(106 days)
The application can be used in clinical workflows that benefit from the co-registration of vascular image data as a planning or preplanning step.
Image Fusion Angio is intended to co-register digital subtraction angiographies with volumetric medical image data.
The provided text describes the acceptance criteria and a study proving the device meets these criteria for the Brainlab Elements Image Fusion Angio device.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as quantitative thresholds in a table format within this document. Instead, the document focuses on demonstrating substantial equivalence to predicate and reference devices, particularly in terms of fusion accuracy.
The performance is reported through nonclinical performance testing (accuracy tests).
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance (Image Fusion Angio) | Reported Reference Device Performance (iPlan RT Image) |
|---|---|---|---|
| Phantom Bench Test (CTA, 3D-DSA to 2D-DSA) | Similar or better targeting accuracy compared to the reference device and within expected clinical limits for 2D/3D fusion. | 0.5 mm +/- 0.2 mm | 0.8 mm +/- 0.3 mm |
| MRA Bench Test (MRA to 2D-DSA) | Similar or better targeting accuracy compared to the reference device and within expected clinical limits for 2D/3D fusion. | 0.3 mm +/- 0.1 mm | 3.2 mm +/- 0.3 mm |
| Retrospective Study (Clinical Data) | Similar targeting accuracy to phantom bench test and existing literature, and fusions reviewed by medical experts. | 0.36 mm +/- 0.17 mm | Not applicable (device only performance) |
2. Sample Size Used for the Test Set and Data Provenance
- Phantom Bench Test & MRA Bench Test: "The test was repeated 3 times" for each. The data provenance is controlled lab/bench test scenario.
- Retrospective Study: "We used 35 datasets from 16 different clinical sites (11 different scanner types)." The data provenance is retrospective clinical data from multiple sites. The country of origin is not explicitly stated but implies a multi-center approach.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Retrospective Study: "The gold standard fusions were defined by medical experts." The number of experts is not specified (e.g., "by medical experts" could mean one, two, or more).
- Qualifications of Experts: The document states "medical experts" but does not provide specific qualifications (e.g., "radiologist with 10 years of experience" or "neurosurgeon").
4. Adjudication Method for the Test Set
- Retrospective Study: "The gold standard fusions were defined by medical experts." and "All fusions were further reviewed by medical experts." This suggests expert consensus or review, but the specific adjudication method (e.g., 2+1, 3+1) is not detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- No, an MRMC comparative effectiveness study involving human readers improving with AI vs. without AI assistance was not done or reported in this document. The study focuses purely on the accuracy of the algorithm's 2D/3D co-registration.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, the accuracy tests (Phantom Bench Test, MRA Bench Test, Retrospective Study) evaluate the Brainlab Elements Image Fusion Angio and iPlan RT Image algorithms in a standalone manner, measuring their targeting accuracy against a defined gold standard. While medical experts defined and reviewed the ground truth/gold standard, the performance being measured is that of the algorithm itself, not an interaction with a human.
7. The Type of Ground Truth Used
- Phantom Bench Test & MRA Bench Test: "gold standard fusion" (likely established by precise manual registration or by the design of the phantom itself). This represents a highly controlled, measurable ground truth.
- Retrospective Study: "The gold standard fusions were defined by medical experts." This indicates expert consensus as the ground truth for clinical data.
8. The Sample Size for the Training Set
- The document does not provide information regarding the sample size used for the training set for the Image Fusion Angio algorithm. This section only covers performance testing (validation).
9. How the Ground Truth for the Training Set Was Established
- Since the training set information is not provided, how its ground truth was established is also not detailed in this document.
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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
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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 AGOlof-Palme-Str. 981829 MunichGermanyPhone: +49 89 99 15 68 0Fax: +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/ClassificationName: | System, Image Processing, Radiological |
| Predicate Device: | Image Fusion (K170816) |
| Reference Device: | iPlan RT Image (K080886) |
| Device classificationname: | 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 usedfor the co-registration of cerebrovascular image data. |
510(k) summary
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| 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 subtractionangiographies with volumetric medical image data. |
| Operator Profile: | The application is intended to be used by medical professionals and theirassistants working in the field of neurosurgery, neuroradiology orradiotherapy 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 roomsappropriate for surgical interventions. |
| Reason for 510(k)submission: | New device. |
| Substantialequivalence: | Image Fusion Angio 1.0 (Subject Device) is part of a new softwaregeneration at Brainlab. The functionality of the Subject Device has beenpreviously included in the Predicate Device. The Subject Device specificallytakes over the fusion algorithm and the GUI design from the predicatedevice (Image Fusion, K170816). It takes over the ability to load 2D imagesand fuse them to 3D images from the reference device (iPlan RT Image,K080886).All devices provide the functionality co-register anatomical structures ofimage data and can be used in planning workflows to treat cranial lesions. |
| Conclusion: | Functionality and features considered as substantially equivalent have beenverified and validated. The system Image Fusion Angio with its set offunctionalities is substantially equivalent to its predicate and referencedevices. |
| Changes to PredicateDevice: | The new Image Fusion Angio 1.0 Element enlarges the portfolio of alreadycleared Brainlab Elements. Central changes compared to the mainpredicate device Image Fusion are based in focusing on image fusionfunctionality in general. |
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Technological Characteristics of the Subject Device in comparison to the Predicate Device:
| Cleared devicefeature/specificationsImage Fusion 3.0(K170816) | Modified devicefeature/specificationsImage Fusion Angio1.0 | |
|---|---|---|
| HW Requirements andOperating Systems | Equivalent | |
| Data Inputs | Equivalent | |
| Viewing Data | Equivalent | |
| Performing an ImageFusion | Equivalent as follows:The predicate provides identical functionscompared to the subject device except for theability to load 2D images and to co-registerthem to 3D images. This is not critical forequivalence rating, since this is a known andexisting feature. | |
| Fusion Algorithm | Equivalent as follows:The predicate provides the same algorithmcompared to the subject device except for theability to fuse 3D to 2D images. This is notcritical for equivalence rating, since this is aknown and existing feature. | |
| Fusion andVerification Tools | Equivalent | |
| Accepting a FusionResult | Equivalent | |
| Performing a manualfusion | Equivalent | |
| Choosing a Region ofInterest | Equivalent | |
| Edit and Select Pairs | Equivalent |
Technological Characteristics of the Subject Device in
comparison to the Reference Device:
| Cleared devicefeature/specificationsiPlan RT Image(K080886) | Modified devicefeature/specificationsImage Fusion Angio1.0 | |
|---|---|---|
| Fusion Algorithm | Equivalent as follows:The reference device provides functionality for a2D/3D co-registration in an equivalent contextbut uses a differing algorithm with respect to the2D/3D co-registration. This is not critical forequivalence rating, since the resulting co-registration accuracy is equally good, as provenby verification and validation. |
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| Verification/validationsummary: | VerificationVerification has been performed according to the Verification Plan andfollowing internal processes to demonstrate that design specifications aremet 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 |
|---|---|---|
| PhantomBench Test | We performed 2D and 3D scans using a physical vessel phantom.2D and 3D images were fused with Image Fusion Angio and iPlanRT Image (reference device). Targeting accuracies of both devicesto a gold standard fusion were compared to each other (EuclideanDistances between predefined landmarks). The test was repeated 3times. | Targeting accuracy, ImageFusion Angio:0.5 mm +/- 0.2 mmTargeting accuracy, iPlanRT Image:0.8 mm +/- 0.3 mm |
| MRA BenchTest | We performed 2D and 3D scans using a retrospective patient dataset. 2D and 3D images were fused with Image Fusion Angio andiPlan RT Image (reference device). Targeting accuracies of bothdevices to a gold standard fusion were compared to each other(Euclidean Distances between predefined landmarks). The test wasrepeated 3 times. | Targeting accuracy, ImageFusion Angio:0.3 mm +/- 0.1 mmTargeting accuracy, iPlanRT Image:3.2 mm +/- 0.3 mm |
| RetrospectiveStudy | We used 35 datasets from 16 different clinical sites (11 differentscanner types). We performed 2D/3D fusions with Image FusionAngio. The gold standard fusions were defined by medical experts.Targeting accuracies of predefined landmarks (Euclidean distanceto gold standard fusion) were calculated. All fusions were furtherreviewed by medical experts. | Targeting accuracy: 0.36mm +/- 0.17 mmThe result is similar to theresult of the phantombench test and similar tothe findings in theliterature. |
§ 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).