(262 days)
neuroinspire is a stereotactic software application intended to allow trained clinicians to plan surgical trajectories for neurological procedures. neuroinspire a stereotactic region for this planning based on fiducial markers in CT images. neuroinspire reports specific surgical trajectories intended to be manually set on head frame systems validated for use with neuroinspire has been validated with the Leksell Stereotactic System Type G (comprising of head ring, head frame and CT Localizer). No other components of the Leksell Stereotactic System should be used. No other stereotactic system should be used. The user should consult Section 1.7 Accuracy of these Instructions for Use to assess if the accuracy of neuroinspire is suitable for their needs.
neuroinspire surgical planning software is an application that enables the viewing of medical images to support the image based neurosurgery. It may be used by neurosurgeons to reconstruct and display multiple image sets to facilitate 2D and 3D targeting and trajectory planning in relation to an intended neurological surgical procedure. It allows the neurosurgeon to download and integrate MRI and CT DICOM (digital imaging communication) images of a patient's brain onto a PC-based platform. The neurosurgeon can then virtually slice the brain into sections, zoom in for close-ups and rotate images in order to visualize and analyze the patient's brain prior to surgery.
neuroinspire has been validated with the Leksell Stereotactic System Type G (comprising of head ring, head frame and CT Localizer).
neuroinspire surgical planning software allows a neurosurgeon to:
- . load data acquired from an MRI scanner
- . load data acquired from a CT scanner;
- manually reconstruct target anatomy using multi-planer views; .
- calculate target coordinates;
- plan trajectories; ●
- print a surgical plan.
The information provided describes the acceptance criteria and the study conducted for the 'neuro | inspire' device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Maximum Euclidean Positional Error: < 2 mm | Mean: 0.96 mm, 99% CI upper bound: 1.090 mm |
| Maximum Angular Error: < 2° | Mean: 0.45°, 99% CI upper bound: 0.539° |
2. Sample Size and Data Provenance for Test Set
- Sample Size: The document does not explicitly state the number of trajectories or target points tested for verification. It mentions "a number of representative brain targets" within a CT phantom.
- Data Provenance: The data was generated through nonclinical testing using a CT phantom. Therefore, it is not from a specific country of origin, and it is prospective in nature as it was generated specifically for this study.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
- The document states that "A ground truth measurement of a CT phantom mimicking a human skull and containing a number of representative brain targets was established using a portable CMM system."
- It does not specify the number of experts, their qualifications, or if any experts were involved in establishing this instrument-based ground truth. The ground truth appears to be derived from precise measurements using a Coordinate Measuring Machine (CMM) system.
4. Adjudication Method for Test Set
- The document does not describe any adjudication method. Given that the ground truth was established using a CMM system, an adjudication process involving human experts would likely not be relevant for this type of objective measurement.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done. The document explicitly states "No clinical data has been submitted." Human factors studies were conducted to validate user experience, but these are distinct from comparative effectiveness studies evaluating reader performance.
6. Standalone Performance Study
- Yes, a standalone (algorithm only without human-in-the-loop performance) study was conducted. The performance data presented (positional and angular accuracy) directly reflects the device's ability to transfer trajectory information from its software plan to the Leksell stereotactic system, a process that relies on the device's calculations and measurement outputs.
7. Type of Ground Truth Used
- The ground truth used was instrument-based physical measurements. It was established by "a ground truth measurement of a CT phantom mimicking a human skull and containing a number of representative brain targets... using a portable CMM system." This is a precise physical measurement rather than expert consensus, pathology, or outcomes data.
8. Sample Size for Training Set
- The document provides no information regarding a specific training set size. The device is a "stereotactic software application intended to allow trained clinicians to plan surgical trajectories for neurological procedures." It is not described as an AI/ML algorithm that requires a traditional training set in the context of learned tasks. Instead, it is a calculation and planning tool.
9. How Ground Truth for Training Set Was Established
- As the device is a planning software and not a machine learning model requiring a training set with labeled ground truth in the conventional sense, this information is not applicable and hence not provided in the document. The software's development would have involved verification and validation against known mathematical and physical principles, rather than learning from a labeled training dataset.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 15, 2017
Renishaw plc % Roberto Liddi Head of Regulatory Affairs and Quality Assurance New Mills Wotton-under-edge, Gloucestershire, GL12 8JR GB
Re: K163666 Trade/Device Name: neuro | inspire Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: August 21, 2017 Received: September 11, 2017
Dear Dr. Liddi:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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/ResourcesforYou/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 J. Hoffmann -S
Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K163666
Device Name neuro | inspire
Indications for Use (Describe)
neuroinspire is a stereotactic software application intended to allow trained clinicians to plan surgical trajectories for neurological procedures. neuroinspire a stereotactic region for this planning based on fiducial markers in CT images. neuroinspire reports specific surgical trajectories intended to be manually set on head frame systems validated for use with neuroinspire has been validated with the Leksell Stereotactic System Type G (comprising of head ring, head frame and CT Localizer). No other components of the Leksell Stereotactic System should be used. No other stereotactic system should be used. The user should consult Section 1.7 Accuracy of these Instructions for Use to assess if the accuracy of neuroinspire is suitable for their needs.
| 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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Image /page/3/Picture/0 description: The image shows the Renishaw logo. The word "RENISHAW" is in orange, and below it, the words "apply innovation" are in black. The Renishaw logo is a registered trademark.
510(k) Summary 4:
1. Submitter:
Renishaw plc.
| New Mills | |||||
|---|---|---|---|---|---|
| Wotton-under-Edge | |||||
| Gloucestershire | |||||
| GL12 8JR | |||||
| United Kingdom | |||||
| Phone: | 0044 1453 524600 | ||||
| Contact person: | Roberto Liddi | ||||
| Head of Regulatory Affairs & Quality Assurance | |||||
| Renishaw plc. | |||||
| New Mills | |||||
| Wotton-under-Edge | |||||
| Gloucestershire | |||||
| GL12 8JR | |||||
| United Kingdom | |||||
| Phone: | 0044 1453 524600 | ||||
| Email: | roberto.liddi@renishaw.com | ||||
| Preparation date: 14th September 2017 | |||||
| Device: | |||||
| Trade name: | neuro inspireTM | Common name: | neuroinspire | ||
| Classification regulation: | 21 CFR 882.4560 | Stereotaxic instrument | |||
| Product code: | HAW | ||||
| Predicate device: | |||||
| Brainlab AG | iPlan Stereotaxy | K101627 | |||
| Device Classification Name: | Stereotaxic Instrument | ||||
| Regulatory Class: | Class II |
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Image /page/4/Picture/0 description: The image shows the Renishaw logo. The word "RENISHAW" is in large, orange, sans-serif font. Below the company name is the slogan "apply innovation" in a smaller, black, sans-serif font. To the right of the company name is a small, orange square with a white line through it.
4. Device description:
neuroinspire surgical planning software is an application that enables the viewing of medical images to support the image based neurosurgery. It may be used by neurosurgeons to reconstruct and display multiple image sets to facilitate 2D and 3D targeting and trajectory planning in relation to an intended neurological surgical procedure. It allows the neurosurgeon to download and integrate MRI and CT DICOM (digital imaging communication) images of a patient's brain onto a PC-based platform. The neurosurgeon can then virtually slice the brain into sections, zoom in for close-ups and rotate images in order to visualize and analyze the patient's brain prior to surgery.
neuroinspire has been validated with the Leksell Stereotactic System Type G (comprising of head ring, head frame and CT Localizer).
neuroinspire surgical planning software allows a neurosurgeon to:
- . load data acquired from an MRI scanner
- . load data acquired from a CT scanner;
- manually reconstruct target anatomy using multi-planer views; .
- calculate target coordinates;
- plan trajectories; ●
- print a surgical plan.
5. Indications for Use:
neuroinspire is a stereotactic software application intended to allow trained clinicians to plan surgical trajectories for neurological procedures. neuroinspire defines a stereotactic region for this planning based on fiducial markers in CT images. neuroinspire reports specific surgical trajectories intended to be manually set on head frame systems validated for use with neuroinspire. neuroinspire has been validated with the Leksell Stereotactic System Type G (comprising of head frame and CT Localizer). No other components of the Leksell Stereotactic System should be used. No other stereotactic system should be used. The user should consult Section 1.7 Accuracy of these Instructions for Use to assess if the accuracy of neuroinspire is suitable for their needs.
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Image /page/5/Picture/0 description: The image shows the Renishaw logo. The word "RENISHAW" is in orange, and below it, the words "apply innovation" are in black. The Renishaw logo is a registered trademark.
| Function | Predicate Description ofBrainLab iPlan StereotaxyK101627 | Comparison of Predicate to neuroinspire | Equivalence |
|---|---|---|---|
| Intended Use | The viewing, presentation and documentation of medical imaging, including different modules for image processing, image fusion, atlas assisted visualization and segmentation, intraoperative functional planning where the output can be used e.g. with stereotactic image guided surgery or other devices for further processing and visualization | Software application running on a standard computer workstation for viewing and presentation of medical images. It provides the capability for processing of patient images and the planning of surgical procedures for any medical condition in which the use of stereotactic image guide brain based neurosurgery is considered appropriate | Same |
| AC/PCLocalization | This planning task allows the definition of AC/PC co-ordinate system | This planning task allows the definition of AC/PC co-ordinate system | Same |
| Localization | Assign a localizer frame for CT or MRI localization Perform automatic detection of localizer rods | Assign a localizer frame for CT localization Perform automatic detection of localizer rods | SubstantiallyEquivalent |
| TrajectoryPlanning | Plan pathways for surgical instruments or resection, definition of entry, target points and diameter for trajectories | Plan pathways for surgical instruments or resection, definition of entry, target points and diameter for trajectories | Same |
| Stereotacticplanning | Planning of stereotactic trajectories Usage of AC/PC coordinates and Schaltenbrandt-Wahren atlas. Calculation of stereotactic arc settings for planned trajectories | Planning of stereotactic trajectories Usage of AC/PC coordinates and Shaltenbrandt-Wahren atlas. Calculation of stereotactic arc settings for planned trajectories | Same |
| Function | Predicate DescriptionofBrainLab iPlanStereotaxyK101627 | Comparison ofPredicate toneuroinspire | Equivalence |
| Load andImport | Load existing treatmentdata from different datasources, import patientdata from DICOM orother archive types,manage(delete/copy/move)patient folders | neuroinspire importspatient data in DICOMform. It managespatient data locally (onthe PC) but does notmodify or delete thesource hospital data.This is a safetymeasure as theoriginal data cannot bealtered through theuse of neuroinspire. | SubstantiallyEquivalent |
| View andAdjustment | Review patient data invarious reconstructionsor overlay, side-by-sidecomparison of differentmodalities, aligning thedata set orientation,import or exportscreenshot images | neuroinspire allows thereview of patient datain variousreconstructions oroverlay, side-by-sidecomparison of MRIand CT modalities,alignment of datasetsand export ofscreenshots, but thereis no import ofscreenshot data. | SubstantiallyEquivalent |
| ImageFusion | Align available imagesets automatically,manually or usinglandmarks for variouscombinations of imagessets and modalities suchas CT MRI, PET andSPECT. Visualverification of alignment. | neuroinspire alignsavailable image setsautomatically,manually or usinglandmarks for variouscombinations ofimages sets andmodalities but onlyMRI and CT modalitiesare supported. MRIand CT are the mostcommon imagingmodalities used inneurosurgery. | SubstantiallyEquivalent |
| Function | Predicate DescriptionofBrainLab iPlanStereotaxy | Comparison ofPredicate toneuroinspire | Equivalence |
| K101627 | |||
| ObjectCreation | Outline anatomicalstructures using manualor automaticsegmentation methods.Advanced manipulationfor 3D objects withscaling, logicaloperations and objectsplitting. Volumetricmeasurements basedon the created 3Dobjects | With neuroinspire theuser can manuallysegment anatomicalstructures usingmanual segmentationmethods. There are noautomaticsegmentationfunctions but thevolume of asegmented features isreported. | SubstantiallyEquivalent |
| Save andExport | Save the currenttreatment plan to thepatient folder. Export theresults to the navigation,as DICOM or STLformat | The neuroinspire usercan save and exportthe treatment plans ina proprietary format,not in DICOM or STLand does not exportthe results to anavigation system. | SubstantiallyEquivalent |
| RegistrationPoints | Automatic detection ofCT or MR registrationmarkers for navigation,manual placement ofmarkers and anatomicallandmarks | No equivalence isclaimed | No equivalence isclaimed |
| AdvancedObjectPlanning | Mirror and splitsegmented structures | No equivalence isclaimed | No equivalence isclaimed |
| BOLD MRImapping | Processing of bloodoxygen level dependent(BOLD) MRI data.Definition of blockdesign functional task,calculation of activationareas based on BOLDMRI data, time seriesview for activationsignal, creation of 3Dobjects from activation | No equivalence isclaimed | No equivalence isclaimed |
| Function | Predicate DescriptionofBrainLab iPlanStereotaxy | Comparison ofPredicate toneuroinspire | Equivalence |
| K101627 | |||
| FiberTracking | Processing of diffusiontensor imaging (DTI)using various ways todefine and combineseed regions of interest.Definition of multiplefiber bundles andcreation of 3D objectsfrom fiber bundles.Volumetricmeasurements anddetailed fiber information | No equivalence isclaimed | No equivalence isclaimed |
| Electroderecording | Planning of parallelelectrode tracks. Enterand displaymicroelectroderecording andstimulation results,display informationstepwise along tracks | No equivalence isclaimed | No equivalence isclaimed |
6. Comparison to Technological Characteristics with Predicate Device:
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Image /page/7/Picture/0 description: The image shows the Renishaw logo. The word "RENISHAW" is in orange, and below it, the words "apply innovation" are in black. The Renishaw logo is a registered trademark.
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Image /page/8/Picture/0 description: The image shows the Renishaw logo. The word "RENISHAW" is in large, orange, sans-serif font. Below the word "RENISHAW" is the phrase "apply innovation" in a smaller, black, sans-serif font. To the right of the word "RENISHAW" is a small, stylized image that is also orange.
a. Conclusion
Except for the differences stated above, the proposed neuroinspire software is similar in design, intended use and operation to the predicate, K101627. The last five functions in the above table are specific areas of functionality that extend the scope of BrainLab's iPlan Stereotaxy device beyond the scope of neuroinspire.
7. Performance Data:
a. Nonclinical Data
Verification and validation of this device was conducted and documentary evidence has been provided as part of this submission. The software is considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.
Software was developed in compliance with FDA software guidance and IEC 62304.
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Image /page/9/Picture/0 description: The image shows the Renishaw logo. The word "RENISHAW" is in orange, and below it is the phrase "apply innovation" in black. To the right of the word "RENISHAW" is a small, light-colored graphic.
Human factors studies have been carried out to validate the safe and effective user experience, the documentary evidence of these studies has been provided as part of this submission.
A ground truth measurement of a CT phantom mimicking a human skull and containing a number of representative brain targets was established using a portable CMM system. Testing was performed and demonstrated that the positional and angular accuracy of transferring the trajectory information from neuroinspire to the Leksell stereotactic system is <2 mm and <2° respectively. The documentary evidence of this measurement has been provided as part of this submission, results are summarized below:
Specification for maximum Euclidean positional error: <2 mm
Mean: 0.96 mm ST Dev: 0.42 mm 99% Cl: 0.130 mm 99% CI upper bound: 1.090mm
Specification for maximum angular error: <2°
Mean: 0.45°
ST Dev: 0.29°
99% Cl: 0.089°
99% CI upper bound: 0.539°
b. Clinical Data
No clinical data has been submitted.
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Image /page/10/Picture/0 description: The image contains the Renishaw logo. The logo consists of the word "RENISHAW" in orange, with the tagline "apply innovation" in black underneath. To the right of the word "RENISHAW" is a small graphic element, also in orange.
8. Conclusions:
The conclusions drawn from the nonclinical tests demonstrate that the device, when used as intended, is as safe, as effective, and performs as well as or better, than the legally marketed device identified in section 3 of this summary.
4-8 Device name: neuro | inspire™ Traditional 510(k) submission Submitter: Renishaw plc
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).