Cranial EM System

• K Number: K213989
• Device Name: Cranial EM System
• Manufacturer: Brainlab AG
• Date Cleared: 2022-09-08 ( 262 days)
• Product Code: HAW
• Regulation Number: 882.4560
• Type: Traditional
• Panel: Neurology
• Reference & Predicate Devices: K192703 , K201175 , K042391
• Predicate For: K223288

Intended Use

Cranial EM is intended as an image-guided planning and navigation system to enable neurosurgery procedures. The device is indicated for any medical condition in which a reference to a rigid anatomical structure can be identified relative to images (CT, CTA, X-Ray, MR, MRA, and ultrasound) of the anatomy, such as:

• Cranial Resection
  • Resection of tumors and other lesions
  • Resection of skull-base tumor or other lesions
• Intracranial catheter placement

Device Description

The Subject Device, Cranial EM System, consists of software and hardware components. It links patient anatomy (using a patient reference) and instruments in the real world or "patient space" to patient scan data or "image space". This allows for the continuous localization of medical instruments and patient anatomy for medical interventions in cranial procedures. The tracking data are acquired via electromagnetic tracking. Cranial EM is a touchscreen-based intraoperative navigation software. The placement of surgical instruments in a three-dimensional representation overlaid on anatomical image sets, such as MR and/or CT, can support the surgeon during various surgical interventions. Cranial EM uses scanned images of the patient that are acquired before surgery is performed.

The following software make up the main module of the device:

• 1. EM Setup 2.1
• 2. Head Registration 2.1
• 3. EM Instruments 2.1
• 4. Navigation 2.1

The Subject Device Consists of the following hardware components:
Platforms:

• 1. Kick 2 Navigation Station (Article Number: 18202)
• 2. Curve Navigation 17700 (Article Number: 17700)

Instruments:

• 1. EM Patient Reference 2.0 (18099-24)
• 2. EM Pointer (18099-02C)
• 3. EM Instrument Reference (18099-05A)
• 4. EM Registration Pointer (18099-23)
• 5. EM Stylet 2.0 (18097-01)
• 6. EM Short Pointer (18099-27)
• 7. EM Skull Reference Base (18099-06)

AI/ML Overview

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance (Cranial EM System)
Mean location error	≤ 2 mm
Mean trajectory angle error	≤ 2 degrees

2. Sample Size and Data Provenance for Test Set:
The provided document does not specify a distinct sample size for a test set in terms of patient data or case studies. Instead, it mentions "System accuracy tests (Software + platforms + instruments)" were conducted. The data provenance is not explicitly stated as country of origin, nor whether it was retrospective or prospective patient data. The accuracy tests described appear to be laboratory performance evaluations of the device's hardware and software components rather than clinical trials with patient data.

3. Number and Qualifications of Experts for Ground Truth:
Not applicable. The ground truth for the core accuracy metrics (mean location error and mean trajectory angle error) was established through technical measurements of the system's performance, not through expert consensus on clinical cases.

4. Adjudication Method for Test Set:
Not applicable. Since the ground truth was established through technical measurements (System accuracy tests), an adjudication method for a test set involving human interpretation is not relevant here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document states, "No clinical testing submitted for the Subject Device. Data from existing literature was leveraged for validating the Subject Device's indications." Therefore, no MRMC comparative effectiveness study was conducted, and no effect size for human readers' improvement with AI assistance is provided for this submission.

6. Standalone Performance:
Yes, a standalone performance evaluation was done. The "System accuracy tests (Software + platforms + instruments)" directly assess the algorithm's performance (in conjunction with its hardware) without a human-in-the-loop. The reported performance metrics (mean location error ≤ 2 mm, mean trajectory angle error ≤ 2 degrees) are results of this standalone testing.

7. Type of Ground Truth Used:
The type of ground truth used for the device's core accuracy metrics (mean location error and mean trajectory angle error) was technical measurement and engineering specifications. This is established by rigorous performance testing of the device hardware and software against known physical standards.

8. Sample Size for the Training Set:
The document does not provide information regarding a specific "training set" for an AI algorithm in the context of device accuracy. The "System accuracy tests" were likely performance validation tests rather than training data for an adaptive algorithm.

9. How the Ground Truth for the Training Set was Established:
Not applicable. Information regarding a training set and its ground truth establishment is not provided in the document. The device's validation appears to rely on established engineering principles and performance testing against predefined accuracy standards, rather than machine learning models requiring extensive training data.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized caduceus. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

September 8, 2022

Brainlab AG Chiara Cunico Manager, Regulatory Affairs Olof-Palme-Str. 9 Munchen, 81829 Germany

Re: K213989

Trade/Device Name: Cranial EM System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: August 9, 2022 Received: August 9, 2022

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

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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 mediation-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 ([e-mail]) or phone [phone] 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) K213989

Device Name Cranial EM System

Indications for Use (Describe)

Cranial EM is intended as an image-guided planning and navigation system to enable neurosurgery procedures. The device is indicated for any medical condition in which a reference to a rigid anatomical structure can be identified relative to images (CT, CTA, X-Ray, MR, MRA, and ultrasound) of the anatomy, such as:

• · Cranial Resection
  • o Resection of tumors and other lesions
• o Resection of skull-base tumor or other lesions
• Intracranial catheter placement

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

September 8, 2022

General Information
Manufacturer	Brainlab AG; Olof-Palme Str.9; 81829, Munich, Germany
EstablishmentRegistration	8043933
Device Name	Neurological Stereotaxic Instrument
Trade Name	• Cranial EM system
Product Code	HAW
Regulation Number	882.4560
Regulatory Class	II
Panel	Neurology
Predicate Devices	Primary: StealthStation Cranial Software v1.3.0 (K201175) by MedtronicSecondary: Kolibri Cranial Magnetic (K042391) by Brainlab AGReference Device: Cranial IGS System (K192703) by Brainlab AG
Contact Information
Primary Contact	Alternate Contact
Chiara CunicoManager RAPhone: [phone]Email: [e-mail]	Regulatory Affairs BrainlabPhone: [phone]Fax: [phone]Email: [e-mail]

1. Indications for Use

Cranial EM is intended as an image-guided planning and navigation system to enable neurosurgery procedures.

The device is indicated for any medical condition in which a reference to a rigid anatomical structure can be identified relative to images (CT, CTA, X-Ray, MR, MRA and ultrasound) of the anatomy, such as:

• Cranial Resection
  • o Resection of tumors and other lesions
  • o Resection of skull-base tumor or other lesions
• Intracranial catheter placement

2. Device Description

The Subject Device, Cranial EM System, consists of software and hardware components. It links patient anatomy (using a patient reference) and instruments in the real world or "patient space" to patient scan data or "image space". This allows for the continuous localization of medical instruments and patient anatomy for medical interventions in cranial procedures. The tracking data are acquired via electromagnetic tracking.

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K213989 Page 2 of 9

Cranial EM is a touchscreen-based intraoperative navigation software. The placement of surgical instruments in a three-dimensional representation overlaid on anatomical image sets, such as MR and/or CT, can support the surgeon during various surgical interventions. Cranial EM uses scanned images of the patient that are acquired before surgery is performed.

The following software make up the main module of the device:

• 1. EM Setup 2.1 2. Head Registration 2.1 3. EM Instruments 2.1
• 4. Navigation 2.1

The Subject Device Consists of the following hardware components:

Platforms:

• 1. Kick 2 Navigation Station (Article Number: 18202)
• 2. Curve Navigation 17700 (Article Number: 17700)

Instruments:

• 1. EM Patient Reference 2.0 (18099-24)
• 2. EM Pointer (18099-02C)
• 3. EM Instrument Reference (18099-05A)
• 4. EM Registration Pointer (18099-23)
• 5. EM Stylet 2.0 (18097-01)
• 6. EM Short Pointer (18099-27)
• 7. EM Skull Reference Base (18099-06)

3. Substantial Equivalence

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Topic	Subject Device: Cranial EMSystem	Primary Predicate:StealthStation CranialSoftware v1.3.0 (K201175)	Secondary Predicate:Kolibri Cranial Magnetic(K042391)	Reference Device: CranialImage Guided SurgerySystem (K192703)	Comment
Indications forUse	Cranial EM is intended as an image-guided planning and navigation systemto enable neurosurgery procedures.The device is indicated for any medicalcondition in which a reference to a rigidanatomical structure can be identifiedrelative to images (CT, CTA, X-Ray, MR,MRA and ultrasound) of the anatomy,such as:• Cranial Resectiono Resection of tumors and otherlesionso Resection of skull-base tumor orother lesions• Intracranial catheter placement	The StealthStation™ System, withStealthStation™ Cranial Software, isintended as an aid for locatinganatomical structures in either openor percutaneous neurosurgicalprocedures. Their use is indicatedfor any medical condition in whichthe use of stereotactic surgery maybe appropriate, and where referenceto a rigid anatomical structure, suchas the skull, can be identified relativeto images of the anatomy.This can include, but is not limitedto, the following cranial procedures(including stereotactic frame-basedand stereotactic frame alternatives-based procedures):• Tumor resections• General ventricular catheterplacement• Pediatric ventricular catheterplacement• Depth electrode, lead, and probeplacement• Cranial biopsies	The BrainLAB Kolibri IGSSystem is intended to be anintraoperative image guidedlocalization system to enableminimally invasive surgery. Itlinks a freehand probe, trackedby a magnetic sensor systemor a passive marker sensorsystem to a virtual computerimage space on a patient'spreoperative diagnostic imagedata set being processed bythe Kolibri computerworkstation. The system isindicated for any medicalcondition in which the use ofstereotactic surgery may beappropriate and where areference to a rigid anatomicalstructure, such as the skull, along bone, or vertebra, can beidentified relative to a CT, X-rayor MR based model of theanatomy.Example image guided cranialsurgery procedures include butare not limited to:1. Tumor resections2. Skull base surgery3. Cranial biopsies4. Craniotomies/Craniectomies5. Pediatric CatheterShunt Placement6. General CatheterShunt Placement	The Cranial IGS System, when usedwith a compatible navigationplatform and compatible instrumentaccessories, is intended as animage-guided planning andnavigation system to enablenavigated surgery. It linksinstruments to a virtual computerimage space on patient image datathat is being processed by thenavigation platform.The system is indicated for anymedical condition in which areference to a rigid anatomicalstructure can be identified relative toimages (CT, CTA, X-Ray, MR, MRAand ultrasound) of the anatomy,including:•Cranial Resectiono Resection of tumors andother lesionso Resection of skull-basetumor or other lesions•AVM Resection•Cranial biopsies•Intracranial catheter placement•Intranasal structures and ParanasalSinus Surgery•Functional endoscopic sinussurgery (FESS)•Revision & distorted anatomysurgery all intranasal structures andparanasal sinuses	The wording has beenrephrased with thepurpose to improvereadability and claritywithout affecting thecontent.The included proceduresare grouped differently:resections are bundledand approaches ascraniotomy not listedseparately. Catheterplacement are bundlewithout patient populationspecifications. Biopsies,depth electrodeplacement, ENTindications or AVM are notpart of the indications ofthe subject device.The Subject Devices'indications are within thesubset of the primarypredicate and referencedevices' indications.
Topic	Subject Device: Cranial EMSystem	Primary Predicate:StealthStation CranialSoftware v1.3.0 (K201175)	Secondary Predicate:Kolibri Cranial Magnetic(K042391)	Reference Device: CranialImage Guided SurgerySystem (K192703)	Comment
Localizationtechniquebased on:	Electromagnetic trackingThe Field generator emits lowintensity and varyingelectromagnetic field which inducesmall currents in the sensorsembedded in the EM instruments.The position and spatial orientationof the sensors integrated in the EMinstruments are calculated in theBase station.	Electromagnetic trackingThe Side Emitter emits lowintensity and varyingelectromagnetic field whichinduce small currents in thesensors embedded EMinstruments. The position andspatial orientation of the sensorsintegrated in the EM instrumentsare calculated in the InstrumentInterface Box.	Electromagnetic trackingThe Field generator emitslow intensity and varyingelectromagnetic field whichinduce small currents in thesensors of the EMinstruments. The positionand spatial orientation of thesensors integrated in the EMinstruments are calculated inthe Base station.	Optical Tracking- N/A	General localizationtechniquesremain the same w.r.t.the predicate devices:K201175 and K042391.K19270 uses an opticaltracking system.Therefore it´s notcomparable with theother systems
TrackingAccuracy	Under representative worst-caseconfiguration, the Cranial EMSystem is tested to ensure that itsmean location error is ≤ 2 mm andits mean trajectory angle error is ≤ 2degrees.	Under representative worst-caseconfiguration, the StealthStationS8 System with StealthStationCranial Software v1.3.0, hasdemonstrated performance in3D positional accuracy with amean error ≤ 2.0 mm and intrajectory angle accuracy with amean error ≤ 2 degrees.	≤ 2.5 mm distance RMS(Root Mean Square)≤ 2.5° angle RMS (RootMean Square)	Under representative worst-caseconfiguration, the Cranial EMSystem is tested to ensure thatits mean location error is ≤ 2 mmand its mean trajectory angleerror is ≤ 2 degrees.	The subject device andprimary predicatedevice are bothmeeting the sameaccuracy requirements.Refer to Ground truthaccuracy test report[0000279513]
Topic	Subject Device: Cranial EM System	Primary Predicate:StealthStation CranialSoftware v1.3.0 (K201175)	Secondary Predicate:Kolibri Cranial Magnetic(K042391)	Reference Device: CranialImage Guided SurgerySystem (K192703)	Comment
FieldGenerator	Manufacturer: NDILocalizer: Aurora V3Emitter Type: sideTracking Volume: 500x500x400 mmImage: Drawing of tracking volumeImage: Drawing of tracking volumeField strength:Image: Graph of field strength	Manufacturer: MedtronicLocalizer: AXIEM IIIEmitter Type: side, flatTracking Volume: 460x460x310 mm (side), 400x400x375 mm (flat)Image: Drawing of tracking volumeImage: Drawing of tracking volumeField strength:$< 2.10 x (f / 3350) V/m$ where f isthe frequency in Hz from 3kHzto 5MHz as set by IEEEStandard C95.1 - 2005	Manufacturer: NDILocalizer: Aurora V1Emitter Type: sideTracking Volume:500x500x500 mmField strength: same assubject device.	Optical Tracking- N/A	The tracking volume ofthe subject device andpredicate devicescovers the region ofinterest. The subjectdevice has a slightlybigger volume in x, yand z directioncompared to theprimary predicate.Compared to thesecondary predicate,the volume of the fieldgenerator was reducedin the new version to400 mm in z direction toensure accuratepositioning of the headin the tracking volume.During Usability testingit was verified thatrepresentative clinicalusers are able toposition, register andnavigate within thereduced/new trackingvolume of the subjectdevice [Usabilitysummary 0000269739,rev. 1].
Topic	Subject Device: Cranial EMSystem	Primary Predicate:StealthStation CranialSoftware v1.3.0 (K201175)	Secondary Predicate:Kolibri Cranial Magnetic(K042391)	Reference Device: CranialImage Guided SurgerySystem (K192703)	Comment
Touch screen	Curve Navigation 17700:Type: LCD TFT displaySize: 31.5"Color depth: 1.073B colorsResolution: 3840 x 2160 pixelsTouch technology: ProjectedcapacitiveKick 2 Navigation Station 18202:Type: LCD TFT displaySize: 21.5"Color depth: 16.7M colorsResolution: 1920 x 1080 pixelsTouch technology: Projectedcapacitive	Monitor dimension: 15.3" x 25.5"x 2.5"Resolution: 2560x1440 pixels	Type: LCD TFT displaySize: 15"Color depth: 16M colorsResolution: 1024 x 768pixelsTouch technology:AccuTouch resistive	-----	Two new platforms ashardware componentshave been includedwith the SubjectDevice.
Electricalspecifications	Curve Navigation 17700:• Frequency: 50 / 60 Hz• Power consumption: 7.6 A @100 VAC, 3.3 A @ 240 VACKick 2 Navigation Station 18202:• Frequency: 50 / 60 Hz• Power consumption: 3 A @ 100VAC, 1.5 A @ 240 VAC	Frequency: 50 / 60 HzInput voltage: 100 - 230 VMaximum power: 900 VATypical power dissipation: 400 –600 VA	Frequency: 50 / 60 HzPower consumption: 3 A @100-115 V, 15 A @ 230 V	-----	Two new platforms ashardware componentshave been includedwith the Subject Device
Data loadingpossibilities	• USB• NetworkWireless transfer	• USB• CD / DVDWireless transfer	• USB• CD/DVD	• USB• NetworkWireless transfer	Only state of the artdata loadingpossibilities aresupported.Cybersecurity summary[0000271450] containsthe details on risksrelated to cybersecurityand the measuresimplemented includedadditionalrecommendedconsiderations.
Topic	Subject Device: Cranial EMSystem	Primary Predicate:StealthStation CranialSoftware v1.3.0 (K201175)	Secondary Predicate:Kolibri Cranial Magnetic(K042391)	Reference Device: CranialImage Guided SurgerySystem (K192703)	Comment
Imagingmodalitysupported[HeadRegistrationapplication]	CT, MR	X-Ray based, MR based,Nuclear Medicine based	CT, MR	CT, MR	CT and MR are themain supportedmodalities wherepatient registration isalso supported. Nuclearmedicine basedmodalities aresupported for display inthe navigation.Main supportedmodalities are same.
Planningfeatures[NavigationApp]	Plan Entry and TargetSelection 3D Model Building	Plan Entry and TargetSelection 3D Model Building Advanced Visualization Create Patient BasedAnatomical CoordinateSpace Stereotactic Frame Settings BrainAtlas: Schaltenbrand-Wahren Atlas withTalairach GridSTarFixTM Designer Annotations	N/A	Plan Entry and TargetSelection 3D Model Building Advanced Visualization	Planning featuresrelevant for the coveredindications for use aresame.

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Topic	Subject Device: Cranial EMSystem	Primary Predicate:StealthStation CranialSoftware v1.3.0 (K201175)	Secondary Predicate:Kolibri Cranial Magnetic(K042391)	Reference Device: CranialImage Guided SurgerySystem (K192703)	Comment
NavigationViews[NavigationApp]	Axial Coronal Sagittal Inline 1 Inline 2 Probe's Eye 3D Overview Video View (e.g: Endoscope) Autopilot-View	Axial Coronal Sagittal Trajectory 1 Trajectory 2 Probes Eye Target Guidance,Trajectory Guidance Endoscopic Look Ahead Ultrasound Video In Ultrasound Overlay,3D, Microscope Injection,Video Input	Axial Coronal Sagittal Probes Eye	Axial Coronal Sagittal Inline 1 Inline 2 Probe's Eye Split Probe's Eye Skin Overview Skin Probe's Eye Bone Overview 3D Overview Video View Ultrasound video Acquired 2-D ultrasoundimages Acquired 3-D ultrasounddata sets Ultrasound reconstruction:superimposition ofultrasound video with thecorrelated diagnostic imagedata Autopilot-View	Main navigation viewsare identical to those inprimary and secondarypredicate devices.

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4. Performance Data

The following tests were conducted:

• System accuracy tests (Software + platforms + instruments)
• Platform expected service life verification
• Biocompatibility and reprocessing and shelf life sterility tests for applicable instruments
• User contact biocompatibility assessment
• Routine Software verification
• Platform Verification
• Usability Evaluation

No clinical testing submitted for the Subject Device. Data from existing literature was leveraged for validating the Subject Device's indications.

5. Conclusion

Based on the battery of non-clinical testing conducted for the Subject Device as listed above, and based on the Substantial Equivalence discussion, the Subject Device was demonstrated to be as safe and effective as the predicate devices for the intended use and indications stated.

Regulation Number and Section

§ 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).