Who is the manufacturer of visor2 system?

Eemagine Medical Imaging Solutions GmbH filed the 510(k) submission for visor2 system (K210109).

What is the FDA product code for visor2 system?

HAW. It is classified under 21 CFR 882.4560 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for visor2 system?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like visor2 system?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

visor2 system

K210109 · Eemagine Medical Imaging Solutions GmbH · HAW · Apr 8, 2022 · Neurology

Device Facts

Record ID	K210109
Device Name	visor2 system
Applicant	Eemagine Medical Imaging Solutions GmbH
Product Code	HAW · Neurology
Decision Date	Apr 8, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.4560
Device Class	Class 2

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.

Device Story

3D navigation system for TMS coil positioning; inputs include MRI data, scalp landmarks, and optional EMG signals; uses optical stereotactic tracking (infrared camera and tracking tools) to register patient head and coil in 3D space; provides visual guidance on All-in-One touch display; operated by trained physicians in clinical/outpatient settings; aids accurate coil placement relative to anatomical/functional targets; benefits patient by ensuring precise stimulation delivery; does not perform stimulation itself.

Clinical Evidence

Bench testing only. No clinical data required. Performance validated via electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and system accuracy testing. Overall system accuracy demonstrated <4mm. EMG acquisition accuracy validated to 10% of parameters. Biocompatibility confirmed for patient-contacting pointer tool.

Technological Characteristics

Cart-based system with All-in-One PC; optical tracking via NDI infrared camera; tracking tools made of Polyurethane (PUR); connectivity via DICOM for MRI/fMRI import; optional EMG amplifier (eego EE-410); software-controlled navigation; electrical safety per IEC 60601-1; EMC per IEC 60601-1-2.

Indications for Use

Indicated for 3D navigation to aid positioning of TMS coils over preselected brain regions using MRI data or scalp landmarks, with optional EMG recording, in clinical procedures. For use by trained physicians; not for surgical use.

Regulatory Classification

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.

Predicate Devices

Neural Navigator (K191422)

Reference Devices

HORIZON TMS Therapy System with Navigation (K183376)
Nexstim Navigational Brain Stimulation (NBS) System 4 (K112881)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ 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) | | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------| | <div> <svg height="12" width="12"> <rect fill="black" height="12" width="12" x="0" y="0"></rect> </svg> Prescription Use (Part 21 CFR 801 Subpart D) </div> | Over-The-Counter Use (21 CFR 801 Subpart C) | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff RAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 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 visor2 system. | Berlin | | Company Name: eemagine | Reference (eemagine): e.g. contract ID | | Company Contact: Frank Zanow, Chief Executive Officer eemagine Medical Imaging Solutions GmbH | | | Date Summary Prepared: April 8, 2022 | eemagine GmbH Gubener Str.47 D-10243 Berlin Tel. +49 30 29048404 Fax. +49 30 29048405 www.eemagine.com | | Trade Name: visor2 system | | | Common Name: Accessory to Repetitive Transcranial Magnetic Stimulation | | | Classification Name: Repetitive Transcranial Magnetic Stimulation System 21 CFR 882.4560, Product Code: HAW, Class II | | | Primary Predicate: K191422, Neural Navigator Manufacturer: Soterix Medical, Inc., New York, NY 10001 | CEO/Geschäftsführer: Ralf Hauffe, Ph.D. | | Reference Devices: K183376, HORIZON TMS Therapy System with Navigation Manufacturer: Magstim Company Ltd., Whitland, GB Sa34 0hr | Registration: HRB 7128 VAT ID: DE201608185 | | K112881, Nexstim Navigational Brain Stimulation (NBS) System 4, Nexstim NBS System 4 with NEXSPEECH® Manufacturer: NEXSTIM OY, Helsinki, FI-00510 | Commerzbank Berlin BIC Code CoBaDEBB120 IBAN | 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. {4}------------------------------------------------ # 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 Device visor2 system | Primary Predicate Neural Navigator (K191422) | Reference Device HORIZON TMS Therapy System with Navigation (K183376) | Reference Device Nexstim Navigational Brain Stimulation (NBS) System 4, Nexstim NBS System 4 with NEXSPEECH® (K112881) | Discussion of comparison | | Product Code, Classification | HAW (Subsequent: GWF, IKN, OBP) 21 CFR 882.4560, Class II | HAW (Subsequent: GWF, IKN, OBP) 21 CFR 882.4560, Class II | OBP, HAW, IKN 21 CFR 882.5805, Class II | GWF, HAW, IKN 21 CFR 882.1870, Class II | Classification of Subject Device, Primary Predicate and Reference Device matches. The Subject Device is an accessory to TMS therapy systems, providing location for the TMS coil. | | Intended use | As an accessory to TMS systems, provide navigation, location support for placement of the TMS coil on the skull in relation to a prior acquired MRI image. | A neuronavigation system indicated for accurate positioning of the treatment coil of the CloudTMS Therapy System with respect to target brain regions based on data obtained from MRI measurements. | A repetitive transcranial magnetic stimulation system that delivers transcranial repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex to treat the symptoms of major depressive | Non-invasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System provides information that may be used in the assessment of the primary motor cortex for pre- procedural planning. | The intended use of Subject Device, Primary Predicate and both Reference Devices match fully with regards to all aspects related to effectiveness and safety (navigation of a TMS coil relative to MRI and/or scalp landmarks/targets). As accessory to the TMS system, the device under review provides TMS coil location support. The device under review provides a locating feature to TMS systems. The device under review is an optional accessory to | | Substantial Equivalence Technical Characteristics | | | | | | | Feature | Subject Device visor2 system | Primary Predicate Neural Navigator (K191422) | Reference Device HORIZON TMS Therapy System with Navigation (K183376) | Reference Device Nexstim Navigational Brain Stimulation (NBS) System 4, Nexstim NBS System 4 with NEXSPEECH® (K112881) | Discussion of comparison | | 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 or 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 MagStim Company Ltd.: Double 70mm Remote Coil (3190-00 rev2), Double 70mm Air Film (3910-00) MagVenture A/S: Double 75mm (C-B60), Double Cooled 75mm (Cool-B65), | The Neural Navigator is a neuronavigation system indicated for accurate positioning of the treatment coil of the CloudTMS Therapy System with respect to target brain regions based on data obtained from MRI measurements. Specifically, the Neural Navigator is indicated for use with the following CloudTMS Therapy System coils manufactured by Neurosoft Ltd: AFEC-02-100 and AFEC-02-100-C. | HORIZON® is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode. | The Nexstim Navigated Brain Stimulation System (NBS System) 4 is indicated for non- invasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System 4 provides information that may be used in the assessment of the primary motor cortex for preprocedural planning. Nexstim NEXSPEECH, when used together with the Nexstim NBS System 4, is indicated for noninvasive localization of cortical areas that do not contain essential speech function. Nexstim NEXSPEECH provides information that may be used in pre-surgical planning in patients undergoing brain surgery. Intraoperatively, the localization information provided by | The indication of use of Subject Device, Primary Predicate and both Reference Devices match fully with regard to all aspects related to effectiveness and safety (navigation of a TMS coil relative to MRI and/or scalp landmarks/targets). The Subject Device is more flexible with regard to supported coils than any of the Reference and Predicate system. As accessory to the TMS system, the device under review provides TMS coil location support. The visor2 system under review is an optional accessory to support locating/navigating TMS coil feature to existing TMS systems for their intended use. Note: The reference device K183376 HORIZON TMS Therapy System with Navigation includes a StimGuide feature to support TMS coil location/navigation. The StimGuide feature is a sub licensed variation of the visor2 system, was reviewed in the Horizon TMS Therapy System with Navigation, K183376, to support TMS coil location. | | Substantial Equivalence Technical Characteristics | | | | | | | Feature | Subject Device visor2 system | Primary Predicate Neural Navigator (K191422) | Reference Device HORIZON TMS Therapy System with Navigation (K183376) | Reference Device Nexstim Navigational Brain Stimulation (NBS) System 4, Nexstim NBS System 4 with NEXSPEECH® (K112881) | Discussion of comparison | | | 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. | | | NEXSPEECH® is intended to be verified by direct cortical stimulation. The Nexstim NBS System 4 and NBS System 4 with NEXSPEECH® are not intended to be used during a surgical procedure. The Nexstim NBS System 4 and NBS System 4 with NEXSPEECH® are intended to be used by trained clinical professionals. | | | TMS Coil Position Principle | Based on anatomy (MRI picture) and indirect targeting of treatment target through measured distance and direction using optical stereotactic navigation. | Based on Anatomy (MRI picture) and electro-magnetic field navigation. | Indirect targeting of treatment target through measured distance and direction using optical stereotactic navigation and anatomy. | Based on Anatomy (MRI picture) and optical stereotactic navigation. | All devices support the location/navigation of the TMS coil. The reference device K183376 HORIZON TMS Therapy System with Navigation includes a StimGuide feature to support TMS coil location/navigation uses the same methodology as the visor2 system under review. The StimGuide feature is a sub licensed variation of the visor2 system. Subject Device, Primary Predicate and both Reference Devices all use the same or equivalent position principle registering the physical head/scalp and a coil via tracker tools tracked by a stereo infrared camera 3D tracking system or in case of the Primary Predicate Device electro-magnetic field tracking. Electro-magnetic | | Substantial Equivalence Technical Characteristics | | | | | | | Feature | Subject Device visor2 system | Primary Predicate Neural Navigator (K191422) | Reference Device HORIZON TMS Therapy System with Navigation (K183376) | Reference Device Nexstim Navigational Brain Stimulation (NBS) System 4, Nexstim NBS System 4 with NEXSPEECH® (K112881) | Discussion of comparison | | Fundamental | Infrared locators and 3D tracking | Electro-magnetic field tracking | Infrared locators and 3D tracking | Infrared locators and camera | field tracking and optical field tracking are both relying on identifying the position of tools in 3D space. Optical tracking is in general more precise as it relies on shorter wavelength than electrical tracking. All devices define targets either via landmarks in a co-registered MRI image (same principle in all systems using nasion-ear landmarks) or directly on the scalp. Further, all devices define a point that represents the centre position of the coil for navigation. This is either referred to as a geometrical centre of the coil defining the maximum of the field simply by geometry of the coil or referring to the electrical field maximum by design for any treatment coil including tilted designs. This point is at the geometric centre of the coil and as close as possible to the scalp surface. The display of any modelled induced electrical field in the head tissue does not impact the accuracy of the stimulus delivered relative to the target but only illustrates the field distribution of a TMS stimulus induced in head tissue. The Primary Predicate device as well as the Subject Device and the Horizon Reference device rely on geometry directly for the defining the stimulation centre point while reference K112881 calculates an E-field for this purpose. With regard to effectiveness and safety all devices follow the same working principle and perform with identical effectiveness. The Subject Device does not impose any new or additional safety risks. Comparison and discussion for | | Substantial Equivalence Technical Characteristics | | | | | | | Feature | Subject Device visor2 system | Primary Predicate Neural Navigator (K191422) | Reference Device HORIZON TMS Therapy System with Navigation (K183376) | Reference Device Nexstim Navigational Brain Stimulation (NBS) System 4, Nexstim NBS System 4 with NEXSPEECH® (K112881)…

visor2 system

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Device Story

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Reference Devices

Submission Summary (Full Text)

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