(377 days)
Not Found
No
The summary describes a standard image-guided surgery system that links instruments to patient image data for navigation. There is no mention of AI, ML, or any related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML models. The performance studies focus on accuracy metrics common to navigation systems, not AI/ML model performance.
No
The device is an image-guided planning and navigation system for surgery, which assists the surgeon but does not directly treat the patient.
No
This device is for image-guided surgical planning and navigation, assisting in procedures like resections and biopsies, rather than diagnosing a condition.
No
The device description explicitly states that the Cranial IGS System consists of both software and hardware components (instruments).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Cranial IGS System is an image-guided surgery system. Its purpose is to assist surgeons during procedures by providing navigation and localization of instruments relative to patient anatomy based on medical images. It does not perform any tests on biological samples.
- Intended Use: The intended use clearly describes a system for surgical planning and navigation, not for analyzing biological samples.
- Device Description: The description focuses on software and hardware for tracking instruments and patient anatomy in a surgical setting.
- Performance Studies: The performance studies described relate to the accuracy of the navigation system in terms of location and trajectory error, not the performance of a diagnostic test.
Therefore, the Cranial IGS System falls under the category of a surgical navigation system, which is a medical device used during surgical procedures, not an in vitro diagnostic device.
N/A
Intended Use / 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
Product codes (comma separated list FDA assigned to the subject device)
HAW
Device Description
The Cranial IGS System consists of software and hardware (instruments) components that when used with a compatible navigation or "IGS platform" enables navigated surgery. It links instruments in the real world or "patient scan data or "image space". This allows for the continuous localization of medical instruments and patient anatomy for medical interventions in cranial and ENT procedures.
Mentions image processing
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.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, CTA, X-Ray, MR, MRA and ultrasound
Anatomical Site
Cranial, Intranasal structures, Paranasal Sinus
Indicated Patient Age Range
There are no demographic, regional or cultural limitations for patients.
Intended User / Care Setting
The application is intended to be used by medical professionals who perform neurosurgery and ENT surgery (e.g. neurosurgeons, surgeons' assistants and operating room personnel).
The system is developed to run on Brainlab IGS Platform, which shall be used in hospital environments, specifically in rooms which are appropriate for surgical interventions (e.g. operation rooms).
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 has been performed according to the Verification Plan and following internal processes to demonstrate that design specifications are met by the device.
The software changes have been tested in accordance with the Brainlab software development life cycle process. Verification and validation testing activities were performed at the software system, integration, and component levels to show sufficient implementation of the changes as per the specifications. Software testing conducted includes:
- System level software verification
- Accuracy testing
- Integration tests with other Brainlab software applications and IGS platforms
- Component level code verification
Furthermore, in accordance with the design controls process, the following tests were deemed required to evaluate the Cranial IGS System performance across the hardware and electrical components:
- Electrical safety
- Electromagnetic compatibility (EMC)
- Biocompatibility
- Sterilization
All testing was utilized to verify the subject device performance as intended.
Validation of the functionalities, including nonclinical performance tests (accuracy tests, see below), has been performed in accordance with the internal processes.
Usability tests have been performed as well to ensure that the device can be used safely and that measures against potential use related risks are effective.
Nonclinical performance testing (Accuracy): The system has a mean accuracy of 2 mm for location error and 2° for trajectory angle error.
The following table summarizes the performance verification results of the system:
- Location error: Mean 1.3 mm, Standard deviation 0.5 mm, 99th percentile 2.2 mm
- Trajectory angle error: Mean 0.73°, Standard deviation 0.34°, 99th percentile 1.3°
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" above the word "ADMINISTRATION".
October 8, 2020
Brainlab AG Chiara Cunico Manager Regulatory Affairs Olof-Palme-Str. 9 Munich, 81829 DE
Re: K192703
Trade/Device Name: Cranial Image Guided Surgery System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: September 2, 2020 Received: September 8, 2020
Dear Chiara Cunico:
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 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
1
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 (OS) 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,
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) K192703
Device Name
Cranial Image Guided Surgery System
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
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
510(K) SUMMARY CRANIAL IMAGE GUIDED SURGERY SYSTEM
IN ACCORDANCE WITH REQUIREMENTS OF 21 CFR PART 807.92
| GENERAL INFORMATION | ||
|---|---|---|
| Manufacturer: | Brainlab AG | |
| Olof-Palme-Straße 9 | ||
| 81829 Munich | ||
| Germany | ||
| Ph: + 49-899915681 0 | ||
| Fax: +49 89 991568 5033 | ||
| Establishment Registration #: | 8043933 | |
| Date of preparation: | October 8th, 2020 | |
| Device Name: | Cranial Image Guided Surgery System | |
| Trade Name(s): | Navigation Software Cranial | |
| Navigation Software ENT | ||
| Registration Software Cranial | ||
| Automatic Registration 2.0 | ||
| Ultrasound Navigation Software (BK) | ||
| Intraoperative Structure Update | ||
| Classification Name: | Neurological Stereotaxic Instrument, 21 CFR 882.4560 | |
| Classification Product Code | HAW | |
| Review Panel: | Neurology | |
| Device Class: | Class II | |
| Primary Predicate Device: | K092467, Cranial Image Guided Surgery System, by Brainlab AG | |
| Secondary Predicate Device: | K070106, VectorVision Fluoro 3D, by Brainlab AG |
4
| CONTACT INFORMATION | |
|---|---|
| Primary contact person | Alternative contact person |
| Chiara Cunico | Regulatory Affairs Brainlab |
| Manager RA | Email: regulatory.affairs@brainlab.com |
| phone: +49 89 99 15 68 1738 | phone: +49 89 99 15 68 0 |
| Email: Chiara.cunico@brainlab.com | fax: +49 89 99 15 68 5033 |
INTENDED USE / INDICATIONS FOR USE
Cranial IGS System:
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
DEVICE DESCRIPTION
The Cranial IGS System consists of software and hardware (instruments) components that when used with a compatible navigation or "IGS platform" enables navigated surgery. It links instruments in the real world or "patient scan data or "image space". This allows for the continuous localization of medical instruments and patient anatomy for medical interventions in cranial and ENT procedures.
OPERATOR PROFILE
The application is intended to be used by medical professionals who perform neurosurgery and ENT surgery (e.g. neurosurgeons, surgeons' assistants and operating room personnel).
PATIENT POPULATION
There are no demographic, regional or cultural limitations for patients.
INTENDED USE ENVIRONMENT
The system is developed to run on Brainlab IGS Platform, which shall be used in hospital environments, specifically in rooms which are appropriate for surgical interventions (e.g. operation rooms).
5
OPERATING PRINCIPLE
The operating principle of the subject device is the following:
- Infrared tracking: An infrared camera recognizes an infrared passive marker array which is in a fix position to the patient's head. Suitable instruments can be spatially tracked with respect to this marker array.
Alignment of the patient's anatomy to the digital patient image data is performed through localizing surface skin points or landmarks points to the patient (this step is also known as registration). In addition for automatic registration methods, the alignment of the patient's anatomy to the digital patient image data is performed through coordinate transformations of localizing markers. This enables representing the position of a tracked instrument in relation to the patient's anatomy in digital patient image data (this step is also known as navigation). The Subject device interfaces with other Brainlab applications which provides, e.g. planning data.
INTENDED PART OF THE BODY OR TYPE OF TISSUE APPLIED TO OR INTERACTED WITH
The intended part of body depends on the instrument used. Whereas the navigation software does not have any patient contact, some instruments are designed to be used in a sterile environment and also for getting in contact with the patient's bone or soft tissue.
REASON FOR 510(K) SUBMISSION
Additional indication and other changes that do not affect the fundamental scientific technology of the device.
SUBSTANTIAL EQUIVALENCE
The functionality of the subject device has been previously included in the Predicate Devices. The Subject Device specifically takes over the functionalities from the primary predicate device and moved them to separate applications to have dedicated applications for specific tasks. It takes over the ability to navigate on 2D fluoroscopic images, specially, Digital Subtraction Angiographies for arteriovenous malformation resection.
6
| Technological
Characteristics
of the Subject Device in
comparison to the primary
predicate device | | Cleared device
feature/specifications | Modified device
feature/specifications |
|---------------------------------------------------------------------------------------------------------------|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Intended Use /
Indications for Use | Cranial Image Guided
Surgery System (K092467)
The 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
Pediatric Catheter
Shunt Placement
General Catheter Shunt
Placement
Thalamotomies/
Palliodotomies
ENT Procedures
Transphenoidal procedures
Maximillary antrostomies
Ethmoidectomies
Spheno-idotomies/
sphenoid explorations
Turbinate resections
Frontal sinusotomies
Intranasal procedures | Cranial Image Guided
Surgery System
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 on
all intranasal
structures and
paranasal sinuses |
| | Brainlab IGS
Platform | Brainlab Kolibri
Brainlab Vector Vision | Brainlab Kick
Brainlab Curve |
7
Technological
Characteristics
of the Sibject
Device in
comparison to the
secondary predicate device
| Brainlab Buzz IGS | ||
|---|---|---|
| Operating Systems | Windows XP | Windows 7 |
| Windows 8.1 | ||
| Windows 10 | ||
| Data Inputs | Equivalent | |
| Tracking | ||
| Technology | Equivalent | |
| Navigation Features | Equivalent | |
| Angio Navigation | ||
| Views | Navigation of CTA and | |
| MRA | Navigation of 2D DSA | |
| images | ||
| Pre-calibrated | ||
| Instrument Tracking | Equivalent | |
| Calibrated | ||
| Instrument Tracking | Equivalent |
| | Cleared device
feature/specifications | Modified device
feature/specifications |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | VectorVision Fluoro 3D
(K070106) | Cranial Image Guided
Surgery System |
| Intended Use /
Indications for Use | Brainlab Vector Vision
fluoro3D is intended as an
intraoperative image-
guided localization system
to enable minimally
invasive surgery. It links a
freehand probe, tracked by
a passive marker sensor
system to virtual computer
image space on a patient's
preoperative or
intraoperative 2D or 3D
image data.
VectorVision fluoro3D
enables computer-assisted
navigation of medical
image data, which can
either be acquired
preoperatively or
intraoperatively by an
appropriate image
acquisition system.
The software offers screw
implant size planning and
navigation on rigid bone | 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: |
8
| | structures with
precalibrated and
additional individually-
calibrated surgical tools.
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, the pelvis, a
long bone or vertebra can
be identified relative to the
acquired image (CT, MR,
2D fluoroscopic image or
3D fluoroscopic image
reconstruction) and/or an
image data based model of
the anatomy. | 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 on
all intranasal
structures I and
paranasal sinuses |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Brainlab IGS
Platform | Brainlab Kolibri
Brainlab Vector Vision | Brainlab Kick
Brainlab Curve
Brainlab Buzz IGS |
| Operating Systems | Windows XP | Windows 7
Windows 8.1
Windows 10 |
| Angio Navigation
Views | Fluoro Navigation:
Navigation of medical
image data based on exact
position display of
instrument tip. | Angio Views: Navigation
of medical image data
based on exact position
display of instrument tip. |
Verification/Validation summary:
Verification:
Verification has been performed according to the Verification Plan and following internal processes to demonstrate that design specifications are met bv the device.
The software changes have been tested in accordance with the Brainlab software development life cycle process. Verification and validation testing activities were performed at the software system, integration, and component levels to show sufficient implementation of the changes as per the specifications. Software testing conducted includes:
- . System level software verification
- Accuracy testing ●
- Integration tests with other Brainlab software applications and . IGS platforms
- . Component level code verification
Furthermore, in accordance with the design controls process, the following tests were deemed required to evaluate the Cranial IGS System performance across the hardware and electrical components:
- . Electrical safety
- Electromagnetic compatibility (EMC) .
9
- Biocompatibility .
- Sterilization ●
All testing was utilized to verify the subject device performance as intended.
Validation:
Validation of the functionalities, including nonclinical performance tests (accuracy tests, see below), has been performed in accordance with the internal processes.
Usability tests have been performed as well to ensure that the device can be used safely and that measures against potential use related risks are effective.
Nonclinical performance testing (Accuracy)
The system has a mean accuracy of 2 mm for location error and 2° for trajectory angle error.
The following table summarizes the performance verification results of the system:
| | Mean | Standard
deviation | 99th percentile |
|---------------------------|--------|-----------------------|-----------------|
| Location error | 1.3 mm | 0.5 mm | 2.2 mm |
| Trajectory
angle error | 0.73° | 0.34° | 1.3° |
CONCLUSION
Functionality and features considered as substantially equivalent have been verified and validated. The Cranial Image Guided Surgery System with its set of functionalities is substantially equivalent to its predicate devices.