(190 days)
The Image Fusion Element is an application for the co-registration of image data within medical procedures by using rigid and deformable registration methods. It is intended to align anatomical structures between data sets.
The Image Fusion Element can be used in clinical workflows that benefit from the co-registration of image data. For example, this applies to navigation systems or medical data information terminals for image processing or image guided surgery in general as well as for treatment planning software for radiosurgery and radiotherapy. The device itself does not have specific clinical indications.
The Image Fusion Element is intended to co-register volumetric medical image data (e.g. MR, CT). It allows rigid image registration to adjust different spatial position and orientation of two data sets. It also offers deformable registration to compensate image distortion or spatial deviation between image acquisitions.
The Image Fusion Element gives the possibility to show basic planning content (e.g. objects, points, trajectories) defined from one dataset on another dataset and to display datasets of corresponding anatomic planes simultaneously. Further it could process co-registered data to highlight differences between distinct scanning sequences or to assess the response to a treatment.
The provided document is a 510(k) premarket notification for Brainlab AG's "Image Fusion" device. It outlines the device's intended use, technological characteristics, and a summary of safety and effectiveness, primarily through demonstrating substantial equivalence to predicate devices.
However, this document does not contain the detailed study information typically found in a clinical performance study report that would prove the device meets specific acceptance criteria using a test set, ground truth, and statistical analysis as requested in your prompt. The document outlines a verification and validation (V&V) process, but it does not specify quantitative acceptance criteria or report the results of a controlled study against a predefined ground truth in the manner you've described.
Instead, the document focuses on:
- Substantial Equivalence: Comparing the device's features and functionality to existing legally marketed predicate devices (Mirada XD, K101228, and iPlan, K113732). The "Changes to Predicate Device" section and the "Technological Characteristics" table highlight this comparison.
- Verification and Validation Summary: Stating that verification and validation were performed according to internal plans and processes, including usability testing, to ensure design specifications are met and the device can be used safely. There are no specific performance metrics or statistical results presented.
Therefore, I cannot provide the information requested in your numbered list for this specific device from the provided text, as the necessary details regarding acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement for a clinical performance study are not present.
The document's statement: "Functionality and features considered as substantially equivalent have been verified and validated. The system Image Fusion with its set of functionalities is substantially equivalent to its predicate devices," serves as the core of its argument for market clearance rather than presenting a detailed clinical study demonstrating quantitative performance against specific acceptance criteria.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 26, 2017
Brainlab AG % Mr. Alexander Schwiersch Regulatory Affairs Manager Olof-Palme-Str. 9 Munchen 81829 GERMANY
Re: K170816
Trade/Device Name: Image Fusion Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ, JAK Dated: September 15, 2017 Received: September 21, 2017
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. 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 (reporting of medical device-
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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael D. O'Hara For
Robert Ochs, 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)
Device Name Image Fusion
Indications for Use (Describe)
The Image Fusion Element can be used in clinical workflows that benefit from the co-registration of image data. For example, this applies to navigation systems or medical data information terminals for image guided surgery in general as well as for treatment planning software for radiotherapy. The device itself does not have specific clinical indications.
Type of Use (Select one or both, as applicable)
| ☒ 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
| Manufacturer: | Brainlab AGOlof-Palme-Str. 981829 MünchenGermanyPhone: +49 89 99 15 68 0Fax: +49 89 99 15 68 5033 |
|---|---|
| Submitter: | Rainer Birkenbach |
| Contact person: | Alexander Schwiersch |
| Summary date: | 9/15/2017 |
| Device: | Image Fusion |
| Trade name: | Elements Image FusionElements Cranial Distortion CorrectionElements Spine Curvature CorrectionElements Contrast Clearance Analysis |
| Common/Classification Name: | System, Image Processing, Radiological |
| Main Predicate Device: | Mirada XD (K101228) |
| Secondary Predicate Device: | iPlan (K113732) |
| Device classification name: | Picture archiving and communications system |
| Regulatory Class: | Class II |
| Regulation Number: | 21 CFR 892.2050 |
| Product Code: | LLZ |
| Intended use: | The Image Fusion Element is an application for the co-registration of imagedata within medical procedures by using rigid and deformable registrationmethods. It is intended to align anatomical structures between data sets. |
| Indications for use: | The Image Fusion Element can be used in clinical workflows that benefitfrom the co-registration of image data. For example, this applies tonavigation systems or medical data information terminals for imageprocessing or image guided surgery in general as well as for treatmentplanning software for radiosurgery and radiotherapy. The device itself doesnot have specific clinical indications. |
| Device description: | The Image Fusion Element is intended to co-register volumetric medicalimage data (e.g. MR, CT). It allows rigid image registration to adjustdifferent spatial position and orientation of two data sets. It also offersdeformable registration to compensate image distortion or spatial deviationbetween image acquisitions. |
| The Image Fusion Element gives the possibility to show basic planningcontent (e.g. objects, points, trajectories) defined from one dataset onanother dataset and to display datasets of corresponding anatomic planessimultaneously. Further it could process co-registered data to highlightdifferences between distinct scanning sequences or to assess the responseto a treatment. | |
| Operator ProfileThe application is intended to be used by medical professionals and theirassistants working in the field of neurosurgery, traumatology or radiotherapyplanning. | |
| Patient PopulationThere are no demographic, regional or cultural limitations for patients. | |
| Conditions of useThe Image Fusion Element is designed to be used- in a hospital office environment or at any other location offering acomputer- in an operating room / suite or in rooms appropriate for surgicalinterventions | |
| Substantialequivalence: | Image Fusion is part of a new software generation at Brainlab. It containsfeatures for rigid fusion (co-registration) of medical image data, verificationof such calculation results as well as a user interface which is substantiallyequivalent to the reference predicate device iPlan 3.0 (K113732). Further itcontains features for deformable registration (elastic fusion) of cranial orspinal image data as well as tools for assessing results of a treatment,which are substantially equivalent to the primary predicate device MiradaXD (K101228). |
| Conclusion: | Functionality and features considered as substantially equivalent have beenverified and validated. The system Image Fusion with its set offunctionalities is substantially equivalent to its predicate devices. |
| Changes to PredicateDevice: | The new Image Fusion 3.0 Element enlarges the portfolio of already clearedBrainlab Elements. Central changes compared to the main predicate deviceiPlan 3.0 are based in focusing on image fusion functionality in general (co-registration and deformable registration). |
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Technological Characteristics:
| Cleared devicefeature/specificationsMirada XD (K101228) | Modified devicefeature/specificationsImage Fusion 3.0 | |
|---|---|---|
| Characteristics | ||
| Starting of adeformationcalculation | Yes | Yes |
| Verification ofdeformation(correction) result | Yes | Yes |
| Cleared devicefeature/specifications | Modified devicefeature/specifications | |
| iPlan 3.0.6 (K113732):- Cranial- ENT- CMF- Stereotaxy- Spine- Flow- View | Image Fusion 3.0:- Image Fusion- Cranial DistortionCorrection- Spine CurvatureCorrection- Contrast ClearanceAnalysis | |
| Characteristics | ||
| Selection of intendedapplication container | Yes | Yes |
| Import/export ofmedical data | Yes | Yes |
| Display of data,Switching of vieworientation | Yes | Yes |
| Starting of a rigidfusion calculation | Yes | Yes |
| Verification of rigidfusion result | Yes | Yes |
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 has been performed in accordance with the Validation 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 (g).
§ 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).