(106 days)
iPlan RT Image (K080886)
No
The summary does not mention AI, DNN, or ML, nor does it describe training or test sets in a way that suggests the use of these technologies for learning or adaptation. The performance studies focus on accuracy of image co-registration, which is a common image processing task that can be achieved with traditional algorithms.
No
This device is for co-registration of image data for planning or preplanning steps, not for direct therapeutic intervention. It is a radiological image processing system.
No
The device is described as assisting in planning or preplanning clinical workflows by co-registering vascular image data, not making a diagnosis. Its function is image processing for treatment planning, as indicated by its common name "System, Image Processing, Radiological" and intended users in neurosurgery, neuroradiology, or radiotherapy planning.
Yes
The device description and performance studies focus solely on the software's image processing and co-registration capabilities, with no mention of associated hardware components being part of the device itself. The testing involves data from physical phantoms and patient scans, but the device being tested is the software's ability to process and fuse this data.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The described device, "Image Fusion Angio," is an image processing system that co-registers medical images (angiographies and volumetric data). It works with existing medical images, not with samples taken from the body.
- Intended Use: The intended use is for planning and preplanning steps in clinical workflows that benefit from image co-registration. This is a diagnostic imaging tool, not a diagnostic test performed on a biological sample.
- Input: The input is medical image data, not biological samples.
- Classification Name: The classification name "System, Image Processing, Radiological" further confirms its role in processing radiological images, not performing in vitro tests.
Therefore, the device falls under the category of medical imaging software or a radiological image processing system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The application can be used in clinical workflows that benefit from the co-registration of vascular image data as a planning or preplanning step.
There are no demographic, regional or cultural limitations for patients.
The system shall be used in a hospital office environment or rooms appropriate for surgical interventions.
Product codes
LLZ, JAK
Device Description
Image Fusion Angio is intended to co-register digital subtraction angiographies with volumetric medical image data.
Mentions image processing
System, Image Processing, Radiological
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital subtraction angiographies, CTA, 3D-DSA, 2D-DSA, MRA
Anatomical Site
cerebrovascular
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professionals and their assistants working in the field of neurosurgery, neuroradiology or radiotherapy planning.
The system shall be used in a hospital office environment or rooms appropriate for surgical interventions.
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
Phantom Bench Test: We performed 2D and 3D scans using a physical vessel phantom. 2D and 3D images were fused with Image Fusion Angio and iPlan RT Image (reference device). Targeting accuracies of both devices to a gold standard fusion were compared to each other (Euclidean Distances between predefined landmarks). The test was repeated 3 times.
MRA Bench Test: We performed 2D and 3D scans using a retrospective patient data set. 2D and 3D images were fused with Image Fusion Angio and iPlan RT Image (reference device). Targeting accuracies of both devices to a gold standard fusion were compared to each other (Euclidean Distances between predefined landmarks). The test was repeated 3 times.
Retrospective Study: We used 35 datasets from 16 different clinical sites (11 different scanner types). We performed 2D/3D fusions with Image Fusion Angio. The gold standard fusions were defined by medical experts. Targeting accuracies of predefined landmarks (Euclidean distance to gold standard fusion) were calculated. All fusions were further reviewed by medical experts.
Summary of Performance Studies
Phantom Bench Test:
- Study Type: Nonclinical performance testing (Accuracy)
- Sample Size: Not explicitly stated, "repeated 3 times".
- Key Results:
- Targeting accuracy, Image Fusion Angio: 0.5 mm +/- 0.2 mm
- Targeting accuracy, iPlan RT Image: 0.8 mm +/- 0.3 mm
MRA Bench Test:
- Study Type: Nonclinical performance testing (Accuracy)
- Sample Size: Not explicitly stated, "repeated 3 times".
- Key Results:
- Targeting accuracy, Image Fusion Angio: 0.3 mm +/- 0.1 mm
- Targeting accuracy, iPlan RT Image: 3.2 mm +/- 0.3 mm
Retrospective Study:
- Study Type: Nonclinical performance testing (Accuracy)
- Sample Size: 35 datasets from 16 different clinical sites (11 different scanner types).
- Key Results: Targeting accuracy: 0.36 mm +/- 0.17 mm. The result is similar to the result of the phantom bench test and similar to the findings in the literature.
Key Metrics
- Targeting accuracy (Euclidean Distance):
- Phantom Bench Test:
- Image Fusion Angio: 0.5 mm +/- 0.2 mm
- iPlan RT Image: 0.8 mm +/- 0.3 mm
- MRA Bench Test:
- Image Fusion Angio: 0.3 mm +/- 0.1 mm
- iPlan RT Image: 3.2 mm +/- 0.3 mm
- Retrospective Study: 0.36 mm +/- 0.17 mm
- Phantom Bench Test:
Predicate Device(s)
Image Fusion (K170816)
Reference Device(s)
iPlan RT Image (K080886)
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 and Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
April 25, 2019
Brainlab AG % Mr. Alexander Schwiersch Regulatory Affairs Manager Olof-Palme-Str. 9 München, 81829 GERMANY
Re: K190042
Trade/Device Name: Brainlab Elements Image Fusion Angio Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ, JAK Dated: March 22, 2019 Received: March 28, 2019
Dear Mr. Schwiersch:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Michael D. O'Hara
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K190042
Device Name Brainlab Elements Image Fusion Angio
Indications for Use (Describe)
The application can be used in clinical workflows that benefit from the co-registration of vascular image data as a planning or preplanning step.
There are no demographic, regional or cultural limitations for patients.
The system shall be used in a hospital office environment or rooms appropriate for surgical interventions.
| 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 OF SAFETY AND EFFECTIVENESS FOR IMAGE FUSION ANGIO
In accordance with requirements of 21 CFR Part 807.92
| Manufacturer: | Brainlab AG
Olof-Palme-Str. 9
81829 Munich
Germany
Phone: +49 89 99 15 68 0
Fax: +49 89 99 15 68 5033 |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Rainer Birkenbach |
| Contact person: | Alexander Schwiersch |
| Summary date: | 12/21/2018 |
| Device: | Image Fusion Angio |
| Trade name: | Brainlab Elements Image Fusion Angio |
| Common/Classification
Name: | System, Image Processing, Radiological |
| Predicate Device: | Image Fusion (K170816) |
| Reference Device: | iPlan RT Image (K080886) |
| Device classification
name: | Picture archiving and communications system |
| Regulatory Class: | Class II |
| Regulation Number: | 21 CFR 892.2050 |
| Product Code: | LLZ |
| Intended use: | Image Fusion Angio 1.0 is a software application that is intended to be used
for the co-registration of cerebrovascular image data. |
510(k) summary
4
| Indications for use: | The application can be used in clinical workflows that benefit from the co-
registration of vascular image data as a planning or preplanning step. |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device description: | Image Fusion Angio is intended to co-register digital subtraction
angiographies with volumetric medical image data. |
| Operator Profile: | The application is intended to be used by medical professionals and their
assistants working in the field of neurosurgery, neuroradiology or
radiotherapy planning. |
| Patient Population: | There are no demographic, regional or cultural limitations for patients. |
| Conditions of Use: | The system shall be used in a hospital office environment or rooms
appropriate for surgical interventions. |
| Reason for 510(k)
submission: | New device. |
| Substantial
equivalence: | Image Fusion Angio 1.0 (Subject Device) is part of a new software
generation at Brainlab. The functionality of the Subject Device has been
previously included in the Predicate Device. The Subject Device specifically
takes over the fusion algorithm and the GUI design from the predicate
device (Image Fusion, K170816). It takes over the ability to load 2D images
and fuse them to 3D images from the reference device (iPlan RT Image,
K080886).
All devices provide the functionality co-register anatomical structures of
image data and can be used in planning workflows to treat cranial lesions. |
| Conclusion: | Functionality and features considered as substantially equivalent have been
verified and validated. The system Image Fusion Angio with its set of
functionalities is substantially equivalent to its predicate and reference
devices. |
| Changes to Predicate
Device: | The new Image Fusion Angio 1.0 Element enlarges the portfolio of already
cleared Brainlab Elements. Central changes compared to the main
predicate device Image Fusion are based in focusing on image fusion
functionality in general. |
5
Technological Characteristics of the Subject Device in comparison to the Predicate Device:
| | Cleared device
feature/specifications
Image Fusion 3.0
(K170816) | Modified device
feature/specifications
Image Fusion Angio
1.0 |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| HW Requirements and
Operating Systems | Equivalent | |
| Data Inputs | Equivalent | |
| Viewing Data | Equivalent | |
| Performing an Image
Fusion | Equivalent as follows:
The predicate provides identical functions
compared to the subject device except for the
ability to load 2D images and to co-register
them to 3D images. This is not critical for
equivalence rating, since this is a known and
existing feature. | |
| Fusion Algorithm | Equivalent as follows:
The predicate provides the same algorithm
compared to the subject device except for the
ability to fuse 3D to 2D images. This is not
critical for equivalence rating, since this is a
known and existing feature. | |
| Fusion and
Verification Tools | | Equivalent |
| Accepting a Fusion
Result | | Equivalent |
| Performing a manual
fusion | | Equivalent |
| Choosing a Region of
Interest | | Equivalent |
| Edit and Select Pairs | | Equivalent |
Technological Characteristics of the Subject Device in
comparison to the Reference Device:
| | Cleared device
feature/specifications
iPlan RT Image
(K080886) | Modified device
feature/specifications
Image Fusion Angio
1.0 |
|------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| Fusion Algorithm | Equivalent as follows:
The reference device provides functionality for a
2D/3D co-registration in an equivalent context
but uses a differing algorithm with respect to the
2D/3D co-registration. This is not critical for
equivalence rating, since the resulting co-
registration accuracy is equally good, as proven
by verification and validation. | |
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| Verification/validation
summary: | Verification
Verification has been performed according to the Verification Plan and
following internal processes to demonstrate that design specifications are
met by the device. |
| ------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
Validation
Validation of the functionalities, including nonclinical performance tests (accuracy tests, see below), has been performed in accordance with the Clinical Evaluation Plan and following internal processes.
Usability tests have been performed as well to ensure that the device can be used safely and that measures against potential use related risks are effective.
The validation has been performed with software and units that are considered equivalent to the final version of the product (in terms of functionality and user interface), as demanded by 21 CFR 820.30 (q).
Nonclinical performance testing (Accuracy)
To evaluate the accuracy of the 2D/3D co-registration we took the following pathway (detailed results see table below):
- Phantom Bench Test to compare the 2D/3D fusion accuracy of । CTA, 3D-DSA to 2D-DSA of the Subject Device to the Reference Device.
- -MRA Bench Test - to compare the 2D/3D fusion accuracy of MRA to 2D-DSA of the Subject Device to the Reference Device.
- -Retrospective Study - to confirm similar accuracy as shown in the Phantom Bench Test.
Due to the results of the nonclinical tests we demonstrated that the device is as safe, as effective and performs as well as the reference device
| Test | Test Method Summary | Results |
|---|---|---|
| Phantom | ||
| Bench Test | We performed 2D and 3D scans using a physical vessel phantom. | |
| 2D and 3D images were fused with Image Fusion Angio and iPlan | ||
| RT Image (reference device). Targeting accuracies of both devices | ||
| to a gold standard fusion were compared to each other (Euclidean | ||
| Distances between predefined landmarks). The test was repeated 3 | ||
| times. | Targeting accuracy, Image | |
| Fusion Angio: | ||
| 0.5 mm +/- 0.2 mm | ||
| Targeting accuracy, iPlan | ||
| RT Image: | ||
| 0.8 mm +/- 0.3 mm | ||
| MRA Bench | ||
| Test | We performed 2D and 3D scans using a retrospective patient data | |
| set. 2D and 3D images were fused with Image Fusion Angio and | ||
| iPlan RT Image (reference device). Targeting accuracies of both | ||
| devices to a gold standard fusion were compared to each other | ||
| (Euclidean Distances between predefined landmarks). The test was | ||
| repeated 3 times. | Targeting accuracy, Image | |
| Fusion Angio: | ||
| 0.3 mm +/- 0.1 mm | ||
| Targeting accuracy, iPlan | ||
| RT Image: | ||
| 3.2 mm +/- 0.3 mm | ||
| Retrospective | ||
| Study | We used 35 datasets from 16 different clinical sites (11 different | |
| scanner types). We performed 2D/3D fusions with Image Fusion | ||
| Angio. The gold standard fusions were defined by medical experts. | ||
| Targeting accuracies of predefined landmarks (Euclidean distance | ||
| to gold standard fusion) were calculated. All fusions were further | ||
| reviewed by medical experts. | Targeting accuracy: 0.36 | |
| mm +/- 0.17 mm | ||
| The result is similar to the | ||
| result of the phantom | ||
| bench test and similar to | ||
| the findings in the | ||
| literature. |