(351 days)
Unknown
The summary describes image processing algorithms (segmentation, registration) which can be implemented using traditional methods or AI/ML. The document does not explicitly state the use of AI/ML, nor does it provide details about training or test sets that would definitively indicate AI/ML usage. The predicate device name "Aline Ablation Intelligence" might suggest AI, but this summary doesn't confirm its use in the described device.
No
The device is a medical imaging software intended to assist physicians in planning liver ablation procedures and confirming ablation zones. It is not directly used for treatment or therapy.
No
The "Intended Use / Indications for Use" section explicitly states, "The software is not intended for diagnosis."
Yes
The device description explicitly states that Ablation-fit is a "stand-alone medical imaging software" and details its functionalities which are entirely software-based (image loading, handling, visualization, segmentation, registration, 3D reconstruction, virtualization). There is no mention of any accompanying hardware component that is part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the software is used to assist physicians in planning and confirming ablation zones during follow-up. It explicitly states: "The software is not intended for diagnosis." IVDs are primarily used for the diagnosis of diseases or other conditions.
- Device Description: The device is described as a medical imaging software that processes DICOM images for visualization, segmentation, registration, and simulation of procedures. This aligns with medical imaging software used for procedural planning and assessment, not for in vitro testing of biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (e.g., blood, urine, tissue). The input is medical imaging data (DICOM images).
Therefore, based on the provided text, Ablation-fit is a medical imaging software intended for use in the planning and follow-up of liver ablation procedures, and it does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Ablation-fit is a medical imaging application available for use with liver ablation procedures.
Ablation-fit is used to assist physicians in planning, permitting the graphical display of anatomy involved in the procedure, ablation targets and ablation needle placement.
Ablation-fit is used to assist physicians in confirming ablation zones during follow-up.
The software is not intended for diagnosis. The software is not intended to predict ablation volumes or predict ablation success.
Product codes
QTZ
Device Description
Ablation-fit is a stand-alone medical imaging software that integrates Reconstruction, Segmentation, Registration and Visualization algorithms into a user interface to support physicians during liver ablation treatments planning and follow-up.
Ablation-fit allows to perform the entire workflow from DICOM (Digital Imaging and COmmunications in Medicine) images to 3D reconstruction of volume of interests, ablation probe placement and treatment outcome verification.
Specifically, Ablation-fit main functionalities include:
- Image loading from different supports (including PACS),
- DICOM images handling and visualization in axial, sagittal, coronal views,
- image segmentation,
- tools for manual edit of segmentations.
- 3D visualization,
- virtualization of ablation probe placement,
- pre- and post-treatment images registration.
The software permits segmentation and 3D reconstruction of volumes of interest. The software contours all of this anatomic information not only in axial, sagittal, and coronal planes for 2D visualization, but also three-dimensionally. Every computed segmentation can be manually modified in the 2D axial visualization and consequently the three-dimensional mapping of the scan changes accordingly.
Ablation-fit let the user simulate the virtual needle insertion and shows the desired ellipsoid of ablation.
Once the ablation procedure has been performed, pre- and post-treatment scans are registered. Consequently, the software can verify whether the ablation zones entirely surrounds the lesion and the safety margin.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Contrast-enhanced CT
Anatomical Site
Liver
Indicated Patient Age Range
The intended patient population of the Ablation-fit software is the patient demographic chosen by physicians to undergo liver ablation treatment (including patient with soft tissue lesions).
Intended User / Care Setting
Physicians
In operating rooms
In office environments within hospitals
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
Bench tests that compare the output of all segmentation and registration processes with ground truth annotated by qualified experts show that the algorithms performed as expected. Additionally, all semi-automatic functionalities underwent testing by three radiologists to account for variability resulting from user interaction. Quantitative testing related to these topics has been performed according to "Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions Guidance".
Additionally, to supplement the software validation for Ablation-fit, we conducted software testing using retrospective image data of ablation procedures. The purpose of such analysis was to retrospectively evaluate the accuracy of Ablation-fit in assessing the outcome of lesion percutaneous thermal ablations and the accuracy of the automatically performed segmentations.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.".
Bench tests that compare the output of all segmentation and registration processes with ground truth annotated by qualified experts show that the algorithms performed as expected. Additionally, all semi-automatic functionalities underwent testing by three radiologists to account for variability resulting from user interaction. Quantitative testing related to these topics has been performed according to "Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions Guidance".
Also, a user acceptance test was performed according to ANSI AAMI IEC 62366-1:2015+AMD1:2020. This user acceptance test performs both verification and validation of Ablationfit.
Measurement Accuracy Test was also performed in order to evaluate the accuracy of measurements carried out with Ablation-fit software on CT images.
Additionally, to supplement the software validation for Ablation-fit, we conducted software testing using retrospective image data of ablation procedures. The purpose of such analysis was to retrospectively evaluate the accuracy of Ablation-fit in assessing the outcome of lesion percutaneous thermal ablations and the accuracy of the automatically performed segmentations.
Performance, functional, and algorithmic testing outcomes show that Ablation-fit satisfies the device's user demands and requirements, which are deemed to be substantially equivalent to those of the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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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.
R.A.W. Srl % Chiara Ferrari Q&R Officer Via Soperga 13 Milan, 20127 ITALY
September 12, 2023
Re: K222938
Trade/Device Name: Ablation-fit Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QTZ Dated: August 10, 2023 Received: August 10, 2023
Dear Chiara Ferrari:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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.
Jessica Lamb
Jessica Lamb, PhD 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
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Indications for Use
510(k) Number (if known) K222938
Device Name Ablation-fit
Indications for Use (Describe)
Ablation-fit is a medical imaging application available for use with liver ablation procedures.
Ablation-fit is used to assist physicians in planning, permitting the graphical display of anatomy involved in the procedure, ablation targets and ablation needle placement.
Ablation-fit is used to assist physicians in confirming ablation zones during follow-up.
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) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
I. Submitter
Manufacturer: R.A.W. S.r.1. Address: Via Soperga 13, 20127 Milan, Italy Phone: +39 3400747597
Contact Person: Chiara Ferrari Applicant Correspondent: Chiara Ferrari Email: quality@endo-sight.it Date Prepared: August 10th, 2023
II. Device
| 510(k) Number | K222938 |
|---|---|
| Device Name | Ablation-fit |
| Trade or Proprietary | |
| Name: | Ablation-fit |
| Common or Usual Name: | Ablation-fit |
| Classification Name: | Medical image management and processing system |
| Primary Product Code: | QTZ |
| Regulation Number: | 21 CFR 892.2050 |
| Regulatory Class | II |
III. Predicate Device
Substantial equivalence is claimed to the following device:
Primary predicate device:
- Aline Ablation Intelligence Class II 21 CFR 892.2050, Radiology, LLZ, which has ● been the subject of a cleared 510(k) with the FDA log number K202297.
| 510(k) Number | K202297 |
|---|---|
| Trade Name | Aline Ablation Intelligence |
| Manufacturer | Mirada Medical Ltd |
| Device Name | Aline Ablation Intelligence |
| Regulation Number | 892.2050 |
| Regulation Name | Picture archiving and communications system |
| Regulatory Class | II |
| Primary Product Code | LLZ |
Reference device:
The following reference device, which shares similar planning functions with Ablation-fit, is used in this submission to support the claim regarding the level of concern associated with Ablation-fit.
- Visible Patient Suite- Class II 21 CFR 892.2050, Radiology, LLZ, which has ● been the subject of a cleared 510(k) with the FDA log number K212896.
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| 510(k) Number | K212896 |
|---|---|
| Trade Name | Visible Patient Suite |
| Manufacturer | Visible Patient, SAS |
| Device Name | Visible Patient Suite |
| Regulation Number | 892.2050 |
| Regulation Name | Medical image management and processing system |
| Regulatory Class | II |
| Primary Product Code | LLZ |
IV. Device Description
Ablation-fit is a stand-alone medical imaging software that integrates Reconstruction, Segmentation, Registration and Visualization algorithms into a user interface to support physicians during liver ablation treatments planning and follow-up.
Ablation-fit allows to perform the entire workflow from DICOM (Digital Imaging and COmmunications in Medicine) images to 3D reconstruction of volume of interests, ablation probe placement and treatment outcome verification.
Specifically, Ablation-fit main functionalities include:
- Image loading from different supports (including PACS),
- DICOM images handling and visualization in axial, sagittal, coronal views,
- image segmentation,
- tools for manual edit of segmentations.
- 3D visualization,
- virtualization of ablation probe placement,
- pre- and post-treatment images registration. ●
The software permits segmentation and 3D reconstruction of volumes of interest. The software contours all of this anatomic information not only in axial, sagittal, and coronal planes for 2D visualization, but also three-dimensionally. Every computed segmentation can be manually modified in the 2D axial visualization and consequently the three-dimensional mapping of the scan changes accordingly.
Ablation-fit let the user simulate the virtual needle insertion and shows the desired ellipsoid of ablation.
Once the ablation procedure has been performed, pre- and post-treatment scans are registered. Consequently, the software can verify whether the ablation zones entirely surrounds the lesion and the safety margin.
V. Indications for Use
Ablation-fit is a medical imaging application available for use with liver ablation procedures.
Ablation-fit is used to assist physicians in planning, permitting the graphical display of anatomy involved in the procedure, ablation targets and ablation needle placement.
Ablation-fit is used to assist physicians in confirming ablation zones during follow-up.
The software is not intended for diagnosis. The software is not intended to predict ablation volumes or predict ablation success.
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| Characteristic | Ablation-fit | Aline Ablation
Intelligence | Equivalence | |
|--------------------------|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | R.A.W. s.r.l. | Mirada Medical Ltd | N/A | |
| 510(k) number | K222938 | K202297 | N/A | |
| Classification | Class II. 892.2050 QTZ | Class II. 892.2050 LLZ | N/A | |
| Clinical
equivalence | Target
Population | The intended patient
population of the
Ablation-fit software is the
patient demographic
chosen by physicians to
undergo liver ablation
treatment (including
patient with soft tissue
lesions). | The intended patient
population of the Aline
Ablation Intelligence
software is the patient
demographic chosen by
physicians to undergo
ablation treatment
(including
patient with soft tissue
lesions). | Ablation-fit
target population
is limited to liver
ablation
treatment. |
| | Where used | The software is intended
to be used:
• In operating rooms
• In office environments
within hospitals | The application's use
environment is the
Operating Room and the
hospital healthcare
environment such
as interventional radiology
control room. | Equivalent |
| | Site in the body | Liver | Not specified | Ablation-fit is
intended to be
used only on
liver |
| Intended Users | Physicians | Physicians | Equivalent | |
| Technical
equivalence | Design | stand-alone desktop
software application with
tools and features
designed to assist users in
planning ablation
procedures as well as tools
for evaluating ablation
procedure's outcome | stand-alone desktop
software application with
tools and features
designed to assist users in
planning ablation
procedures as well as tools
for evaluating ablation
procedure's outcome | Equivalent |
| | Energy Used
and/or
Delivered | 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 | Equivalent |
| | Supported
modalities | Contrast-enhanced CT | CT, MR | Ablation-fit does
not support MR
modalities |
| | Data
visualization | • 2D visualization tools:
Window and level, pan,
zoom, cross-hairs, slice
navigation.
• 3D visualization of all
segmented abdomen
structures | • 2D visualization tools:
Window and level, pan,
zoom, cross-hairs, slice
navigation.
• 3D visualization of
segmented
targets/ablation zones. | Ablation-fit can
visualize 3D
spatial rendering
of all segmented
structures. These
additional
anatomical
segmentations
have the goal to
highlight the
presence of the
anatomy to the
user when |
| | | planning intervention | | |
| | Data segmentation | • Automatic segmentation for liver, spleen, bones, liver vessels, skin
• Tools for interactive segmentation for liver, spleen and liver targets/ablation zone
• Tools for manual segmentation editing and/or correction | • No automatic segmentation of organs
• Tools for interactive segmentation of targets/ablation zone
• Tools for manual segmentation editing and/or correction | Ablation-fit provides an automatic segmentation of abdomen organs |
| | Planning function | Overlaying and positioning virtual ablation needles and user-selected estimates of the ablation regions onto the medical images | Overlaying and positioning virtual ablation needles and user-selected estimates of the ablation regions onto the medical images | Equivalent |
| | Data registration | • Automatic image registration of pre- and post-treatment images
• Blending tools to assess the correctness of the registration | • Automatic image registration of pre- and post-treatment images
• Manual registration correction | Ablation-fit has not a manual registration correction, but it provides a tool for the assessment of the correctness of the registration |
| | Ablation confirmation function | Ablation-fit can perform registration of pre-treatment, containing the identified targets and post-treatment scans containing ablation zone. The segmented and registered volumes between the two scans (targets, ablation zones) are then showed together on the same scan and in 3D. In addition, different colors enhance the residual target volume and safety margins. | Aline Ablation Intelligence can perform a 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 to help the user in analyzing if the ablation zone covers the target tissue with the desired amount of margin. | Equivalent |
VI. Comparison of Technological Characteristics
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Ablation-fit is substantially equivalent to its predicate device with respect to:
- Image acquisition of CT images
- Image segmentation of targets and ablation zones ●
- . Segmentation interactive tools and possible manual corrections
- 3D visualization of targets and ablation zones ●
- Virtual ablation needles and user-selected estimates of the ablation regions onto the medical . images
- Automatic image registration of pre- and post-treatment images .
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-
Overlay of targets and ablation zones in 3D and 2D visualization
The main differences between Ablation-fit and its predicate device concern the following aspects: -
Ablation-fit is intended to be used only for liver ablation procedures ●
-
Ablation-fit is not intended to be used with MR images. This is clearly stated on labeling and ● indication for use.
-
. Ablation-fit performs image segmentation of abdominal structures, enabling computation of 3D volumes and providing accurate 3D representations of segmented structures and their spatial relationships. This allows the highlighting of anatomical structures to the user when planning interventions. In the predicate device, only targets and ablation zones are 3D segmented. Nevertheless, all segmentation processes underwent extensive validation, demonstrating their compliance with acceptance criteria. Moreover, the reference device we have included in this submission (Visible Patient Suite - K212896) presents similar functions for organ segmentation (including liver, bones, vessels) and is used for planning purposes, as specified in its intended use.
-
Ablation-fit does not provide manual registration correction. Instead, Ablation-fit permits to assess the correctness of the image registration providing the blending tool.
The subject software has the similar intended use and technological/functional features as its predicate device in providing tools and workflow designs to support physicians during liver ablation treatments planning and follow-up. The slight differences between the subject and predicate device (supported modalities, data visualization and data segmentation, data registration) do not raise new questions of safety and effectiveness as demonstrated by verification activities. Based on the comparison of technological characteristics and performance data provided within this submission, the data supports the substantial equivalence of Ablation-fit to the identified predicate device.
VII. Performance Data
Ablation-fit was designed and developed according to the software life-cycle process described in ANSI AAMI IEC 62304:2006/A1:2016.
First, a design and development project plan was defined, together with software requirements. They were transformed into software design specifications and software architecture. Specific tests are then planned and performed to verify both software units and software integration of the requirements. Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.".
Bench tests that compare the output of all segmentation and registration processes with ground truth annotated by qualified experts show that the algorithms performed as expected. Additionally, all semi-automatic functionalities underwent testing by three radiologists to account for variability resulting from user interaction. Quantitative testing related to these topics has been performed according to "Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions Guidance".
Also, a user acceptance test was performed according to ANSI AAMI IEC 62366-1:2015+AMD1:2020. This user acceptance test performs both verification and validation of Ablationfit.
Measurement Accuracy Test was also performed in order to evaluate the accuracy of measurements carried out with Ablation-fit software on CT images.
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Additionally, to supplement the software validation for Ablation-fit, we conducted software testing using retrospective image data of ablation procedures. The purpose of such analysis was to retrospectively evaluate the accuracy of Ablation-fit in assessing the outcome of lesion percutaneous thermal ablations and the accuracy of the automatically performed segmentations.
Performance, functional, and algorithmic testing outcomes show that Ablation-fit satisfies the device's user demands and requirements, which are deemed to be substantially equivalent to those of the predicate device.
VIII. Conclusion
In conclusion, Ablation-fit functions at least as safely and effectively as the designated predicate device and is essentially equivalent to it, according to performance tests and device evaluations contained in this 510(k) submission. Ablation-fit meets requirements for safety and effectiveness and does not introduce any new potential safety risks.