SIS Software

K162830 · Surgical Information Sciences, Inc. · LLZ · Feb 14, 2017 · Radiology

Device Facts

• Record ID: K162830
• Device Name: SIS Software
• Applicant: Surgical Information Sciences, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Feb 14, 2017
• 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 Software is an application intended for use in the viewing, presentation of medical imaging, including different modules for image fusion, and intraoperative functional planning where the 3D output can be used with stereotactic image quided surgery or other devices for further processing and visualization. The device can be used in conjunction with other clinical methods as an aid in visualization of the subthalamic nuclei (STN).

Device Story

SIS Software is a medical imaging application for viewing, presentation, and intraoperative functional planning. It takes standard clinical MRI (1.5T or 3T) as input and uses a machine learning algorithm trained on a reference database of high-resolution 7T MRI images to identify and segment the subthalamic nucleus (STN). The device generates a patient-specific 3D anatomical model of the STN, which is exported to stereotactic image-guided surgery systems. Used by surgeons, neurologists, and radiologists in clinical settings, the software supplements standard clinical methods to improve visualization of brain structures not easily seen on standard MRI. By providing more accurate anatomical localization, the device assists in neurosurgical planning, potentially improving surgical precision and patient outcomes.

Clinical Evidence

Validation study used 34 subjects (68 STNs) scanned with both clinical (1.5T/3T) and high-field (7T) MRI. Data was independent of the training/development set. Primary endpoints: center of mass distance, surface distance, and Dice coefficient. Results: 95% of center of mass distances ≤ 2.0mm (p<0.0001 vs. standard of care); 100% of surface distances ≤ 2.0mm. Mean Dice coefficient was 0.64. Bench testing using leave-one-out cross-validation on 10 subjects showed 1mm average distance error.

Technological Characteristics

Software-based medical imaging application. Uses machine learning and image processing algorithms to generate 3D segmented anatomical models from 1.5T or 3T MRI scans by referencing a database of 7T MRI images. Performs image fusion, slice-by-slice segmentation, and 3D object conversion. Supports export to stereotactic planning systems. Operates on standard clinical imaging hardware.

Indications for Use

Indicated for medical professionals, including surgeons, neurologists, and radiologists, as an aid in the visualization of the subthalamic nuclei (STN) and for intraoperative functional planning using medical imaging.

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

• Medtronic's StealthStation (K050438)
• Medtronic's Stealth Viz Advanced Planning Application with StealthDTl Package (K081512)

Reference Devices

• Brainreader ApS' Neuroreader Image Processing Software (K140828)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three human profiles facing to the right, stacked on top of each other, with flowing lines extending from the bottom profile.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 14, 2017

Surgical Information Sciences, Inc. % Ms. Janice Hogan Regulatory Counsel Hogan Lovells US LLP 1835 Market Street, 29th Floor PHILADELPHIA PA 19103

Re: K162830

Trade/Device Name: SIS Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 12, 2017 Received: January 12, 2017

Dear Ms. Hogan:

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-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.

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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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'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

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### 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 on last paqe

510(k) Number (if known)

K162830

Device Name

SIS Software

Indications for Use (Describe)

SIS Software is an application intended for use in the viewing, presentation of medical imaging, including different modules for image fusion, and intraoperative functional planning where the 3D output can be used with stereotactic image quided surgery or other devices for further processing and visualization. The device can be used in conjunction with other clinical methods as an aid in visualization of the subthalamic nuclei (STN).

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) | |
|-----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| <div> <span style="text-decoration: overline;"></span>Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span style="text-decoration: none;"></span>Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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### 510(k) SUMMARY

### Surgical Information Sciences, Inc.'s SIS Software Device

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

Surgical Information Sciences. Inc. 60 South 6th Street, Suite 2410 Minneapolis, MN 55402 Contact Person: Mark Headrick Phone: [phone] E-mail: [e-mail]

Date Prepared: January 12, 2017

### Trade Name of Device

SIS Software

### Common or Usual Name / Classification Name

Picture Archiving and Communication System (Product Code: LLZ; 21 C.F.R. 892.2050)

### Predicate and Reference Devices

Medtronic's StealthStation (K050438) Medtronic's Stealth Viz Advanced Planning Application with StealthDTl Package (K081512) Brainreader ApS' Neuroreader Image Processing Software (K140828) (Reference device)

# Intended Use / Indications for Use

SIS Software is an application 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 and visualization. The device can be used in coniunction with other clinical methods as an aid in visualization of the subthalamic nuclei (STN).

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

# Technological Characteristics

SIS Software uses machine learning and image processing to enhance standard clinical images for the visualization of the subthalamic nucleus ("STN"). The SIS Software supplements the information available through standard clinical methods, providing additional, adjunctive information to surgeons, neurologists and radiologists for use in visualization and planning stereotactic surgical procedures. SIS Software provides a patient

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specific, 3D anatomical model of the patient's own brain structures that supplements other clinical information to facilitate visualization in neurosurqical procedures. The software makes use of the fact that some structures in the brain are not easily visualized in 1.5T or 3T clinical MRJ, but are better visualized using high-resolution and high-contrast 7T MRI.

The company's software methodology relies on a reference database of high-resolution brain images (7T MRI) and standard clinical brain images (1.5T or 3T MRI). The 7T images allow visualization of anatomical structures that are then used to find regions of interest within the brain (i.e., the STN) on a patient's clinical image.

SIS visualization is incorporated in the standard clinical MR data, thereby not changing the current standard-of-care workflow protocol and does not require any additional visualization software or hardware platforms.

### Performance Data

Developmental testing of the reference database was performed using 10 subject datasets that were retrospectively selected from the locked SIS reference database. For each of the selected datasets, the patient's 7T MRI and labeled structures were excluded from the dataset, such that only the corresponding clinical MRI image remained for the test. The subject machine-learning method then predicted the subthalamic nucleus (STN) on these removed datasets and this prediction was compared to the STN as segmented on the 7T image of that subject to validate the prediction when the tested subject was removed from the dataset (standard leave-one-out statistical procedure). The average distance between the predicted and the original (on the 7T) was 1mm, the actual size of the pixel (data resolution). The overlap between the 3D predicted and the original STN was significantly better (p<0.05) in comparison to the overall of a standard atlas and the original STN.

The pivotal validation testing of the subject device, including the reference database, included images from 34 subjects to validate the performance of the SIS Software. A set of 68 STNs (from 34 subjects) were scanned with both clinical MRI (1.5T and 3T) and High Field (7T) MRI. None of the 68 STNs were part of the company's database for algorithm development and none were used to optimize or design the company's software. Thus, this validation data set was completely separate from the data set that was used for development. The software development was frozen and labeled before tested on this validation set.

Three measurements were used to compare the SIS visualization via the subject software and ground truth STNs (manually segmented clinical images and 7T images superimposed): (1) Center of mass distance; (2) Surface distance; and (3) Dice coefficient values.

In sum, 90% of the center of mass distances and surface distances were below 1.9mm and 0.8mm, respectively. Specifically, 95% of the center of mass distances and 100% of the surface distances were not greater than 2.0mm. Thus, the study met the pre-specified criteria of 90% of center of mass distances and surface distances not greater than 2.0mm. Furthermore, the proportion of visualizations not greater than 2.0mm was conservatively estimated from the literature to be 20%. Therefore, the rate of successful visualizations from SIS Software (95% of the center of mass distances not greater than 2.0mm) is significantly greater than the standard of care (p<0.0001). The corresponding confidence intervals are as follows:

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- (a) 90% of the center of mass distances and surface distances were below 1.9mm and 0.8mm, respectively (95% CI: 80.74 - 95.56%);
- (b) 95% of the center of mass distances were not greater than 2.0mm (95% C): 86.91 98.37%):
- (c) 100% of the surface distances were not greater than 2.0mm (95% Cl: 94.25 100%).

In addition, the Dice coefficient in this dataset was 0.64, which was expected given the small size of the STN.

In sum, the SIS Software performed as intended and clinical validation data results observed were as expected.

# Substantial Equivalence

With regard to technological characteristics, both the SIS Software and the predicates (K050438; K081512) are all software applications that can be used for visualization, presentation and documentation of medical imaging, including different modules for image processing, image fusion, intraoperative functional planning where the 2D or 3D output can be used with stereotactic image guided surgery or other devices for further processing and visualization. In addition, the SIS Software, like the identified predicate and reference devices, use proprietary algorithms to generate 3D segmented anatomical models from patient's MRI scans.

The SIS Software and predicate devices also all perform image fusion of datasets using automated or manual image matching techniques. Below provides a summary comparison between the SIS Software and the predicate and reference devices.

| | SIS Software | Medtronic<br>Navigation,<br>Inc.'s<br>Stealth Viz<br>Advanced<br>Planning<br>Application with<br>StealthDTI<br>Package<br>(K081512) | Medtronic<br>Navigation,<br>Inc.'s<br>StealthStation<br>(K050438) | Braindreader<br>ApS'<br>NeuroReader<br>Medical<br>Image<br>Processing<br>Software<br>(K140828) |
|--------------------------------------------------------------------------------------------------------------------|--------------|-------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Allows for importing of<br>digital imaging sets | Yes | Yes | Yes | Yes |
| Uses proprietary<br>software algorithm to<br>generate 3D segmented<br>anatomical models from<br>patient's MR scans | Yes | Yes | Yes | Yes |
| Allows for review and<br>analysis of data in<br>various 2D and 3D<br>presentation formats | Yes | Yes | Yes | Yes |

| | | | | SIS Software Technological Characteristics Comparison Table | |
|--|--|--|--|-------------------------------------------------------------|--|
|--|--|--|--|-------------------------------------------------------------|--|

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| | SIS Software | Medtronic<br>Navigation,<br>Inc.'s<br>Stealth Viz<br>Advanced<br>Planning<br>Application with<br>StealthDTI<br>Package<br>(K081512) | Medtronic<br>Navigation,<br>Inc.'s<br>StealthStation<br>(K050438) | Braindreader<br>ApS'<br>NeuroReader<br>Medical<br>Image<br>Processing<br>Software<br>(K140828) |
|-------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Performs image fusion of<br>datasets using<br>automated or manual<br>image matching<br>technique | Yes; atlas-based<br>mapping (patient<br>specific);<br>reference<br>database | Yes; atlas-based<br>mapping | Yes, atlas-based<br>mapping | Yes; reference<br>database |
| Segments structures in<br>images with manual and<br>automated tools and<br>converts them into 3D<br>objects for display | Yes | Yes | Yes | Yes |
| Creates hybrid datasets<br>by filing in segmented<br>regions slice-by-slice on<br>anatomical datasets | Yes | Yes | Yes | Yes |
| Exports results to<br>planning system | Yes | No | Yes | Yes |

In sum, the SIS Software has the same intended use and similar indications, technological characteristics, and principles of operation as its predicate and reference devices. The minor technological differences between the subject device and its predicate and reference devices raise no different questions of safety or effectiveness. Performance data demonstrate that the SIS Software performs as intended and is substantially equivalent.