(262 days)
Not Found
No
The summary describes standard image processing and surgical planning tools, with no mention of AI or ML algorithms being used for tasks like image analysis, segmentation, or trajectory optimization. The performance studies focus on accuracy based on a phantom, not on the performance of an AI/ML model.
No.
The device is a surgical planning software that assists surgeons in preparing for neurological procedures, but it does not directly treat or interact therapeutically with the patient. It is used for planning, not treatment.
No
Explanation: The device is described as surgical planning software that uses medical images to assist neurosurgeons in planning trajectories for neurological procedures. It does not provide a diagnosis of a patient's condition.
Yes
The device is described as a "software application" and "surgical planning software" that runs on a "PC-based platform". While it is validated for use with a specific stereotactic system (Leksell Stereotactic System Type G), the device itself is the software that performs the planning functions and does not include the physical hardware of the stereotactic system. The validation focuses on the accuracy of transferring information from the software to the hardware, not on the software including or being part of the hardware.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health, such as diagnosing, monitoring, or screening for diseases or conditions.
- neuroinspire's Function: neuroinspire is a software application used for surgical planning based on medical images (CT and MRI). It helps clinicians plan trajectories for neurological procedures. It does not analyze biological specimens from the body.
- Intended Use: The intended use clearly states it's for "planning surgical trajectories for neurological procedures" and "to support the image based neurosurgery." This is a surgical planning tool, not a diagnostic test performed on a biological sample.
Therefore, neuroinspire falls under the category of a medical device, specifically a surgical planning software, but it is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
HAW
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.
Mentions image processing
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
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI, CT
Anatomical Site
patient's brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained clinicians, 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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Data: Verification and validation of this device was conducted. The software is considered as a "major" level of concern. Software was developed in compliance with FDA software guidance and IEC 62304.
Human factors studies have been carried out to validate the safe and effective user experience.
Testing demonstrated that the positional and angular accuracy of transferring the trajectory information from neuroinspire to the Leksell stereotactic system is
§ 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).
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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
1
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 of
BrainLab iPlan Stereotaxy
K101627 | 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/PC
Localization | 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 | Substantially
Equivalent |
| Trajectory
Planning | 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 |
| Stereotactic
planning | 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 Description
of
BrainLab iPlan
Stereotaxy
K101627 | Comparison of
Predicate to
neuroinspire | Equivalence |
| Load and
Import | Load existing treatment
data from different data
sources, import patient
data from DICOM or
other archive types,
manage
(delete/copy/move)
patient folders | neuroinspire imports
patient data in DICOM
form. It manages
patient data locally (on
the PC) but does not
modify or delete the
source hospital data.
This is a safety
measure as the
original data cannot be
altered through the
use of neuroinspire. | Substantially
Equivalent |
| View and
Adjustment | Review patient data in
various reconstructions
or overlay, side-by-side
comparison of different
modalities, aligning the
data set orientation,
import or export
screenshot images | neuroinspire allows the
review of patient data
in various
reconstructions or
overlay, side-by-side
comparison of MRI
and CT modalities,
alignment of datasets
and export of
screenshots, but there
is no import of
screenshot data. | Substantially
Equivalent |
| Image
Fusion | Align available image
sets automatically,
manually or using
landmarks for various
combinations of images
sets and modalities such
as CT MRI, PET and
SPECT. Visual
verification of alignment. | neuroinspire aligns
available image sets
automatically,
manually or using
landmarks for various
combinations of
images sets and
modalities but only
MRI and CT modalities
are supported. MRI
and CT are the most
common imaging
modalities used in
neurosurgery. | Substantially
Equivalent |
| Function | Predicate Description
of
BrainLab iPlan
Stereotaxy | Comparison of
Predicate to
neuroinspire | Equivalence |
| | K101627 | | |
| Object
Creation | Outline anatomical
structures using manual
or automatic
segmentation methods.
Advanced manipulation
for 3D objects with
scaling, logical
operations and object
splitting. Volumetric
measurements based
on the created 3D
objects | With neuroinspire the
user can manually
segment anatomical
structures using
manual segmentation
methods. There are no
automatic
segmentation
functions but the
volume of a
segmented features is
reported. | Substantially
Equivalent |
| Save and
Export | Save the current
treatment plan to the
patient folder. Export the
results to the navigation,
as DICOM or STL
format | The neuroinspire user
can save and export
the treatment plans in
a proprietary format,
not in DICOM or STL
and does not export
the results to a
navigation system. | Substantially
Equivalent |
| Registration
Points | Automatic detection of
CT or MR registration
markers for navigation,
manual placement of
markers and anatomical
landmarks | No equivalence is
claimed | No equivalence is
claimed |
| Advanced
Object
Planning | Mirror and split
segmented structures | No equivalence is
claimed | No equivalence is
claimed |
| BOLD MRI
mapping | Processing of blood
oxygen level dependent
(BOLD) MRI data.
Definition of block
design functional task,
calculation of activation
areas based on BOLD
MRI data, time series
view for activation
signal, creation of 3D
objects from activation | No equivalence is
claimed | No equivalence is
claimed |
| Function | Predicate Description
of
BrainLab iPlan
Stereotaxy | Comparison of
Predicate to
neuroinspire | Equivalence |
| | K101627 | | |
| Fiber
Tracking | Processing of diffusion
tensor imaging (DTI)
using various ways to
define and combine
seed regions of interest.
Definition of multiple
fiber bundles and
creation of 3D objects
from fiber bundles.
Volumetric
measurements and
detailed fiber information | No equivalence is
claimed | No equivalence is
claimed |
| Electrode
recording | Planning of parallel
electrode tracks. Enter
and display
microelectrode
recording and
stimulation results,
display information
stepwise along tracks | No equivalence is
claimed | No equivalence is
claimed |
6. Comparison to Technological Characteristics with Predicate Device:
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Image /page/6/Picture/0 description: The image shows the Renishaw logo. The word "RENISHAW" is written in orange, with the tagline "apply innovation" written in black below it. To the right of the word "RENISHAW" is a symbol that is partially obscured.
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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