(201 days)
Not Found
Not Found
No
The description focuses on mathematical modeling (finite element and neural activation models) for visualizing VNA, image processing, and manual segmentation, without mentioning AI or ML algorithms.
No.
The device is a software tool designed to assist medical professionals in planning the programming of deep brain stimulation devices. It visualizes data and helps create stimulation plans, but it does not directly administer therapy or interact with the patient's body to treat a condition. The therapeutic device is the Medtronic deep brain stimulation (DBS) device itself, which the software helps plan for.
No
The device is intended to assist medical professionals in planning the programming of stimulation for patients receiving deep brain stimulation (DBS) devices by visualizing the Volume of Neural Activation (VNA) relative to patient anatomy. It helps in creating patient-specific stimulation plans and generating reports, rather than diagnosing a condition or disease.
Yes
The device description explicitly states "The SureTune4 Software" and details its functions as importing, processing, and visualizing medical images and data for planning DBS programming. There is no mention of accompanying hardware components that are part of the regulated device itself. While it interacts with imaging hardware and DBS devices, the regulated entity described is the software.
Based on the provided information, the SureTune4 Software is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. This typically involves analyzing biological samples like blood, urine, or tissue.
- SureTune4's Function: The SureTune4 Software's intended use and description clearly state that it is a planning tool for medical professionals to assist in programming deep brain stimulation (DBS) devices. It uses medical imaging data (MRI, Oarm, CT) and mathematical modeling to visualize the potential effects of stimulation on the patient's anatomy.
- No Specimen Analysis: The software does not analyze any biological specimens from the patient. Its input is imaging data, not biological samples.
Therefore, the SureTune4 Software falls under the category of a medical device, specifically a software-as-a-medical-device (SaMD), but it is not an IVD.
N/A
Intended Use / Indications for Use
The SureTune4 Software is indicated to assist medical professionals in planning the programming of stimulation for patients receiving approved Medtronic deep brain stimulation (DBS) devices.
Product codes
QQC
Device Description
The SureTune4 Software is intended to assist medical professionals in planning the programming of deep brain stimulation (DBS) by visualizing the Volume of Neural Activation (VNA) relative to patient anatomy. It is used to visualize patient-specific information within the patient's anatomy. Integrated preoperative and postoperative magnetic resonance imaging (MRI), Oarm™, and computed tomography (CT) images are uploaded to SureTune4 and can be navigated through in multiple 2D projections and 3D reconstructions. Medtronic DBS lead models are positioned in the corresponding artifacts and potential stimulation settings and electrode configurations entered. The SureTune4 Software mathematically combines finite element (FE) based electric field model of the lead with an axon based neural activation model to translates potential stimulation settings and electrode configurations into a visualized VNA field to indicate the shape and the area or volume of anatomy that will be activated by the stimulation.
The SureTune4 software is used to do the following:
- TM Import MR, O-arm ", and CT patient images over a DICOM network or from . physical media (hard drive, USB drive, CD, or DVD)
- Import DICOM archives from StealthStation TM S7 TM systems with Cranial 3.x . software and StealthStation S8 Cranial software systems, and SureTune4 systems over a DICOM network
- Combine MR. O-arm and CT images for more detail .
- Superimpose an anatomical atlas to better understand the position of structures of . interest relative to a patient's anatomy
- Manually segment structures of interest to highlight particular brain structures .
- . Localize graphical Medtronic DBS lead models (based on preoperative imaging)
- Enter electrophysiological annotations .
- Visualize VNA fields relative to structures of interest in the patient anatomy or . lead position
- . Create patient-specific stimulation plans for DBS programming
- Generate reports that summarize stimulation plans for patients .
- Export patient sessions to SureTune4 XLS spreadsheets (in Microsoft™ Excel format) .
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
magnetic resonance imaging (MRI), Oarm™, and computed tomography (CT)
Anatomical Site
Brain
Indicated Patient Age Range
Not Found (Pediatric extrapolation indicates existing clinical data were not leveraged for pediatric population)
Intended User / Care Setting
medical professionals (Neurologist, Neurosurgeons)
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)
Clinical performance testing was not provided for the SureTune4. Instead, the sponsor performed a user needs validation study and a formative usability evaluation.
User Needs Validation Study:
- Purpose: To determine whether the device meets user needs
- Subjects: 8 (5 Neurologist (N)/3 Neurosurgeons (NS))
- Prior to testing, participants received training on the SureTune4 software features and functions.
- Testing consisted of two main categories of questions:
- Q1: Meet need to visualize anatomy & simulated stimulation field?
- Q2: Meet need to segment anatomy from patient images?
- Participants rated user needs on a scale of 1-5; an average score of 3 or higher was considered a pass.
- Results: All user needs received an average rating of 3 or greater; therefore, the protocol passed.
Formative Usability Evaluation:
- Purpose: To identify use difficulties and assess safety and efficacy of use
- Subjects: 15 (8 NS/7 N)
- Consisted of Simulated Use Testing with the following use scenarios:
- Task Completion
- Trends in Use Difficulties
- Qualitative Feedback
- Participant Safety Scores
- Results: Passed - Some minor use difficulties were observed but were appropriately mitigated.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5855 Brain stimulation programming planning software.
(a)
Identification. The brain stimulation programming planning software is a prescription device intended to assist in planning stimulation programming for implanted brain stimulators.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Software verification, validation, and hazard analysis must be performed.
(2) Usability assessment must demonstrate that the intended user(s) can safely and correctly use the device.
(3) Labeling must include:
(i) The implanted brain stimulators for which the device is compatible.
(ii) Instructions for use.
(iii) Instructions and explanations of all user-interface components.
(iv) A warning regarding use of the data with respect to not replacing clinical judgment.
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DE NOVO CLASSIFICATION REQUEST FOR SURETUNE4 SOFTWARE
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Brain stimulation programming planning software. The brain stimulation programming planning software is a prescription device intended to assist in planning stimulation programming for implanted brain stimulators.
NEW REGULATION NUMBER: 21 CFR 882.5855
CLASSIFICATION: Class II
PRODUCT CODE: QQC1
BACKGROUND
DEVICE NAME: SureTune4 Software
SUBMISSION NUMBER: DEN210003
DATE OF DE NOVO: February 3, 2021
SPONSOR INFORMATION: Medtronic Neuromodulation 7000 Central Ave., N.E. Minneapolis, Minnesota 55432
INDICATIONS FOR USE
The SureTune4 Software is indicated to assist medical professionals in planning the programming of stimulation for patients receiving approved Medtronic deep brain stimulation (DBS) devices.
LIMITATIONS
The sale, distribution, and use of the SureTune4 are restricted to prescription use in accordance with 21 CFR 801.109.
SureTune4 Software does not replace clinical judgment.
Warning: All DBS programming decisions remain in the programming clinician's iudgment. All programmed settings should be screened and selected based on patient physiological response. Reliance on anatomy data in place of clinical judgment could result in excessive stimulation, inadequate stimulation, or stimulation to an unintended
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target.
PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
DEVICE DESCRIPTION
The SureTune4 Software is intended to assist medical professionals in planning the programming of deep brain stimulation (DBS) by visualizing the Volume of Neural Activation (VNA) relative to patient anatomy. It is used to visualize patient-specific information within the patient's anatomy. Integrated preoperative and postoperative magnetic resonance imaging (MRI), Oarm™, and computed tomography (CT) images are uploaded to SureTune4 and can be navigated through in multiple 2D projections and 3D reconstructions. Medtronic DBS lead models are positioned in the corresponding artifacts and potential stimulation settings and electrode configurations entered. The SureTune4 Software mathematically combines finite element (FE) based electric field model of the lead with an axon based neural activation model to translates potential stimulation settings and electrode configurations into a visualized VNA field to indicate the shape and the area or volume of anatomy that will be activated by the stimulation.
The SureTune4 software is used to do the following:
- TM Import MR, O-arm ", and CT patient images over a DICOM network or from . physical media (hard drive, USB drive, CD, or DVD)
- Import DICOM archives from StealthStation TM S7 TM systems with Cranial 3.x . software and StealthStation S8 Cranial software systems, and SureTune4 systems over a DICOM network
- Combine MR. O-arm and CT images for more detail .
- Superimpose an anatomical atlas to better understand the position of structures of . interest relative to a patient's anatomy
- Manually segment structures of interest to highlight particular brain structures .
- . Localize graphical Medtronic DBS lead models (based on preoperative imaging)
- Enter electrophysiological annotations .
- Visualize VNA fields relative to structures of interest in the patient anatomy or . lead position
- . Create patient-specific stimulation plans for DBS programming
- Generate reports that summarize stimulation plans for patients .
- Export patient sessions to SureTune4 XLS spreadsheets (in Microsoft™ Excel format) .
This medical device product has functions subject to FDA premarket review as well as functions that are not subject to FDA premarket review. For this De Novo request, if the product has functions that are not subject to FDA premarket review, FDA assessed those functions only to the extent that they either could adversely impact the safety and effectiveness of the functions subject to FDA premarket review or they are included as a labeled positive impact that was considered in the assessment of the functions subject to FDA premarket review.
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SUMMARY OF NONCLINICAL/BENCH STUDIES
SOFTWARE
The submission contained all of the elements of software documentation corresponding to the "Moderate" level of concern, as outlined in the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Adequate documentation describing the software/firmware, software specifications, architecture design, software development environment, traceability, revision level history, unresolved anomalies provide the foundation that the software will operate in a manner as described in the specifications. Hazard analysis was performed to characterize software risks including device malfunction and measurement related errors. The submission included verification and validation (V&V) testing to address the potential hazards with satisfactory results.
Software design verification was done to establish objective evidence to ensure design outputs have met design input requirements. The following testing was performed, and all testing met the acceptance criteria as defined in the verification protocols, successfully providing objective evidence that the final design was verified to meet the design input requirements.
- Patient image import from PACS or physical media .
- SureTune data archive import and export .
- StealthStation archive import ●
- Patient and session management .
- Patient image viewing ●
- AC/PC definition and visualization .
- . Patient image fusion (registration)
- Import of read-only stereotaxic frame registration for supported frames ●
- Anatomical atlas segmentation and visualization .
- Anatomical manual segmentation and visualization o
- Planned surgical lead traiectory definition and visualization ●
- Automatic and manual positioning/orientation of non-directional and directional DBS . leads
- Electrophysiological input and visualization .
- . Volume of neural activation generation and visualization
- . Planned stimulation settings report output
- Patient fiber tract visualization .
- Receive and send DICOM data over the network using DICOM protocols .
- Clinician Programmer network data transfer .
- Client/Server network data transfer .
- SureTune Server configuration .
- SureTune Software Installation .
SUMMARY OF CLINICAL INFORMATION
Clinical performance testing was not provided for the SureTune4. Instead, the sponsor performed a user needs validation study and a formative usability evaluation.
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User Needs Validation Study
Purpose: To determine whether the device meets user needs Subjects: 8 (5 Neurologist (N)/3 Neurosurgeons (NS)) Prior to testing, participants received training on the SureTune4 software features and functions. Testing consisted of the following two main categories of questions:
- . Q1: Meet need to visualize anatomy & simulated stimulation field?
- . Q2: Meet need to segment anatomy from patient images?
The participants were asked to rate the user needs on a scale of 1-5. An average score of 3 or higher for the user needs was considered a pass.
Results: All user needs received an average rating of 3 or greater; therefore, the protocol passed.
Formative Usability Evaluation
Purpose: To identify use difficulties and assess safety and efficacy of use Subjects: 15 (8 NS/7 N) Consisted of Simulated Use Testing with the following use scenarios:
- . Task Completion
- . Trends in Use Difficulties
- . Qualitative Feedback
- . Participant Safety Scores
Results: Passed - Some minor use difficulties were observed but were appropriately mitigated.
Pediatric Extrapolation
In this De Novo request, existing clinical data were not leveraged to support the use of the device in a pediatric patient population.
LABELING
The labeling is sufficient and satisfies the requirements of 21 CFR 801.109 for prescription devices. In addition to adequate instructions for use, the labeling must include the following regarding the limitations of the device:
- The implanted brain stimulators for which the device is compatible. ●
- . Warning: SureTune4 Software does not replace clinical judgment. All DBS programming decisions remain in the programming clinician's judgment. All programmed settings should be screened and selected based on patient physiological response. Reliance on anatomy data in place of clinical judgment could result in excessive stimulation, inadequate stimulation, or stimulation to an unintended target
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RISKS TO HEALTH
The table below identifies the risks to health that may be associated with use of brain stimulation programming planning software.
| Identified Risks to Health | Mitigation Measures |
|---|---|
| Suboptimal stimulation settings leading to | |
| temporary injury or impairment and/or | |
| ineffective stimulation | Software verification, validation, and hazard |
| analysis | |
| Usability assessment | |
| Labeling |
Table 1 - Identified Risks to Health and Mitigation Measures
SPECIAL CONTROLS
In combination with the general controls of the FD&C Act, the brain stimulation programming planning software is subject to the following special controls:
-
- Software verification, validation, and hazard analysis must be performed
-
- Usability assessment must demonstrate that the intended user(s) can safely and correctly use the device.
-
- Labeling must include:
- a. The implanted brain stimulators for which the device is compatible.
- b. Instructions for use.
- c. Instructions and explanations of all user-interface components.
- d. A warning regarding use of the data with respect to not replacing clinical judgement.
BENEFIT/RISK DETERMINATION
The risks of the device are based on software verification, and hazard analyses, as well as data collected in human factors and usability clinical studies described above. The risks of the device include temporary injury or impairment and/or ineffective stimulation due to suboptimal stimulation settings and/or software failure. These are mitigated by the following:
- The SureTune4 has no direct link with the implanted device and its programming, ●
- Usability assessment, ●
- Labeling states that all programming decisions remain in the programming clinician's judgment and programmed settings should be screened and selected based on patient physiological response.
- Labeling states that the VNA models a visual representation of neuronal tissue activation ● across a range of stimulation settings and electrode configurations and does not replace observation of the patient for therapeutic effects or side effects.
- Software documentation including verification and validation testing and hazard analysis. .
The probable benefits of the device are based on nonclinical laboratory studies as well as data collected in human factors and usability clinical studies as described above. In support of the De Novo, the sponsor has provided software documentation and validation testing,
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VNA modeling description and justification, human factors/usability testing, auto-detect lead orientation algorithm accuracy testing, image fusion accuracy testing, and cybersecurity information and testing. All testing passed prespecified acceptance criteria and no safety concerns were raised.
Additional factors to be considered in determining probable risks and benefits for the SureTune4 include the following sources of uncertainty associated with the device: accuracy of the VNA model, accuracy of the anatomy segmentation, and no data to demonstrate it can optimize programming. However, no claims are associated with these aspects of the device and as a tool, the testing provided evidence of a clinical benefit for this device.
Patient Perspectives
This submission did not include specific information on patient perspectives for this device.
Benefit/Risk Conclusion
In conclusion, given the available information above, for the following indication statement:
The SureTune4 Software is indicated to assist medical professionals in planning the programming of stimulation for patients receiving approved Medtronic deep brain stimulation (DBS) devices.
The probable benefits outweigh the probable risks for the SureTune4 Software. The device provides benefits and the risks can be mitigated by the use of general and the identified special controls.
CONCLUSION
The De Novo request for the SureTune4 Software is granted and the device is classified under the following:
Product Code: QQC Device Type: Brain stimulation programming planning software Class: II Regulation: 21 CFR 882.5855