(112 days)
Not Found
No
The summary describes automated segmentation and diffusion tract generation, but does not explicitly mention AI or ML, nor does it provide details about training or test sets typically associated with such technologies. The focus is on image processing and planning tools.
No
This is a treatment planning software used for pre-operative planning and viewing, not a device that directly provides therapy.
No
The device is described as treatment planning software that uses medical images for pre-operative planning of neuro-surgical treatments. It explicitly states its indications for use are for "viewing, simulation of cranial surgical procedures and reviewing of existing treatment plans," not for diagnosis. While it uses "diagnostic images," its function is planning, not diagnosing a condition.
Yes
The device description explicitly states it is "treatment planning software" and is "operated on a stand-alone computer workstation," with no mention of accompanying hardware components being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices and accessories used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- BrightMatter Planning's Function: BrightMatter Planning is a software used for pre-operative planning of neuro-surgical treatments based on medical image data. It processes images, segments structures, and helps define trajectories for surgery.
- No Sample Analysis: The description clearly states the software works with medical image data (MR, CT, DTI) and does not involve analyzing biological samples taken from a patient.
Therefore, BrightMatter Planning falls under the category of medical imaging software or surgical planning software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
BrightMatter Planning's indications for use are the viewing, 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.
BrightMatter Planning Software Indications of Use (describe) included different modules for use are the 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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR or CT
Anatomical Site
Cranial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgical Planner in an office setting, in preparation for one of several possible surgical procedures. Medical professionals, including but not limited to surgeons and radiologists.
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)
Non-Clinical Testing:
The following bench (software validation) testing was conducted on BrightMatter Planning Software:
- 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:
- 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 Software in actual and simulated use settings. The results support substantial equivalence to the predicate device and demonstrate that the BrightMatter Planning Software is safe for its intended use.
Clinical Testing:
This technology is not new, therefore a clinical study was not considered necessary prior to release. Additionally, there was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. The substantial equivalence of the device is supported by the non-clinical testing.
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.
Not Found
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).
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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)) | ||
|---|---|---|
| Submitter: | Synaptive Medical Inc. | |
| MaRS Centre, South Tower | ||
| 101 College Street, Suite 200 | ||
| Toronto, ON M5G 1L7 Canada | ||
| Contact Person: | Cameron Piron | |
| President | ||
| Telephone: 416-673-6679 | ||
| Email: cameron.piron@synaptivemedical.com | ||
| Synaptive Medical Inc. | ||
| MaRS Centre, South Tower | ||
| 101 College Street, Suite 200 | ||
| 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 | |
| Product Code LLZ, Class II | ||
| Picture archiving and communication system. | ||
| Product Code: | LLZ, Class II | |
| Manufacturer: | Synaptive Medical Inc. | |
| MaRS Centre, South Tower | ||
| 101 College Street, Suite 200 | ||
| Toronto, ON M5G 1L7 Canada | ||
| Establishment Registration: | N/A | |
| Primary Predicate Device: | Manufacturer: Meterialise NV | |
| Trade name: SurgiCase System | ||
| 510(k) Number: K073449 | ||
| Date Cleared: Apr 16, 2008 | ||
| Table 5.1 510(k) Summary (As required by section 21 CFR 807.92(c)) | ||
| Secondary Predicate | ||
| 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, | |
| 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 | ||
| Comparisons | Both the predicate device and the subject device (BrightMatter | |
| Planning Software) are software applications that import DICOM image | ||
| data files, provide image processing fuctions such as image fusion and | ||
| segmentation, and produce output that can be used for image guided | ||
| surgery. | ||
| The primary predicate device, SurgiCase System, is a software system | ||
| that helps transfer of images from medical scanners (MR or CT). The | ||
| subject device also supports transfer of images from scanners but is | ||
| limited to detailed visualization of MR images. Both the predicate | ||
| system and subject system provide the ability to reformat pre- | ||
| operative images, segment and select regions from the scanned images | ||
| and visualize the images in 3D without patient contact or surgical insult. | ||
| Like the predicate device, the subject device also supports simulation | ||
| and evaluation of surgical treatment options using pre-operative | ||
| images. The end result in both systems is a surgical plan that cannot be | ||
| subsequently altered by other users once the plan is exported. Hence, | ||
| BrightMatter Planning is substantially equivalent to SurgiCase system | ||
| from intended use and technological characteristics points of view and | ||
| does not raise different questions of safety. | ||
| The predicate device (iPlan) lists these trade names: iPlan Cranial, iPlan | ||
| Stereotaxy, iPlan ENT, iPlan Spine, iPlan View and iPlan CMF. These | ||
| predicate device modules include functionality that is not part of the | ||
| subject device. The subject device is substantially equivalent to the | ||
| predicate device's iPlan Cranial module. The subject device does not | ||
| include the following predicate device functionality: | ||
| Atlas assisted visualization. Functional planning using BOLD MRI mapping.Comparison of the subject device to the predicate iPlan Cranial module, | ||
| shows that the two products are very similar in features and functions. | ||
| The comparison was made using the following technical characteristics | ||
| of the two products: |
- Load and import data | |
| | - View and Adjustment of data - Registration points | |
| | - Image fusion - Object creation | |
| | - Advanced Object Planning - BOLD MRI mapping | |
| | - Fiber tracking | |
| | - Trajectory planning - 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
compared with Siemens syngo MR B17 software and were
demonstrated to be equivalent in performance. | |
| Non-Clinical Testing | The following bench (software validation) testing was conducted on
BrightMatter Planning Software:
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:
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
Software in actual and simulated use settings. The results support
substantial equivalence to the predicate device and demonstrate that
the BrightMatter Planning Software is safe for its intended use. | |
| Clinical Testing | This technology is not new, therefore a clinical study was not
considered necessary prior to release. Additionally, there was no
clinical testing required to support the medical device as the indications
for use is equivalent to the predicate device. The substantial
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
Software to be substantially equivalent to the predicate devices. | |
| | The BrightMatter Planning Software has the same technological
characteristics as the predicate devices in that it has a similar intended
use, same general operating principle, and same technology. The
specific details of the predicate device may vary from those of
BrightMatter Planning Software, but testing shows that similar results
are produced. Performance of DTI-derived image generation and
tractography results were compared with Siemens syngo MR B17 and
were shown to be equivalent. | |
| | It has been shown in this 510(k) submission that the differences
between the BrightMatter Planning Software and the Brainlab AG iPlan
Cranial (K113732) do not raise any questions regarding safety and
effectiveness. The BrightMatter Planning Software, as designed and
manufactured, is substantially equivalent to, and as safe and effective
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.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
6
Page 2-Mr. Piron
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 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 r ou may obtain other general million. 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 yours,
Smh.7)
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
7
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K140337
Device Name BrightMatter Planning Software
| Indications for Use (Describe) | |
|---|---|
| -------------------------------- | -- |
mucations of Ose (25schbo) including different modules for use are the mage 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.
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)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Sanh. 7)
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 is estimated to average 79 hours per response, including the data needed and complete The burden time for this collection of nibination is estimalitian the data needed and complete
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and review the collection of information. Send comments regarding the burgen in and review the collection of inlormation. Golls sons for reducing this burden, to:
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