Predicate Devices

K191422, Neural Navigator

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a 3D navigation system for TMS coil positioning based on MRI data or scalp landmarks and optional EMG. It focuses on hardware components, compatibility, and performance metrics related to accuracy and safety. There is no mention of AI, ML, or related concepts like training/test sets, which are typically included in summaries for devices utilizing these technologies.

Therapeutic

No.
The device is a 3D navigation system that aids in positioning TMS coils, but it does not directly provide therapy. It is used to guide the placement of therapeutic devices (TMS coils) which are separately cleared by the FDA.

Diagnostic

No.

The device is a 3D navigation system that aids in positioning TMS coils. While it uses MRI data and can optionally record EMG signals to guide placement, its primary function is for navigation and positioning, not for diagnosing a disease or condition. The text also states it is "used to aid 3D navigation", which indicates a supportive rather than a diagnostic role.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the visor2 system consists of hardware components including a cart, an All-in-One medical computer, a mounting plate, and a Tracking camera with mounting arm.

IVD (In Vitro Diagnostic)

Based on the provided information, the visor2 device is not an In Vitro Diagnostic (IVD).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
visor2 Function: The visor2 system is a 3D navigation system used to guide the positioning of Transcranial Magnetic Stimulation (TMS) coils over the brain. It uses MRI data or scalp landmarks and optionally EMG recording.
No Specimen Analysis: The description of the visor2 system does not involve the analysis of any specimens taken from the human body. Its function is entirely focused on external navigation and positioning of a separate medical device (TMS coil) on the patient's head.

Therefore, the visor2 device falls under the category of a medical device used for guiding a therapeutic procedure, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

HAW, GWF, IKN, OBP

Device 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

MRI measurements

Anatomical Site

brain regions

Indicated Patient Age Range

Not Found

Intended User / Care Setting

trained physician / clinical procedures

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical Performance Tests to Demonstrate Substantial Equivalency:

Test: Electrical Safety
- Test Method Summary: IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 +A1:2012
- Result: Pass
Test: Electromagnetic Compatibility
- Test Method Summary: IEC 60601-1-2 Edition 4.0 2014-02
- Result: Pass
Test: The visor2 system under review is an accessory to Repetitive Transcranial Magnetic Stimulation (TMS) systems.
- Test Method Summary: Review and document compliance with Class II Special Controls guidance document: Repetitive Transcranial Magnetic Stimulation Systems, issued July 26, 2011
- Result: Pass
Test: System performance to specifications
- Test Method Summary: Hardware, software and system evaluations.
- Result: Pass
Test: Biocompatibility evaluation
- Test Method Summary: The Pointer Tool is the only supplied patient contacting component of the visor2 system. The patient contact materials in their final finished form, are identical to the StimGuide TMS coil location/navigation feature in K183376.
- Result: Pass
Test: Software verification, validation
- Test Method Summary: The visor2 system software was developed and documentation provided in compliance with the FDA Guidance document: Guidance for the Content of Premarket Submissions for Software Content in Medical Devices, May 11, 2005. Intentional and unintentional cybersecurity risks and mitigations are applied.
- Result: Pass

Performance Testing Summary:

Test: Commercial TMS Coil compatibility
- Test Method Summary: Validation testing is used with users that use respective coils covering the workflow on confirming expected accuracy.
- Results: 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.
Test: Over all accuracy of TMS coil position relative to the head (absolute value)
- Test Method Summary: Worst case upper limit of the position mismatch in positioning the coil relative to the head.
- Results: Pass, Range less than or equal to 10 mm
Test: Position accuracy (Tracking camera)
- Test Method Summary: Volumetric Accuracy: based on a single marker stepped through more than 900 positions throughout the measurement volume using the mean of 30 samples at each position at 20°C.
- Results: Main PASS criteria: The stimulus position should be within 4mm of the physical setup and the distance between stimulus target and stimulus below 2mm.
Test: Navigation Principle
- Test Method Summary: Same as the main accuracy test that covers all aspects of the main navigation principle. Further to this it is checked that the distance between target and stimulus can be reduced to 2mm. Main navigation principle is 'point based registration' between MRI space and patient space, and the calibration of navigation tools. It is tested via a comparison of known nominal positions/rotations in the physical world with tracked coil positions to covers all relevant tolerances and deviations in tools and other mechanical structures.
- Results: Main PASS criteria: Accuracy limit in validation workflow 4mm
Test: Coil Compatibility
- Test Method Summary: Covered by the general test as each coil is registered by the user as part of the workflow. Coil mount fixated on the TMS coil handle. Coil tracker mount firmly attached. Coil tracker calibrated to coil dimensions via calibration board. Tracking tools material composition: Polyurethane (PUR).
- Results: Passed validation
Test: Coil Compatibility - Validation
- Test Method Summary: The user is guided through the coil calibration and tracking steps and a questionnaire is used to trace the validation content and result. Validation reports for specific coils as listed in indications for use. Testing of coil calibration & validation in physical setup, robust with camera movement.
- Results: Declaration of Conformity by Northern Digital Inc. and over-all system accuracy better than 4mm
Test: Tracking System Accuracy
- Test Method Summary: Compatible camera Northern Digital Inc. (NDI) (refer to system components defined in user guide). Main relevant tests covering this aspect: In this test a coil / coil-tracking-tool is placed at known nominal positions with fully constraint orientation and measured against a ground truth in the physical scene. This covers all tolerances summing up when using the system including initial nasion-ear and coil registration steps.
- Results: The match between positions and length in over-all system accuracy better than 4mm
Test: System Accuracy
- Test Method Summary: Same as tracking system accuracy. The tracking accuracy testing covers all tolerances summing up when using the system including initial nasion-ear and coil registration steps.
- Results: Main criteria: Accuracy of landmarks to MRI within 2mm.
Test: Imaging Modality
- Test Method Summary: MRI image with known landmark positions is loaded and positions of them are checked in the render 3D scene against the ground truth. MRI image with known landmark positions is loaded and positions of them are checked in the render 3D scene against the ground truth.
- Results: 10% accuracy in EMG parameters for functional mapping. Over-all position system accuracy better than 4mm.
Test: Selection of targets via anatomical and functional landmarks
- Test Method Summary: Visor2 follows the same scheme as reference HORIZON TMS Therapy System with Navigation and defines targets via anatomical or functional landmarks. The latter uses EMG. The EMG test is done by applying a known function to the input of the patient leads and making sure the waveform in visor2 follows the ground truth applied with the defined accuracy. For navigation again the overall accuracy test for the system is applied and needs to pass.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K191422, Neural Navigator

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

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

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

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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

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)
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 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)	Discussion of comparison
for locating
TMS coil
location
with regard to
prior acquired
MRI images	infrared camera
technology for
land-marking to
facial and skull
features using
tracking tools.	using tracking
tools.	infrared camera
technology for
land-marking to
facial and skull
features using
tracking tools.	technology for
land-marking to
facial and skull
feature using
tracking tools.
Electric field
calculation used
to visualize an
estimated field
generated by the
TMS coil.	position principle". All
systems/devices except Primary
Predicate use the same stereo
infrared 3D camera tracking
principle (and same supplier for
this component) to track tools
attached to the TMS coil and the
head in space. The predicate
device uses electro-magnetic field
tracking with similar accuracy.
All systems except the Horizon
Reference co-register an MRI
image with the physical head
using nasion, left and right
preauricular points on the head
and in the MRI image (or only on
the head if individual MRI is not
used). The induced electrical field
of the coil is used in K112881 to
represent the modelled field
maximum while the Primary
Predicate, the Subject Device, and
the Reference device K183376
uses the coil geometry that give
equivalent results. The Subject
Device allows the user to
optionally show the induced
electrical field and align the field
maximum with the targeted
location. With regard to
effectiveness and safety, all
devices use the same principle
and perform identically.
Main
Components	All-In-One
computer:
User
interface,
Isolation
Transformer
For TMS Coil
location support:
3D Tracking
subsystem
(Stereotactic
camera
positioning
system),	3D Tracking
subsystem
Head band for
TMS coil
location/Navigati
on	HORIZON®
TMS Therapy
System
a. HORIZON®
User
Interface;
b. HORIZON®
Mainframe;
c. HORIZON®
Power
Supply;
d. HORIZON®
MT Remote
Coil;	3D Tracking
subsystem
a. Mobile
Nexstim cart
b. Nexstim TMS
stimulator
c. Nexstim
stimulation
coil
d. Stereotactic
camera (arm-
mounted
tracking unit)	Both the visor2 system and
primary predicate are cart based
systems that substantially consist
of a computer based navigation
system and navigation tools and
accessories.
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. The same TMS coil
navigation components are
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
	board,
Reference
tracking tool,
Pointer tool,
Coil tracker
visor2 cart
eego amplifier,
EE-410
(for optional
EMG acquisition)		e. HORIZON® E-
z Cool Coil
W/StimGuide
Tracking
Reference ('E-
z Cool Coil
(SG)');
f. HORIZON® E-
z Cart and
Arm
StimGuide
Accessories:
a. Interconnecting
Cables;
b. Footswitch;
c. Pointer Tool;
d. Head
Reference.
e. eego amplifier,
EE-410
(for optional
EMG
acquisition)	e. 6-channel
Nexstim EMG
f. NBS computer
system with
dual 23”
displays, PC
and NBS
software
g. Three-pedal
foot switch
h. Nexstim
cooling unit
(optional)
i. Electronically-
adjustable
patient chair
j. System also
includes
tracking tools:
NBS head
tracker,
coil tracker,
and
digitizing pen	applied in this reference device as
applied in the visor2 system
Software
Controlled	Yes	Yes	Yes	Yes	All devices rely on software for
user interface and applicable
functions. The interfaces are very
similar and use workflow panels
combined with 3D render views.
Software
operates on a
personal
computer
(PC)	Yes	Yes	Yes	Unknown	All devices use a very similar
deployment environment on
standard medical compliant
computers.
Software
Level of
Concern	Moderate	Unknown	Moderate	Unknown	Both the visor2 system under
review and the reference device
K183376 HORIZON TMS
Therapy System with Navigation
by the StimGuide feature have a
moderate software level concern.
Other devices are equivalently
rated.
Prescription
Only	Yes	Yes	Yes	Yes	All devices are prescription only
devices for use by medical
professionals.
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
TMS Coil
Positioning
Feature	Visor2 system
Applies
commercially
available Polaris
tracking system
from Northern
Digital Inc.	BrainTRAK
Applies electro-
magnetic tracking	StimGuide
feature
Applies
commercially
available Polaris
tracking system
from Northern
Digital Inc.	Nexstim NBS
Applies
commercially
available Polaris
tracking system
from Northern
Digital Inc.	All devices except Primary
Predicate apply the same tracking
technology.

The optical and electro-magnetic
tracking principle are both relying
on fields that are received either
by infrared sensors for optical
tracking or by receiver arrays for
the electro-magnetic case. These
fields are analyzed via tracking
tools in 3D space.

Both principles are equivalent and
do not differ in effectiveness or
safety aspects. |
| TMS Coil
Navigation
Patient
Contacting
Components | Tracking
Reference
Pointer Tool
EMG sticker
Electrodes
(Commercially
available) | Head strap(s) | Tracking
Reference
Pointer Tool
EMG Electrodes
(Commercially
available) | NBS head tracker
Digitizing pen
EMG Electrodes
(Commercially
available) | Compared to the predicate the
visor2 system supports physical
anatomical land marking and
fixation of the Tracking reference
to the head by sticker electrodes
whereas the predicate applies a
head strap.

Using adhesive stickers in the
Subject device instead of the head
band can reduce risks for shifts of
the tracker tool compared to the
Predicate Device and will thus
have the same or better
effectiveness and safety. |
| Duration of
TMS Coil
tracking
patient
contact |