(45 days)
No
The summary describes image processing, 3D model creation, and visualization software for pre-operative planning and training. It does not mention AI, ML, or related concepts like training/test sets for such algorithms. The focus is on transforming and displaying existing medical images.
No
The device is described as a software interface for image segmentation and pre-operative planning and surgical training in a virtual environment. It does not exert any direct therapeutic action on a patient.
No
The "Device Description" explicitly states, "The SuRgical Planner (SRP) BrainStorm is not intended to be used for diagnosis."
Yes
The device description explicitly states, "The SRP BrainStorm product does not include any custom hardware and is a software-based device that runs on a high-performance desktop PC assembled using 'commercial off-the-shelt' components." This confirms it is a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for image segmentation, transfer of image information, pre-operative planning, and surgical training in a virtual environment. These activities are related to surgical procedures and planning, not diagnostic testing performed on biological samples.
- Device Description: The description explicitly states, "The SuRgical Planner (SRP) BrainStorm is not intended to be used for diagnosis." This is a clear indication that it is not an IVD.
- Nature of the Device: The device processes medical images (CT, MR, XA) to create 3D models and facilitate visualization and planning. IVDs, on the other hand, are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
The device falls under the category of medical imaging software used for surgical planning and training, which is distinct from in vitro diagnostics.
N/A
Intended Use / Indications for Use
The SuRgical Planner (SRP) BrainStorm is intended for use as a software interface and image segmentation system for the transfer of image information from a CT, MR, or X-ray 3D Angiography (XA) medical scanner to an output file. It can also be used for pre-operative planning and surgical training in a virtual environment.
Product codes
LLZ
Device Description
The SuRgical Planner (SRP) BrainStorm is intended for use as a software interface and image segmentation system for the transfer of image information from a CT, MR, or X-ray 3D Angiography (XA) medical scanner to an output file. It can also be used for pre-operative planning and surgical training in a virtual environment.
The SuRgical Planner (SRP) BrainStorm is not intended to be used for diagnosis.
The SRP BrainStorm software has the ability of creating 3D models of the patient data from 2D scan slices. Additionally, it provides the user with the ability to input, display, color, and manipulate the 2D scan slices via a 3D representation. The software transforms 2D medical images into a dynamic interactive 3D scene with multiple point of views on a high-definition (HD) touch screen monitor. The use of a virtual reality (VR) or augmented reality (AR) headset provides the surgeon a 3D stereoscopic display of the same scene inside the VR / AR headset. While wearing the VR / AR headset, the surgeon can perform a virtual / simulated "fly-through" inside the 3D scene using controllers to perform such actions as rotate, zoom in and zoom out. The use of the SuRgical Planner (SRP) BrainStorm with VR / AR headset and controllers is not intended for use during surgery. The SRP BrainStorm is intended for use for pre-operative planning.
The SRP BrainStorm software includes additional features to facilitate the review of relevant data by a multidisciplinary team that includes neurosurgeons and neurologists for pre-operative surgical planning.
The SRP BrainStorm product does not include any custom hardware and is a software-based device that runs on a high-performance desktop PC assembled using "commercial off-the-shelt" components that meet minimum performance requirements. The design is based on an advanced, touch screen friendly, Graphical User Interface (GUI) that runs an underlying simulation engine to process medical images in DICOM format, and an image generator software engine.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR, or X-ray 3D Angiography (XA)
Anatomical Site
Brain (implied by "BrainStorm" and "neurosurgery")
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Multidisciplinary team that includes neurosurgeons and neurologists for pre-operative surgical planning.
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 performance testing was performed in support of the substantial equivalence determination. A formal verification and validation plan was executed to confirm that the SRP BrainStorm meets its intended use and performance requirements. In addition, simulated use human factors and usability validation was performed to validate the modifications conform to the user needs and the intended use of the device. Software design verification and validation testing was performed per the same internal design control requirements and methods used for the predicate device.
Verification and validation tests demonstrated the SRP BrainStorm is as safe and effective as the predicate SRP, and performs as intended in the specified use conditions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
July 17, 2020
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text. The word "Administration" is on a separate line and is smaller than the other words.
Surgical Theater, Inc. % Mr. Kevin Murrock Sr. Director of Quality and Regulatory 781 Beta Drive MAYFIELD VILLAGE OH 44143
Re: K201465
Trade/Device Name: SuRgical Planner (SRP) BrainStorm Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: June 2, 2020 Received: June 3, 2020
Dear Mr. Murrock:
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/cfpmp/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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name SuRgical Planner (SRP) BrainStorm
Indications for Use (Describe)
The SuRgical Planner (SRP) BrainStorm is intended for use as a software interface and image segmentation system for the transfer of image information from a CT, MR, or X-ray 3D Angiography (XA) medical scanner to an output file. It can also be used for pre-operative planning and surgical training in a virtual environment.
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 D) |
ounter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the logo for Surgical Theater. The logo features a stylized, three-dimensional shape that resembles a curved, metallic ribbon or band. Part of the ribbon is silver, while another section is gold. Below the shape, the words "SURGICAL" and "THEATER" are stacked on top of each other in a sans-serif font.
Special 510(k) Premarket Notification
SuRgical Planner (SRP) BrainStorm
510(k) SUMMARY
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR 8807.92.
Date Prepared: July 15, 2020
Manufacturer/Submitter:
Surgical Theater, Inc. 781 Beta Drive Mayfield Village, Ohio 44143 Phone: (216) 496-7884 Fax: (216) 916-3806
Establishment Registration Number: 3010197287
Contact Person:
Kevin M. Murrock Sr. Director of Quality and Regulatory Surgical Theater, Inc. 781 Beta Drive Mayfield Village, Ohio 44143 Phone: (330) 472-6520 Email: kmurrock@surgicaltheater.net
Name of Device
- Trade Name: SuRgical Planner (SRP) BrainStorm
LLZ
II
21 CFR 892.2050
-
Common Name: System, Image Processing, Radiological ● Classification Name: Picture Archiving and Communications System
- Regulation Number: ●
- Product Code:
- Regulatory Classification: ●
- Device Panel: Radiology
Predicate Device
SuRgical Planner (SRP), 510(k) Number: K170793
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Image /page/4/Picture/0 description: The image shows a logo for "Surgical Theater". The logo features a stylized, abstract shape resembling a curved, metallic structure with a gold accent on one side. Below the shape, the words "SURGICAL" and "THEATER" are stacked on top of each other in a simple, sans-serif font. The text is in a color that complements the metallic tones of the abstract shape above.
Special 510(k) Premarket Notification
Indications for Use:
The SuRgical Planner (SRP) BrainStorm is intended for use as a software interface and image segmentation system for the transfer of image information from a CT, MR, or X-ray 3D Angiography (XA) medical scanner to an output file. It can also be used for pre-operative planning and surgical training in a virtual environment.
The only differences in the Indications for Use statement between the subject device and the predicate are the removal of "Surgical Theater, LLC" and the change from "SuRgical Planner (SRP)" to "SuRgical Planner (SRP) BrainStorm". While the Indications for Use statement of the subject device is not identical to that of the predicate device, these modifications do not alter the intended use nor do they affect the safety and effectiveness of the device.
Device Description:
The SuRgical Planner (SRP) BrainStorm is intended for use as a software interface and image segmentation system for the transfer of image information from a CT, MR, or X-ray 3D Angiography (XA) medical scanner to an output file. It can also be used for pre-operative planning and surgical training in a virtual environment.
The SuRgical Planner (SRP) BrainStorm is not intended to be used for diagnosis.
The SRP BrainStorm software has the ability of creating 3D models of the patient data from 2D scan slices. Additionally, it provides the user with the ability to input, display, color, and manipulate the 2D scan slices via a 3D representation. The software transforms 2D medical images into a dynamic interactive 3D scene with multiple point of views on a high-definition (HD) touch screen monitor. The use of a virtual reality (VR) or augmented reality (AR) headset provides the surgeon a 3D stereoscopic display of the same scene inside the VR / AR headset. While wearing the VR / AR headset, the surgeon can perform a virtual / simulated "fly-through" inside the 3D scene using controllers to perform such actions as rotate, zoom in and zoom out. The use of the SuRgical Planner (SRP) BrainStorm with VR / AR headset and controllers is not intended for use during surgery. The SRP BrainStorm is intended for use for pre-operative planning.
The SRP BrainStorm software includes additional features to facilitate the review of relevant data by a multidisciplinary team that includes neurosurgeons and neurologists for pre-operative surgical planning.
The SRP BrainStorm product does not include any custom hardware and is a software-based device that runs on a high-performance desktop PC assembled using "commercial off-the-shelt" components that meet minimum performance requirements. The design is based on an advanced, touch screen friendly, Graphical User Interface (GUI) that runs an underlying simulation engine to process medical images in DICOM format, and an image generator software engine.
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Image /page/5/Picture/0 description: The image shows a logo for "Surgical Theater". The logo features a stylized, abstract design above the text. The design appears to be a curved, metallic shape with a gold accent on one side. The text "SURGICAL THEATER" is written in a simple, sans-serif font, with each word on a separate line.
Technological Characteristics
The proposed SRP BrainStorm has similar technological characteristics compared to the predicate device.
The subject and predicate devices are based on the following same technological characteristics:
- The ability to create 3D models of the patient data from 2D scan slices. Additionally, it provides the user with the ability to input, display, color, and manipulate the 2D scan slices via a 3D representation. The software transforms 2D medical images into a dynamic interactive 3D scene with multiple point of views on a high-definition (HD) touch screen monitor.
- The use of a virtual reality (VR) headset provides the surgeon a 3D stereoscopic display . of the same scene inside the VR headset. While wearing the VR headset, the surgeon can perform a virtual / simulated "fly-through" inside the 3D scene using controllers to perform such actions as rotate, zoom in and zoom out.
- . Except for the modifications described below, all other functions are available on both the predicate and proposed devices.
The following modifications were implemented in SRP BrainStorm to provide additional features to be used by a multidisciplinary team that includes neurosurgeons and neurologists for pre-operative surgical planning for neurological disorders:
- . Support for augmented reality (AR) headset display and controller to enable the surgeon to experience a 3D stereoscopic view of the same scene displayed on the LED monitor, and also perform actions previously available with a VR headset.
- . A simplified planner mode that includes additional features that may be used to facilitate multidisciplinary communication for planning neurosurgery:
- Tools to detect electrodes from the post electrodes implantation CT and display O the results in the 3D scene.
- Import file containing brain wave recordings that shows the EEG graph output о detected during stimulation of each inserted electrode contact.
- Provide a 360° representation of the locations and intensities of the EEG о recordings over time, enabling the team to visually correlate between a physical position of an electrode to the graph readings detected by it in the 3D scene. No analysis is done on the brain wave recordings, all display and visualization are based on the raw voltage values saved in the imported data file.
The differences between the subject and predicate device do not raise any new questions regarding safety and effectiveness. Based on the information provided in this 510(k) submission, the SRP BrainStorm is considered substantially equivalent to the predicate SRP in terms of fundamental scientific technology.
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Image /page/6/Picture/0 description: The image shows a logo for "Surgical Theater". The logo features a stylized, three-dimensional shape resembling a curved, metallic structure with a gold accent on one side. Below the shape, the words "SURGICAL THEATER" are written in a simple, sans-serif font, stacked vertically.
Special 510(k) Premarket Notification
Summary of Non-Clinical Performance Data
Non-clinical performance testing was performed in support of the substantial equivalence determination. A formal verification and validation plan was executed to confirm that the SRP BrainStorm meets its intended use and performance requirements. In addition, simulated use human factors and usability validation was performed to validate the modifications conform to the user needs and the intended use of the device. Software design verification and validation testing was performed per the same internal design control requirements and methods used for the predicate device.
Verification and validation tests demonstrated the SRP BrainStorm is as safe and effective as the predicate SRP, and performs as intended in the specified use conditions.
Substantial Equivalence Conclusion
Based on the information provided in this 510(k) submission, the SRP BrainStorm is substantially equivalent to the predicate SRP in terms of indications for use, technological characteristics, and safety and effectiveness. Any differences between the subject and predicate device do not raise any new concerns regarding safety and effectiveness.