(130 days)
Yes
The device description explicitly states that "SIS Software uses machine learning and image processing".
No.
The device is used for imaging, visualization, and planning, not for directly treating a condition or disease. It aids in visualization for surgical procedures but does not perform therapy itself.
No
The device is described as an "aid in visualization" and provides "adjunctive information" for planning surgical procedures, but it explicitly states that it "supplements the information available through standard clinical methods" and does not make a diagnosis on its own. While it helps in visualizing anatomical structures, its primary role is to assist in planning rather than to identify or classify a disease state.
Yes
The device is explicitly described as "SIS Software" and its function is the viewing, presentation, and processing of medical imaging. While it can be used in conjunction with other devices (like stereotactic image guided surgery systems), the core device being described and cleared is the software itself. The description focuses on the software's algorithms, data processing, and visualization capabilities, without mentioning any accompanying hardware components that are part of the device being submitted for clearance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- SIS Software Function: The SIS Software processes and visualizes medical imaging data (MRI) of the brain. It does not analyze samples taken from the body. Its purpose is to aid in the visualization and planning of surgical procedures based on existing imaging data.
Therefore, the SIS Software falls under the category of medical imaging software or surgical planning software, not In Vitro Diagnostics.
No
The input letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device. The 'Control Plan Authorized (PCCP) and relevant text' section is marked 'Not Found', and no other section contains the required explicit approval language.
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.
Product codes
LLZ
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
1.5T or 3T clinical MRI, 7T MRI
Anatomical Site
Brain structures, Subthalamic Nuclei (STN)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professionals, including but not limited to surgeons, neurologists and radiologists.
Description of the training set, sample size, data source, and annotation protocol
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.
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).
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Developmental testing:
- Study Type: Developmental testing (retrospective)
- Sample Size: 10 subject datasets
- Key Results: 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
§ 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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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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: (612) 335-8683 E-mail: mark.headrick@surqicalis.com
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