(53 days)
Yes
The device description explicitly states that the software is "based on machine learning and image processing" and uses "pre-trained deep learning neural network models".
No.
The device is a software-only system designed for viewing, presentation, and documentation of medical imaging, aiding in visualization and localization for surgical planning, but it does not directly treat or diagnose a disease or condition.
No
The device aids in visualization and localization for surgical procedures using image processing and deep learning, but its intended use statement does not indicate it is for diagnosing a disease or condition. It is for surgical planning and guidance.
Yes
The device description explicitly states "The SIS System version 5.6.0 is a software only device".
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: IVDs are designed to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- This device analyzes medical images: The SIS System processes and analyzes medical images (MR and CT scans) of the brain. It does not interact with or analyze biological samples.
- The intended use is image processing and visualization: The primary purpose of the device is to aid in the viewing, presentation, and documentation of medical imaging for surgical planning and guidance.
Therefore, the SIS System falls under the category of medical imaging software or surgical planning software, not an In Vitro Diagnostic device.
No
The document 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," indicating no relevant information regarding PCCP approval in the provided text.
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
QIH, LLZ
Device Description
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) 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
MR, CT
Anatomical Site
Brain (basal ganglia area, specifically the subthalamic nucleus (STN) and globus pallidus externa and interna (GPe/GPi))
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 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.
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)
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.
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.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
510(k) Number (if known)
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)
| ☑ Requisition Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart G) |
区 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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: 612-325-0187 E-mail: ann.quinlan.smith@surqicalis.com
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)
4
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.
5
| | SIS System version
5.6.0
(subject device) | SIS System version
5.1.0 (K210071)
(predicate device) | Comparison |
|----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | SIS System 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) and globus
pallidus externa and
interna (GPe and GPi,
respectively).
Typical users of the SIS
System are medical
professionals, including
but not limited to
surgeons, neurologists
and radiologists. | Similar. Addition of
clarifying statement
(about use in medical
procedures in which
anatomical structure
locations such as STN,
GPe and GPi are
identified in images,
including deep brain
stimulation lead
placement) does not
raise different questions
of safety or
effectiveness because
predicate was already
intended for use in such
procedures and other
reference devices (e.g.,
StealthStation with
Cranial Software,
K153660) with similar
functions include this
language. |
| User Population | Medical professionals,
including but not limited
to surgeons,
neurologists and
radiologists. | Medical professionals,
including but not limited
to surgeons,
neurologists and
radiologists. | Same |
| Allows for importing
of digital imaging sets | Yes | Yes | Same |
| | SIS System version
5.6.0
(subject device) | SIS System version
5.1.0 (K210071)
(predicate device) | Comparison |
| Uses proprietary
software algorithm to
generate 3D
segmented anatomical
models from patient's
MR scans | Yes | Yes | Same |
| Allows for review and
analysis of data in 2D
and 3D formats | Yes | Yes | Same |
| Performs image fusion
of datasets using
automated or manual
image matching
technique | Yes | Yes | Same |
| Segments structures
in images with manual
and automated tools
and converts them
into 3D objects for
display | Yes | Yes | Same |
| Creates hybrid
datasets by filing in
segmented regions
slice-by-slice on
anatomical datasets | Yes | Yes | Same |
| Can be downloaded to
planning system | Yes | Yes | Same |
| Segmentation of CT
scan to identify
structures in relation
to those visualized on
MR | Yes | Yes | Same |
| Feature to Account for
CT images with gantry
tilt | Yes | Yes | Same |
| Cross-registers
images and creates 3D
(fused) model | Yes | Yes | Same |
| Uses registration
methods (linear and
non-linear) by multiple
registration tools
(ANTS and ELASTIX) | Yes | Yes | Same |
6
Conclusions
The SIS System version 5.6.0 is as safe and effective as the predicate version previously cleared in K210071.