(164 days)
K082060 VECTORVISION CRANIAL
Not Found
No
The summary describes a navigation system that uses image data and tracking to guide surgical instruments. There is no mention of AI, ML, deep learning, or any related concepts in the intended use, device description, or performance studies. The focus is on accuracy measurements of the navigation system itself.
No
This device is an image-guided planning and navigation system for surgery; it assists surgeons by providing information and guiding instruments, but it does not directly perform a therapeutic action or deliver a therapy.
No
The device is described as an image-guided planning and navigation system for surgery, providing information based on medical imaging to assist with surgical procedures. It does not provide a medical diagnosis on its own.
No
The device is described as a software module that runs on a Brainlab navigation system, which consists of hardware components (computer, display, IR tracking camera). It also interfaces with compatible instrument accessories. While the subject device itself is software, its functionality is dependent on and integrated with specific hardware, making it part of a larger hardware-software system, not a standalone software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for "image guided planning and navigation system to enable open and minimally invasive surgery." It assists in surgical procedures by providing navigation based on medical images and the position of instruments and the microscope.
- Device Description: The description details a software module that runs on a navigation system and interfaces with a surgical microscope. It provides information based on the field of view and position relative to patient imaging data.
- Lack of In Vitro Activity: An IVD is a medical device that is used to perform tests on samples taken from the human body (such as blood, urine, tissue) to diagnose, monitor, or screen for diseases or conditions. This device does not perform any tests on biological samples. It is used during surgery to guide the surgeon.
The device is a surgical navigation system, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Brainlab Navigation System - Microscope Navigation Software module, that when used with a Brainlab navigation system and compatible instrument accessories, is intended as image guided planning and navigation system to enable open and minimally invasive surgery.
It links an instrument and the view of the surgical field (e.g. video, view through surgical microscope) to a virtual computer image space on patient mage data being processed by the navigation. The system is indicated for any medical condition in which a reference to a rigid anatomical structure can be identified relative to images (CT, CTA, X-Ray, MR, MRA and ultrasound) of the anatomy
Product codes (comma separated list FDA assigned to the subject device)
HAW
Device Description
The Microscope Navigation Software (also referred to as subject device or Microscope App) is a software. It runs on a Brainlab navigation system consisting of a computer, a display and an IR tracking camera (referred to as platform) and a Brainlab Image Guided Surgery software (referred to as IGS software).
The Microscope Navigation encapsulates microscope specific functionality and separates it from the IGS software.
The device interfaces with the IGS software and e.g. utilizes the registration provided by the IGS software.
The device assists surgeries where a surgical microscope is used. It provides information based on the field of view through the microscope, the microscope position relative to the patient and the medical imaging data of the patient.
The subject device provides functionality to verify and correct a patient registration.
The Microscope Navigation does not provide its own registration.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, CTA, X-Ray, MR, MRA and ultrasound
Anatomical Site
rigid anatomical structure (e.g., skull, long bone, vertebra)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Verification summary:
- Test: Microscope focus point accuracy
- Test Method Summary: The focal point crosshair is aligned to a landmark on a phantom for different working distances. The distance between landmark and focus point measured by the IGS System.
- Results: The accuracy of the focus point in the focal plane is 1.2 mm +/- 0.5 mm (99th percentile 2.4 mm).
The three-dimensional error including the distance of the focus point is measured to 1.9 mm +/- 1.0 mm (99th percentile 4.6 mm).
- Test: Navigation Update
- Test Method Summary: The Navigation Update is performed on a phantom for different initial registration accuracies. The accuracy of the initial accuracy is compared to the accuracy after an update on landmarks on the phantom.
- Results: The Navigation Update can improve registration errors.
For translations and rotations parallel to the focus plane the Navigation Update is accurate up to 0.8 mm +/- 0.3 mm (99th percentile 1.4 mm).
The subject device is part of a set of application of an IGS system. The errors above are measured under a OR setup conditions with optimal paired-point registrations. The ground accuracy provided by the subject device is sufficient to assess navigation accuracy repeatedly throughout a procedure and identify deviations.
The subject device uses identical calibration methods. The tracking method and algorithms are identical. Instrument design and marker geometry is unchanged. The subject device is substantial equivalent to its predecessor.
Validation summary:
The validation comprises usability tests which to ensure that the user interface can be used safely and effectively. All tests were rated as successfully passed according to their acceptance criteria. The non-clinical validation has been performed with software and equipment that are identical or equivalent to the final version of the product.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Microscope focus point accuracy:
- Focal plane accuracy: 1.2 mm +/- 0.5 mm (99th percentile 2.4 mm)
- Three-dimensional error: 1.9 mm +/- 1.0 mm (99th percentile 4.6 mm)
Navigation Update accuracy for translations and rotations parallel to the focus plane: 0.8 mm +/- 0.3 mm (99th percentile 1.4 mm)
Predicate Device(s)
K082060 VECTORVISION CRANIAL
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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/0 description: The image contains 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 1, 2018
Brainlab AG Alexander Schwiersch Regulatory Affairs Manager Olof-Palme-Straße 9 81829 Munich, Germany
Re: K172820
Trade/Device Name: Microscope Navigation Software Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: January 30, 2018 Received: February 2, 2018
Dear Alexander Schwiersch:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael J. Hoffmann -S
for
Carlos L. Peña. PhD. MS 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) K172820
Device Name Microscope Navigation Software
Indications for Use (Describe)
The Brainlab Navigation System - Microscope Navigation Software module, that when used with a Brainlab navigation system and compatible instrument accessories, is intended as image guided planning and navigation system to enable open and minimally invasive surgery.
It links an instrument and the view of the surgical field (e.g. video, view through surgical microscope) to a virtual computer image space on patient mage data being processed by the navigation. The system is indicated for any medical condition in which a reference to a rigid anatomical structure can be identified relative to images (CT, CTA, X-Ray, MR, MRA and ultrasound) of the anatomy
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY MICROSCOPE NAVIGATION 1.0
IN ACCORDANCE WITH REQUIREMENTS OF 21 CFR PART 807.92
| Manufacturer: | Brainlab AG
Olof-Palme-Straße 9
81829 Munich
Germany |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Oliver Fleig |
| Contact person: | Alexander Schwiersch |
| Summary date | June 20, 2017 |
| Device | Microscope Navigation |
| Trade name | Microscope Navigation Software |
| Common name: | Frameless Stereotaxic Navigation System |
| Classification name: | Neurological Stereotaxic Instrument (21 CFR 882.4560, Product Code HAW) |
| Predicate Device: | K082060 VECTORVISION CRANIAL |
| Regulatory Class: | Class II |
| Regulation Number: | 882.4560 |
| Intended use: | The Brainlab Navigation System - Microscope Navigation Software is a software
module, that when used with a Brainlab navigation system and compatible instrument
accessories, is intended as image guided planning and navigation system to enable
open and minimally invasive surgery.
It links an instrument and the view of the surgical field (e.g. video, view through surgical
microscope) to a virtual computer image space on patient image data being processed
by the navigation workstation. The system is indicated for any medical condition in
which a reference to a rigid anatomical structure can be identified relative to images
(CT, CTA, X-Ray, MR, MRA and ultrasound) of the anatomy |
4
| Device description: | The Microscope Navigation Software (also referred to as subject device or Microscope
App) is a software. It runs on a Brainlab navigation system consisting of a computer, a
display and an IR tracking camera (referred to as platform) and a Brainlab Image
Guided Surgery software (referred to as IGS software).
The Microscope Navigation encapsulates microscope specific functionality and
separates it from the IGS software.
The device interfaces with the IGS software and e.g. utilizes the registration provided
by the IGS software. |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The device assists surgeries where a surgical microscope is used. It provides
information based on the field of view through the microscope, the microscope position
relative to the patient and the medical imaging data of the patient.
The subject device provides functionality to verify and correct a patient registration.
The Microscope Navigation does not provide its own registration. | |
| Reason for 510(k)
submission: | New device. |
Substantial Microscope Navigation has been verified and validated using non-clinical data equivalence: according to Brainlab procedures for product design and development. The information provided by Brainlab in this 510(k) application supports the claim of substantial equivalence to the predicate device VectorVision Cranial.
Microscope Navigation separates microscope specific functionality in an separate application. Microscope specific views are bundled in this application.
Comparison of Subject Device and Predicate Device
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| | Predicate Device
VectorVision Cranial K082060 | Subject Device
Microscope Navigation |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Brainlab Cranial IGS System is
intended to be an intra-operative image
guided localization system to enable
minimally invasive surgery. It links a
freehand probe, tracked by a magnetic
sensor system or a passive marker sensor
system to a virtual computer image space
on patient image data being processed by
the navigation workstation.
The system is indicated for any medical
condition in which the use of stereotactic
surgery may be appropriate and where a
reference to a rigid anatomical structure,
such as the skull, a long bone, or vertebra,
can be identified relative to a CT, CTA, X-
Ray, MR, MRA and ultrasound based
model of the anatomy.
Example procedures include but are not
limited to:
Cranial Procedures:
Tumor resections Skull base surgery Cranial biopsies Craniotomies/ Craniectomies | The Brainlab Navigation System -
Microscope Navigation Software is a
software module, that when used with a
compatible computer and compatible
instrument accessories, is intended as image
guided planning and navigation system to
enable open and minimally invasive surgery.
It links an instrument and the view of the
surgical field (e.g. video, view through
surgical microscope) to a virtual computer
image space on patient image data being
processed by the computer. The system is
indicated for any medical condition in which a
reference to a rigid anatomical structure can
be identified relative to images (CT, CTA, X-
Ray, MR, MRA and ultrasound) of the
anatomy |
| Brainlab
Platform | Brainlab Kolibri
Brainlab VectorVision | Brainlab Kick
Brainlab Curve |
| Operating
System | Windows XP | Windows 7
Windows 8.1 |
| Application(Use) | Cranial Procedures: Tumor resections Skull base surgery Cranial biopsies Craniotomies/ Craniectomies | Cranial Procedures: Tumor resections Skull base surgery Cranial biopsies Craniotomies/Craniectomies |
| GUI | Microscope functionality integrated in the
predicated device software | Microscope separated from predicated
device. Microscope specific views |
| Tracking
technology | passive, reflective markers | passive, reflective markers |
| | Predicate Device
VectorVision Cranial K082060 | Subject Device
Microscope Navigation |
| Changes to
Predicate
Device: | | Microscope Navigation separates microscope
specific functionality from the predicate
device.
Microscope Navigation adds a functionality to
adjust small deviations in patient to data set
registration (referred to as Registration
Update or Navigation Update in the technical
file). The adjustment is based on the
discrepancy between data to patient overlay |
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Verification summary:
| Test | Test Method Summary | Results |
|---|---|---|
| Microscope focus | ||
| point accuracy | The focal point crosshair is aligned to a | |
| landmark on a phantom for different | ||
| working distances. The distance | ||
| between landmark and focus point | ||
| measured by the IGS System. | The accuracy of the focus point in the focal | |
| plane is 1.2 mm +/- 0.5 mm (99th percentile | ||
| 2.4 mm). | ||
| The three-dimensional error including the | ||
| distance of the focus point is measured to | ||
| 1.9 mm +/- 1.0 mm (99th percentile 4.6 mm). | ||
| Navigation | ||
| Update | The Navigation Update is performed on | |
| a phantom for different initial registration | ||
| accuracies. The accuracy of the initial | ||
| accuracy is compared to the accuracy | ||
| after an update on landmarks on the | ||
| phantom. | The Navigation Update can improve | |
| registration errors. | ||
| For translations and rotations parallel to the | ||
| focus plane the Navigation Update is accurate | ||
| up to 0.8 mm +/- 0.3 mm (99th percentile | ||
| 1.4 mm). |
The subject device is part of a set of application of an IGS system. The errors above are measured under a OR setup conditions with optimal paired-point registrations. The ground accuracy provided by the subject device is sufficient to assess navigation accuracy repeatedly throughout a procedure and identify deviations.
The subject device uses identical calibration methods. The tracking method and algorithms are identical. Instrument design and marker geometry is unchanged. The subject device is substantial equivalent to its predecessor.
7
Validation summary:
The validation comprises usability tests which to ensure that the user interface can be used safely and effectively. All tests were rated as successfully passed according to their acceptance criteria. The non-clinical validation has been performed with software and equipment that are identical or equivalent to the final version of the product.