(260 days)
Not Found
Yes
The summary explicitly states, "With this submission, an already existing feature is now performed introducing a new algorithm using artificial intelligence and machine (AI/ML). This ML based functionality is used as an aid in the registration step (in surface matching) by allowing a pre-registration based on guide points which are delivered by this algorithm." It also mentions the use of a Convolutional Network (CNN) and supervised learning.
Yes
The device is intended to support surgeons in performing cranial stereotactic procedures, specifically for biopsy of intracranial lesions and placement of stereoelectroencephalography (SEGG) electrodes. These are medical procedures performed to diagnose or treat a disease or condition, which falls under the definition of a therapeutic device.
No.
The device is described as an image-guided surgery system intended to support a surgeon in planning and achieving trajectories for surgical instruments, primarily for biopsy and electrode placement. While it uses images and provides positional information, its core function is guidance during a procedure, not diagnosis.
No
The device description explicitly states that the Alignment System Cranial consists of a "combination of hardware and software" and lists several hardware components like a computer unit, touch display, infrared tracking camera, positioning devices (articulated arms), and indication-specific instruments.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is to support surgeons in planning and achieving trajectories for surgical instruments during cranial stereotactic procedures (biopsy and sEEG electrode placement). This is a surgical navigation and guidance system, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details a system that tracks the position of instruments in relation to patient anatomy using optical tracking and displays this information on medical images. It involves hardware like a computer, display, camera, and positioning devices, as well as software for planning and guidance. This aligns with the description of a surgical navigation system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information based on such analysis. The system's function is to guide surgical procedures based on imaging data and instrument tracking.
Therefore, the Alignment System Cranial is a surgical navigation and guidance system, not an In Vitro Diagnostic device.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / Indications for Use
Alignment System Cranial is intended to support the surgeon to plan and to achieve a trajectory with surgical instruments during cranial stereotactic procedures.
The indications for use are biopsy of intracranial lesions and placement of stereoelectroencephalography (SEGG) electrodes.
Product codes
HAW
Device Description
The subject device Alignment System Cranial is an image guided surgery system intended to support the surgeon to plan and to achieve a trajectory with surgical instruments during cranial stereotactic procedures using optical tracking technology.
For this purpose, the Alignment System Cranial consists of a combination of hardware and software. The Alignment Software Cranial with its sw components is installed on an Image Guided Surgery (IGS) platform (Curve, Curve Navigation 17700, Kick 2 Navigation Station or Buzz Navigation) consisting of a computer unit, a touch display and an infrared tracking camera. During surgery, the subject device tracks the position of instruments in relation to the patient anatomy and identifies this position on pre- or intraoperative images. The position of the surgical instruments is continuously updated on these images by optical tracking. This position information is used by the Alignment Software Cranial to align either passive or active positioning devices to a planned trajectory for subsequent surgical steps.
The Alignment System Cranial has different configurations of hardware devices depending on which positioning device is used and which indication is performed. The Alignment Software Cranial 2.0 supports the active positioning devices Surgical Base System 1.4 and Cirq Arm System 2.0 (+ Cirq Robotic Alignment Module + Cirq Robotic Disposable Kinematic Unit) as well as the passive positioning device Varioquide. Both types of positioning devices consist of articulated arms with different joints where additional devices and surgical instruments can be attached to for further robotic or manual alignment respectively to a defined trajectory.
In addition, the subject device offers a set of indication specific instruments to support biopsy and sEEG procedures. This instrumentation consists of instrument holders, tracking arrays, guide tubes, reduction tube, bone anchors, drill bits and depth stops. None of the instruments is delivered sterile. All patient contacting materials consist of different alloys of stainless steel.
Mentions image processing
Yes
Mentions AI, DNN, or ML
This ML based functionality is used as an aid in the registration step (in surface matching) by allowing a pre-registration based on guide points which are delivered by this algorithm. This pre-registration step is not mandatory. The AI/ML algorithm is a Convolutional Network (CNN) developed using a Supervised Learning approach.
Input Imaging Modality
Not Found
Anatomical Site
cranial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon, clinical environment
Description of the training set, sample size, data source, and annotation protocol
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 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 the test pool. The test pool data is set aside at the beginning of the project.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software Verification and Validation Testing: Included product specifications, risk analysis or incremental test strategies. Software was considered a "major" level of concern. Performance testing comparing conventional to machine learning based landmark detection was performed showing equivalent performance as in the third predicate device.
Usability Evaluation: Summative usability was carried out according to IEC 62366-1 in a simulated clinical environment to validate new use scenarios: Varioguide for biopsy and Cirq for sEEG workflows. Covered guidance provided by the updated Alignment Software Cranial, handling of instruments, assembly of positioning devices. Proven safe and effective.
System accuracy testing: Evaluated positional and angular navigation accuracy for biopsy and sEG procedures, including software, platforms, positioning devices and instruments in realistic clinical setup and worst case scenarios.
Key results:
- Mean Positional Error of the placed instrument's tip ≤ 2 mm
- Mean Angular Error of the placed instrument's axis ≤ 2°
Achieves same accuracy performance as the three predicate devices.
Electrical safety and electromagnetic compatibility (EMC): Compliance evaluated according to IEC 60601-1, AIM 7351731 and IEC 60601-1-2. Tests showed that the subject device performs as intended.
Instruments verification included:
- Biocompatibility assessment
- Cleaning and disinfection evaluation/reprocessing validation
- Mechanical properties of instruments by performing life cycle simulations and verification of clearance fits, material fatigue, functionality, etc.
- Stability performance testing for drill bits.
No clinical testing was needed as optical tracking technology in image guided surgery for the included indications is well established.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Mean Positional Error of the placed instrument's tip ≤ 2 mm
Mean Angular Error of the placed instrument's axis ≤ 2°
Predicate Device(s)
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).
0
September 9, 2023
Image /page/0/Picture/1 description: The image shows 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 consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
Brainlab AG Esther Moreno Garcia QM Consultant Olof-Palme-Str.9 Munich, 81829 Germany
Re: K223864
Trade/Device Name: Alignment System Cranial. Alignment Software Cranial. Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: August 10, 2023 Received: August 10, 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" in large, bold font on the left side of the image. On the right side of the image, it says "Digitally signed by Adam D. Pierce -S" followed by the date "2023.09.09" and the time "09:08:17-04'00'". The text on the right side of the image is smaller than the text on the left side of the image. The image appears to be a digital signature.
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) K223864
Device Name
Alignment System Cranial; Alignment Software Cranial;
Cirq Alignment Software Cranial Biopsy; Cirg Alignment Software Cranial sEEG;
Varioguide Alignment Software Cranial
Indications for Use (Describe)
Alignment System Cranial is intended to support the surgeon to plan and to achieve a trajectory with surgical instruments during cranial stereotactic procedures.
The indications for use are biopsy of intracranial lesions and placement of stereoelectroencephalography (SEGG) electrodes.
| 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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3
Image /page/3/Picture/1 description: The image shows the Brainlab logo. The logo consists of a stylized pink symbol on the left, resembling a brain or neural network. To the right of the symbol is the word "BRAINLAB" in bold, pink capital letters. The overall design is clean and modern.
510(k) Summary
August 10, 2023
| General Information | |
|---|---|
| Manufacturer | Brainlab AG; Olof-Palme-Str.9, 81829, Munich, Germany |
| Establishment Registration | 8043933 |
| Trade Name | Alignment System Cranial |
| Alignment Software Cranial | |
| Cirq Alignment Software Cranial Biopsy | |
| Cirq Alignment Software Cranial sEEG | |
| Varioguide Alignment Software Cranial | |
| Classification Name | Neurological Stereotaxic Instrument |
| Product Code | HAW |
| Regulation Number | 882.4560 |
| Regulatory Class | Class II |
| Panel | Neurology |
| Predicate Device(s) | Primary Predicate: K191597 Stealth Autoguide System |
| Secondary Predicate: K210989 Cirq Robotic Alignment System | |
| Third Predicate: K192703 Cranial Image Guided Surgery System | |
| Contact Information | |
| Primary Contact | Alternate Contact |
| Esther Moreno Garcia | Chiara Cunico |
| QM Consultant - Regulatory Affairs | Phone: +49 89 99 15 68 0 |
| Phone: +49 89 99 15 68 0 | Fax: +49 89 99 15 68 5033 |
| Email: regulatory.affairs@brainlab.com | Email: chiara.cunico@brainlab.com |
1. Indication for Use
Alignment System Cranial is intended to support the surgeon to plan and to achieve a trajectory with surgical instruments during cranial stereotactic procedures.
The indications for use are biopsy of intracranial lesions and placement of stereoelectroencephalography (SEEG) electrodes.
Device Description 2.
The subject device Alignment System Cranial is an image guided surgery system intended to support the surgeon to plan and to achieve a trajectory with surgical instruments during cranial stereotactic procedures using optical tracking technology.
4
Image /page/4/Picture/1 description: The image shows the Brainlab logo. The logo consists of a stylized pink symbol on the left, resembling a medical symbol or a stylized brain. To the right of the symbol is the word "BRAINLAB" in large, pink, sans-serif letters. The logo is simple and modern, with a focus on the company name.
For this purpose, the Alignment System Cranial consists of a combination of hardware and software. The Alignment Software Cranial with its sw components is installed on an Image Guided Surgery (IGS) platform (Curve, Curve Navigation 17700, Kick 2 Navigation Station or Buzz Navigation) consisting of a computer unit, a touch display and an infrared tracking camera. During surgery, the subject device tracks the position of instruments in relation to the patient anatomy and identifies this position on pre- or intraoperative images. The position of the surgical instruments is continuously updated on these images by optical tracking. This position information is used by the Alignment Software Cranial to align either passive or active positioning devices to a planned trajectory for subsequent surgical steps.
The Alignment System Cranial has different configurations of hardware devices depending on which positioning device is used and which indication is performed. The Alignment Software Cranial 2.0 supports the active positioning devices Surgical Base System 1.4 and Cirq Arm System 2.0 (+ Cirq Robotic Alignment Module + Cirq Robotic Disposable Kinematic Unit) as well as the passive positioning device Varioquide. Both types of positioning devices consist of articulated arms with different joints where additional devices and surgical instruments can be attached to for further robotic or manual alignment respectively to a defined trajectory.
In addition, the subject device offers a set of indication specific instruments to support biopsy and sEEG procedures. This instrumentation consists of instrument holders, tracking arrays, guide tubes, reduction tube, bone anchors, drill bits and depth stops. None of the instruments is delivered sterile. All patient contacting materials consist of different alloys of stainless steel.
With this submission, an already existing feature is now performed introducing a new algorithm using artificial intelligence and machine (AI/ML). This ML based functionality is used as an aid in the registration step (in surface matching) by allowing a pre-registration based on guide points which are delivered by this algorithm. This pre-registration step is not mandatory. The AI/ML algorithm is a Convolutional 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 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 the test pool. The test pool data is set aside at the beginning of the project. This is a static algorithm (locked).
The Alignment Software Cranial has the following accessories:
- . Automatic Registration providing an automatic registration for subsequent use.
- . Automatic Registration iMRI providing an automatic image registration for intraoperatively acquired MR images.
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Image /page/5/Picture/1 description: The image shows the Brainlab logo. The logo consists of a stylized brain icon on the left and the word "BRAINLAB" in capital letters on the right. The color of the logo is pink.
3. Substantial Equivalence
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| Characteristic | Primary Predicate
K191597 | Secondary Predicate
K210989 | Third Predicate
K192703 | Subject device |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
use | The Stealth Autoguide System
is a positioning and guidance
system intended for the
spatial positioning and
orientation of instrument
holders or tool guides to be
used by neurosurgeons to
guide standard neurosurgical
instruments, based on a pre-
operative plan and feedback
from an image-guided
navigation system with three-
dimensional imaging
software.
The Stealth Autoguide System
is a remotely-operated
positioning and guidance
system, indicated for any
neurological condition in
which the use of stereotactic
surgery may be appropriate
(for example, stereotactic
biopsy, stereotactic EEG, laser
tissue ablation, etc.). | The Cirq Robotic Alignment
Module is an intraoperative
robotic positioning system
and an accessory to
compatible Brainlab IGS
Cranial software applications.
Using spatial information
from an image guided
navigation system, the Cirq
Robotic Alignment Module
enables the surgeon to align
and hold surgical instruments
according to pre-planned
trajectories.
The Cirq Robotic Alignment
Module is indicated for
stereotactic biopsies of
intracranial lesions | 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 among others:
Cranial biopsies | Alignment System Cranial is
intended to support the
surgeon to plan and to
achieve a trajectory with
surgical instruments during
cranial stereotactic
procedures.
The medical indications for
use are biopsy of intracranial
lesions and placement of
stereo-
electroencephalography
(SEEG) electrodes. |
| Localization
technique | Optical markers on tool
holder | Infrared tracking camera is
recognizing infrared passive
markers | Infrared tracking camera is
recognizing infrared passive
markers | Same |
| | | Instrument tracking in
relation to the patients
anatomy. | Instrument tracking in
relation to the patients
anatomy. | |
| | | | | |
| | | | | |
| System accuracy | Under representative worst
case configuration: Mean
navigation accuracy of ±2 mm
and angular axis displacement
of ±2° | Under representative worst
case configuration: Mean
navigation accuracy of ±2 mm
and angular axis displacement
of ±2° | Under representative worst
case configuration: Mean
navigation accuracy of ±2 mm
and angular axis displacement
of ±2° | Same |
| Operating
principle | Preoperative images
(StealthStation)
Surgical planning
(StealthStation)
Patient registration
Guidance of instruments
Trajectory alignment | Preoperative images
Surgical planning
Patient registration
Guidance of instruments
Trajectory alignment with
Cirq Arm System plus Cirq
Robotic Alignment Module | Preoperative images
Surgical planning
Patient registration
Guidance of instruments
Trajectory alignment with
VarioGuide | Same
Subject device supports
alignment with both
VarioGuide or with Cirq Arm
System plus Cirq Robotic
Alignment Module |
| Planning
software | Compatible with:
S8 Cranial v1.1
Synergy Cranial v.3.1 | Compatible with:
Cranial 3.1
Trajectory 2.5 | Compatible with:
Cranial 3.1
Trajectory 2.5 | Same
In addition, Intra-op
trajectory planning feature
added to Alignment Software
Cranial |
| Alignment
Instrumentation | Navigated Trajectory Guide
Tool Holders (Drill Guides,
Reducing Tubes)
Height Guides
Tapping Tube | Cirq Arm System:
Instrument Holder Cranial +
Tracking Array Cranial
(Navigation and holding)
Cranial Drill Bit + Depth Stop
(Safe drilling)
Biopsy minimally invasive:
Guide Tube + Bone Anchor
(Holding and guiding of drill) | VarioGuide:
Biopsy with burr hole:
Compatible disc set (Biopsy
needle guidance) | Similar
Alignment instrumentation is
generally used in all devices
with a combination of
holders, guides and tubes.
Instrumentation has been
extended to support new
sEEG indication. |
| Instrument
fixation | Special tool holders for
different applications
mounted to the Stealth
AutoGuide | Cirq Robotic Disposable
Kinematic Unit to which
instrument holder is attached | Disc sets are mechanically
connected to the VarioGuide
assembly depending on
guiding diameter | Mechanical connection is
used in all devices for
instrument fixation. Identical
to predicate 2 and 3. |
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Image /page/6/Picture/1 description: The image shows the Brainlab logo. The logo consists of a stylized pink symbol on the left and the word "BRAINLAB" in pink capital letters on the right. The symbol appears to be a stylized representation of the brain.
7
Image /page/7/Picture/1 description: The image features the Brainlab logo, which is rendered in a vibrant pink color. To the left of the word "BRAINLAB" is a stylized graphic, also in pink, that appears to be a representation of the brain. The text "BRAINLAB" is written in a bold, sans-serif font, making it easily readable and prominent within the logo.
| Alignment
process | Fine alignment robotically
performed by Autoguide | Rough alignment:
Manual positioning of Cirq
Arm System with Autopilot
feature (Alignment Software)
close to final position
Fine alignment:
Robotic movement of Cirq
Robotic Alignment Module | Rough and fine alignment by
manual positioning of
VarioGuide along planned
trajectory with Autopilot
feature (Cranial Navigation) | Similar alignment process as
Predicate 1 and identical to
Predicates 2 and 3. |
|-------------------------|------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Patient
Registration | Optical Registration Device
(via StealthStation) | Optical registration from
Cranial 3.1
Methods: Surface matching,
landmark registration
Surface matching: No pre-
registration available. | Optical registration
(Registration 3.5)
Methods: Surface matching,
landmark registration.
Surface matching: Detection
of anatomical landmarks in
pre-registration based on an
atlas of the human anatomy. | Optical registration
(Registration 3.6). Same
registration methods as in
Brainlab predicates.
Compared to Predicate 3,
overall functionality is the
same, but landmarks (used
for pre-registration) are
delivered by an Al/ML based
method.
Testing demonstrated there
are no concerns regarding
safety and effectiveness. |
| IGS Platforms | StealthStation surgical
navigation platform
consisting of computer, touch
monitor and stereotactic
camera. | Curve, Kick and Buzz
Navigation models are used,
consisting of computer, touch
monitor and IR camera. | Curve, Kick and Buzz
Navigation models are used,
consisting of computer, touch
monitor and IR camera. | Similar to predicates.
Modified platforms (Kick 2
Navigation Station and Buzz
Navigation) and new platform
model (Curve Navigation
17700) but with overall same
components and operating
principle. |
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Image /page/8/Picture/0 description: The image shows the Brainlab company logo. The logo consists of a stylized caduceus symbol on the left, followed by the word "BRAINLAB" in all capital letters. The color of the logo is a bright pink.
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 landmark detection feature in the pre-registration step now implemented using AI/ML, performance testing comparing conventional to machine learning based landmark detection was performed showing equivalent performance as in the third 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 to validate the new use scenarios: Varioguide for biopsy and Cirq for sEEG workflows. This covered aspects such as the guidance provided by the updated Alignment Software Cranial, the handling of instruments or the assembly of the positioning devices with overall focus on new or changed features. The final designs were proven safe and effective for use in the defined use scenarios.
System accuracy testing
The positional and angular navigation accuracy for biopsy and sEG procedures of the Subject Device including the software, the platforms, the positioning devices 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 Angular Error of the placed instrument's axis ≤ 2°
Therefore, the Subject Device achieves the same accuracy performance as the three predicate devices considered.
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. The tests have shown that the subject device performs as intended.
Instruments
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Image /page/9/Picture/1 description: The image shows the Brainlab logo. The logo consists of a stylized pink symbol on the left, resembling a brain with interconnected pathways. To the right of the symbol, the word "BRAINLAB" is written in bold, pink capital letters.
Instruments verification included:
- . Biocompatibility assessment considering the materials used in the devices, manufacturing, processing, biological and chemical test data, and the history of safety and effectiveness of the device materials in contact with the human body.
- Cleaning and disinfection evaluation/reprocessing validation.
- . Mechanical properties of instruments by performing life cycle simulations and verification of clearance fits, material fatigue, functionality, etc.
- . Stability performance testing was performed in selected worst case situations for the drill bits to ensure they can withstand the loads they might be exposed to during use.
No clinical testing was needed for the Subject Device since optical tracking technology in the scope of image guided surgery for the included indications for use is well established in the market.
5. Conclusion
The comparison of the Subject Device with the predicate devices shows that the Alignment System Cranial has similar functionality, intended use and technological characteristics as the predicate devices. Based on the comparison to the predicates and the performance testing conducted, the Subject Device is considered substantially equivalent to the predicate devices.