Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physiological signal amplifier and associated software for acquiring and displaying bioelectric signals. There is no mention of AI, ML, or any related technologies for analysis or interpretation of the data. The software is described as managing user interface, presentation, post-processing, storage, archiving, and printing.

Therapeutic

No.
The device is intended to acquire bioelectric signals and aid diagnosis and monitoring, and it includes stimulators for evoked response analysis, but it does not perform any direct therapeutic action on the patient.

Diagnostic

Yes.
The device is intended to acquire bioelectric signals to "aid the diagnosis and monitoring of potential disorders" of the nervous system and muscles.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the devices include physiological signal amplifiers, electrical stimulators, auditory stimulators, and photic stimulators, which are hardware components. While the software is essential for data processing and user interface, it is part of a system that includes significant hardware.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes. This typically involves analyzing samples like blood, urine, tissue, etc.
Device Function: The NExT Station and NExT Station Advanced are described as physiological signal amplifiers that acquire bioelectric signals directly from the patient's body (central and peripheral nervous system and muscles).
Method of Use: The device uses electrodes placed on the patient to capture electrical activity, and includes stimulators to evoke responses. This is a direct interaction with the patient's body, not an analysis of a specimen in vitro.

The device is clearly intended for in vivo (within the living body) diagnostic procedures (EMG and Evoked Potentials).

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The NExT Station and NExT Station Advanced are physiological signal amplifiers intended to be used during Electromyography (EMG) and Evoked Potential (EP) exams to acquire bioelectric signals produced by the patient's central and peripheral nervous system and muscles. The devices include Galileo NT Line software to record and display acquired data to aid the diagnosis and monitoring of potential disorders of the central and peripheral nervous system and muscles.

The devices include an electrical stimulator, an auditory stimulator, and a photic stimulator as accessories that may optionally be used in evoked response analysis.

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

GWL, OLT, IKN, GWE, GWF, GWJ

Device Description

EMG Family devices (NExT Station and NExT Station Advanced) are capable of detecting electrical signals produced by the central and peripheral nervous systems and by striated muscles. In connection with a PC, where the Galileo NT Line software is installed, they allow to perform both spontaneous and evoked electromyographic activity easily and in all their phases. Their fields of application are Electromyography (EMG) and Evoked Potentials (EP).

EB Neuro EMG Family devices include all the elements necessary for the acquisition of neurographic signals, for their analog-digital conversion and pre-processing, for audio monitoring, for the delivery of electrical, acoustic and visual stimulation. The functions of user interface, presentation, post-processing, storage, signals archiving and printing and data extracted from them are managed by a PC installed with the Galileo NT Line software.

Two versions are available depending on the support where the Medical Device is placed:

“Mobile” is a mobile device placed on a cart, powered at 115V by Isolation Transformer and connected with a PC with Galileo NT Line medical device software running on the PC.
“Portable” is a portable device placed on a desk, powered at 115V by medical power supply and connected with a PC with Galileo NT Line medical device software running on a Laptop PC.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Patient's central and peripheral nervous system and muscles.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Intended User: Neurology physicians, Neurophysiopathology technicians under physician's supervision, other physicians such as anesthesiologists, neonatologists and nursing staff of intensive care unit.
Care Setting: Hospital environments.

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)

Due to the enhancements made to the electronic and electrical components, it was necessary to verify the electrical/mechanical/thermal safety and electromagnetic compatibility (EMC) of the subject devices. This was performed using the exact same test methods used for the predicate device using FDA-recognized external standards ANSI/AAMI ES60601-1 and IEC 60601-1-2. LED visual stimulators passed Light Safety Testing performed in accordance with EN ISO 15004-2 (Light Hazard Protection) and EN 62471 (Photobiological Safety of Lamps and Lamp Systems).

Incremental software enhancements and bug fixes in the subject devices compared to the predicate devices were determined to not have any safety or effective implications on the device. Each incremental released version was subjected to verification testing, at unit, integration and/or system level, as appropriate for the update in the scope of that version. In addition, the subject devices of this 510(k) submission were subjected to a complete and comprehensive V&V testing.

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.

K133517, K142064

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.

Not Found

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

§ 882.1835 Physiological signal amplifier.

(a)
Identification. A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physiological sources (e.g., the electroencephalogram).(b)
Classification. Class II (performance standards).

Summary

0

December 12, 2024

Image /page/0/Picture/1 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

EB Neuro S.p.A. % Barry Ashar President Makromed, Inc. 88 Stiles Road Salem, New Hampshire 03079

Re: K242832

Trade/Device Name: NExT Station; NExT Station Advanced Regulation Number: 21 CFR 882.1835 Regulation Name: Physiological Signal Amplifier Regulatory Class: Class II Product Code: GWL, OLT, IKN, GWE, GWF, GWJ Dated: November 12, 2024 Received: November 12, 2024

Dear Barry Ashar:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

1

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).

2

Sincerely,

Image /page/2/Picture/3 description: The image contains the text "Patrick Antkowiak -S" in a simple, sans-serif font. To the left of the text is a faded, stylized logo that appears to be the letters "FDA". The text is arranged vertically, with "Patrick" on the top line, "Antkowiak" on the second line, and "-S" on the third line. The overall impression is clean and professional.

for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

3

Indications for Use

510(k) Number (if known) K242832

Device Name NExT Station NExT Station Advanced

Indications for Use (Describe)

The NExT Station and NExT Station Advanced are physiological signal amplifiers intended to be used during Electromyography (EMG) and Evoked Potential (EP) exams to acquire bioelectric signals produced by the patient's central and peripheral nervous system and muscles. The devices include Galileo NT Line software to record and display acquired data to aid the diagnosis and monitoring of potential disorders of the central and peripheral nervous system and muscles.

The devices include an electrical stimulator, an auditory stimulator, and a photic stimulator as accessories that may optionally be used in evoked response analysis.

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

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

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K242832

Special 510(k) SUMMARY NExT Station and NExT Station Advanced

Date Prepared:	October 18, 2024
Submitter Information
Company and
Manufacturer Name:	EB Neuro S.p.A.
Contact Person:	Name: Barry Ashar
Phone: 603.674.9074
Fax:
Device Information
Trade Name:	NEXT Station and NEXT Station Advanced
Common Name:	Physiological Signal Amplifier
Classification and
Product Code:	21 CFR 882.1835
GWL - Amplifier, Physiological Signal
Additional Product Codes:
OLT, IKN – EP and EMG
GWE, GWF, GWJ – Auditory, Photic and Electrical stimulators
Device Class:	Class II
Predicate Device:	K133517, Nemus 2 System (Hardware, amplifier) (GWL)
K142064, Galileo NT Software (OLT)
EB Neuro S.p.A.
21 CFR 882.1835
Device Description	EMG Family devices (NEXT Station and NEXT Station Advanced) are capable of detecting electrical signals produced by the central and peripheral nervous systems and by striated muscles. In connection with a PC, where the Galileo NT Line software is installed, they allow to perform both spontaneous and evoked electromyographic activity easily and in all their phases. Their fields of application are Electromyography (EMG) and Evoked Potentials (EP).

EB Neuro EMG Family devices include all the elements necessary for the acquisition of neurographic signals, for their analog-digital conversion and pre-processing, for audio monitoring, for the delivery of electrical, acoustic and visual stimulation. The functions of user interface, presentation, post-processing, storage, signals archiving and printing and data extracted from them are managed by a PC installed with the Galileo NT Line software.

Two versions are available depending on the support where the Medical Device is placed:

“Mobile” is a mobile device placed on a cart, powered at 115V by Isolation Transformer and connected with a PC with Galileo NT Line medical device software running on the PC.
“Portable” is a portable device placed on a desk, powered at 115V by medical power supply and connected with a PC with Galileo NT Line medical device software running on a Laptop PC. |
| Intended Use: | The NEXT Station and NExT Station Advanced are physiological signal amplifiers intended to be used during Electromyography (EMG) and Evoked Potential (EP) exams to acquire bioelectric signals produced by the patient's central and peripheral nervous system and muscles. The devices include Galileo NT Line software to record and display acquired data to aid the diagnosis and monitoring of potential disorders of the central and peripheral nervous system and muscles.

The devices include an electrical stimulator, an auditory stimulator, and a photic stimulator as accessories that may optionally be used in evoked response analysis. |
| Technological
Comparison | The subject devices are essentially a bundled together package of our own previously cleared predicate devices. The first predicate device Nemus 2 is an EMG amplifier hardware and the second predicate device Galileo NT is an EMG analysis software. They were previously 510(k) cleared on their own and are now being bundled together as a full EMG system.

No new features are added to the subject devices compared to the predicate devices. The subject devices essentially have the same design as |
| | the predicate devices. Both the subject and predicate devices use very
similar components and accessories. |
| | The basic operational procedures including system setup, patient
preparations, signal acquisition, data storage and analysis are identical
between the subject and predicate devices. |
| | Subject devices' technological characteristics remain the same as those of
the predicate devices. The following changes are made in the subject
devices compared to the predicate devices:

Two predicate devices (one hardware, the other software)
previously cleared in their own separate 510(k)s are now being
combined together as the subject device, with the exact same
intended use as the ones of the predicate devices.
Since the subject device now includes the software, it is provided
with accessories like PC, keyboard, mouse and screen. Everything
is mounted together on a cart or offered as a desktop setup. The
predicate hardware device didn't include these. The predicate
software device didn't include these as the user was asked to
install the software on any platform of their choice.
The predicate hardware device had 2 EMG channels, the subject
device has 4 EMG channels.
Some hardware components have been upgraded for better
performance, for example, better quality Low Pass Filter for
improved noise reduction.
The predicate hardware device included one visual stimulator, the
subject device includes three visual stimulators to address user
needs. All visual stimulators have passed EMC and Light Safety
testing. |
| Basis for Equivalence | The subject devices are essentially a bundled together package of our
own previously cleared predicate devices, with the same intended use
and technological characteristics. The first predicate device Nemus 2 is
an EMG amplifier hardware and the second predicate device Galileo NT
is an EMG analysis software. They were previously 510(k) cleared on
their own and are now being bundled together as a full EMG system. |
| Performance Testing | Due to the enhancements made to the electronic and electrical
components, it was necessary to verify the electrical/mechanical/thermal
safety and electromagnetic compatibility (EMC) of the subject devices.
This was performed using the exact same test methods used for the
predicate device using FDA-recognized external standards ANSI/AAMI
ES60601-1 and IEC 60601-1-2. LED visual stimulators passed Light |
| Safety Testing performed in accordance with EN ISO 15004-2 (Light
Hazard Protection) and EN 62471 (Photobiological Safety of Lamps and
Lamp Systems). | |
| Incremental software enhancements and bug fixes in the subject devices
compared to the predicate devices were determined to not have any
safety or effective implications on the device. Each incremental released
version was subjected to verification testing, at unit, integration and/or
system level, as appropriate for the update in the scope of that version.
In addition, the subject devices of this 510(k) submission were subjected
to a complete and comprehensive V&V testing. | |

5

6

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Item	Subject Devices
	NEXT Station	NEXT Station
Advanced	Nemus 2
(K133517)	Galileo NT
(K142064)
Intended Use	The NEXT Station and
NEXT Station
Advanced are
physiological signal
amplifiers intended to
be used during
Electromyography
(EMG) and Evoked
Potential (EP) exams to
acquire bioelectric
signals produced by the
patient's central and
peripheral nervous
system and muscles.
The devices include
Galileo NT Line
software to record and
display acquired data to
aid the diagnosis and
monitoring of potential
disorders of the central
and peripheral nervous
system and muscles.

The devices include an
electrical stimulator, an
auditory stimulator, and
a photic stimulator as | The NEXT Station and
NEXT Station
Advanced are
physiological signal
amplifiers intended to
be used during
Electromyography
(EMG) and Evoked
Potential (EP) exams to
acquire bioelectric
signals produced by the
patient's central and
peripheral nervous
system and muscles.
The devices include
Galileo NT Line
software to record and
display acquired data to
aid the diagnosis and
monitoring of potential
disorders of the central
and peripheral nervous
system and muscles.

The devices include an
electrical stimulator, an
auditory stimulator, and
a photic stimulator as | Medical Device
intended to acquire
bioelectric signals
produced by the
patient's central
and peripheral
nervous system
and muscles. The
acquired signals
are transmitted to a
PC during
recording of
neurophysiology
examinations.
The device may
use electrical
stimulus, sound
stimulus, or visual
stimulus for use in
evoked response
analysis. | Intended to
record and
display EEG,
Video-EEG,
LTM, PSG,
EMG, EP data
acquired from the
patient body
through EB
Neuro acquisition
platform, to aid
the diagnosis and
monitoring of
potential
disorders of the
central and
peripheral
nervous system
and muscles. | Similar. See Note

|

|--|

9

Item	Subject Devices		Predicate Devices	Comments
	NExT Station	NExT Station
Advanced	Nemus 2
(K133517)	Galileo NT
(K142064)
	accessories that may
optionally be used in
evoked response
analysis.	accessories that may
optionally be used in
evoked response
analysis.
Intended Usage
Site	Hospital environments.	Hospital environments.	Hospitals,
laboratory,
institutions, or
other test
environments.
The device may be
placed in Intensive
Care Unit or
Operating Room
for continuous
recording.	The device is
intended to
be used in the
clinical and
hospital
environment
(including the
hospital
room, emergency
room, intensive
care unit, neuro-
intensive care
unit, critical care
unit).	Same
Intended User	Neurology physicians,
Neurophysiopathology
technicians under
physician's supervision,
other physicians such as
anesthesiologists,
neonatologists and
nursing staff of intensive
care unit.	Neurology physicians,
Neurophysiopathology
technicians under
physician's supervision,
other physicians such as
anesthesiologists,
neonatologists and
nursing staff of intensive
care unit.	The user can only
be on the order of a
physician.	This device is
intended to
be used by
qualified
medical
practitioners who
will exercise
professional
judgment in using
the information.	Same
Item	Subject Devices		Predicate Devices	Comments
	NExT Station	NExT Station
Advanced	Nemus 2
(K133517)	Galileo NT
(K142064)
System
Configuration	It is a signal acquisition
device connected to a PC
with Galileo NT software
running on the PC. It can
be placed on a trolley
(mobile version) or on a
desk (portable version).	It is a signal acquisition
device connected to a PC
with Galileo NT software
running on the PC. It can
be placed on a trolley
(mobile version) or on a
desk (portable version).	It is a signal
acquisition device
intended to be
connected to a PC
with Galileo NT
software running on
the PC. The PC can
be placed on a
trolley (mobile
version) or on a desk
(portable version).	It is a software
only device,
deployed on a
Windows-based
PC.	Similar. See Note

```
   |
```

Lens Goggles
Stimulator II
Pattern Monitor | - Flash LED
Stimulator
Lens Goggles
Stimulator II
Pattern Monitor | - Flash LED
Stimulator | N/A | Similar. See Note

```
   |
```

| Performance Standards | | | | | |
| Electrical,
Mechanical and
Thermal Safety | ANSI AAMI 60601-1 | ANSI AAMI 60601-1 | ANSI AAMI 60601-1 | N/A | Same |
| Electromagnetic
Compatibility | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | N/A | Same |
| EMG and EP
Requirements | IEC 60601-2-40 | IEC 60601-2-40 | IEC 60601-2-40 | N/A | Same |
| Light Hazard
Protection | EN ISO 15004-2 | EN ISO 15004-2 | EN ISO 15004-2 | N/A | Same |
| Photobiological
Safety of Lamps
and Lamp
Systems | EN 62471 | EN 62471 | EN 62471 | N/A | Same |
| Medical Device
Software | IEC 62304 | IEC 62304 | IEC 62304 | IEC 62304 | Same |
| Medical Device
Risk
Management | ISO 14971 | ISO 14971 | ISO 14971 | ISO 14971 | Same |

10

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Note 1: The subject devices are essentially a bundled package of the two predicate devices. As a result, their intended use is a combination of the intended uses of the predicate devices.

=

15

Note 2: The subject devices are essentially a bundled package of the two predicate devices. As a result, their system onfiguration is a combination of the system configuration of the predicate devices.

Note 3: The subject devices are essentially a bundled package of the two predicate devices. As a result, their components and accessories are a combination of the components and accessories of the predicate devices.

Note 4: Difference in the number and type of channels address different market needs and preferences, they do not raise any additional questions of safety or effectiveness.

Note 5: Subject devices remove high frequency components for effective removal of noise and artifacts..

Note 6: Subject devices have same EMG A/D conversion resolution, have higher EP A/D conversion resolution.

Note 7: Subject devices have maximum sampling frequency higher than predicate devices, ensuring a higher fidelity digitization.

Note 8: Additional stimulation output on the subject devices has no impact on safety or effectiveness.

Note 9: Additional optional visual stimulators available with the subject devices were tested and verified to conform to the EMC requirements of IEC 60601-1-2 requirements as well as to the Light Safety requirements of EN ISO 15004-2 and EN 62471. They have no impact on safety or effectiveness.

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CONCLUSION

The subject devices (NExT Station and NExT Station Advanced) and the predicate devices (Nemus 2 and Galileo NT) have identical intended use /indication for use. The subject devices are essentially a bundled together package of previously cleared predicate devices. The first predicate device Nemus 2 is an EMG amplifier hardware and the second predicate device Galileo NT is an EMG analysis software. They were previously 510(k) cleared on their own and are being bundled together as a full EMG system.

Subject devices' technological characteristics remain the same as those of the predicate devices. The basic operational procedures including system setup, patient preparations, signal acquisition. data storage and analysis are identical between the subject and predicate devices.

Both the subject and predicate device use very similar components and accessories. The differences in their configurations due to the enhancements listed in section 12.5 above do not have any impact on the safety and effectiveness of the subject device.

The subject devices do not introduce any new safety considerations in comparison to the predicate devices. All identified differences between the two systems are minor and without any known impact on safety or efficacy.

Based on the information and supporting documentation provided in this premarket notification, the subject devices (NExT Station and NExT Station Advanced) are substantially equivalent to the cited predicate devices (Nemus 2 and Galileo NT).