 20CM, 27CM
- Medtronic Covidien: Emprint Antenna 15CM, 20CM, 30CM
- NeuWave Medical: LK Probe 15CM, 20CM; LK XT Probe 15CM, 20CM; PR Probe 15CM, 20CM; PR XT Probe 15CM, 20CM
- Varian Medical Systems: Ximitry Probe 15CM, 20CM, 27CM
Cryo ablation
- Boston Scientific: IceForce 2.1 CX, CX L; IcePearl 2.1 CX, CX L; IceRod 1.5 CX; IceSeed 1.5 CX, CX S;Ice Sphere 1.5 CX
- IceCure Medical: ProSense 10G Spheric, Elliptic 14CM, Elliptic 18.5CM; ProSense 13G Spheric, Elliptic
- Varian Medical Systems: ISOLIS 2.1 E Probe 15CM, 20CM; ISOLIS 2.1 S Probe 15CM, 20CM; RA Slimline 1.7 15CM, 20CM; RA Slimline 1.7 Round 15CM, 7CM; RA Slimline 2.4 15CM, 23CM; RA 3.8 13CM, 28CM; V-Probe

For treatment confirmation (including segmentation and registration), the software is compatible with all ablation devices as these functions are independent from probes/power settings.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) clearance letter for BioTraceIO Vision (V1.7):

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" with numerical thresholds against which the performance metrics are directly compared. Instead, it presents performance metrics from various algorithmic tests, implying that the achieved performance was deemed acceptable for clearance. Based on the provided performance data, here's a table that summarizes the key metrics:

Imaging Modality	Algorithm	Metric	Reported Device Performance	Implied Acceptance Criteria (Minimum Threshold for Clearance)
CT	Liver Segmentation	Mean DICE	0.98	Implied: High DICE score (e.g., >0.90 for organ segmentation)
MR	Liver Segmentation	Mean DICE	0.93	Implied: High DICE score (e.g., >0.90 for organ segmentation)
CT	Kidney Segmentation	Mean DICE	0.91	Implied: High DICE score (e.g., >0.90 for organ segmentation)
CT	Liver Ablation Target Segmentation	Mean DICE	0.82	Implied: Good DICE score (e.g., >0.75 for target segmentation)
CT	Kidney Ablation Target Segmentation (1, 2, 3 strokes)	Mean DICE	0.79	Implied: Good DICE score (e.g., >0.75 for target segmentation)
MR	Liver Ablation Target Segmentation	Mean DICE	0.76	Implied: Good DICE score (e.g., >0.75 for target segmentation)
CT	Liver Ablation Zone Segmentation	Mean DICE	0.88	Implied: Good DICE score (e.g., >0.85 for ablation zone)
CT	Kidney Ablation Zone Segmentation (1, 2, 3 strokes)	Mean DICE	0.76, 0.77, 0.78	Implied: Good DICE score (e.g., >0.75 for ablation zone)
CT	Kidney Ice Ball Segmentation (1, 2, 3 strokes)	Mean DICE	0.80, 0.81, 0.83	Implied: Good DICE score (e.g., >0.80 for ice ball)
CT	Liver Vessels Segmentation (HV+PV)	Mean DICE	0.72	Implied: Acceptable DICE score (e.g., >0.70 for vessels)
CT	Liver Vessels Segmentation (HV+PV)	Mean Centerline DICE	0.76	Implied: Acceptable Centerline DICE score (e.g., >0.75 for vessels)
CT/MR	Liver Registration Pre-ablation MR – Pre-ablation CT	MCD	5.04 mm	Implied: Acceptable registration accuracy (e.g., < 5-10 mm)
CT	Kidney Registration Diagnostic CT – Pre-ablation CT	MCD	4.61 mm	Implied: Acceptable registration accuracy (e.g., < 5 mm)
CT	Liver Registration Pre-ablation CT – Post-ablation CT	MCD	4.09 mm	Implied: Acceptable registration accuracy (e.g., < 5 mm)
CT	Kidney Registration Pre-ablation CT – Post-ablation CT	MCD	3.06 mm	Implied: Acceptable registration accuracy (e.g., < 5 mm)
CT/MR	Liver Registration Pre-ablation MR – Post-ablation CT	MCD	4.75 mm	Implied: Acceptable registration accuracy (e.g., < 5 mm)

Note: The "Implied Acceptance Criteria" are inferred from the successful clearance and commonly accepted performance benchmarks in medical imaging. The FDA clearance document itself does not explicitly list these thresholds.

2. Sample Sizes Used for the Test Set and the Data Provenance

The document provides details of the training sets for different algorithms. However, it does not explicitly state the sample size or provenance for the test set used for the performance validation summarized in the table. The performance data section refers to "validation results" but doesn't detail the test cohort separately from the training cohort or its specific characteristics (country of origin, retrospective/prospective). This is a common characteristic of 510(k) summaries which often highlight training data but may not provide granular details on validation sets.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

The document does not specify the number or qualifications of experts used to establish the ground truth for the test set. It mentions that ground truth for the training set was established, but not for the validation exercises specifically.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1) used for establishing the ground truth for the algorithms' test sets.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

The provided text does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed. The performance data focuses on algorithmic performance (DICE, MCD) in a standalone manner, not on human reader improvement with AI assistance. The device's intended use is to "assist physicians" and the clinical accuracy of segmentation/registration is stated as "the responsibility of the user." This suggests the focus was on the algorithm's accuracy as a tool rather than a comprehensive human-AI interaction study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance study was done. The performance data presented (Mean DICE and Mean Corresponding Distance) directly reflects the accuracy of the algorithms (segmentation, registration) in isolation, without human intervention in the loop during the measurement of these specific metrics. For example, for "Ablation Target Segmentation", it presents the algorithm's DICE score, not a human reader's improvement using the tool. However, it's important to note that for "Ablation Target Segmentation" (Kidney and Liver) and "Ablation Zone Segmentation" (Kidney and Ice Ball), it differentiates between 1, 2, or 3 strokes, indicating that some level of user input still contributes to the algorithm's final output for these specific functionalities. The performance metrics themselves ("Mean DICE", "MCD") are measures of the algorithm's output compared to ground truth.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The document does not explicitly state the type of ground truth used for validation (e.g., expert consensus, pathology, surgical findings). For the training set, it can be inferred that expert annotations were used, but this is not explicitly stated for the validation.

8. The Sample Size for the Training Set

The training set sample sizes are provided for the AI algorithms:

Liver Segmentation Algorithm for CT Processing: 1091 contrast-enhanced CT images.
Liver Segmentation for MR Processing: 418 MR images.
Liver Vessel Segmentation Algorithm for CT processing: 393 contrast-enhanced CT images.
Kidney Segmentation for CT processing: 300 contrast-enhanced preoperative CT images.

9. How the Ground Truth for the Training Set Was Established

The document does not explicitly detail the method for establishing the ground truth for the training set. It mentions the imaging procedure (e.g., "Contrast-enhanced CT images taken for diagnostic reading") which implies that clinical images with pre-existing or subsequently generated expert annotations would have been used for training. However, the exact process (e.g., number of annotators, their qualifications, adjudication) is not specified.

Summary

FDA 510(k) Clearance Letter - BioTraceIO Vision (V1.7)

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

September 8, 2025

Techsomed Medical Technologies
Dalia Dickman
Head of Regulatory Affairs
6 Ofra Haza St.
Or Yehuda, 6032303
Israel

Re: K251931
Trade/Device Name: BioTraceIO Vision (V1.7)
Regulation Number: 21 CFR 892.2050
Regulation Name: Medical Image Management And Processing System
Regulatory Class: Class II
Product Code: QTZ, QIH, LLZ
Dated: July 13, 2025
Received: July 14, 2025

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.

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K251931 - Dalia Dickman Page 2

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).

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 (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-reporting-combination-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 Rule"). 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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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

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K251931 - Dalia Dickman Page 3

the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/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,

for

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

Enclosure

Page 4

Indications for Use

Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions.

K251931

Please provide the device trade name(s).

BioTraceIO Vision (V1.7)

Please provide your Indications for Use below.

BioTraceIO Vision is a Computed Tomography (CT) and Magnetic Resonance (MR) image processing software package available for use with ablation procedures.

BioTraceIO Vision is controlled by the user via a user interface.

BioTraceIO Vision imports images from CT and MR scanners and facility PACS systems for display and processing during ablation procedures.

The software is not intended for diagnosis. The software is not intended to predict ablation volumes or predict ablation success.

Please select the types of uses (select one or both, as applicable).

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

BioTraceIO Vision Page 9 of 30

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510(K) SUMMARY

Techsomed's BioTraceIO Vision

Submitter

Techsomed Medical Technologies LTD.
6 Ofra Haza St.
Or Yehuda 6032303
ISRAEL
Phone: +972545595951

Contact Person: Dalia Dickman, PhD.

Date Prepared: September 4, 2025

Name of Device: BioTraceIO Vision (V1.7)

Common or Usual Name: BioTraceIO Vision

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	K240773
Trade Name	BioTraceIO Vision 1.4
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

BioTraceIO Vision has six distinct workflow steps:

Data Import
Anatomic Structures Segmentation (Liver, Kidney, Hepatic Vein, Portal Vein, Ablation Target)

K251931

Page 6

Instrument Placement (Needle Planning) for Microwave Ablation (MWA) or Cryoablation (Cryo) Procedures
Ablation Zone/Ice ball Segmentation
Registration of Pre-Procedure Images
Treatment Confirmation (Registration of Pre- and Post-Interventional Images; Quantitative Analysis)

Key features of the BioTraceIO Vision Software include:

Workflow steps availability
Manual and automated tools for anatomic structures and ablation target/zone segmentation
Overlaying and positioning virtual instruments (ablation needles) and user-selected estimates of the ablation regions onto the medical images
Image 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 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.

BioTraceIO Vision 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

BioTraceIO Vision is intended to be used for ablations with the following ablation instruments:

For needle planning, the software currently supports the following needle models:

Microwave ablation
- AngioDynamics: Solero Probe 14CM, 19CM, 29CM
- HS HOSPITAL SERVICE: Amica Probe (16G) 15CM, 20CM, 27CM; Amica Probe (14G) 15CM, 20CM, 27CM
- Medtronic Covidien: Emprint Antenna 15CM, 20CM, 30CM
- NeuWave Medical: LK Probe 15CM, 20CM; LK XT Probe 15CM, 20CM; PR Probe 15CM, 20CM; PR XT Probe 15CM, 20CM
- Varian Medical Systems: Ximitry Probe 15CM, 20CM, 27CM

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Cryo ablation
- Boston Scientific: IceForce 2.1 CX, CX L; IcePearl 2.1 CX, CX L; IceRod 1.5 CX; IceSeed 1.5 CX, CX S;Ice Sphere 1.5 CX
- IceCure Medical: ProSense 10G Spheric, Elliptic 14CM, Elliptic 18.5CM; ProSense 13G Spheric, Elliptic
- Varian Medical Systems: ISOLIS 2.1 E Probe 15CM, 20CM; ISOLIS 2.1 S Probe 15CM, 20CM; RA Slimline 1.7 15CM, 20CM; RA Slimline 1.7 Round 15CM, 7CM; RA Slimline 2.4 15CM, 23CM; RA 3.8 13CM, 28CM; V-Probe

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

BioTraceIO Vision is a Computed Tomography (CT) and Magnetic Resonance (MR) image processing software package available for use with ablation procedures.

BioTraceIO Vision is controlled by the user via a user interface.

BioTraceIO Vision imports images from CT and MR scanners and facility PACS systems for display and processing during ablation procedures.

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 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 six distinct workflow steps:

Data Import
Anatomic Structures Segmentation (Liver, Kidney, Hepatic Vein, Portal Vein, Ablation Target)
Instrument Placement (Needle Planning) for Microwave Ablation (MWA) or Cryoablation (Cryo) Procedures
Ablation Zone Segmentation
Registration of Pre-Procedure Images
Treatment Confirmation (Registration of Pre- and Post-Interventional Images; Quantitative Analysis)

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The following technological differences exist between the subject and the predicate device:

The primary difference is the addition of support for kidney ablation procedures (MWA and cryoablation) using Computed Tomography (CT), whereas the predicate device was limited to liver ablation procedures using CT and Magnetic Resonance (MR). The modifications include kidney-specific segmentation algorithms and CT registration algorithms, as well as user interface updates to support ablation modality selection and cryoablation-specific visualizations. The UI enhancements introduced for cryoablation are applicable to both kidney and liver cryoablation procedures. These differences do not raise new questions of safety or effectiveness, as performance data demonstrate that BioTraceIO Vision 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	Predicate Device	Comments
	BioTraceIO Vision (Ver 1.7)	VisAble.IO (Ver 1.4)
		Renamed as BioTraceIO Vision
510(k) number	TBD	K240773
Classification	Class II 892.2050 QTZ, QIH, LLZ	Class II 892.2050 QTZ, QIH, LLZ	Same
Intended Use	The intended patient population is patients chosen by interventional radiologists to undergo ablation treatment (including patients with soft tissue lesions).	The intended patient population is patients chosen by interventional radiologists to undergo ablation treatment (including patients with soft tissue lesions).	Same
Indications for Use	BioTraceIO Vision is a Computed Tomography (CT) and Magnetic Resonance (MR) image processing software package available for use with ablation procedures.BioTraceIO Vision is controlled by the user via a user interface.BioTraceIO Vision imports images from CT and MR scanners and facility PACS systems for display and	BioTraceIO Vision is a Computed Tomography (CT) and Magnetic Resonance (MR) image processing software package available for use with liver ablation procedures.BioTraceIO Vision is controlled by the user via a user interface.BioTraceIO Vision imports images from CT and MR scanners and facility PACS systems for display and	The term "liver" was removed from the Indications for Use to reflect expanded support for kidney ablation procedures. Core functionality remains unchanged; BioTraceIO Vision continues to provide image import, visualization, segmentation, registration, and planning tools for

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	Subject Device	Predicate Device	Comments
	processing during ablation procedures.BioTraceIO Vision is used to assist physicians in planning ablation procedures, including identifying ablation targets and virtual ablation needle placement. BioTraceIO Vision 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.	processing during liver ablation procedures.BioTraceIO Vision is used to assist physicians in planning ablation procedures, including identifying ablation targets and virtual ablation needle placement. BioTraceIO Vision 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.	ablation procedures. Existing liver registration algorithms were adapted for kidney anatomy and segmentation algorithms were developed for kidney anatomy. These modifications represent an extension of established functionality and do not raise new questions of safety or effectiveness. Performance testing of V1.7 supports equivalence to the predicate device.
User Population	Qualified trained physicians	Qualified trained physicians	Same
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	Same
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	Same
Technological Characteristics	BioTraceIO Vision 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 the device is the Operating Room and the hospital healthcare environment such as	BioTraceIO Vision 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 healthcare environment such as	Same

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	Subject Device	Predicate Device	Comments
	interventional radiology control room. BioTraceIO Vision has six distinct workflow steps:• Data Import• Anatomic Structures Segmentation• Instrument Placement (Needle Planning)• Ablation Zone Segmentation• Registration of Pre-Procedure Images• Treatment Confirmation (Registration of Pre- and Post-Interventional Images; Quantitative Analysis)	interventional radiology control room. BioTraceIO Vision has six distinct workflow steps:• Data Import• Anatomic Structures Segmentation• Instrument Placement (Needle Planning)• Ablation Zone Segmentation• Registration of Pre-Procedure Images• Treatment Confirmation (Registration of Pre- and Post-Interventional Images; Quantitative Analysis)
Design: Supported modalities	CT, MR	CT, MR	Same
Design: Data Visualization	Window and level, pan, zoom, cross- hairs, slice navigation	Window and level, pan, zoom, cross- hairs, slice navigation	Same
Design; Image Segmentation	Tools for segmenting 3D VOIs, including target tissues, ice ball (for cryoablation), ablation zones, vessels, liver and kidney.	Tools for segmenting 3D VOIs, including target tissues, ablation zones, vessels and liver.	Addition of tools for segmenting 3D VIOs for kidney. These modifications represent an extension of established functionality and do not raise new questions of safety or effectiveness. Performance testing of V1.7 supports equivalence to the predicate device.

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	Subject Device	Predicate Device	Comments
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.	Same
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.	Same

Performance Data

BioTraceIO Vision 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 BioTraceIO Vision 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 Testing
Image Registration Testing
Measurement and Quantification Testing

The liver segmentation, liver vessel segmentation and kidney segmentation algorithms for CT and MR (MR for liver only) processing are AI algorithms. The training dataset characteristics are as follows:

Liver Segmentation Algorithm for CT Processing:

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

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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 Segmentation for MR Processing:

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

Liver Vessel Segmentation Algorithm for CT processing:

Patients
- 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

Kidney Segmentation for CT processing:

Patients:
- 300 contrast-enhanced preoperative CT images in axial orientation
- Age distribution: 58.9 ± 13.8
- Sex distribution: 40.0% female, 59.7% male, 0.3% other
- Location of clinical sites: North America
- Imaging procedure: Contrast-enhanced CT images taken for diagnostic reading and planning of nephrectomy surgery
- Number of clinical sites: 2

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The following table provides a summary of the validation results:

Imaging Modality	Algorithm	Metric	Performance
Organ Segmentation
CT	Liver Segmentation	Mean DICE	0.98
MR	Liver Segmentation	Mean DICE	0.93
CT	Kidney Segmentation****	Mean DICE	0.91
Ablation Target Segmentation
CT	Liver Ablation Target Segmentation	Mean DICE	0.82
CT	Kidney Ablation Target Segmentation	1 stroke*** Mean DICE	0.79
		2 strokes*** Mean DICE	0.79
		3 strokes*** Mean DICE	0.79
MR	Liver Ablation Target Segmentation	Mean DICE	0.76
Ablation Zone Segmentation
CT	Liver Ablation Zone Segmentation	Mean DICE	0.88
CT	Kidney Ablation Zone Segmentation	1 stroke*** Mean DICE	0.76
		2 strokes*** Mean DICE	0.77
		3 strokes*** Mean DICE	0.78
CT	Kidney Ice Ball Segmentation	1 stroke*** Mean DICE	0.80
		2 strokes*** Mean DICE	0.81
		3 strokes*** Mean DICE	0.83
Vessel Segmentation
CT	Liver Vessels Segmentation* (HV+PV)	Mean DICE	0.72
		Mean Centerline DICE	0.76
Registration
CT/MR	Liver Registration Pre-ablation MR – Pre-ablation CT	MCD**	5.04 mm
CT	Kidney Registration Diagnostic CT – Pre-ablation CT	MCD**	4.61 mm
CT	Liver Registration Pre-ablation CT – Post-ablation CT	MCD**	4.09 mm
CT	Kidney Registration Pre-ablation CT – Post-ablation CT	MCD**	3.06 mm
CT/MR	Liver Registration Pre-ablation MR – Post-ablation CT	MCD**	4.75 mm

*Liver vessel segmentations range from a minimum of 2nd order branches to a maximum of 6th order branches; *MCD = Mean corresponding distance; Stroke – user input based on defined procedure to draw the strokes as defined in labeling; The kidney segmentation function of the device has been validated on CT images acquired from GE and Siemens scanners only and in patients with fewer than five (5) renal tumors.

BioTraceIO Vision 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 BioTraceIO Vision include manual and semi-automated segmentation. 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 BioTraceIO Vision function.

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Registration tools provided within BioTraceIO Vision 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 BioTraceIO Vision 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 BioTraceIO Vision 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 BioTraceIO Vision 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 BioTraceIO Vision (1.7) is as safe and effective as the cleared BioTraceIO Vision (K240773). The BioTraceIO Vision 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 BioTraceIO Vision and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the BioTraceIO Vision (1.7) is as safe and effective as the cleared BioTraceIO Vision (K240773). Thus, the BioTraceIO Vision is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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).