(21 days)
Not Found
Yes
The device description explicitly states that "SIS Software uses machine learning and image processing".
No
The device is used for viewing, presentation, documentation of medical imaging, and intraoperative functional planning to aid in visualization, not for direct treatment or therapy.
No
The device is intended for viewing, presentation, documentation of images, and intraoperative functional planning to aid visualization and planning of surgical procedures, rather than diagnosing a condition.
Yes
The device description explicitly states "SIS Software" and describes its functions as image processing, image fusion, and planning. It also mentions modifications to the software and enhancements to the web user interface. There is no mention of any accompanying hardware component 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 tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The SIS Software processes and visualizes medical imaging data (MRI and CT scans) of the brain. It does not analyze biological samples from the patient.
- Intended Use: The intended use is for viewing, presentation, documentation, processing, fusion, and planning related to medical imaging and surgical procedures. It's an aid in visualization and planning, not a diagnostic test performed on a biological sample.
Therefore, the SIS Software falls under the category of medical imaging software or surgical planning software, not an In Vitro Diagnostic device.
No
The provided text does not contain any explicit statement that the FDA has reviewed, approved, or cleared a PCCP for this specific 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, 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 conjunction with other clinical methods as an aid in visualization of the subthalamic nuclei (STN).
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
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 adjunctive information for use in visualization and planning stereotactic surgical procedures. SIS Software provides a patientspecific, 3D anatomical model of the patient's own brain structures that supplements other clinical information to facilitate visualization in neurosurgical procedures.
The version of the software that is the subject of the current submission (Version 3.6.0) is a modification to the predicate SIS Software version 3.3.0 that was cleared under K183019. The subject and predicate devices rely on the same core technological principles. The only minor changes were modifications to enable the use of a more comprehensive MR to post operation CT registration methodology, and image processing techniques for CT images acquired with gantry tilt. The web user interface has also been enhanced to allow additional options for administrators/supervisors, and has added audit logging functions.
Mentions image processing
Yes
Mentions AI, DNN, or ML
SIS Software uses machine learning and image processing to enhance standard clinical images for the visualization of the subthalamic nucleus ("STN").
Input Imaging Modality
MRI and CT scans
Anatomical Site
brain structures (subthalamic nuclei (STN))
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Typical users of the SIS Software are medical professionals, including but not limited to surgeons, neurologists 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)
Following the modifications, the software verification and validation testing has been repeated to validate that the modified software functions as specified and performs similarly to the predicate device. In particular, the company has repeated the MRI to CT registration testing using the new methodology, which demonstrated that the software continued to register MR images to the CT space. The error was within the acceptance criteria, and was comparable to that for SIS Software version 3.3.0, which used the same protocol. In addition, the new image processing for CT images with gantry tilt has been tested to validate objects segmentation. Using the same CT scans that were used in the validation testing for the predicate device, results demonstrated that the cropping image processing does not affect the performance of the software as compared to its predicate.
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).
0
September 13, 2019
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized image of an eagle, and the text on the right is written in a bold, sans-serif font. The text is blue, and the symbol is black and white.
Surgical Information Sciences, Inc. % Ms. Kelliann Payne Regulatory Counsel Hogan Lovells, US LLP 1735 Market Street, Suite 2300 PHILADELPHIA PA 19103
Re: K192304
Trade/Device Name: SIS Software Version 3.6.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: August 23, 2019 Received: August 23, 2019
Dear Ms. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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 mediation-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 SIS Software Version 3.6.0
SIS Software is an application intended for use in the viewing, presentation and documentation of medical imaging, including different modules for image processing, 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 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)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
Sponsor's Name, Contact Information, and Date Prepared
Surgical Information Sciences, Inc. 10405 6th Avenue North, Suite 110 Plymouth, MN 55441 Contact Person: Ann Quinlan-Smith Phone: 612-325-0187 E-mail: ann.quinlan.smith@surqicalis.com
Date Prepared: August 23, 2019
Trade Name of Device: SIS Software version 3.6.0
Common or Usual Name/Classification Name: System, Image Processing, Radiological (Product Code: LLZ; 21 C.F.R. 892.2050)
Regulatory Class: Class II
Predicate Device: Surgical Information Sciences SIS Software version 3.3.0 (K183019)
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 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.
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 adjunctive information for use in visualization and planning stereotactic surgical procedures. SIS Software provides a patientspecific, 3D anatomical model of the patient's own brain structures that supplements other clinical information to facilitate visualization in neurosurgical procedures.
The version of the software that is the subject of the current submission (Version 3.6.0) is a modification to the predicate SIS Software version 3.3.0 that was cleared under K183019. The subject and predicate devices rely on the same core technological principles. The only minor changes were modifications to enable the use of a more comprehensive MR to post operation CT registration methodology, and image processing techniques for CT images acquired with gantry
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tilt. The web user interface has also been enhanced to allow additional options for administrators/supervisors, and has added audit logging functions.
Substantial Equivalence
The subject and predicate versions of the SIS Software have the same intended use and indications for use. The subject software version, like the predicate, operates on other computing platforms and uses a proprietary algorithm to generate 3D segmented anatomical models from patients' MRI and CT scans. The visualization of the STN is performed in exactly the same way as for the predicate device. While minor modifications to the registration and CT image processing techniques are introduced, the environment of use, role in the clinical workflow, and basis for the device algorithm remain the same, and the core image processing/segmentation principles employed to enable these steps resemble those employed for the MR-based visualization step already cleared. In addition, software validation testing using the same protocol as used for the predicate confirmed that the subject device continues to perform in accordance with its specifications and is as safe and as effective as the predicate.
| | SIS Software version 3.6.0
(Subject) | SIS Software version 3.3.0
(Predicate) |
|-------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|-------------------------------------------|
| Allows for importing of
digital imaging sets | Yes | Yes |
| Uses proprietary
software algorithm to
generate 3D segmented
anatomical models from
patient's MR scans | Yes | Yes |
| Allows for review and
analysis of data in 2D
and 3D formats | Yes | Yes |
| Performs image fusion of
datasets using
automated or manual
image matching
technique | Yes | Yes |
| Segments structures in
images with manual and
automated tools and
converts them into 3D
objects for display | Yes | Yes |
| Creates hybrid datasets
by filing in segmented
regions slice-by-slice on
anatomical datasets | Yes | Yes |
| SIS Software Technological Characteristics Comparison Table | ||||
|---|---|---|---|---|
| -- | -- | -- | -- | ------------------------------------------------------------- |
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| | SIS Software version 3.6.0
(Subject) | SIS Software version 3.3.0
(Predicate) |
|-----------------------------------------------------------------------------------------------------------------------|-----------------------------------------|-------------------------------------------|
| Can be downloaded to
planning system | Yes | Yes |
| Segmentation of CT scan
to identify structures in
relation to those
visualized on MR | Yes | Yes |
| Feature to Account for
CT images with gantry tilt | Yes | No |
| Cross-registers images
and creates 3D (fused)
model | Yes | Yes |
| Different registration
methods (linear and non-
linear) by multiple
registration tools (ANTS
and ELASTIX) | Yes | No |
Performance Data
Following the modifications, the software verification and validation testing has been repeated to validate that the modified software functions as specified and performs similarly to the predicate device. In particular, the company has repeated the MRI to CT registration testing using the new methodology, which demonstrated that the software continued to register MR images to the CT space. The error was within the acceptance criteria, and was comparable to that for SIS Software version 3.3.0, which used the same protocol. In addition, the new image processing for CT images with gantry tilt has been tested to validate objects segmentation. Using the same CT scans that were used in the validation testing for the predicate device, results demonstrated that the cropping image processing does not affect the performance of the software as compared to its predicate.
Conclusions
The updated SIS Software version 3.6.0 is as safe and effective as the predicate version previously cleared in K183019. The subject device has the same intended use and indications for use as the predicate, and very similar technological characteristics and principles of operation, with minor differences supported by performance validation testing that the subject device is as safe and effective as the predicate device and performs as intended. Thus, the minor technological differences between SIS Software version 3.6.0 and its predicate device raise no new issues of safety or effectiveness, and the updated SIS Software version 3.6.0 is substantially equivalent.