(377 days)
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 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.
The provided text describes the Cranial Image Guided Surgery System, which is a medical device. The information details the device's intended use, technological characteristics compared to predicate devices, and a summary of verification and validation activities.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the "Cranial Image Guided Surgery System" are not explicitly stated as distinct acceptance criteria values in the document. Instead, the document presents performance verification results (accuracy), which are implicitly the performance targets for the device. The "mean accuracy" values mentioned are the internal acceptance criteria the device was required to meet.
| Performance Metric | Acceptance Criteria (Implicit from "mean accuracy") | Reported Device Performance (Mean) | Reported Device Performance (Standard Deviation) | Reported Device Performance (99th percentile) |
|---|---|---|---|---|
| Location error | ≤ 2 mm | 1.3 mm | 0.5 mm | 2.2 mm |
| Trajectory angle error | ≤ 2° | 0.73° | 0.34° | 1.3° |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Nonclinical performance testing (Accuracy)" and "The following table summarizes the performance verification results of the system." However, it does not specify the sample size (e.g., number of test cases, number of images, or number of simulated scenarios) used for these accuracy tests.
The data provenance is also not explicitly stated in terms of country of origin or whether the data was retrospective or prospective. Given that it's "nonclinical performance testing," it is likely that the testing involved phantom studies or simulated scenarios rather than real patient data.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
The document does not specify the number of experts used to establish ground truth for the test set or their qualifications. The accuracy testing seems to be based on physical measurements against established ground truth (e.g., from a phantom or known geometry), rather than expert consensus on image interpretation.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method (e.g., 2+1, 3+1, none) for the test set. Given that the performance testing is focused on mechanical/measurement accuracy (location and trajectory angle errors), an adjudication method requiring human interpretation would not be applicable in the same way as it would be for a diagnostic AI system.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
The document does not indicate that an MRMC comparative effectiveness study was done. The assessment presented is focused on the device's accuracy in navigation, not on a comparison of human reader performance with and without AI assistance. This device is an image-guided surgery system, which assists surgeons during procedures, rather than an AI diagnostic tool primarily interpreted by human readers.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
The "Nonclinical performance testing (Accuracy)" described can be considered a form of standalone performance evaluation for the algorithm's core functionality (localization and trajectory determination). The results presented (location error, trajectory angle error) are metrics of the system's inherent accuracy, without explicitly involving real-time human interaction for performance measurement in these specific tests. However, the device is ultimately intended for human-in-the-loop use in surgery.
7. The Type of Ground Truth Used
The ground truth used for the "Nonclinical performance testing (Accuracy)" appears to be physical measurement against a known standard or ideal. For instance, in a phantom study, the "true" location and trajectory would be precisely known or measurable, allowing for the calculation of errors from the device's output. The text does not specify if it was expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
The document does not provide any information regarding the sample size used for the training set. It primarily discusses the device's verification and validation, but not the development or training of any underlying algorithms (if applicable, beyond traditional image processing and navigation).
9. How the Ground Truth for the Training Set Was Established
Since no information on a "training set" is provided, there is no mention of how ground truth for a training set was established. The device's functionality appears to be based on established navigation principles and software engineering, rather than a machine learning model that requires a labeled training dataset with associated ground truth for learning.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, 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
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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
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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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510(K) SUMMARY CRANIAL IMAGE GUIDED SURGERY SYSTEM
IN ACCORDANCE WITH REQUIREMENTS OF 21 CFR PART 807.92
| GENERAL INFORMATION | ||
|---|---|---|
| Manufacturer: | Brainlab AGOlof-Palme-Straße 981829 MunichGermanyPh: + 49-899915681 0Fax: +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 CranialNavigation Software ENTRegistration Software CranialAutomatic Registration 2.0Ultrasound 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 |
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| 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).
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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.
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| TechnologicalCharacteristicsof the Subject Device incomparison to the primarypredicate device | Cleared devicefeature/specifications | Modified devicefeature/specifications | |
|---|---|---|---|
| Intended Use /Indications for Use | Cranial Image GuidedSurgery System (K092467)The Cranial IGS System isintended to be an intra-operative image guidedlocalization system to enableminimally invasive surgery. Itlinks a freehand probe,tracked by a magnetic sensorsystem or a passive markersensor system to a virtualcomputer image space onpatient image data beingprocessed by the navigationworkstation.The system is indicated forany medical condition in whichthe use of stereotactic surgerymay be appropriate andwhere a reference to a rigidanatomical structure, such asthe skull, a long bone, orvertebra, can be identifiedrelative to a CT, CTA, X-Ray,MR, MRA and ultrasoundbased model of the anatomy.Example procedures includebut are not limited to:Cranial Procedures:Tumor resectionsSkull base surgeryCranial biopsiesCraniotomies/CraniectomiesPediatric CatheterShunt PlacementGeneral Catheter ShuntPlacementThalamotomies/PalliodotomiesENT ProceduresTransphenoidal proceduresMaximillary antrostomiesEthmoidectomiesSpheno-idotomies/sphenoid explorationsTurbinate resectionsFrontal sinusotomiesIntranasal procedures | Cranial Image GuidedSurgery SystemThe Cranial IGS System,when used with acompatible navigationplatform and compatibleinstrument accessories,is intended as an image-guided planning andnavigation system toenable navigatedsurgery. It linksinstruments to a virtualcomputer image spaceon patient image datathat is being processedby the navigationplatform.The system is indicatedfor any medical conditionin which a reference to arigid anatomical structurecan be identified relativeto images (CT, CTA, X-Ray, MR, MRA andultrasound) of theanatomy, including:Cranial Resection• Resection of tumorsand other lesions• Resection of skull-base tumor or otherlesions• AVM ResectionCranial biopsiesIntracranial catheterplacementIntranasal structures andParanasal Sinus Surgery• Functionalendoscopic sinussurgery (FESS)• Revision & distortedanatomy surgery onall intranasalstructures andparanasal sinuses | |
| Brainlab IGSPlatform | Brainlab KolibriBrainlab Vector Vision | Brainlab KickBrainlab Curve |
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Technological
Characteristics
of the Sibject
Device in
comparison to the
secondary predicate device
| Brainlab Buzz IGS | ||
|---|---|---|
| Operating Systems | Windows XP | Windows 7Windows 8.1Windows 10 |
| Data Inputs | Equivalent | |
| TrackingTechnology | Equivalent | |
| Navigation Features | Equivalent | |
| Angio NavigationViews | Navigation of CTA andMRA | Navigation of 2D DSAimages |
| Pre-calibratedInstrument Tracking | Equivalent | |
| CalibratedInstrument Tracking | Equivalent |
| Cleared devicefeature/specifications | Modified devicefeature/specifications | |
|---|---|---|
| VectorVision Fluoro 3D(K070106) | Cranial Image GuidedSurgery System | |
| Intended Use /Indications for Use | Brainlab Vector Visionfluoro3D is intended as anintraoperative image-guided localization systemto enable minimallyinvasive surgery. It links afreehand probe, tracked bya passive marker sensorsystem to virtual computerimage space on a patient'spreoperative orintraoperative 2D or 3Dimage data.VectorVision fluoro3Denables computer-assistednavigation of medicalimage data, which caneither be acquiredpreoperatively orintraoperatively by anappropriate imageacquisition system.The software offers screwimplant size planning andnavigation on rigid bone | The Cranial IGS System,when used with acompatible navigationplatform and compatibleinstrument accessories,is intended as an image-guided planning andnavigation system toenable navigatedsurgery. It linksinstruments to a virtualcomputer image spaceon patient image datathat is being processedby the navigationplatform.The system is indicatedfor any medical conditionin which a reference to arigid anatomical structurecan be identified relativeto images (CT, CTA, X-Ray, MR, MRA andultrasound) of theanatomy, including: |
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| structures withprecalibrated andadditional individually-calibrated surgical tools.The system is indicated forany medical condition inwhich the use ofstereotactic surgery maybe appropriate and wherea reference to a rigidanatomical structure, suchas the skull, the pelvis, along bone or vertebra canbe identified relative to theacquired image (CT, MR,2D fluoroscopic image or3D fluoroscopic imagereconstruction) and/or animage data based model ofthe anatomy. | Cranial Resection• Resection of tumorsand other lesions• Resection of skull-base tumor or otherlesions• AVM ResectionCranial biopsiesIntracranial catheterplacementIntranasal structures andParanasal Sinus Surgery• Functionalendoscopic sinussurgery (FESS)• Revision & distortedanatomy surgery onall intranasalstructures I andparanasal sinuses | |
|---|---|---|
| Brainlab IGSPlatform | Brainlab KolibriBrainlab Vector Vision | Brainlab KickBrainlab CurveBrainlab Buzz IGS |
| Operating Systems | Windows XP | Windows 7Windows 8.1Windows 10 |
| Angio NavigationViews | Fluoro Navigation:Navigation of medicalimage data based on exactposition display ofinstrument tip. | Angio Views: Navigationof medical image databased on exact positiondisplay 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) .
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- 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 | Standarddeviation | 99th percentile | |
|---|---|---|---|
| Location error | 1.3 mm | 0.5 mm | 2.2 mm |
| Trajectoryangle 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.
§ 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).