SIS System (Version 5.6.0)

K223032 · Surgical Information Sciences, Inc. · QIH · Nov 21, 2022 · Radiology

Device Facts

• Record ID: K223032
• Device Name: SIS System (Version 5.6.0)
• Applicant: Surgical Information Sciences, Inc.
• Product Code: QIH · Radiology
• Decision Date: Nov 21, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device

Intended Use

SIS System is intended for use in the viewing, presentation and documentation of medical imaging, including different modules for image processing, image fusion, and intraoperative functional planning where the 3D output can be used with stereotactic image guided surgery or other devices for further processing, visualization and localization. The device can be used in conjunction with other clinical methods as an aid in visualization and location of the subthalamic nuclei (STN) and globus pallidus externa and interna (GPe and GPi, respectively) in neurological procedures. The system is indicated for surgical procedures in which anatomical structure locations are identified in images, including Deep Brain Stimulation Lead Placement. Typical users of the SIS Software are medical professionals, including but not limited to surgeons, neurologists and radiologists.

Device Story

Software-only device; processes patient-specific clinical MR images to generate 3D anatomical models of basal ganglia structures (STN, GPe, GPi); utilizes pre-trained deep learning neural networks; incorporates 7T MRI data for ground truth training; performs image fusion (MR/CT); identifies implanted leads in post-operative CT; enables 3D visualization for stereotactic surgical planning. Used by surgeons, neurologists, and radiologists in clinical settings; output provides adjunctive information for surgical navigation and lead placement; aids in precise anatomical localization; improves surgical planning accuracy.

Clinical Evidence

Bench testing only. Software verification testing validated functionality against predicate criteria. Visualization accuracy testing performed for STN and GPi/GPe structures. MRI-to-CT registration accuracy and lead segmentation/detection functionality validated through repeated testing.

Technological Characteristics

Software-only device; utilizes deep learning neural networks for image segmentation and 3D modeling; supports linear and non-linear image registration (ANTS and ELASTIX tools); performs image fusion; compatible with standard clinical MR and CT imaging; standalone software application.

Indications for Use

Indicated for medical professionals (surgeons, neurologists, radiologists) performing neurological procedures requiring visualization and localization of subthalamic nuclei (STN) and globus pallidus (GPe/GPi), including Deep Brain Stimulation (DBS) lead placement.

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

• Surgical Information Sciences SIS Software version 5.1.0 (K210071)

Reference Devices

• StealthStation System with StealthStation Cranial Software (K153660)

Submission Summary (Full Text)

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November 21, 2022

Surgical Information Sciences, Inc. % Kelliann Payne Partner Hogan Lovells US LLP 1735 Market Street, 23rd Floor PHILADELPHIA PA 19103

Re: K223032

Trade/Device Name: SIS System (Version 5.6.0) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QIH, LLZ Dated: September 29, 2022 Received: September 29, 2022

Dear Kelliann Payne:

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/cfpmn/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

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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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

D.G.K.

Daniel M. Krainak, Ph.D. Assistant Director Magnetic Resonance and Nuclear Medicine Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

510(k) Number (if known)

K223032

Device Name

SIS System (version 5.6.0)

Indications for Use (Describe)

SIS System is intended for use in the viewing, presentation of medical imaging, including different modules for image processing, image fusion, and intraoperative functional planning where the 3D output can be used with stereotactic image guided surgery or other processing, visualization and localization. The device can be used in conjunction with other clinical methods as an aid in visualization and location of the subthalamic nuclei (STN) and globus pallidus externa and interna (GPe and GPi, respectively) in neurological procedures. The system is indicated for surgical procedures in which anatomical structure locations are identified in images, including Deep Brain Stimulation Lead Placement.

Typical users of the SIS Software are medical professionals, including but not limited to surgeons, neurologists and radiologists.

Type of Use (Select one or both, as applicable)

| <span style="font-family: sans-serif;"> ☑ Requisition Use (Part 21 CFR 801 Subpart D) </span> |
|--------------------------------------------------------------------------------------------------|
| <span style="font-family: sans-serif;"> ☐ Over-The-Counter Use (21 CFR 801 Subpart G) </span> |

区 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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# K223032

#### 510(k) SUMMARY Surgical Information Sciences, Inc.'s SIS System (version 5.6.0)

#### Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Surgical Information Sciences, Inc. 4602 141st Ln NE Ham Lake, MN 55304 Contact Person: Ann Quinlan-Smith Phone: [phone] E-mail: [e-mail]

Date Prepared: September 29, 2022

Trade Name of Device: SIS System version 5.6.0

#### Common or Usual Name/Classification Name

Primary: Automated Radiological Image Processing Software (Product Code: QIH; 21 C.F.R 892.2050)

Secondary: System, Image Processing, Radiological (Product Code: LLZ; 21 C.F.R 892.2050)

#### Regulatory Class: Class II

#### Predicate Devices

Predicate: Surgical Information Sciences SIS Software version 5.1.0 (K210071)

- Reference: Medtronic Navigation, Inc. StealthStation System with StealthStation Cranial Software (K153660)
#### Intended Use / Indications for Use

SIS System is intended for use in the viewing, presentation and documentation of medical imaging, including different modules for image processing, image fusion, and intraoperative functional planning where the 3D output can be used with stereotactic image guided surgery or other devices for further processing, visualization and localization. The device can be used in conjunction with other clinical methods as an aid in visualization and location of the subthalamic nuclei (STN) and globus pallidus externa and interna (GPe and GPi, respectively) in neurological procedures. The system is indicated for surgical procedures in which anatomical structure locations are identified in images, including Deep Brain Stimulation Lead Placement.

Typical users of the SIS Software are medical professionals, including but not limited to surgeons, neurologists and radiologists.

#### Technological Characteristics

The SIS System version 5.6.0 is a software only device based on machine learning and image processing. The device is designed to enhance standard clinical images for the visualization of structures in the basal ganglia area of the brain, specifically the subthalamic nucleus (STN)

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and globus pallidus externa and interna (GPe/GPi). The output of the SIS system supplements the information available through standard clinical methods by providing additional, adjunctive information to surgeons, neurologists, and radiologists for use in viewing brain structures for planning stereotactic surqical procedures and planning of lead output.

The SIS System version 5.6.0 provides a patient-specific, 3D anatomical model of specific brain structures based on the patient's own clinical MR image using pre-trained deep learning neural network models. As discussed in more detail below, the method incorporates ultra-high resolution 7T (7 Tesla) Magnetic Resonance images to determine ground truth for the training data set to train the deep learning models. These pre-trained deep learning neural network models are then applied to a patient's clinical image to predict the shape and position of the patient's specific brain structures of interest. SIS System is further able to locate and identify implanted leads, where implanted, visible in post-operative CT images and place them in relation to the brain structure of interest from the preoperative processing.

The proposed device is a modification to the SIS System version 5.1.0 that was cleared under K210071. The primary change is an update to the indications for use statement to clarify that deep brain stimulation (DBS) lead placement is a type of procedure that may be assisted by the information generated by the SIS System. The technological characteristics of the proposed device are fundamentally the same with minor updates to the backend of the software. The core algorithm that processes patient images has not changed since the prior clearance.

### Performance Data

Following the modifications, the software verification testing was repeated to validate that the software functions as specified and performs similarly to the predicate device using the same test methods and acceptance criteria for the previously cleared predicate device. Visualization accuracy testing was repeated to validation of the STN and GPi/GPe structures. In addition, the company repeated the MRI to CT registration to ensure that 3D transformation remains accurate. The company also repeated the testing for image processing of CT images to validate the lead segmentation, as well as testing for electrode orientation to validate the lead detection functionality. The results of this testing demonstrated that the SIS System version 5.6.0 has been fully verified and the updated device performs as intended and is as safe and effective compared to the predicate.

#### Substantial Equivalence

The SIS System version 5.6.0 is as safe and effective as the SIS System version 5.1.0. The SIS System version 5.6.0 has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor differences in the indications for use do not raise new questions of safety or effectiveness. Performance data demonstrate that the SIS System version 5.6.0 is as safe and effective as the predicate device. Thus, the SIS System version 5.6.0 is substantially equivalent.

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| | SIS System version<br>5.6.0<br>(subject device) | SIS System version<br>5.1.0 (K210071)<br>(predicate device) | Comparison |
|----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use /<br>Indications for Use | SIS System is intended<br>for use in the viewing,<br>presentation and<br>documentation of<br>medical imaging,<br>including different<br>modules for image<br>processing, image<br>fusion, and<br>intraoperative functional<br>planning where the 3D<br>output can be used with<br>stereotactic image<br>guided surgery or other<br>devices for further<br>processing,<br>visualization and<br>localization. The device<br>can be used in<br>conjunction with other<br>clinical methods as an<br>aid in visualization and<br>location of the<br>subthalamic nuclei<br>(STN) and globus<br>pallidus externa and<br>interna (GPe and GPi,<br>respectively) in<br>neurological<br>procedures. The system<br>is indicated for surgical<br>procedures in which<br>anatomical structure<br>locations are identified<br>in images, including<br>Deep Brain Stimulation<br>Lead Placement.<br>Typical users of the SIS<br>Software are medical<br>professionals, including<br>but not limited to<br>surgeons, neurologists<br>and radiologists. | SIS System is an<br>application intended for<br>use in the viewing,<br>presentation and<br>documentation of<br>medical imaging,<br>including different<br>modules for image<br>processing, image<br>fusion, and<br>intraoperative functional<br>planning where the 3D<br>output can be used with<br>stereotactic image<br>guided surgery or other<br>devices for further<br>processing and<br>visualization. The<br>device can be used in<br>conjunction with other<br>clinical methods as an<br>aid in visualization of<br>the subthalamic nuclei<br>(STN) and globus<br>pallidus externa and<br>interna (GPe and GPi,<br>respectively).<br>Typical users of the SIS<br>System are medical<br>professionals, including<br>but not limited to<br>surgeons, neurologists<br>and radiologists. | Similar. Addition of<br>clarifying statement<br>(about use in medical<br>procedures in which<br>anatomical structure<br>locations such as STN,<br>GPe and GPi are<br>identified in images,<br>including deep brain<br>stimulation lead<br>placement) does not<br>raise different questions<br>of safety or<br>effectiveness because<br>predicate was already<br>intended for use in such<br>procedures and other<br>reference devices (e.g.,<br>StealthStation with<br>Cranial Software,<br>K153660) with similar<br>functions include this<br>language. |
| User Population | Medical professionals,<br>including but not limited<br>to surgeons,<br>neurologists and<br>radiologists. | Medical professionals,<br>including but not limited<br>to surgeons,<br>neurologists and<br>radiologists. | Same |
| Allows for importing<br>of digital imaging sets | Yes | Yes | Same |
| | SIS System version<br>5.6.0<br>(subject device) | SIS System version<br>5.1.0 (K210071)<br>(predicate device) | Comparison |
| Uses proprietary<br>software algorithm to<br>generate 3D<br>segmented anatomical<br>models from patient's<br>MR scans | Yes | Yes | Same |
| Allows for review and<br>analysis of data in 2D<br>and 3D formats | Yes | Yes | Same |
| Performs image fusion<br>of datasets using<br>automated or manual<br>image matching<br>technique | Yes | Yes | Same |
| Segments structures<br>in images with manual<br>and automated tools<br>and converts them<br>into 3D objects for<br>display | Yes | Yes | Same |
| Creates hybrid<br>datasets by filing in<br>segmented regions<br>slice-by-slice on<br>anatomical datasets | Yes | Yes | Same |
| Can be downloaded to<br>planning system | Yes | Yes | Same |
| Segmentation of CT<br>scan to identify<br>structures in relation<br>to those visualized on<br>MR | Yes | Yes | Same |
| Feature to Account for<br>CT images with gantry<br>tilt | Yes | Yes | Same |
| Cross-registers<br>images and creates 3D<br>(fused) model | Yes | Yes | Same |
| Uses registration<br>methods (linear and<br>non-linear) by multiple<br>registration tools<br>(ANTS and ELASTIX) | Yes | Yes | Same |

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# Conclusions

The SIS System version 5.6.0 is as safe and effective as the predicate version previously cleared in K210071.