(190 days)
No
The summary describes image registration methods (rigid and deformable) but does not mention AI, ML, or related terms. The performance studies focus on verification and validation against specifications, not on training or testing of AI/ML models.
No.
The device is used for image co-registration and processing to aid in medical procedures, but it does not directly treat or diagnose a disease or condition. It is a tool for medical professionals to use in planning and guidance.
No
Explanation: The device is an "Image Fusion Element" intended for co-registration of image data for use in various medical procedures and planning. While it processes medical images, its stated purpose is to align and display data, or highlight differences for assessing treatment response, rather than diagnosing a disease or condition itself. It is a tool for image processing and visualization, not for generating a diagnosis.
Yes
The device is described as an "application" and its function is solely image processing and co-registration of existing medical image data. There is no mention of any hardware component being part of the device itself, only that it is used on a computer in a hospital or operating room environment.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The description of the Image Fusion Element clearly states its purpose is to co-register and process medical image data (MR, CT) of anatomical structures (cranial or spinal). It does not involve the analysis of biological samples like blood, urine, or tissue.
- The intended use is for image processing and guidance during medical procedures. The examples provided (navigation systems, image guided surgery, treatment planning) all relate to using the image data for visualization, planning, and guidance, not for diagnosing a condition based on the analysis of a specimen.
- The device description focuses on image registration and display. The functionalities described are related to aligning and presenting image data, not to performing tests on biological samples.
Therefore, the Image Fusion Element falls under the category of medical imaging software or image processing software used in clinical workflows, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ, JAK
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
volumetric medical image data (e.g. MR, CT)
Anatomical Site
Not Found
Indicated Patient Age Range
There are no demographic, regional or cultural limitations for patients.
Intended User / Care Setting
Operator Profile
The application is intended to be used by medical professionals and their assistants working in the field of neurosurgery, traumatology or radiotherapy planning.
Conditions of use
The Image Fusion Element is designed to be used
- in a hospital office environment or at any other location offering a computer
- in an operating room / suite or in 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
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-
Image /page/0/Picture/11 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized graphic of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the graphic.
1
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
2
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510 (K) SUMMARY OF SAFETY AND EFFECTIVENESS FOR IMAGE FUSION
| Manufacturer: | Brainlab AG
Olof-Palme-Str. 9
81829 München
Germany
Phone: +49 89 99 15 68 0
Fax: +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 Fusion
Elements Cranial Distortion Correction
Elements Spine Curvature Correction
Elements 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 image
data within medical procedures by using rigid and deformable registration
methods. It is intended to align anatomical structures between data sets. |
| Indications for use: | 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. |
| Device description: | 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. |
| | Operator Profile
The application is intended to be used by medical professionals and their
assistants working in the field of neurosurgery, traumatology or radiotherapy
planning. |
| | Patient Population
There are no demographic, regional or cultural limitations for patients. |
| | Conditions of use
The Image Fusion Element is designed to be used
- in a hospital office environment or at any other location offering a
computer - in an operating room / suite or in rooms appropriate for surgical
interventions |
| Substantial
equivalence: | Image Fusion is part of a new software generation at Brainlab. It contains
features for rigid fusion (co-registration) of medical image data, verification
of such calculation results as well as a user interface which is substantially
equivalent to the reference predicate device iPlan 3.0 (K113732). Further it
contains features for deformable registration (elastic fusion) of cranial or
spinal image data as well as tools for assessing results of a treatment,
which are substantially equivalent to the primary predicate device Mirada
XD (K101228). |
| Conclusion: | 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. |
| Changes to Predicate
Device: | The new Image Fusion 3.0 Element enlarges the portfolio of already cleared
Brainlab Elements. Central changes compared to the main predicate device
iPlan 3.0 are based in focusing on image fusion functionality in general (co-
registration and deformable registration). |
4
5
Technological Characteristics:
| | Cleared device
feature/specifications
Mirada XD (K101228) | Modified device
feature/specifications
Image Fusion 3.0 |
|-------------------------------------------------------|------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristics | | |
| Starting of a
deformation
calculation | Yes | Yes |
| Verification of
deformation
(correction) result | Yes | Yes |
| | Cleared device
feature/specifications | Modified device
feature/specifications |
| | iPlan 3.0.6 (K113732):
- Cranial
- ENT
- CMF
- Stereotaxy
- Spine
- Flow
- View | Image Fusion 3.0:
- Image Fusion
- Cranial Distortion
Correction - Spine Curvature
Correction - Contrast Clearance
Analysis |
| Characteristics | | |
| Selection of intended
application container | Yes | Yes |
| Import/export of
medical data | Yes | Yes |
| Display of data,
Switching of view
orientation | Yes | Yes |
| Starting of a rigid
fusion calculation | Yes | Yes |
| Verification of rigid
fusion 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).