(137 days)
Not Found
Yes
The device description mentions "semi-automatic contouring" and "Manual and semi-automatic registration using rigid and deformable registration," and the performance studies section details the evaluation of "Semi-automatic segmentation algorithms" with metrics like Dice coefficient and sensitivity, which are commonly associated with ML-based image analysis tasks. While the term "AI" or "ML" is not explicitly used, the description of semi-automatic algorithms and their performance evaluation strongly suggests the use of ML techniques for image segmentation and registration.
No
The device is a software application for image processing, visualization, and comparison of medical images to assist in planning and assessing ablative procedures. It does not directly perform or deliver therapy. "Thermal ablation cannot be triggered from myAblation Guide."
No
The "Intended Use / Indications for Use" section explicitly states, "The software is not intended for diagnosis and is not intended to predict ablation volumes or predict ablation success."
Yes
The device description explicitly states "myAblation Guide is a software medical device". While it operates on existing hardware (CT scanners or workstations), the device itself is the software application.
Based on the provided information, MyAblation Guide is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- MyAblation Guide's Function: MyAblation Guide processes and visualizes medical images (CT, MR, PET/CT, CBCT) acquired from the patient in vivo. It assists in planning and assessing ablative procedures based on these images.
- Intended Use Statement: The "Intended Use / Indications for Use" explicitly states: "The software is not intended for diagnosis..." This directly contradicts the primary purpose of an IVD.
- Device Description: The description focuses on image processing, visualization, and planning tools for procedures performed on the patient, not on analyzing biological samples.
While MyAblation Guide is a medical device that uses medical images, its function is related to procedural planning and assessment based on in vivo imaging, not the analysis of in vitro biological specimens for diagnostic purposes.
No
The letter explicitly states "Not Found" for "Control Plan Authorized (PCCP) and relevant text," which means there is no specific approval or clearance of a PCCP for this device mentioned.
Intended Use / Indications for Use
myAblation Guide is a software application for image processing, 2D/3D visualization, and comparison of medical images imported from multiple imaging modalities.
The software is controlled by the end user interface on a workstation with DICOM connectivity or as an integrated version on a Siemens CT scanner workstation.
The application is used to assist in the preparation and performance of ablative procedures, including of ablation targets, virtual ablation probe placement and contouring of ablated areas, as well as supporting the User in their assessment of the treatment. The application can only be used by trained Users.
The software is not intended for diagnosis and is not intended to predict ablation volumes or predict ablation success.
Product codes (comma separated list FDA assigned to the subject device)
QTZ
Device Description
myAblation Guide is a software medical device that is used in the context of percutaneous ablative procedures with straight instruments. It is used by clinical professionals in a hospital premise; it can be either deployed on compatible CT scanners or a computer workstation.
The application is operated by medical professionals such as Interventional Radiologists and medical technologists with current license and/or certification as required by regional authority. myAblation Guide allows operating functions in an arbitrary sequence. In addition, it includes a structured sequence of steps for ease of utility.
The application supports anatomical datasets from CT, MR, CBCT, as well as PET/CT.
The application includes means and functionalities to support in:
· Multimodality viewing and contouring of anatomical, and multi-parametric images such as CT, CBCT, PET/CT, MRI
· Multiplanar reconstruction (MPR) thin/thick, minimum intensity projection (MIP), volume rendering technique (VRT)
· Freehand and semi-automatic contouring of regions-of-interest on any orientation including oblique
- Manual and semi-automatic registration using rigid and deformable registration
- · Expansion of created contour structures to visualize a safety margin
· Functionality to support the user in creating virtual ablation needle paths and associated virtual ablation zones derived from manufacturer data - · Export of virtual needle paths in the Dicom SSO format
- · Supports the user in comparing, contouring, and ablation needle planning based on datasets acquired with different imaging modalities
- Supports multimodality image fusion
- · Supports user's procedure flow via a task stepper
Thermal ablation cannot be triggered from myAblation Guide.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MRI, PET, PET-CT, CBCT images
Anatomical Site
Not Found
Indicated Patient Age Range
The patient demographic chosen by physicians to undergo percutaneous ablation treatment (including patient with soft tissue lesions).
Intended User / Care Setting
Operating Room and the hospital healthcare environment.
The application is operated by medical professionals such as Interventional Radiologists and medical technologists with current license and/or certification as required by regional authority.
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
Semi-automatic segmentation algorithms:
The clinical performance testing of the semi-automatic liver ablation zone segmentation has been evaluated by Moltz et al (Moltz J. & .- O., 2008) as well as in a retrospective internal study. Altogether, CT-datasets from 60 patients have been assessed. The evaluated cases comprise hepatocellular carcinoma (HCC) and non-HCC cases.
To assess the algorithm's performance on liver metastases, Moltz et al conducted a study evaluating five different data sets comprising of ten liver metastases originating from diverse primary turnors.
The internal analysis of the lesion segmentation included a total of 50 patients.
The ablation zone algorithm analysis involved a total of 33 patients with 41 available ablation zones.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Testing:
myAblation Guide underwent non-clinical testing to demonstrate the design and performance of the devices meet the established design criteria and are substantial equivalent to the predicate devices. The subject device successfully completed functional, usability, and other software-related design testing.
Semi-automatic segmentation algorithms:
The clinical performance testing of the semi-automatic liver ablation zone segmentation has been evaluated by Moltz et al (Moltz J. & .- O., 2008) as well as in a retrospective internal study. Altogether, CT-datasets from 60 patients have been assessed. The evaluated cases comprise hepatocellular carcinoma (HCC) and non-HCC cases.
To assess the algorithm's performance on liver metastases, Moltz et al conducted a study evaluating five different data sets comprising of ten liver metastases originating from diverse primary turnors. With a Dice coefficient (Dice similarity index) of 0.82 the algorithm effectively demonstrated the segmentation of both hyperdense and hypodense lesions, regardless of their placement within the liver or in its surrounding areas.
The internal analysis of the lesion segmentation included a total of 50 patients. The DICE for all lesion types is 0.65 with a sensitivity of 0.82.
The ablation zone algorithm analysis involved a total of 33 patients with 41 available ablation zones. The DICE for liver ablation zones is 0.65 with an overall sensitivity of 0.95.
Clinical Testing (N/A):
No clinical studies were carried out for the subject device, and therefore, no such clinical data is provided within this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Dice / True Positive Lesion: 0.65 (All Lesion Types), 0.62 (HCC), 0.66 (non-HCC)
Sensitivity: 0.82 (All Lesion Types), 0.81 (HCC), 0.81 (non-HCC)
Sensitivity is referred to as: "Sensitivity = TP / (TP + FN)" with true positive (TP) defined as Intersection over Union (IoU) ≥ 0.1 and false negative (FN) as IoU
§ 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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Siemens Healthcare GmbH % Lynn Allman Senior Director, Regulatory Affairs Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto, California 94304
August 6, 2024
Re: K240796
Trade/Device Name: myAblation Guide (VB80A) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QTZ Dated: July 15, 2024 Received: July 16, 2024
Dear Lynn Allman:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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
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Indications for Use
510(k) Number (if known) K240796
Device Name myAblation Guide (VB80A)
Indications for Use (Describe)
MyAblation Guide is a software application for image processing, 2D/3D visualization, and comparison of medical images imported from multiple imaging modalities.
The software is controlled by the end user interface on a workstation with DICOM connectivity or as an integrated version on a Siemens CT scanner workstation.
The application is used to assist in the preparation and performance of ablative procedures, including of ablation targets, virtual ablation probe placement and contouring of ablated areas, as well as supporting the User in their assessment of the treatment. The application can only be used by trained Users.
The software is not intended for diagnosis and 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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Image /page/3/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a series of orange dots arranged in a pattern.
510(k) Summary
myAblation Guide (Version VB80A)
The following information is provided as required by 21 CFR 807.92
I. Submitter and Manufacturer Information:
| Name and Address: | Varian Medical Systems Inc.
3100 Hansen Way, Palo Alto CA 94304 |
|--------------------|--------------------------------------------------------------------|
| Contact Name: | Lynn Allman, Senior Director Regulatory Affairs |
| E-mail: | submissions.support@varian.com |
| Date Prepared: | August 6th, 2024 |
| Manufacturer Name: | Siemens Healthcare GmbH |
| Manufacturer Name: | Siemens Healthcare GmbH |
|---|---|
| Mfg. Address: | Henkestr. 127 |
| 91052 Erlangen | |
| Germany |
Device Information: II.
| Proprietary Name: | myAblation Guide (VB80A) |
|---|---|
| Common/ Usual Name: | System, Image Processing, Radiological |
| Classification Name: | Medical image management and processing system |
| Classification Panel: | Radiology |
| Regulation Number: | §892.2050 Medical image management and processing system |
| Product Code | QTZ |
III. Predicate Device:
Aline Ablation Intelligence 1.0.0 (K202297)
This predicate has not been subject to a design-related recall.
IV. Subject Device Description:
myAblation Guide is a software medical device that is used in the context of percutaneous ablative procedures with straight instruments. It is used by clinical professionals in a hospital premise; it can be either deployed on compatible CT scanners or a computer workstation.
The application is operated by medical professionals such as Interventional Radiologists and medical technologists with current license and/or certification as required by regional authority. myAblation Guide allows operating functions in an arbitrary sequence. In addition, it includes a structured sequence of steps for ease of utility.
The application supports anatomical datasets from CT, MR, CBCT, as well as PET/CT.
4
The application includes means and functionalities to support in:
· Multimodality viewing and contouring of anatomical, and multi-parametric images such as CT, CBCT, PET/CT, MRI
· Multiplanar reconstruction (MPR) thin/thick, minimum intensity projection (MIP), volume rendering technique (VRT)
· Freehand and semi-automatic contouring of regions-of-interest on any orientation including oblique
- Manual and semi-automatic registration using rigid and deformable registration
- · Expansion of created contour structures to visualize a safety margin
· Functionality to support the user in creating virtual ablation needle paths and associated virtual ablation zones derived from manufacturer data
- · Export of virtual needle paths in the Dicom SSO format
- · Supports the user in comparing, contouring, and ablation needle planning based on datasets acquired with different imaging modalities
- Supports multimodality image fusion
- · Supports user's procedure flow via a task stepper
Thermal ablation cannot be triggered from myAblation Guide.
V. Indications for Use Statement:
MyAblation Guide is a software application for image processing, 2D/3D visualization, and comparison of medical images imported from multiple imaging modalities.
The software is controlled by the end user via a user interface on a workstation with DICOM connectivity or as an integrated version on a Siemens CT scanner workstation.
The application is used to assist in the preparation and performance of ablative procedures, including contouring of ablation targets, virtual ablation probe placement and contouring of ablated areas, as well as supporting the User in their assessment of the treatment. The application can only be used by trained Users.
The software is not intended for diagnosis and is not intended to predict ablation volumes or predict ablation success.
VI. Substantial Equivalence Discussion:
The following table compares the subject device to the predicate device with respect to indications for use, principles of operation, technological characteristics, and performance, and forms the basis for the determination of substantial equivalence.
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Healthinee
| Feature And/or Specification Of
New/Modified Device | Predicate Device
510(K) ID # K202297
Aline Ablation Intelligence (From
Mirada Medical) | MyAblation Guide
(Subject Device) | Analysis/Differences |
|---------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Aline Ablation Intelligence is a Computed
Tomography (CT) and Magnetic Resonance
(MR) image processing software package
available for use with ablation procedures.
Aline Ablation Intelligence is controlled by
the user via a user interface on a
workstation.
Aline Ablation Intelligence imports images
from CT and MR scanners and facility
PACS systems for display and processing
during ablation procedures.
Aline Ablation Intelligence is used to assist
physicians in planning ablation procedures,
including identifying ablation targets and
virtual ablation needle placement.
Aline Ablation Intelligence 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. | MyAblation Guide is a software application
for image processing, 2D/3D visualization,
and comparison of medical images
imported from multiple imaging modalities.
The software is controlled by the end user
via a user interface on a workstation with
DICOM connectivity or as an integrated
version on a Siemens CT scanner
workstation.
The application is used to assist in the
preparation and performance of ablative
procedures, including contouring of
ablation targets, virtual ablation probe
placement and contouring of ablated areas,
as well as supporting the User in their
assessment of the treatment. The
application can only be used by trained
Users.
The software is not intended for diagnosis
and is not intended to predict ablation
volumes or predict ablation success. | Substantially equivalent
The myAblation Guide intended use is
similar to the intended use of the
predicate device. Both devices are used to
process a variety of medical images in
support of ablation procedures. |
| Intended Users | Physicians | Physicians | Same as predicate |
| Intended patient population | The patient demographic chosen by
interventional radiologists to undergo
ablation treatment (including patient with
soft tissue lesions). | The patient demographic chosen by
physicians to undergo percutaneous
ablation treatment (including patient with
soft tissue lesions). | Same as predicate |
| US product code | 21 CFR 892.2050 | 21 CFR 892.2050 | Same as predicate |
| Operating Environment | Operating Room and the hospital healthcare
environment such as interventional
radiology control room. | Operating Room and the hospital healthcare
environment | Same as predicate |
| Feature And/or Specification Of
New/Modified Device | Predicate Device
510(K) ID # K202297
Aline Ablation Intelligence (From
Mirada Medical) | MyAblation Guide
(Subject Device) | Analysis/Differences |
| Operating System / Platform | Microsoft Windows compatible machine.
64-bit Windows 7 and 10. | Windows 10 | Substantially equivalent |
| Supported modalities | CT, MRI. | CT, MRI, PET, PET-CT, CBCT images | Substantially equivalent
Software validation and verification tests
to ensure the performance and
compatibility of modalities not seen in the
predicate do not raise different concerns of
safety or effectiveness. |
| (Semi-)Automatic Structure Segmentation | Yes | Yes, for livers | Substantially equivalent |
| Structure Margin Indication | Yes | Yes | Substantially equivalent |
| Simulation of virtual needle path (Virtual
Ablation Probe Planning) | Yes | Yes | Substantially equivalent |
| 3D Visualization of segmented structures,
including Ablation Zone | Yes | Yes | Substantially equivalent |
| Data export to myNeedle Guide on Siemens
Healthineers syngo CT systems | No | Yes | Data export tests to these compatible
devices do not raise significantly different
concerns of safety or effectiveness. |
| Image registration: Overlay of Virtual Ablation
Probe and Achieved Ablation Probe Position | Yes | Yes | Substantially equivalent |
| Image registration: Overlay of planned and
achieved ablation zone in 2D/3D for visual
Evaluation of Ablation Result | Yes | Yes | Substantially equivalent |
Table 1: Comparison of Technological Characteristics between subject and predicate devices
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Image /page/6/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots.
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Image /page/7/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the text is a graphic of orange dots arranged in a circular pattern.
Performance Data: VII.
1. Non-clinical Testing:
myAblation Guide underwent non-clinical testing to demonstrate the design and performance of the devices meet the established design criteria and are substantial equivalent to the predicate devices. The subject device successfully completed functional, usability, and other softwarerelated design testing.
Semi-automatic segmentation algorithms:
The clinical performance testing of the semi-automatic liver ablation zone segmentation has been evaluated by Moltz et al (Moltz J. & .- O., 2008) as well as in a retrospective internal study. Altogether, CT-datasets from 60 patients have been assessed. The evaluated cases comprise hepatocellular carcinoma (HCC) and non-HCC cases.
To assess the algorithm's performance on liver metastases, Moltz et al conducted a study evaluating five different data sets comprising of ten liver metastases originating from diverse primary turnors. With a Dice coefficient (Dice similarity index) of 0.82 the algorithm effectively demonstrated the segmentation of both hyperdense and hypodense lesions, regardless of their placement within the liver or in its surrounding areas.
(The tabulated results were converted for the purpose of comparing them with our internal study.) The internal analysis of the lesion segmentation included a total of 50 patients. The DICE for all lesion types is 0.65 with a sensitivity of 0.82, as outlined in the following table:
| Metric | All Lesion Types | HCC | non-HCC |
|---|---|---|---|
| Dice / True Positive Lesion | 0.65 | 0.62 | 0.66 |
| Sensitivity | 0.82 | 0.81 | 0.81 |
Sensitivity is referred to as: "Sensitivity = TP / (TP + FN)" with true positive (TP) defined as Intersection over Union (IoU) ≥ 0.1 and false negative (FN) as IoU