BRIGHTMATTER PLANNING SOFTWARE
Device Facts
| Record ID | K140337 |
|---|---|
| Device Name | BRIGHTMATTER PLANNING SOFTWARE |
| Applicant | Synaptive Medical, Inc. |
| Product Code | LLZ · Radiology |
| Decision Date | Jun 2, 2014 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.2050 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device |
Indications for Use
BrightMatter Planning's indications for use are the viewing, image fusion and image segmentation, where the output can be used for image guided surgery. BrightMatter Planning and simulation of cranial surgical procedures and reviewing of existing treatment plans. Typical users of the software are medical professionals, including but not limited to surgeons and radiologists.
Device Story
BrightMatter Planning Software is a stand-alone workstation application for pre-operative neurosurgical planning. It imports DICOM medical image data (MR/CT); performs image fusion and segmentation (including automated skull segmentation); generates diffusion tracts from DTI data; and allows manual annotation of regions of interest. The software enables 2D/3D visualization and trajectory planning. Operated by surgeons or radiologists in an office setting, the software produces treatment plans that are exported to PACS for use in image-guided surgical systems. By providing detailed visualization and surgical simulation, the device assists clinicians in developing treatment plans, potentially improving surgical preparation and procedural outcomes.
Clinical Evidence
No clinical data. Substantial equivalence is supported by non-clinical bench testing, including software verification and validation at unit, integration, and system levels. DTI-derived image generation and tractography performance were compared against Siemens syngo MR B17 software and demonstrated to be equivalent.
Technological Characteristics
Stand-alone software workstation. Functions include DICOM data import, 2D/3D visualization, image fusion, automated skull segmentation, DTI-based fiber tracking, and trajectory planning. Connectivity via PACS export. Software development follows a formal life cycle with risk assessment and configuration management. No patient contact.
Indications for Use
Indicated for medical professionals, including surgeons and radiologists, for viewing, image fusion, and segmentation of medical images to assist in the simulation of cranial surgical procedures and review of treatment plans for image-guided surgery.
Regulatory Classification
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.
Special Controls
*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).
Predicate Devices
Reference Devices
- Siemens syngo MR B17 software
Submission Summary (Full Text)
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Synaptive Medical Inc. 510(k) Summary
## 1 510(k) Summary
| Table 5.1 510(k) Summary (As required by section 21 CFR 807.92(c)) | | |
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| Submitter: | Synaptive Medical Inc.<br>MaRS Centre, South Tower<br>101 College Street, Suite 200<br>Toronto, ON M5G 1L7 Canada | |
| Contact Person: | Cameron Piron<br>President<br>Telephone: 416-673-6679<br>Email: cameron.piron@synaptivemedical.com<br>Synaptive Medical Inc.<br>MaRS Centre, South Tower<br>101 College Street, Suite 200<br>Toronto, ON M5G 1L7 Canada | |
| Date Prepared: | May 24, 2014 | |
| Trade Name: | BrightMatter Planning Software | |
| Common/Usual Name: | BrightMatter Planning Software | |
| Classification: | 21 CFR 892.2050<br>Product Code LLZ, Class II<br>Picture archiving and communication system. | |
| Product Code: | LLZ, Class II | |
| Manufacturer: | Synaptive Medical Inc.<br>MaRS Centre, South Tower<br>101 College Street, Suite 200<br>Toronto, ON M5G 1L7 Canada | |
| Establishment Registration: | N/A | |
| Primary Predicate Device: | Manufacturer: Meterialise NV<br>Trade name: SurgiCase System<br>510(k) Number: K073449<br>Date Cleared: Apr 16, 2008 | |
| Table 5.1 510(k) Summary (As required by section 21 CFR 807.92(c)) | | |
| Secondary Predicate<br>Device: | Manufacturer: | BrainLab AG |
| | Trade name: | iPlan Cranial |
| | 510(k) Number: | K113732 |
| | Date Cleared: | May 7, 2012 |
| Device Description | BrightMatter Planning is a treatment planning software that | |
| | enables the user to view and process medical image data. The | |
| | software is intended for pre-operative planning of neuro-surgical | |
| | treatments based on image guided surgical systems. The planning | |
| | software system provides the ability to visualize diagnostic | |
| | images in 2D and 3D formats and fusion of image datasets. The | |
| | software automatically segments the skull from the acquired | |
| | image and generates diffusion tracts from DTI data. The user can | |
| | also manually annotate regions of interest, resulting in structures | |
| | which can subsequently be visualized in 3D. | |
| | The end result of such processing is a set of images that can be | |
| | used to develop a treatment plan for a neuronavigational | |
| | procedure. The treatment plan is developed by a trained person. | |
| | A trained person can use the software to segment structures, | |
| | define regions of interest and establish one or more trajectories. | |
| | | The software, operated on a stand-alone computer workstation, |
| | | is expected to be used by a Surgical Planner in an office setting, in |
| | | preparation for one of several possible surgical procedures. The |
| | | resulting treatment plan can be exported to a PACS for |
| | | subsequent use in image guided surgery. |
| Intended Use | BrightMatter Planning's indications for use are the viewing, | |
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| | | simulation of cranial surgical procedures and reviewing of existing |
| | treatment plans. | |
| | Typical users of the software are medical professionals, including | |
| | | but not limited to surgeons and radiologists. |
| Table 5.1 510(k) Summary (As required by section 21 CFR 807.92(c)) | | |
| Summary of Technical<br>Comparisons | Both the predicate device and the subject device (BrightMatter<br>Planning Software) are software applications that import DICOM image<br>data files, provide image processing fuctions such as image fusion and<br>segmentation, and produce output that can be used for image guided<br>surgery. | |
| | The primary predicate device, SurgiCase System, is a software system<br>that helps transfer of images from medical scanners (MR or CT). The<br>subject device also supports transfer of images from scanners but is<br>limited to detailed visualization of MR images. Both the predicate<br>system and subject system provide the ability to reformat pre-<br>operative images, segment and select regions from the scanned images<br>and visualize the images in 3D without patient contact or surgical insult.<br>Like the predicate device, the subject device also supports simulation<br>and evaluation of surgical treatment options using pre-operative<br>images. The end result in both systems is a surgical plan that cannot be<br>subsequently altered by other users once the plan is exported. Hence,<br>BrightMatter Planning is substantially equivalent to SurgiCase system<br>from intended use and technological characteristics points of view and<br>does not raise different questions of safety. | |
| | The predicate device (iPlan) lists these trade names: iPlan Cranial, iPlan<br>Stereotaxy, iPlan ENT, iPlan Spine, iPlan View and iPlan CMF. These<br>predicate device modules include functionality that is not part of the<br>subject device. The subject device is substantially equivalent to the<br>predicate device's iPlan Cranial module. The subject device does not<br>include the following predicate device functionality:<br>Atlas assisted visualization. Functional planning using BOLD MRI mapping.Comparison of the subject device to the predicate iPlan Cranial module,<br>shows that the two products are very similar in features and functions. | |
| | The comparison was made using the following technical characteristics<br>of the two products:<br>- Load and import data | |
| | - View and Adjustment of data<br>- Registration points | |
| | - Image fusion<br>- Object creation | |
| | - Advanced Object Planning<br>- BOLD MRI mapping | |
| | - Fiber tracking | |
| | - Trajectory planning<br>- Save and export of plans | |
| | - 3D functionalities | |
| | Table 5.1 510(k) Summary (As required by section 21 CFR 807.92(c)) | |
| | The DTI-derived image creation and tractography results were<br>compared with Siemens syngo MR B17 software and were<br>demonstrated to be equivalent in performance. | |
| Non-Clinical Testing | The following bench (software validation) testing was conducted on<br>BrightMatter Planning Software:<br>Software verification and validation testing for each requirement specification. Software verification and validation testing for each algorithmic function. Software verification and validation testing at the unit, integration, and system level. | |
| | The following quality assurance measures were applied during software development:<br>Software Development Life Cycle Software Risk Assessment. Risk Assessment of Off-the-Shelf (OTS) Software. Software Configuration Management and Version Control. Software issue tracking and resolution. | |
| Design Validation | Design validation was performed using the BrightMatter Planning<br>Software in actual and simulated use settings. The results support<br>substantial equivalence to the predicate device and demonstrate that<br>the BrightMatter Planning Software is safe for its intended use. | |
| Clinical Testing | This technology is not new, therefore a clinical study was not<br>considered necessary prior to release. Additionally, there was no<br>clinical testing required to support the medical device as the indications<br>for use is equivalent to the predicate device. The substantial<br>equivalence of the device is supported by the non-clinical testing. | |
| Table 5.1 510(k) Summary (As required by section 21 CFR 807.92(c)) | | |
| Conclusion: | We conclude that the results of testing show the BrightMatter Planning<br>Software to be substantially equivalent to the predicate devices. | |
| | The BrightMatter Planning Software has the same technological<br>characteristics as the predicate devices in that it has a similar intended<br>use, same general operating principle, and same technology. The<br>specific details of the predicate device may vary from those of<br>BrightMatter Planning Software, but testing shows that similar results<br>are produced. Performance of DTI-derived image generation and<br>tractography results were compared with Siemens syngo MR B17 and<br>were shown to be equivalent. | |
| | It has been shown in this 510(k) submission that the differences<br>between the BrightMatter Planning Software and the Brainlab AG iPlan<br>Cranial (K113732) do not raise any questions regarding safety and<br>effectiveness. The BrightMatter Planning Software, as designed and<br>manufactured, is substantially equivalent to, and as safe and effective<br>as. the referenced predicate device. | |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hamoshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 2, 2014
Synaptive Medical, Inc. % Mr. Cameron Piron President MaRS Centre, South Tower 101 College Street, Suite 200 Toronto Ontario M5G IL7 CANADA
Re: K140337
Trade/Device Name: BrightMatter Planning Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 24, 2014 Received: April 28, 2014
Dear Mr. Piron:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 210(k) premained included (for the indications
referenced above and have determined the device is substantially equivalent in internate referenced above and nave determined the acrise is sedicate devices marketed in interstate for use stated in the enclosure) to legally markets producal Device Amendments, or to commerce prior to May 28, 1970, the chacinem and other provisions of the Federal Food, Drug, devices that have been reclassified in accordance with the proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarked a pproval ions of the and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The You may, therefore, market the device, subject to the gently for annual registration, listing of
general controls provisions of the Act include requirements misbranding and general controls provisions of the Act theider requires against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability adulteration. Please note: CDRFI docs not evaluate information reast be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), ( If your device is classified (See above) into critics major regulations affecting your device can be
it may be subject to additional controls. Existing major regulation F it may be subject to additional Controls. Existing major regaring and the endition, FDA may be found in the Code of Federal Regulations, This 20, Forderal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuality of a substination with other requirements of the Act
that FDA has made a determination that your device Edgerales. You must that FDA has made a delermination that your dovice Federal agencies. You must or any Federal statures and regulations administers of cregistration and listing (21
comply with all the Act's requirements, including, but not insting of medical comply with all the Act 's requirements, including, 'or reporting (reporting of medical CFR Part 807); labeling (21 CFR Part 607); good manufacturing practice requirements as set
device-related adverse events) (21 CFR 803); good manufacturing practice requiremen device-related adverse events) (2) CFR 820); and if applicable, the electronic
forth in the quality systems (2) CFR Part 820); and if applicable, the electronic
(2010); forth in the quality systems (QS) regulation (21-51-542 of the Act); 21 CFR 1000-1050.
prod…
