(444 days)
visor2 is used to aid 3D navigation for positioning of Transcranial Magnetic Stimulation (TMS) coils over preselected brain regions based on data from MRI measurements or scalp landmarks and optional EMG recording in clinical procedures. The visor2 system is compatible with the following commercially available TMS coils of the following TMS companies:
- · Mag & More: PMD70-aCool Double coil Figure-8 (510575)
- MagStim Company Ltd.: Double 70mm Remote Coil (3190-00 rev2), Double 70mm Air Film Coil (3910 00);
- MagVenture A/S: Double 75mm (C-B60), Double Cooled 75mm (Cool-B65), Double 95mm (D-B80), Angulated Double Cooled 97mm (Cool-B70 rev2), Butterfly figure-8 (C-B70)
- · Neuronetics Inc .: NeuroStar coil
The visor2 system must be operated by a trained physician and must not be used during surgical operations.
The visor2 system is a 3D navigation system, supporting external/surface positioning of labeling identified commercially available Transcranial Magnetic Stimulation (TMS) coils based on the anatomical and functional areas for which use of the coil has been FDA cleared and as identified in cleared labeling for the coil. The visor2 system optionally records and processes electrophysiological signals to guide the user in the TMS coil placement. The visor2 system is compatible with TMS stimulators identified in the labeling that meet IEC 60601-1 and IEC 60601-1-2 electrical safety and EMC standards, a compatible optical tracking system, and further compatible accessories. Optionally, a compatible amplifier identified in the labeling may be applied for measuring electrophysiological signals. The visor2 system must be operated by a trained physician, and must not be used during surgical operations.
The visor2 system consists of a cart, an All-in-One medical computer with touch interface, a mounting plate for an optional amplifier applied for EMG recording and a Tracking camera with mounting arm. There are two fundamental visor2 system variants: single or dual display. the second configuration is available with an additional touch display added next to the All-in-One computer. Both variants are identical with regard to hardware features.
The acceptance criteria for the visor2 system and the study results are detailed in the provided text. The device is a 3D navigation system that aids in the positioning of Transcranial Magnetic Stimulation (TMS) coils over preselected brain regions based on MRI measurements or scalp landmarks, with optional EMG recording.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The provided text combines the acceptance criteria (defined as "Main PASS criteria:" or implicitly as "Pass" alongside the test method and results) and the reported device performance within the "Bench testing demonstrated that the performance parameters of the visor2 system meets pre-specified requirements and are substantially equivalent to those of the predicate device" section.
| Test / Feature | Acceptance Criteria (Main PASS criteria / Result) | Reported Device Performance |
|---|---|---|
| Electrical Safety | Pass (IEC 60601-1:2005 + CORR. 1:2006 + CORR. 2:2007 +A1:2012) | Passed |
| Electromagnetic Compatibility | Pass (IEC 60601-1-2 Edition 4.0 2014-02) | Passed |
| Compliance with Special Controls | Pass (Review and document compliance with Class II Special Controls guidance document: Repetitive Transcranial Magnetic Stimulation Systems, issued July 26, 2011) | Passed |
| System performance to specifications | Pass (Hardware, software and system evaluations) | Passed |
| Biocompatibility evaluation | Pass (The Pointer Tool patient contact materials are identical to the StimGuide TMS coil location/navigation feature in K183376) | Passed |
| Software verification, validation | Pass (Compliance with FDA Guidance document: Guidance for the Content of Premarket Submissions for Software Content in Medical Devices, May 11, 2005; including intentional and unintentional cybersecurity risks and mitigations applied) | Passed |
| Commercial TMS Coil compatibility | Pass | The compatible commercially compatible TMS coils are demonstrated to be able to be calibrated and properly applied within the location accuracy defined by the visor2 system. |
| Overall accuracy of TMS coil position relative to the head (absolute value) | N/A (Worst case upper limit of the position mismatch in positioning the coil relative to the head) | Pass, Range <= 10 mm (This appears to be the actual result/performance, implicitly meeting a standard, as the system accuracy below states 4mm as the goal) |
| Position accuracy (Tracking camera) | Pass, Range <= 10 mm | Pass, Range <= 10 mm (This is the acceptance criteria and presented as the result) |
| Navigation Principle | The stimulus position should be within 4mm of the physical setup and the distance between stimulus target and stimulus below 2mm. | Main PASS criteria met. |
| Coil Compatibility | Accuracy limit in validation workflow 4mm | Main PASS criteria met. |
| Coil Compatibility - Validation | Passed validation | Passed validation |
| Tracking System Accuracy | Declaration of Conformity by Northern Digital Inc. and over-all system accuracy better than 4mm | Achieved (stated Declaration of Conformity by Northern Digital Inc. and over-all system accuracy better than 4mm) |
| System Accuracy | The match between positions and length in over-all system accuracy better than 4mm | Achieved (stated match between positions and length in over-all system accuracy better than 4mm) |
| Imaging Modality | Accuracy of landmarks to MRI within 2mm. | Main criteria met. |
| Selection of targets via anatomical and functional landmarks (EMG) | 10% accuracy in EMG parameters for functional mapping; Over-all position system accuracy better than 4mm | Functional mapping with 10% accuracy in EMG parameters achieved. Overall position system accuracy better than 4mm achieved. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The provided document describes non-clinical performance tests (bench testing). It does not mention a "test set" in terms of patient data or clinical images, but rather tests conducted on the device itself and its components.
- Sample Size for Test Set: Not applicable in the context of patient data / images. The testing involved various controlled measurements of the device's accuracy and functionality. For some tests, like "Position accuracy (Tracking camera)", it mentions a single marker stepped through "more than 900 positions".
- Data Provenance: The tests are described as "Bench testing," implying laboratory or engineering testing of the device and its sub-systems.
- Retrospective or Prospective: Not applicable as no patient data is used. These are performance verification tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. The ground truth for these non-clinical performance tests would be established by predefined engineering specifications, calibrated measurement systems, and physical setups, rather than human expert consensus on medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. As no patient data or human interpretation is involved, there is no need for an adjudication method as would be used in a clinical study.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC comparative effectiveness study was done or mentioned. The document explicitly states: "Clinical data are not needed to support substantial equivalence." The device is cleared as an accessory for 3D navigation, focusing on its technical accuracy and compatibility with existing TMS systems rather than direct clinical outcomes or human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The performance metrics provided (e.g., tracking system accuracy, system accuracy, imaging modality accuracy, EMG accuracy) represent the standalone technical performance of the device's navigation and measurement capabilities. While the device is intended for use by a trained physician, the accuracy measurements are objective assessments of the system itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the non-clinical performance tests was based on:
- Known nominal positions/rotations/measurements in a physical setup, using calibrated instruments and methods.
- Pre-defined engineering specifications for parameters like accuracy (e.g., 4mm for system accuracy, 2mm for MRI landmark accuracy, 10% for EMG parameters).
- Declarations of Conformity from component manufacturers (e.g., Northern Digital Inc. for tracking system accuracy).
8. The sample size for the training set
- Not applicable. This device is a navigation system and does not appear to involve machine learning or AI models that require a "training set" in the conventional sense (e.g., for image classification or prediction tasks). Its functionality is based on established principles of optical tracking, 3D spatial registration, and signal processing.
9. How the ground truth for the training set was established
- Not applicable, as there is no "training set" for an AI/ML model for this device's function.
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April 8, 2022
Eemagine Medical Imaging Solutions GmbH % Gary Syring Principal Consultant Quality & Regulatory Associates, LLC 800 Levanger Lane Stoughton, Wisconsin 53589
Re: K210109
Trade/Device Name: visor2 system Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW, GWF, IKN, OBP Dated: March 9, 2022 Received: March 11, 2022
Dear Gary Syring:
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
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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 (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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Pamela Scott Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine 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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510(k) Number (if known) K210109
Device Name visor2 system
Indications for Use (Describe)
visor2 is used to aid 3D navigation for positioning of Transcranial Magnetic Stimulation (TMS) coils over preselected brain regions based on data from MRI measurements or scalp landmarks and optional EMG recording in clinical procedures. The visor2 system is compatible with the following commercially available TMS coils of the following TMS companies:
- · Mag & More: PMD70-aCool Double coil Figure-8 (510575)
- MagStim Company Ltd.: Double 70mm Remote Coil (3190-00 rev2), Double 70mm Air Film Coil (3910 00);
- MagVenture A/S: Double 75mm (C-B60), Double Cooled 75mm (Cool-B65), Double 95mm (D-B80), Angulated Double Cooled 97mm (Cool-B70 rev2), Butterfly figure-8 (C-B70)
- · Neuronetics Inc .: NeuroStar coil
The visor2 system must be operated by a trained physician and must not be used during surgical operations.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for eemagine medical imaging solutions. The word "eemagine" is written in gray, with the words "medical imaging solutions" written in a smaller font below it. To the right of the word "eemagine" are two blue circles with the letter "e" inside them. A blue line connects the two circles, resembling an EKG readout.
eemagine Medical Imaging Solutions GmbH, Gubener Str. 47, D-10243 Berlin
| 510(k) Summary | Date |
|---|---|
| This summary is provided to support the 510(k) pre-market notification for the visor2system. | Berlin |
| Company Name: eemagine | Reference (eemagine):e.g. contract ID |
| Company Contact: Frank Zanow, Chief Executive Officereemagine Medical Imaging Solutions GmbH | |
| Date Summary Prepared: April 8, 2022 | eemagine GmbHGubener Str.47D-10243 BerlinTel. +49 30 29048404Fax. +49 30 29048405www.eemagine.com |
| Trade Name: visor2 system | |
| Common Name: Accessory to Repetitive Transcranial Magnetic Stimulation | |
| Classification Name: Repetitive Transcranial Magnetic Stimulation System21 CFR 882.4560, Product Code: HAW, Class II | |
| Primary Predicate: K191422, Neural NavigatorManufacturer: Soterix Medical, Inc., New York, NY 10001 | CEO/Geschäftsführer:Ralf Hauffe, Ph.D. |
| Reference Devices: K183376, HORIZON TMS Therapy System with NavigationManufacturer: Magstim Company Ltd., Whitland, GB Sa34 0hr | Registration: HRB 7128VAT ID: DE201608185 |
| K112881, Nexstim Navigational Brain Stimulation (NBS)System 4, Nexstim NBS System 4 with NEXSPEECH®Manufacturer: NEXSTIM OY, Helsinki, FI-00510 | Commerzbank BerlinBIC Code CoBaDEBB120IBAN |
DE73120400000458888500
Product Description
The visor2 system is a 3D navigation system, supporting external/surface positioning of labeling identified commercially available Transcranial Magnetic Stimulation (TMS) coils based on the anatomical and functional areas for which use of the coil has been FDA cleared and as identified in cleared labeling for the coil. The visor2 system optionally records and processes electrophysiological signals to guide the user in the TMS coil placement. The visor2 system is compatible with TMS stimulators identified in the labeling that meet IEC 60601-1 and IEC 60601-1-2 electrical safety and EMC standards, a compatible optical tracking system, and further compatible accessories. Optionally, a compatible amplifier identified in the labeling may be applied for measuring electrophysiological signals. The visor2 system must be operated by a trained physician, and must not be used during surgical operations.
The visor2 system consists of a cart, an All-in-One medical computer with touch interface, a mounting plate for an optional amplifier applied for EMG recording and a Tracking camera with mounting arm. There are two fundamental visor2 system variants: single or dual display. the second configuration is available with an additional touch display added next to the All-in-One computer. Both variants are identical with regard to hardware features.
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Indications for Use
visor2 is used to aid 3D navigation for positioning of Transcranial Magnetic Stimulation (TMS) coils over preselected brain regions based on data from MRI measurements or scalp landmarks and optional EMG recording in clinical procedures. The visor2 system is compatible with the following commercially available TMS coils of the following TMS companies:
- · Mag & More: PMD70-aCool Double coil Figure-8 (510575)
- MagStim Company Ltd.: Double 70mm Remote Coil (3190-00 rev2), Double 70mm Air Film Coil (3910 00);
- MagVenture A/S: Double 75mm (C-B60), Double Cooled 75mm (Cool-B65), Double 95mm (D-B80), Angulated Double Cooled 97mm (Cool-B70 rev2), Butterfly figure-8 (C-B70)
- · Neuronetics Inc.: NeuroStar coil
The visor2 system must be operated by a trained physician and must not be used during surgical operations.
| Substantial Equivalence Technical Characteristics | |||||
|---|---|---|---|---|---|
| Feature | Subject Devicevisor2 system | PrimaryPredicateNeuralNavigator(K191422) | ReferenceDeviceHORIZON TMSTherapy Systemwith Navigation(K183376) | ReferenceDeviceNexstimNavigationalBrainStimulation(NBS) System 4,Nexstim NBSSystem 4 withNEXSPEECH®(K112881) | Discussion of comparison |
| Product Code,Classification | HAW(Subsequent:GWF, IKN, OBP)21 CFR882.4560,Class II | HAW(Subsequent:GWF, IKN, OBP)21 CFR882.4560,Class II | OBP, HAW, IKN21 CFR882.5805,Class II | GWF, HAW,IKN21 CFR882.1870,Class II | Classification of Subject Device,Primary Predicate and ReferenceDevice matches.The Subject Device is anaccessory to TMS therapysystems, providing location forthe TMS coil. |
| Intended use | As an accessoryto TMS systems,providenavigation,location supportfor placement ofthe TMS coil onthe skull inrelation to a prioracquired MRIimage. | Aneuronavigationsystem indicatedfor accuratepositioning of thetreatment coil ofthe CloudTMSTherapy Systemwith respect totarget brainregions based ondata obtainedfrom MRImeasurements. | A repetitivetranscranialmagneticstimulationsystem thatdeliverstranscranialrepetitive pulsedmagnetic fields ofsufficientmagnitude toinduce neuralaction potentialsin the prefrontalcortex to treat thesymptoms ofmajor depressive | Non-invasivemapping of theprimary motorcortex of thebrain to itscortical gyrus.The NBS Systemprovidesinformation thatmay be used inthe assessment ofthe primary motorcortex for pre-proceduralplanning. | The intended use of SubjectDevice, Primary Predicate andboth Reference Devices matchfully with regards to all aspectsrelated to effectiveness and safety(navigation of a TMS coil relativeto MRI and/or scalplandmarks/targets).As accessory to the TMS system,the device under review providesTMS coil location support.The device under review providesa locating feature to TMSsystems. The device under reviewis an optional accessory to |
| Substantial Equivalence Technical Characteristics | |||||
| Feature | Subject Devicevisor2 system | PrimaryPredicateNeuralNavigator(K191422) | ReferenceDeviceHORIZON TMSTherapy Systemwith Navigation(K183376) | ReferenceDeviceNexstimNavigationalBrainStimulation(NBS) System 4,Nexstim NBSSystem 4 withNEXSPEECH®(K112881) | Discussion of comparison |
| Indicationsfor Use | visor2 is used toaid 3D navigationfor positioning ofTranscranialMagneticStimulation(TMS) coils overpreselected brainregions based ondata from MRImeasurements orscalp landmarksand optionalEMG recordingin or clinicalprocedures. Thevisor2 system iscompatible withthe followingcommerciallyavailable TMScoils of thefollowing TMScompanies:Mag & More:PMD70-aCoolDouble coilMagStimCompany Ltd.:Double 70mmRemote Coil(3190-00 rev2),Double 70mmAir Film(3910-00)MagVenture A/S:Double 75mm(C-B60), DoubleCooled 75mm(Cool-B65), | The NeuralNavigator is aneuronavigationsystem indicatedfor accuratepositioning of thetreatment coil ofthe CloudTMSTherapy Systemwith respect totarget brainregions based ondata obtainedfrom MRImeasurements.Specifically, theNeural Navigatoris indicated foruse with thefollowingCloudTMSTherapy Systemcoilsmanufactured byNeurosoft Ltd:AFEC-02-100andAFEC-02-100-C. | HORIZON® isindicated for thetreatment ofMajor DepressiveDisorder in adultpatients who havefailed to achievesatisfactoryimprovementfrom priorantidepressantmedication in thecurrent episode. | The NexstimNavigated BrainStimulationSystem (NBSSystem) 4 isindicated for non-invasive mappingof the primarymotor cortex ofthe brain to itscortical gyrus.The NBS System4 providesinformation thatmay be used inthe assessment ofthe primary motorcortex forpreproceduralplanning.NexstimNEXSPEECH,when usedtogether with theNexstim NBSSystem 4, isindicated fornoninvasivelocalization ofcortical areas thatdo not containessential speechfunction. NexstimNEXSPEECHprovidesinformation thatmay be used inpre-surgicalplanning inpatientsundergoing brainsurgery.Intraoperatively,the localizationinformationprovided by | The indication of use of SubjectDevice, Primary Predicate andboth Reference Devices matchfully with regard to all aspectsrelated to effectiveness and safety(navigation of a TMS coil relativeto MRI and/or scalplandmarks/targets). The SubjectDevice is more flexible withregard to supported coils than anyof the Reference and Predicatesystem.As accessory to the TMS system,the device under review providesTMS coil location support.The visor2 system under review isan optional accessory to supportlocating/navigating TMS coilfeature to existing TMS systemsfor their intended use.Note:The reference device K183376HORIZON TMS Therapy Systemwith Navigation includes aStimGuide feature to supportTMS coil location/navigation.The StimGuide feature is a sublicensed variation of the visor2system, was reviewed in theHorizon TMS Therapy Systemwith Navigation, K183376, tosupport TMS coil location. |
| Substantial Equivalence Technical Characteristics | |||||
| Feature | Subject Devicevisor2 system | PrimaryPredicateNeuralNavigator(K191422) | ReferenceDeviceHORIZON TMSTherapy Systemwith Navigation(K183376) | ReferenceDeviceNexstimNavigationalBrainStimulation(NBS) System 4,Nexstim NBSSystem 4 withNEXSPEECH®(K112881) | Discussion of comparison |
| Double 95mm(D-B80),AngulatedDouble Cooled97mm(Cool-B70 rev2),Butterfly figure-8(C-B70)Neuronetics Inc.:NeuroStar coilThe visor2system must beoperated by atrained physicianand must not beused duringsurgicaloperations. | NEXSPEECH® isintended to beverified by directcorticalstimulation.The NexstimNBS System 4and NBS System4 withNEXSPEECH®are not intendedto be used duringa surgicalprocedure. TheNexstim NBSSystem 4 andNBS System 4withNEXSPEECH®are intended to beused by trainedclinicalprofessionals. | ||||
| TMS CoilPositionPrinciple | Based onanatomy (MRIpicture) andindirect targetingof treatmenttarget throughmeasureddistance anddirection usingopticalstereotacticnavigation. | Based onAnatomy (MRIpicture) andelectro-magneticfield navigation. | Indirect targetingof treatmenttarget throughmeasureddistance anddirection usingopticalstereotacticnavigation andanatomy. | Based onAnatomy (MRIpicture) andopticalstereotacticnavigation. | All devices support thelocation/navigation of the TMScoil. The reference deviceK183376 HORIZON TMSTherapy System with Navigationincludes a StimGuide feature tosupport TMS coillocation/navigation uses the samemethodology as the visor2 systemunder review.The StimGuide feature is a sublicensed variation of the visor2system.Subject Device, Primary Predicateand both Reference Devices alluse the same or equivalentposition principle registering thephysical head/scalp and a coil viatracker tools tracked by a stereoinfrared camera 3D trackingsystem or in case of the PrimaryPredicate Device electro-magneticfield tracking. Electro-magnetic |
| Substantial Equivalence Technical Characteristics | |||||
| Feature | Subject Devicevisor2 system | PrimaryPredicateNeuralNavigator(K191422) | ReferenceDeviceHORIZON TMSTherapy Systemwith Navigation(K183376) | ReferenceDeviceNexstimNavigationalBrainStimulation(NBS) System 4,Nexstim NBSSystem 4 withNEXSPEECH®(K112881) | Discussion of comparison |
| Fundamental | Infrared locatorsand 3D tracking | Electro-magneticfield tracking | Infrared locatorsand 3D tracking | Infrared locatorsand camera | field tracking and optical fieldtracking are both relying onidentifying the position of tools in3D space. Optical tracking is ingeneral more precise as it relieson shorter wavelength thanelectrical tracking. All devicesdefine targets either vialandmarks in a co-registered MRIimage (same principle in allsystems using nasion-earlandmarks) or directly on thescalp. Further, all devices define apoint that represents the centreposition of the coil for navigation.This is either referred to as ageometrical centre of the coildefining the maximum of the fieldsimply by geometry of the coil orreferring to the electrical fieldmaximum by design for anytreatment coil including tilteddesigns. This point is at thegeometric centre of the coil and asclose as possible to the scalpsurface. The display of anymodelled induced electrical fieldin the head tissue does not impactthe accuracy of the stimulusdelivered relative to the target butonly illustrates the fielddistribution of a TMS stimulusinduced in head tissue. ThePrimary Predicate device as wellas the Subject Device and theHorizon Reference device rely ongeometry directly for the definingthe stimulation centre point whilereference K112881 calculates anE-field for this purpose. Withregard to effectiveness and safetyall devices follow the sameworking principle and performwith identical effectiveness. TheSubject Device does not imposeany new or additional safety risks.Comparison and discussion for |
| Substantial Equivalence Technical Characteristics | |||||
| Feature | Subject Devicevisor2 system | PrimaryPredicateNeuralNavigator(K191422) | ReferenceDeviceHORIZON TMSTherapy Systemwith Navigation(K183376) | ReferenceDeviceNexstimNavigationalBrainStimulation(NBS) System 4,Nexstim NBSSystem 4 withNEXSPEECH®(K112881) | Discussion of comparison |
| for locatingTMS coillocationwith regard toprior acquiredMRI images | infrared cameratechnology forland-marking tofacial and skullfeatures usingtracking tools. | using trackingtools. | infrared cameratechnology forland-marking tofacial and skullfeatures usingtracking tools. | technology forland-marking tofacial and skullfeature usingtracking tools.Electric fieldcalculation usedto visualize anestimated fieldgenerated by theTMS coil. | position principle". Allsystems/devices except PrimaryPredicate use the same stereoinfrared 3D camera trackingprinciple (and same supplier forthis component) to track toolsattached to the TMS coil and thehead in space. The predicatedevice uses electro-magnetic fieldtracking with similar accuracy.All systems except the HorizonReference co-register an MRIimage with the physical headusing nasion, left and rightpreauricular points on the headand in the MRI image (or only onthe head if individual MRI is notused). The induced electrical fieldof the coil is used in K112881 torepresent the modelled fieldmaximum while the PrimaryPredicate, the Subject Device, andthe Reference device K183376uses the coil geometry that giveequivalent results. The SubjectDevice allows the user tooptionally show the inducedelectrical field and align the fieldmaximum with the targetedlocation. With regard toeffectiveness and safety, alldevices use the same principleand perform identically. |
| MainComponents | All-In-Onecomputer:Userinterface,IsolationTransformerFor TMS Coillocation support:3D Trackingsubsystem(Stereotacticcamerapositioningsystem), | 3D TrackingsubsystemHead band forTMS coillocation/Navigation | HORIZON®TMS TherapySystema. HORIZON®UserInterface;b. HORIZON®Mainframe;c. HORIZON®PowerSupply;d. HORIZON®MT RemoteCoil; | 3D Trackingsubsystema. MobileNexstim cartb. Nexstim TMSstimulatorc. Nexstimstimulationcoild. Stereotacticcamera (arm-mountedtracking unit) | Both the visor2 system andprimary predicate are cart basedsystems that substantially consistof a computer based navigationsystem and navigation tools andaccessories.The reference device K183376HORIZON TMS Therapy Systemwith Navigation includes aStimGuide feature to supportTMS coil location/navigation.The StimGuide feature is a sublicensed variation of the visor2system. The same TMS coilnavigation components are |
| Substantial Equivalence Technical Characteristics | |||||
| Feature | Subject Devicevisor2 system | PrimaryPredicateNeuralNavigator(K191422) | ReferenceDeviceHORIZON TMSTherapy Systemwith Navigation(K183376) | ReferenceDeviceNexstimNavigationalBrainStimulation(NBS) System 4,Nexstim NBSSystem 4 withNEXSPEECH®(K112881) | Discussion of comparison |
| board,Referencetracking tool,Pointer tool,Coil trackervisor2 carteego amplifier,EE-410(for optionalEMG acquisition) | e. HORIZON® E-z Cool CoilW/StimGuideTrackingReference ('E-z Cool Coil(SG)');f. HORIZON® E-z Cart andArmStimGuideAccessories:a. InterconnectingCables;b. Footswitch;c. Pointer Tool;d. HeadReference.e. eego amplifier,EE-410(for optionalEMGacquisition) | e. 6-channelNexstim EMGf. NBS computersystem withdual 23”displays, PCand NBSsoftwareg. Three-pedalfoot switchh. Nexstimcooling unit(optional)i. Electronically-adjustablepatient chairj. System alsoincludestracking tools:NBS headtracker,coil tracker,anddigitizing pen | applied in this reference device asapplied in the visor2 system | ||
| SoftwareControlled | Yes | Yes | Yes | Yes | All devices rely on software foruser interface and applicablefunctions. The interfaces are verysimilar and use workflow panelscombined with 3D render views. |
| Softwareoperates on apersonalcomputer(PC) | Yes | Yes | Yes | Unknown | All devices use a very similardeployment environment onstandard medical compliantcomputers. |
| SoftwareLevel ofConcern | Moderate | Unknown | Moderate | Unknown | Both the visor2 system underreview and the reference deviceK183376 HORIZON TMSTherapy System with Navigationby the StimGuide feature have amoderate software level concern.Other devices are equivalentlyrated. |
| PrescriptionOnly | Yes | Yes | Yes | Yes | All devices are prescription onlydevices for use by medicalprofessionals. |
| Substantial Equivalence Technical Characteristics | |||||
| Feature | Subject Devicevisor2 system | PrimaryPredicateNeuralNavigator(K191422) | ReferenceDeviceHORIZON TMSTherapy Systemwith Navigation(K183376) | ReferenceDeviceNexstimNavigationalBrainStimulation(NBS) System 4,Nexstim NBSSystem 4 withNEXSPEECH®(K112881) | Discussion of comparison |
| TMS CoilPositioningFeature | Visor2 systemAppliescommerciallyavailable Polaristracking systemfrom NorthernDigital Inc. | BrainTRAKApplies electro-magnetic tracking | StimGuidefeatureAppliescommerciallyavailable Polaristracking systemfrom NorthernDigital Inc. | Nexstim NBSAppliescommerciallyavailable Polaristracking systemfrom NorthernDigital Inc. | All devices except PrimaryPredicate apply the same trackingtechnology.The optical and electro-magnetictracking principle are both relyingon fields that are received eitherby infrared sensors for opticaltracking or by receiver arrays forthe electro-magnetic case. Thesefields are analyzed via trackingtools in 3D space.Both principles are equivalent anddo not differ in effectiveness orsafety aspects. |
| TMS CoilNavigationPatientContactingComponents | TrackingReferencePointer ToolEMG stickerElectrodes(Commerciallyavailable) | Head strap(s) | TrackingReferencePointer ToolEMG Electrodes(Commerciallyavailable) | NBS head trackerDigitizing penEMG Electrodes(Commerciallyavailable) | Compared to the predicate thevisor2 system supports physicalanatomical land marking andfixation of the Tracking referenceto the head by sticker electrodeswhereas the predicate applies ahead strap.Using adhesive stickers in theSubject device instead of the headband can reduce risks for shifts ofthe tracker tool compared to thePredicate Device and will thushave the same or bettereffectiveness and safety. |
| Duration ofTMS Coiltrackingpatientcontact | < 1 hour(approximately40 minutes induration) | < 1 hour(approximately40 minutes induration) | < 1 hour(approximately40 minutes induration) | < 1 hour(approximately40 minutes induration) | The duration of the TMSprocedure, including TMS coillocation/navigation is less thanone hour. |
| TrackingSystemAccuracy | 0.25 mm RMS | 1.4 mm RMS,0.5 degrees RMS(accuracy oflocalization oftool) | 0.25 mm RMS | 1.6 mm(mean error inlocalization of thetool) | Compared to the predicate thevisor2 system has comparable andslightly better tracking systemaccuracy. This is mainlyattributed to the infrared optical3D tracking principle.The tracking system accuracy ofthe visor2 system is the same asthe StimGuide TMS coilnavigation feature in the reference |
| Substantial Equivalence Technical Characteristics | |||||
| Feature | Subject Devicevisor2 system | PrimaryPredicateNeuralNavigator(K191422) | ReferenceDeviceHORIZON TMSTherapy Systemwith Navigation(K183376) | ReferenceDeviceNexstimNavigationalBrainStimulation(NBS) System 4,Nexstim NBSSystem 4 withNEXSPEECH®(K112881) | Discussion of comparison |
| SystemAccuracy | 4 mm | 3mm +/- 2.1 mm(when navigatingwith hand-heldprobe)5mm +/- 2.1 mm(when navigatingwith TMS coil) | 4 mm | 5.73 mm (mean)11.46 mm (95%CI) | The system accuracy is within therange of the predicate device andthe reference devices.All devices perform identical withregard to effectiveness and safety. |
| EMGAcquisition | Yes(optional) | Yes | Yes | Yes | As an optional feature, the visor2systems under review supportssurface EMG acquisition. |
| MotorThreshold(MT)ResponseDetection | EMG providesquantitative databased on whichthe user definesMT. | Unknown | Option 1: EMGprovidesquantitativedata based onwhich the userdefines MT.Option 2: Visualqualitativemonitoring forAPB response. | Unknown | The visor2 system under reviewprovides an optional EMGmethod for user-defined MTresponse detection, same as thereference device K183376HORIZON TMS Therapy Systemwith Navigation by the StimGuidefeature. This feature is anadditional indicator for the user tosupport anatomical navigationwith functional mapping. Theprimary predicate does notprovide this feature in theirproduct. The additional EMGfeature does not limit theeffectiveness or safety of thedevice in any way, but supportsthe user with additionalinformation on motor responsedue to TMS stimulation. |
| ScannerInterface | Import of MRIimages inDICOM format.Import offMRI/PETimages.Mapping resultsexported as CSV | DICOM importof MR images;load fMRI/PETimages throughimport wizard.Full DICOMconformancestatementavailable. | Unknown | DICOM importof MR images.Load fMRI/PETimages throughimport tab.Mapping resultsexported asDICOM images | Compared to the predicate theimport and export of files aresimilar and support userpreferences.Supported formats are matching. |
| Substantial Equivalence Technical Characteristics | |||||
| Feature | Subject Devicevisor2 system | PrimaryPredicateNeuralNavigator(K191422) | ReferenceDeviceHORIZON TMSTherapy Systemwith Navigation(K183376) | ReferenceDeviceNexstimNavigationalBrainStimulation(NBS) System 4,Nexstim NBSSystem 4 withNEXSPEECH®(K112881) | Discussion of comparison |
| DICOM imageswith voxelcoloringaccording tomotor responseamplitudes andlanguagemappingclassifications. | Mapping resultsexported asXML text file. | coloringaccording tomotor responseamplitudes andspeech areastimulationresponses. | |||
| MRIFeatures:• fMRI/MRIimport• MRI basedheadmodeling• efieldvisualization | Yes | Yes | Yes | Yes | Same |
| DICOMconformance | Yes | Yes | Yes | Yes | Same |
| Brainsegmentation | Semi-automatedimagesegmentation ofskin and brainfrom patientMRI. | Customautomatic tissuesegmentationroutine toreveal anatomicalstructures of thebrain surface in3D. | Unknown | Automatic tissuesegmentationroutine to revealanatomicalstructures of thebrain surface in3D. | Segmentation is not affectingsafety or effectiveness as itcreates a surface for visualizationof the MRI not just in slices buton curved surface in a 3D renderscene. This does not change theMRI image nor positions ofvoxels relative to referencecoordinates or landmarks. Viaparameters the user can adjust thesurfaces expressed by thedifferent predicates in the word"custom" or "semi-automated". |
| Headmodelcreation | Generation ofaccurate 3-Dmodel of thepatient's head. | Generation ofheadmodel frompatient MRI. | Generation ofaccurate 3-Dmodel of thepatient's head. | Generation ofaccurate 3-Dmodel of thepatient's head. | The head model is generated inthe same way as the 3Dsegmentation and by defining asurface of the segmented headregion based in the MRI voxelspace. The rendering of this doesnot change the MR images in anyway. This feature does not affectsafety nor effectiveness of thedevice. |
| Substantial Equivalence Technical Characteristics | |||||
| FeatureElectricalsafetycompliance | Subject Devicevisor2 system | PrimaryPredicateNeuralNavigator(K191422) | ReferenceDeviceHORIZON TMSTherapy Systemwith Navigation(K183376) | ReferenceDeviceNexstimNavigationalBrainStimulation(NBS) System 4,Nexstim NBSSystem 4 withNEXSPEECH®(K112881) | Discussion of comparison |
| YesIEC 60601-1 | YesIEC 60601-1 | YesIEC 60601-1 | YesIEC 60601-1 | All devices comply with the IEC60601-1 electrical safetyrequirements. | |
| EMCcompliance | YesIEC 60601-1-2 | YesIEC 60601-1-2 | YesIEC 60601-1-2 | YesIEC 60601-1-2 | All devices comply with the IEC60601-1-2 EMC requirements. |
| Compatiblecoils | Mag & More:PMD70-aCoolDouble coilFigure-8;MagStimCompany Ltd.:Double 70mmRemote, Double70mm Air Film;MagVenture A/S:Double 75mm,Double Cooled75mm, Double95mm, AngulatedDouble Cooled97mm, Butterflyfigure-8:Neuronetics, Inc.:NeuroStar coil | Neurosoft Ltd:AFEC-02-100andAFEC-02-100-C. | HORIZON:MT remote coil,E-z Cool Coil,andAFC | Nexstim:Focal Coil,High IntensityCoil, andCooled Coil | The visor2 system under reviewhas demonstrated compatibilitywith the noted commerciallyavailable TMS stimulation coils. |
| Operatingconditions | 10°C - 40°C;between 30%-70%noncondensinghumidity.Air pressure80 kPa-106 kPa | 5°C - 40°C;between 10%-90%noncondensinghumidity. Maxallowed heightfor usage is2000 m above sealevel.Air pressure79 kPa-106 kPa | Unknown | 15°C- 30°C;between 30%-75% non-condensinghumidity.Air Pressure 80kPa- 106 kPa | Similar as noted.The environment of use for thevisor2 system is the controlledenvironment of a hospital orclinic outpatient treatment room. |
| Electricalrating | 100-240 VAC,50/60 Hz | 100-240 VAC,50/60 Hz | Unknown | 100-240 VAC,50/60 Hz | Same as noted |
| Dimensions | 30cm x 8cm x8cm(approximate)(Tracking unit) | 18.5 cm x 29.2cm x 6.4 cm(Electronics Unit) | 30cm x 8cm x8cm(approximate)(Tracking unit) | 27.3 cm x 6.9 cmx 6.9 cm(tracking unit) | Very similar to Predicate and notrelevant to effectiveness norsafety. |
| Substantial Equivalence Technical Characteristics | |||||
| Feature | Subject Devicevisor2 system | PrimaryPredicateNeuralNavigator(K191422) | ReferenceDeviceHORIZON TMSTherapy Systemwith Navigation(K183376) | ReferenceDeviceNexstimNavigationalBrainStimulation(NBS) System 4,Nexstim NBSSystem 4 withNEXSPEECH®(K112881) | Discussion of comparison |
| Powerconsumption | 330 Watts | 50 VA | Unknown | 1000 VA | Similar as noted.The visor2 system is applied incontrolled environments of ahospital or clinic outpatienttreatment facility. The availablepower within these facilities willaccommodate the power needs ofthe visor2. |
| DICOMConformance | DICOMConformancestatementavailable. | DICOMconformancestatementavailable | Unknown | DICOMConformancestatementavailable. | Same as noted |
| PlanningFeatures | Coil targets todeliver TMS tospecific area;includesvisibility, locationand description | Stimulationtargets to deliverTMS to specificarea; includesvisibility, locationand description | Coil targets todeliver TMS tospecific area;includesvisibility, locationand description | Stimulationtargets to deliverTMS to specificarea; includesvisibility, locationand description ofthe target. | Similar as noted.The coil targets are the same asthe stimulation targets. |
| 2D and 3Dviewing | Yes: axial,coronal, sagittalslices throughconfigurable cutplanes in 3Dscene | Yes: axial,coronal, sagittalslices throughconfigurable cutplanes in 3Dscene | Yes: axial,coronal, sagittalslices throughconfigurable cutplanes in 3Dscene | Yes | Similar as noted |
| Scannerinterface | Import ofDICOM MRimages, import offunctional imagedata (fMRI),DICOMconformancestatement,Mapping resultsexported asDICOM, text orcsv files. | DICOM importof MR images;load fMRI/PETimages throughimport wizard.Full dicomconformancestatementavailable.Mapping resultsexported as XMLtext file. | StimGuide is notallowing DICOMor other MRIimport. It onlyincludes featuresfor scalp basednavigation. | DICOM importof MR images;load fMRI/PETimages throughimport tab. | Similar as noted.The visor2 system can importDICOM MR images andfunctional image data. MRimages are applied to supportTMS coil positioning.PT images are not supported |
| Registrationfeature | Crosshairs toregister specificMRI landmarks,pointer tool andhead tracker;validation tests to | Cross-hairs toregister specificMRI landmarks,digitization penand head trackersensors;registration | Crosshairs toregisterlandmarks,pointer tool andhead tracker;validation tests to | Cross-hairs toregister specificMRI landmarks,digitization penand head trackerLED indicators;may performadvanced | Similar as noted.The registration feature is thesame concept and methodbetween the visor2 system and thepredicate. |
| Substantial Equivalence Technical Characteristics | |||||
| Feature | Subject Devicevisor2 system | PrimaryPredicateNeuralNavigator(K191422) | ReferenceDeviceHORIZON TMSTherapy Systemwith Navigation(K183376) | ReferenceDeviceNexstimNavigationalBrainStimulation(NBS) System 4,Nexstim NBSSystem 4 withNEXSPEECH®(K112881) | Discussion of comparison |
| determineinaccuracies. | determineinaccuracies. | determineinaccuracies. | registrationdigitizing ninescalp points;registrationintegrity test todetermineinaccuracies. |
Summary of Technological Characteristics
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Non-clinical Performance Tests to Demonstrate Substantial Equivalency
To establish the technical equivalency of the visor2 system, evaluations were conducted to confirm compliance with performance requirements, including:
| Test | Test Method Summary | Result |
|---|---|---|
| Electrical Safety | IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007+A1:2012 | Pass |
| Electromagnetic Compatibility | IEC 60601-1-2 Edition 4.0 2014-02 | Pass |
| The visor2 system under review isan accessory to RepetitiveTranscranial Magnetic Stimulation(TMS) systems. | Review and document compliance with Class II Special Controlsguidance document: Repetitive Transcranial Magnetic StimulationSystems, issued July 26, 2011 | Pass |
| System performance tospecifications | Hardware, software and system evaluations. | Pass |
| Biocompatibility evaluation | The Pointer Tool is the only supplied patient contacting component of thevisor2 system. The patient contact materials in their final finished form,are identical to the StimGuide TMS coil location/navigation feature inK183376. | Pass |
| Software verification, validation | The visor2 system software was developed and documentation providedin compliance with the FDA Guidance document: Guidance for theContent of Premarket Submissions for Software Content in MedicalDevices, May 11, 2005. Intentional and unintentional cybersecurity risksand mitigations are applied. | Pass |
Bench testing demonstrated that the performance parameters of the visor2 system meets pre-specified requirements and are substantially equivalent to those of the predicate device. A summary of the performance testing is provided in the table below.
| Test | Test Method Summary | Results |
|---|---|---|
| Commercial TMS Coilcompatibility | Validation testing is used with users that userespective coils covering the workflow onconfirming expected accuracy. | PassThe compatible commerciallycompatible TMS coils are |
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| Test | Test Method Summary | Results |
|---|---|---|
| Over all accuracy of TMScoil position relative tothe head (absolute value) | Worst case upper limit of the position mismatch inpositioning the coil relative to the head. | demonstrated to be able to becalibrated and properly applied withinthe location accuracy defined by thevisor2 system. |
| Position accuracy(Tracking camera) | Volumetric Accuracy: based on a single markerstepped through more than 900 positions throughoutthe measurement volume using the mean of 30samples at each position at 20°C. | Pass, Range $\u2264$ 10 mm |
| Navigation Principle | Same as the main accuracy test that covers all aspectsof the main navigation principle. Further to this it ischecked that the distance between target and stimuluscan be reduced to 2mm.Main navigation principle is 'point based registration'between MRI space and patient space, and thecalibration of navigation tools. It is tested via acomparison of known nominal positions/rotations inthe physical world with tracked coil positions tocovers all relevant tolerances and deviations in toolsand other mechanical structures. | Main PASS criteria:The stimulus position should be within4mm of the physical setup and thedistance between stimulus target andstimulus below 2mm. |
| Coil Compatibility | Covered by the general test as each coil is registeredby the user as part of the workflow.Coil mount fixated on the TMS coil handle.Coil tracker mount firmly attached. Coil trackercalibrated to coil dimensions via calibration board.Tracking tools material composition: Polyurethane(PUR) | Main PASS criteria:Accuracy limit in validation workflow4mm |
| Coil Compatibility -Validation | The user is guided through the coil calibration andtracking steps and a questionnaire is used to trace thevalidation content and result.Validation reports for specific coils as listed inindications for use. Testing of coil calibration &validation in physical setup, robust with cameramovement. | Passed validation |
| Tracking System Accuracy | Compatible camera Northern Digital Inc. (NDI) (referto system components defined in user guide).Main relevant tests covering this aspect:In this test a coil / coil-tracking-tool is placed atknown nominal positions with fully constraintorientation and measured against a ground truth in thephysical scene. This covers all tolerances summing upwhen using the system including initial nasion-ear andcoil registration steps. | Declaration of Conformity by NorthernDigital Inc. and over-all system accuracybetter than 4mm |
| System Accuracy | Same as tracking system accuracy.The tracking accuracy testing covers all tolerancessumming up when using the system including initialnasion-ear and coil registration steps. | The match between positions and lengthin over-all system accuracy better than4mm |
| Test | Test Method Summary | Results |
| Imaging Modality | MRI image with known landmark positions is loadedand positions of them are checked in the render 3Dscene against the ground truth.MRI image with known landmark positions is loadedand positions of them are checked in the render 3Dscene against the ground truth. | Main criteria: Accuracy of landmarks toMRI within 2mm. |
| Selection of targets viaanatomical and functionallandmarks | Visor2 follows the same scheme as referenceHORIZON TMS Therapy System with Navigation anddefines targets via anatomical or functionallandmarks. The latter uses EMG.The EMG test is done by applying a known functionto the input of the patient leads and making sure thewaveform in visor2 follows the ground truth appliedwith the defined accuracy. For navigation again theoverall accuracy test for the system is applied andneeds to pass. | 10% accuracy in EMG parameters forfunctional mappingOver-all position system accuracy betterthan 4mm |
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Clinical data are not needed to support substantial equivalence.
Conclusion
The visor2 system met performance requirements equivalent to the predicate device. With regard to supporting the location of the TMS coil to prior acquired MRI images, the intended use and technology of the visor2 system is the same as the predicate device.
§ 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).