(269 days)
Yes
The summary explicitly mentions "machine learning based landmark detection and abnormity detection" and describes training and test sets for a model.
No
This device is an image-guided planning and navigation system for surgical procedures, not a therapeutic device. It helps surgeons plan and navigate, but it does not directly treat the medical condition.
No
The device is an image-guided planning and navigation system for surgical procedures, not a device used to diagnose medical conditions.
No
The device description explicitly states that the system consists of "several devices" including "IGS platforms" which are described as hardware components like "mobile Monitor Cart or a fixed ceiling mounted display and an infrared camera" and "EM tracking unit". It also includes "Surgical instruments for navigation, patient referencing and registration". This indicates the device is not software-only.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples from the human body. The intended use and device description clearly state that this system is used for image-guided planning and navigation during surgical procedures on the patient's anatomy (cranial and craniofacial). It uses imaging data (CT, MR, etc.) of the patient's anatomy, not samples taken from the patient's body (like blood, urine, tissue biopsies, etc.) that are analyzed outside the body.
- The purpose is surgical guidance, not diagnosis. The system's function is to help surgeons navigate instruments relative to the patient's anatomy based on pre-operative or intra-operative images. It is not used to diagnose a disease or condition by analyzing biological samples.
The device is a surgical navigation system, which falls under the category of medical devices used for image-guided surgery.
No
The provided document does not contain any explicit statement that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
Cranial Navigation
The Cranial Navigation is intended as image-guided planning and navigation system to enable navigated cranial surgery. It links instruments to a virtual computer image data being processed by the navigation platform. 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, including:
- Cranial Resection
- · Resection of tumors and other lesions
- · Resection of skull-base tumor or other lesions
- · AVM Resection
- · Craniofacial Procedures (including cranial and midfacial bones)
- · Tumor Resection
- Bone Tumor Defect Reconstruction
- · Bone Trauma Defect Reconstruction
- · Bone Congenital Defect Reconstructions
- · Orbital cavity reconstruction procedures
- · Removal of foreign objects
Cranial EM System
Cranial EM is intended as an image-guided planning and navigation system to enable neurosurgery procedures. The device 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, such as:
- · Cranial Resection
- o Resection of tumors and other lesions
- o Resection of skull-base tumor or other lesions
- · Intracranial catheter placement
Product codes
HAW
Device Description
The subject device consists of several devices: Cranial Navigation using optical tracking technology, its accessory Automatic Registration iMRI, and Cranial EM System using electromaqnetic tracking technology.
Cranial Navigation is an image guided surgery system for navigated treatments in the field of cranial surgery, including the newly added Craniofacial indication. It offers different patient image registration methods and instrument calibration to allow surgical navigation by using optical tracking technology. The device provides different workflows guiding the user through preoperative and intraoperative steps.
The software is installed on a mobile or fixed Image Guided Surgery (IGS) platform to support the surgeon in clinical procedures by displaying tracked instruments in patient's image data. The IGS platforms consist of a mobile Monitor Cart or a fixed ceiling mounted display and an infrared camera for image guided surgery purposes. There are three different product lines of the IGS platforms: "Curve", "Kick" and Buzz Navigation (Ceiling-Mounted).
Cranial Navigation consists of:
- . Several software modules for registration, instrument handling, navigation and infrastructure tasks (main software: Cranial Navigation 4.1 including several components)
- . IGS platforms (Curve Navigation 17700, Kick 2 Navigation Station, Buzz Navigation (Ceiling-Mounted) and predecessor models)
- . Surgical instruments for navigation, patient referencing and registration
Automatic Registration iMRI is an accessory to Cranial Navigation enabling automatic image registration for intraoperatively acquired MR imaging, The registration object can be used in subsequent applications (e.g. Cranial Navigation 4.1). It consists of the software Automatic Registration iMRI 1.0, a registration matrix and a reference adapter.
Similarly, the Cranial EM System, is an image-guided planning and navigation system to enable neurosurgical procedures. It offers instrument handling as well as patient registration to allow surqical navigation by using electromagnetic tracking technology.
It links patient anatomy (using a patient reference) and instruments in the real world or "patient space" to patient scan data or "imaqe space". This allows for the continuous localization of medical instruments and patient anatomy for medical interventions in cranial procedures. It uses the same software infrastructure components as the Cranial Navigation, and the software is also installed on IGS platforms consisting of a mobile monitor cart and an EM tracking unit. It consists of:
- Different software modules for instrument set up, registration and navigation (Main software: Cranial EM 1.1 including several components)
- EM IGS platforms (Curve Navigation 17700 and Kick 2 Navigation Station EM)
- Surgical instruments for navigation, patient referencing and registration
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
CT, CTA, X-Ray, MR, MRA and ultrasound
Anatomical Site
Cranial, Craniofacial (including cranial and midfacial bones)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
The training process begins with the model observing, learning, and optimizing its parameters based on the training pool data.
Description of the test set, sample size, data source, and annotation protocol
The model's prediction and performance are then evaluated against a test pool data is set aside at the beginning of the project. This is a static algorithm (locked).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software Verification and Validation Testing:
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." This included product specifications, risk analysis or incremental test strategies. The software for this device was considered as a "major" level of concern.
For the two features now implemented using AI/ML (landmark detection in the pre-registration step and centering of views if no instrument is tracked to the detected abnormity), performance testing comparing conventional to machine learning based landmark detection and abnormity detection were performed showing equivalent performance as in the predicate device.
Usability Evaluation:
Summative usability was carried out according to the standard IEC 62366-1 "Medical devices – Part 1: Application of usability engineering to medical devices" in a simulated clinical environment for the new Craniofacial indication.
System accuracy testing:
The positional and angular navigation accuracy for cranial procedures of the Subject Device including the software, the platforms and the instruments was evaluated considering a realistic clinical setup and representative worst case scenarios. The results show the following acceptance criteria are fulfilled:
- Mean Positional Error of the placed instrument's tip
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 21, 2023
Brainlab AG Esther Moreno Garcia OM Consultant Regulatory Affairs Olof-Palme-Str. 9 Munich, 81829 Germany
Re: K223288
Trade/Device Name: Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: June 20, 2023 Received: June 20, 2023
Dear Esther Moreno Garcia:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/5 description: The image shows the name "Adam D. Pierce -S" on the left side of the image. On the right side of the image, the text "Digitally Adam D. Date: 202 11:03:25" is present. The text on the right side of the image appears to be a digital signature. The text is black and the background is white.
Digitally signed by Adam D. Pierce -S Date: 2023.07.21 11:03:25 -04'00'
Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223288
Device Name
Cranial Navigation Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI
Indications for Use (Describe) Cranial Navigation
The Cranial Navigation is intended as image-guided planning and navigation system to enable navigated cranial surgery. It links instruments to a virtual computer image data being processed by the navigation platform. 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, including:
- Cranial Resection
- · Resection of tumors and other lesions
- · Resection of skull-base tumor or other lesions
- · AVM Resection
- · Craniofacial Procedures (including cranial and midfacial bones)
- · Tumor Resection
- Bone Tumor Defect Reconstruction
- · Bone Trauma Defect Reconstruction
- · Bone Congenital Defect Reconstructions
- · Orbital cavity reconstruction procedures
- · Removal of foreign objects
Cranial EM System
Cranial EM is intended as an image-guided planning and navigation system to enable neurosurgery procedures. The device 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, such as:
- · Cranial Resection
- o Resection of tumors and other lesions
- o Resection of skull-base tumor or other lesions
- · Intracranial catheter placement
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
510(k) Summary
July 21, 2023
| General Information | |
|---|---|
| Manufacturer | Brainlab AG; Olof-Palme-Str.9, 81829, Munich, Germany |
| Establishment Registration | 8043933 |
| Trade Name | • Cranial Navigation |
| • Navigation Software Cranial | |
| • Navigation Software Craniofacial | |
| • Cranial EM System | |
| • Automatic Registration iMRI | |
| Classification Name | Neurological Stereotaxic Instrument |
| Product Code | HAW |
| Regulation Number | 882.4560 |
| Regulatory Class | Class II |
| Panel | Neurology |
| Predicate Device(s) | Primary Predicate: K192703 Cranial Image Guided Surgery System |
| Secondary Predicates: K162929 Stryker Navigation System | |
| K213989 Cranial EM System | |
| Contact Information | |
| Primary Contact | Alternate Contact |
| Esther Moreno Garcia | |
| QM Consultant - Regulatory Affairs | |
| Phone: +49 89 99 15 68 0 | |
| Email: regulatory.affairs@brainlab.com | Chiara Cunico |
| Phone: +49 89 99 15 68 0 | |
| Fax: +49 89 99 15 68 5033 | |
| Email: chiara.cunico@brainlab.com |
1. Indication for Use
Cranial Navigation
The Cranial Navigation is intended as image-guided planning and navigation system to enable navigated cranial surgery. It links instruments to a virtual computer image space on patient image data being processed by the navigation platform.
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, including:
- Cranial Resection
- · Resection of tumors and other lesions
- Resection of skull-base tumor or other lesions
5
- AVM Resection
- Craniofacial Procedures (including cranial and midfacial bones)
- · Tumor Resection
- Bone Tumor Defect Reconstruction
- Bone Trauma Defect Reconstruction
- · Bone Congenital Defect Reconstructions
- · Orbital cavity reconstruction procedures
- · Removal of foreign objects
Cranial EM System
Cranial EM is intended as an image-guided planning and navigation system to enable neurosurgery procedures.
The device 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, such as:
- · Cranial Resection
- o Resection of tumors and other lesions
- o Resection of skull-base tumor or other lesions
- · Intracranial catheter placement
2. Device Description
The subject device consists of several devices: Cranial Navigation using optical tracking technology, its accessory Automatic Registration iMRI, and Cranial EM System using electromaqnetic tracking technology.
Cranial Navigation is an image guided surgery system for navigated treatments in the field of cranial surgery, including the newly added Craniofacial indication. It offers different patient image registration methods and instrument calibration to allow surgical navigation by using optical tracking technology. The device provides different workflows guiding the user through preoperative and intraoperative steps.
The software is installed on a mobile or fixed Image Guided Surgery (IGS) platform to support the surgeon in clinical procedures by displaying tracked instruments in patient's image data. The IGS platforms consist of a mobile Monitor Cart or a fixed ceiling mounted display and an infrared camera for image guided surgery purposes. There are three different product lines of the IGS platforms: "Curve", "Kick" and Buzz Navigation (Ceiling-Mounted).
Cranial Navigation consists of:
- . Several software modules for registration, instrument handling, navigation and infrastructure tasks (main software: Cranial Navigation 4.1 including several components)
6
- . IGS platforms (Curve Navigation 17700, Kick 2 Navigation Station, Buzz Navigation (Ceiling-Mounted) and predecessor models)
- . Surgical instruments for navigation, patient referencing and registration
With this submission, several already existing features are now performed introducing a new algorithm using artificial intelligence and machine learning (AI/ML). This ML based functionality is used for the detection of inside-brain abnormities in T1-Weighted Contrast-Enhanced Magnetic Resonance (T1+C MR) volumetric images to allow a more convenient centering of the views and as an aid in the registration step (in surface matching) by allowing a pre-registration based on guide points. This pre-reqistration step is not mandatory. The Al/ML algorithm is a Convolutional Neuronal Network (CNN) developed using a Supervised Learning approach. The algorithm was developed using a controlled internal process that defines activities from the inspection of input data to the training and verification of the algorithm. The training process begins with the model observing, learning, and optimizing its parameters based on the training pool data. The model's prediction and performance are then evaluated against a test pool data is set aside at the beginning of the project. This is a static algorithm (locked).
Automatic Registration iMRI is an accessory to Cranial Navigation enabling automatic image registration for intraoperatively acquired MR imaging, The registration object can be used in subsequent applications (e.g. Cranial Navigation 4.1). It consists of the software Automatic Registration iMRI 1.0, a registration matrix and a reference adapter.
Similarly, the Cranial EM System, is an image-guided planning and navigation system to enable neurosurgical procedures. It offers instrument handling as well as patient registration to allow surqical navigation by using electromagnetic tracking technology.
It links patient anatomy (using a patient reference) and instruments in the real world or "patient space" to patient scan data or "imaqe space". This allows for the continuous localization of medical instruments and patient anatomy for medical interventions in cranial procedures. It uses the same software infrastructure components as the Cranial Navigation, and the software is also installed on IGS platforms consisting of a mobile monitor cart and an EM tracking unit. It consists of:
- Different software modules for instrument set up, registration and navigation (Main software: Cranial EM 1.1 including several components)
- EM IGS platforms (Curve Navigation 17700 and Kick 2 Navigation Station EM) ●
- Surgical instruments for navigation, patient referencing and registration ●
It uses the same artificial intelligence/machine learning algorithm as Cranial Navigation to support the registration step by allowing a pre-registration based on guide points/landmarks.
3. Substantial Equivalence
7
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Cranial Navigation:
| Characteristic | Primary Predicate | Secondary Predicate | Subject device |
|---|---|---|---|
| K192703 | K162929 | ||
| Indications for | |||
| use | The Cranial IGS System, | ||
| when used with a | |||
| compatible navigation | |||
| platform and compatible | |||
| instrument accessories, is | |||
| intended as an image- | |||
| guided planning and | |||
| navigation system to | |||
| enable navigated surgery. | |||
| It links instruments to a | |||
| virtual computer image | |||
| space on patient image | |||
| data that is being | |||
| processed by | |||
| the | |||
| navigation platform. | |||
| 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, including: | |||
| • Cranial Resection |
- Resection of tumors and
other lesions - Resection of skull-base
tumor or other lesions - AVM Resection
• Cranial biopsies
• Intracranial catheter
placement
• Intranasal structures and
Paranasal Sinus Surgery - Functional endoscopic
sinus surgery (FESS) - Revision & distorted
anatomy surgery all
intranasal structures and
paranasal sinuses | The Stryker Navigation
System, with the
CranialMap software
application, is intended as
a planning and
intraoperative guidance
system to enable open or
percutaneous computer
assisted surgery.
The system is indicated for
any medical condition in
which the use of
computer-assisted
planning and surgery may
be appropriate. The
system can be used for
intraoperative guidance
where a reference to a
rigid anatomical structure
can be identified.
The system should be
operated only by trained
personnel such as
surgeons and clinic staff.
The system assists in the
positioning of instruments
for cranial procedures,
including: - Cranial biopsies
- Puncture of abscesses
- Craniotomies
- Craniectomies
- Resection of tumors and
other lesions - Removal of foreign
objects - Skull base procedures
- Transnasal neurosurgical
procedures - Transphenoidal pituitary
surgery - Shunt placement,
including pediatric shunt
placement | Compared to primary
predicate same cranial
resection indications.
Craniofacial indications
are newly added and are
equivalent to the
secondary predicate. |
| | | | |
| | | - Placement of electrodes
for recording, stimulation
and lesion generation - Endoscopic Sinus Surgery
(ESS) - Intranasal procedures
- Ear implant procedures
- Craniofacial procedures
- Skull reconstruction
procedures - Orbital cavity
reconstruction
procedures | |
| Mechanism
of
Action | Infrared tracking camera is
recognizing infrared
passive markers
Instrument tracking in
relation to the patients
anatomy. | Active wireless optical
tracking via infrared (IR)
LED signal detection by
the camera. Instrument
tracking in relation to the
patients anatomy. | Same as primary
predicate, similar to
secondary
device. |
| System accuracy | Mean navigation accuracy
of ±2 mm and angular axis
displacement of ±2° | Mean navigation accuracy
of ±2 mm and angular axis
displacement of ±2° | Same |
| Supported
imaging
modalities | CT, CTA, MR, MRA, US and
PET | CT, CTA, MR, MRA, MRI,
fMRI, DTI, PET and SPECT | Same as primary predicate
and similar to secondary
predicate |
| Programming
language | C++ and C# (user
interface) | C and C++ | Similar to both, subject
device uses HTML5 for GUI |
| Operating
System | Microsoft Windows 7,
Microsoft Windows 8.1 | Windows XP Embedded
(SPC 3.0)
Windows 8.1 (SPC3.1)
Off the shelf (OTS) Service
Pack 3 | Similar. Win 8.1 and
Win10 are used to have
latest technology. |
| Align views to
view centroid
with abnormity
detection | Detection of abnormities
based on an atlas of the
human anatomy to allow a
more convenient
centering of views. | N/A | Compared to the primary
predicate device, overall
functionality is the same,
but the abnormity is
detected by an AI/ML
based method. If not all
requirements are met the
previous detection based
on an atlas of the human
anatomy is used, as a
fallback.
Testing demonstrated
that, both precision and
recall of the ML-based
method are higher in
comparison to the atlas-
based method. Thus, the
change in functionality
does not yield any new
concerns regarding safety |
| | | | and effectiveness of the
device. |
| Detection of
anatomical
landmarks/guide
points | Detection of anatomical
landmarks based on an
atlas of the human
anatomy. | N/A | Compared to the primary
predicate device, overall
functionality is the same,
but landmarks (used for
calculation of a pre-
registration) are delivered
by a AI/ML based method.
Testing demonstrated
there are no concerns
regarding safety and
effectiveness. |
| IGS Platforms | Curve, Kick and Buzz
Navigation models are
used, consisting of
computer, touch monitor
and IR camera. | The Stryker platform
consists of a computer, a
monitor, an IR camera,
and IO -Tablet
(input/output). | Similar to predicates.
Modified and new
platform models but with
overall same design and
operating principle. |
| Instruments | Instrumentation for
patient referencing,
registration and
navigation.
Compatible instruments
from KLS Martin. | N/A | Same instrumentation.
Former KLS Martin
Instruments are now
legally manufactured by
Brainlab. |
8
9
Accessory Automatic Registration iMRI:
| Characteristic | Primary Predicate K192703 | Subject device |
|---|---|---|
| Supported image | ||
| modalities | MR | Same |
| Supported | ||
| instruments | Optical standard pointer, Softouch, | |
| calibrated instrument | Similar. Subject device restricts | |
| support to optical standard pointer | ||
| and the Softouch Pointer | ||
| Workflow steps | Data selection, registration calculation, | |
| verify result and adjustments if needed. | Same steps with updated GUI. | |
| Hardware | Matrix and adapter | Similar matrix and adapter. Different |
| design with same characteristics. | ||
| Structure | Functionality as a feature within the | |
| Cranial 3.1 application | Separate application as an accessory | |
| to the navigation. |
Cranial EM System:
| Characteristic | Third Predicate K213989 | Subject device |
|---|---|---|
| Indications for use | Cranial EM is intended as an image- | |
| guided planning and navigation system | ||
| to enable neurosurgery procedures. | Same |
10
| | The device 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,
such as:
•Cranial Resection
-Resection of tumors and other lesions
-Resection of skull-base tumor or
other lesions
•Intracranial catheter placement | |
|-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Tracking
technology | Electromagnetic tracking | Same |
| System accuracy | Mean navigation accuracy of ±2 mm and
angular axis displacement of ±2° | Same |
| Functionality | Functionality for device set up,
registration and navigation. | Same |
| Programming
language | C++ | Same |
| Detection of
anatomical
landmarks/guide
points
(in surface
matching
registration) | Detection of anatomical landmarks
based on an atlas of the human
anatomy. | Compared to the predicate device,
overall functionality is the same, but
landmarks (used for pre-registration)
are delivered by an AI/ML based
method.
Testing demonstrated there are no
concerns regarding safety and
effectiveness. |
| EM IGS Platforms | Curve Navigation 17700 and Kick 2
Navigation Station EM | Same |
| Instruments | Instrumentation for patient referencing,
registration and navigation.
Compatible 3rd party instruments from
KLS Martin. | Same instrumentation.
Former KLS Martin Instruments are now
legally manufactured by Brainlab. |
4. Performance Data
The following testing was conducted on the Subject Device to establish substantial equivalence with the predicate devices:
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." This included product specifications, risk analysis or incremental test strategies. The software for this device was considered as a "major" level of concern.
For the two features now implemented using AI/ML (landmark detection in the pre-registration step and centering of views if no instrument is tracked to the detected abnormity), performance testing
11
comparing conventional to machine learning based landmark detection and abnormity detection were performed showing equivalent performance as in the predicate device.
Usability Evaluation
Summative usability was carried out according to the standard IEC 62366-1 "Medical devices – Part 1: Application of usability engineering to medical devices" in a simulated clinical environment for the new Craniofacial indication.
System accuracy testing
The positional and angular navigation accuracy for cranial procedures of the Subject Device including the software, the platforms and the instruments was evaluated considering a realistic clinical setup and representative worst case scenarios. The results show the following acceptance criteria are fulfilled:
- . Mean Positional Error of the placed instrument's tip ≤ 2 mm
- Mean Anqular Error of the placed instrument's axis ≤ 2º .
Electrical safety and electromagnetic compatibility (EMC)
Compliance to electrical safety, RFID and EMC was evaluated on the Subject device according to the standards: IEC 60601-1, AIM 7351731 and IEC 60601-1-2.
Instruments
Instruments verification included:
- Biocompatibility assessment
- . Cleaning and disinfection evaluation/reprocessing
- Mechanical properties of instruments
- . Aging performance
- . MRI testing (where applicable)
No clinical testing was needed for the Subject Device.
5. Conclusion
The comparison of the Subject Device with the predicate devices shows that Cranial Navigation and its accessory Automatic Registration iMRI and Cranial EM System have similar functionality, intended use and technological characteristics as the predicate device(s). Based on the comparison to the predicates and the performance testing conducted, the Subject Device is considered substantially equivalent to the predicate devices.