Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a system for recording and stimulating electrophysiological signals and does not mention any AI or ML capabilities. The software description focuses on standard software development processes and compliance with relevant standards, not advanced analytical techniques.

Therapeutic

No
The device is described as an intraoperative neuromonitoring system for recording electrophysiological signals and stimulating nerve and muscle tissues, and for diagnostics, not for therapeutic purposes.

Diagnostic

Yes

The "ISIS Neurostimulator" is explicitly stated to be "intended for provision of neurophysiological stimulation when used in surgical procedures and for diagnostics." The system records and displays electrical signals for various electrophysiological measurements, which are diagnostic in nature.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system consists of "custom stimulation and recording hardware" in addition to the software and a standard computer. This indicates it is not a software-only device.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly states the products are for "intraoperative neuromonitoring; for recording of electrophysiological signals and stimulating of nerve and muscle tissues." This involves measuring electrical signals directly from the body, not analyzing samples taken from the body (like blood, urine, or tissue).
Device Description: The description details hardware for stimulation and recording of electrical signals, and software for processing these signals. This aligns with a device used for direct physiological measurement.
Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device operates by interacting directly with the patient's nervous and muscular systems to record and stimulate electrical activity.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Indications for Use

ISIS Headbox 5042xx products:

The products are intended for intraoperative neuromonitoring; for recording of electrophysiological signals and stimulating of nerve and muscle tissues.

The products are intended for use in the operating room to measure and display the electrical signals generated by muscle, peripheral nerves and the central nervous system. The products support the clinical application of Electroencephalography (EEG), Electromyography (EMG), Somatosensory Evoked Potentials (SEP), Motor Evoked Potentials (MEP), and Auditory Evoked Potentials (AEP).

The products are not intended for monitoring life-sustaining functions.

ISIS Neurostimulator 504180:

The ISIS Neurostimulator is intended for provision of neurophysiological stimulation when used in surgical procedures and for diagnostics. It is suitable for continuous operation and can be used in the following fields:

Transcranial electrical stimulation (TES)
Direct cortical stimulation (DCS)
Direct nerve stimulation (DNS)
Transcutaneous electrical nerve stimulation (TNS)
Direct muscle stimulation (DMS)

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

GWF, GWJ, GWQ, ETN, IKN

Device Description

The ISIS Headboxes and the ISIS Neurostimulator constitute multimodality intraoperative neuromonitoring systems called ISIS IOM Systems. These systems consist of custom stimulation and recording hardware, a standard laptop or desktop personal computer running an off-the-shelf operating system, and operating software called NeuroExplorer. As an option, these systems mount on device carriers or housings tailored for intraoperative use.

The ISIS IOM Systems support the following measurement modalities:

Auditory Evoked Potentials
Transcranial and cortical Motor Evoked Potentials
Somatosensory Evoked Potentials
Freerunning and triggered Electromyography
Electroencephalography
Train of Four

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Muscle, peripheral nerves, central nervous system

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Neurophysiologists (clinical neurophysiologists, neurosurgeons, neurologists or medical technical assistants for functional diagnostics) / Operating Room

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)

Biocompatibility: Not applicable, no patient contact materials.
Software: The inomed NeuroExplorer Software is a MODERATE level of concern software. Designed and developed according to a rigorous development process, including software verification and validation. Test results demonstrate compliance with predetermined specifications, applicable guidance documents, and standards.
Electrical Safety: Tested according to IEC 60601-1:2005+A1:2012, IEC 80601-2-26:2019, IEC 60601-2-40:2016. Test results demonstrate compliance.
Electromagnetic Compatibility: Tested according to IEC 60601-1-2:2014. Test results demonstrate compliance.
Performance Testing - Bench: Essential performance and safety were tested for performance in accordance with internal requirements at multiple levels: electrical medical systems, system carrier, amplifier and stimulator modules, operating software and firmware, and accessories. Products successfully underwent bench testing as part of verification and validation.
Human Factors: Testing of the influence of human factors on the devices demonstrates that the products are safe to use and that no further improvement of the user interface design relating to safety is necessary.
Performance Testing - Clinical: No additional clinical testing was performed.

Conclusion: The non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device predicate. The testing in terms of device software, electrical safety, electromagnetic compatibility, bench testing, and human factors engineering demonstrate that the devices are as safe, effective and perform as well as or better than the predicate device.

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.

K162199

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

Not Found

Regulation Number and Section

§ 882.1870 Evoked response electrical stimulator.

(a)
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.(b)
Classification. Class II (performance standards).

Summary

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January 7, 2022

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

inomed Medizintechnik GmbH Tomasz Moszkowski, PhD Product Manager IOM Im Hausgruen 29 Emmendingen, 79312 Germany

Re: K212166

Trade/Device Name: ISIS Headboxes and ISIS Neurostimulator (ISIS IOM Systems: ISIS Xpert®, ISIS Xpert®Plus, ISIS Xpress) Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked Response Electrical Stimulator Regulatory Class: Class II Product Code: GWF Dated: December 2, 2021 Received: December 6, 2021

Dear Alexander Maier:

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,

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

2

Indications for Use

510(k) Number (if known)

Device Name

ISIS Headboxes and ISIS Neurostimulator (ISIS IOM Systems: ISIS Xpert®, ISIS Xpert®Plus, ISIS Xpress)

Indications for Use (Describe) ISIS Headbox 5042xx products:

The products are intended for intraoperative neuromonitoring; for recording of electrophysiological signals and stimulating of nerve and muscle tissues.

The products are intended for use in the operating room to measure and display the electrical signals generated by muscle, peripheral nerves and the central nervous system. The products support the clinical application of Electroencephalography (EEG), Electromyography (EMG), Somatosensory Evoked Potentials (SEP), Motor Evoked Potentials (MEP), and Auditory Evoked Potentials (AEP).

The products are not intended for monitoring life-sustaining functions.

ISIS Neurostimulator 504180:

The ISIS Neurostimulator is intended for provision of neurophysiological stimulation when used in surgical procedures and for diagnostics. It is suitable for continuous operation and can be used in the following fields:

Transcranial electrical stimulation (TES)
Direct cortical stimulation (DCS)
Direct nerve stimulation (DNS)
Transcutaneous electrical nerve stimulation (TNS)
Direct muscle stimulation (DMS)

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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ISIS Headboxes and ISIS Neurostimulator

510(k) Summary

| Submission

Date:	07 July 2021
510(k) Holder:	inomed Medizintechnik GmbH
	Im Hausgrün 29
	79312 Emmendingen, Germany
Submitter and
Application
Correspondent:	Tomasz Moszkowski, Ph.D.
Phone: +49 7641 6414 583
Email: t.moszkowski@inomed.com
Manufacturing
Site:	inomed Medizintechnik GmbH
Im Hausgrün 29
79312 Emmendingen, Germany
Trade Name:	ISIS Headboxes and ISIS Neurostimulator
(ISIS IOM Systems: ISIS Xpert®, ISIS Xpert®Plus, ISIS Xpress)
Common and
Classification
Name:	Evoked response stimulator and intraoperative monitor
Classification
Regulation:	Primary: 21 CFR §882.1870
Secondary: 21 CFR §882.1400, 21 CFR §882.1375, 21 CFR §882.1900
Product Code:	GWF
Subsequent
Product Codes:	GWJ, GWQ, ETN, IKN
Regulation
Medical
Specialty:	Neurology
Substantially
Equivalent
Devices:	Predicate Device:	Predicate
Number	510(k)
Model	Manufacturer/
	K162199		Cadwell Industries Inc./
Cascade
Intraoperative Monitor	IOMAX

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inomed fr

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| Device Description: | The ISIS Headboxes and the ISIS Neurostimulator constitute multimodality intraoperative neuromonitoring systems called ISIS IOM Systems. These systems consist of custom stimulation and recording hardware, a standard laptop or desktop personal computer running an off-the-shelf operating system, and operating software called NeuroExplorer. As an option, these systems mount on device carriers or housings tailored for intraoperative use.

The ISIS IOM Systems support the following measurement modalities:

Auditory Evoked Potentials
Transcranial and cortical Motor Evoked Potentials
Somatosensory Evoked Potentials
Freerunning and triggered Electromyography
Electroencephalography
Train of Four | | | | | | |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|
| Intended Use and Indications for Use: | ISIS Headbox 5042XX:
The products are intended for intraoperative neuromonitoring; for the recording of electrophysiological signals and stimulating nerve and muscle tissues.

The products are intended for use in the operating room to measure and display the electrical signals generated by muscle, peripheral nerves, and the central nervous system. The products support the clinical application of Electroencephalography (EEG), Electromyography (EMG), Somatosensory Evoked Potentials (SEP), Motor Evoked Potentials (MEP), and Auditory Evoked Potentials (AEP).

The products are not intended for monitoring life-sustaining functions.

The members of the ISIS Headbox 5042XX family and their indications for use are listed as follows:
Table 1: Product-specific indications for the use of the ISIS Headbox 5042XX medical product family Product Indications 504285 ISIS Headbox 8 Ch. DIF – 8 Ch. REF – AEP EEG, SSEP, AEP, EMG, MEP 504381 ISIS Headbox 16Ch. REF AEP EEG, SSEP, AEP | | | | | | |

EMG, MEP EEG, SSEP

504271 ISIS Headbox 16 Ch. DIF

504261 ISIS Headbox 16Ch. REF

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ISIS Neurostimulator 504180:

The ાડાડ Neurostimulator is intended for the provision of neurophysiological stimulation when used in surgical procedures and for diagnostics. It is suitable for continuous operation and can be used in the following fields:

Transcranial electrical stimulation (TES) --
-Direct cortical stimulation (DCS)
-Direct nerve stimulation (DNS)
-Transcutaneous electrical nerve stimulation (TNS)
Direct muscle stimulation (DMS) -

Comparison of Intended Use and Indications for Use:

The ISIS Headboxes and ISIS Neurostimulator including accessories as part of ISIS IOM Systems (ISIS Xpert®Plus, ISIS Xpert®, ISIS Xpress) are equivalent in terms of intended use and indications for use to the predicate device. Compared to the predicate device, the subject device is not intended for measuring visually evoked potentials (VEP), galvanic skin response, heart rate, and oxygen saturation (SpOz). These differences, however, do not result in deteriorated clinical performance of the subject device in terms of its intended use nor do they raise questions in terms of safety. The current performance corresponds to the state of the art and adheres to up-to-date guidelines of intraoperative neuromonitoring.

	Subject devices	Predicate device	Claimed Equivalence
System	ISIS Headbox 5042XX
and ISIS
Neurostimulator	Cascade IOMAX	-
Manufacturer	inomed Medizintechnik
GmbH	Cadwell Industries, Inc.	-
Picture	Image: ISIS Headbox 5042XX and ISIS Neurostimulator	Image: Cascade IOMAX	-
510(k)
Number	K212166	K162199	-
Device Class	II	II	Equal
Product
Code	GWF	GWF	Equal
Subsequent
Product
Codes	GWJ, GWQ, ETN, IKN	DQA, ETN, GWE, GWJ,
GWQ, GZO, IKN, JXE, OLT	GWJ – Equal
GWQ – Equal
ETN – Equal
IKN – Equal
GWE, DQA, GZO, JXE, OLT are not within the
scope of the intended
use and indications for
the use of the ISIS
Headbox and ISIS
Neurostimulator
Main function, site of usage, intended user group
Main
function	ISIS Headboxes
5042XX:
"The products are
intended for use in the
operating room to
measure and display the
electrical signals
generated by muscle,
peripheral nerves and
the central nervous
system."	"The Cascade IOMAXTM
Intraoperative Monitor with
Surgical Studio software
(IOMAX) is an
electroneurodiagnostic device
that acquires, displays and
stores physiologic data from
peripheral sensory and motor
nerves, muscles and the
central nervous system,
generated either
spontaneously or elicited by
well-defined stimuli."	Equal
Both the predicate and
subject devices can
acquire, display and
store physiologic data
from peripheral nerves,
muscles and the central
nervous system.
Site of usage	ISIS Headboxes
5042XX:
"The products are
intended for
intraoperative
neuromonitoring"
"The products are
intended for use in the
operating room (...)"	"IOMAX is used (...) in a
professional healthcare facility
environment for pre-operative,
intraoperative and
post-operative testing."	Equivalent
The predicate and the
subject device are
intended for
intraoperative testing.
The Cadwell IOMAX
may in addition be used
for pre-operative and
post-operative
monitoring, which the
subject device is not
intended for. This
difference is clearly
stated within the
intended use statement
of the subject device
and thus does not raise
questions in terms of
product safety and
effectiveness.
Intended
user group	Neurophysiologists
(clinical
neurophysiologists,
neurosurgeons,
neurologists or medical
technical assistants for
functional diagnostics)	"IOMAX is used by or under
the direction of a licensed
physician, surgeon, or
neurologist (...)"	Equivalent
Both the predicate and
subject devices may be
used by licensed
physicians (the ISIS
Headbox intended use
statement specifies the
			physicians to persons
with clinical
neurophysiologic
background and
medical technical
assistants) and
neurologists. Also, both
the predicate and
subject devices may be
used by surgeons. The
notion is more
specifically stated within
the documentation of
the ISIS Headbox, i.e., it
restricts the use to
neurosurgeons that are
licensed
neurophysiologists.
		Indended Use and Indications for Use
Intended use	ISIS Headbox 5042XX:
"The products are
intended for
intraoperative
neuromonitoring; for the
recording of
electrophysiological
signals and stimulating
of nerve and muscle
tissues. (...)"

ISIS Neurostimulator
504180:
"The ISIS
Neurostimulator is
intended for the
provision of
neurophysiological
stimulation when used in
surgical procedures and
for diagnostics. (...)" | "The Cascade IOMAX™
Intraoperative Monitor with
Surgical Studio software
(IOMAX) is an
electroneurodiagnostic device
that acquires, displays and
stores physiologic data from
peripheral sensory and motor
nerves, muscles and the
central nervous system,
generated either
spontaneously or elicited by
well-defined stimuli. (...)
The system also delivers direct
nerve stimulation required for
specific surgical procedures." | Equal
Both the subject and
predicate device are
intended for the
recording of
electrophysiological
signals and stimulation
of nerve and muscle
tissues during
intraoperative
neuromonitoring. |
| Indications
for use | ISIS Headbox 5042XX:
"The products support
the clinical application of
(...) Auditory Evoked
Potentials (AEP) (...)"

ISIS Neurostimulator
504180:
The ISIS
Neurostimulator is
intended for the
provision of
neurophysiological
stimulation (...). It is
suitable for continuous
operation and can be
used in the following
fields:

Transcranial
electrical
stimulation (TES) | "Evoked Potentials (Eps):
IOMAX provides electrical,
auditory or visual stimulation
(...). " | Equivalent
Both the subject and
predicate device are
intended for provision of
electrical and auditory
stimulation. The ISIS
Headbox 504281 and
504285 incorporate an
AEP stimulator. The
ISIS Neurostimulator is
intended to be used for
different modes of
electrical stimulation.
The modes of electrical
stimulation in the ISIS
Neurostimulator are
described in more detail
with regard to TES,
DCS, DNS, TNS, and
DMS than within the
statement of Cadwell |
| | - Direct cortical stimulation (DCS)
Direct nerve stimulation (DNS)
Transcutaneous electrical nerve stimulation (TNS)
Direct muscle stimulation (DMS) | | difference in the formulation of the statement and it does
not raise questions in terms of device safety and effectiveness.
The subject device is not intended for VEP stimulation and recording. |
| | ISIS Headbox 5042XX:
"The products support the clinical application of
Electroencephalography (EEG)" | "EEG: IOMAX measures, displays, records, and stores electrical activity of the brain from two or more electrodes on the head." | Equal
Both the subject and predicate devices are intended for electroencephalography (EEG). |
| | ISIS Headbox 5042XX:
"The products support the clinical application of
(...) Electromyography (EMG)." | "Free Run EMG: IOMAX acquires, displays, records, and stores spontaneous EMG activity of motor nerves by continually displaying a live stream of mechanically induced myotome contractions." | Equal
Both the subject and predicate devices are intended for electromyography (EMG). |
| | ISIS Headbox 5042XX:
"The products support the clinical application of
(...) Motor Evoked Potentials (MEP)."
ISIS Neurostimulator 504180:
"It is suitable for continuous operation and can be used in the following fields: (...) transcranial electrical stimulation (TES)." | "TcMEP: IOMAX delivers transcranial stimulation via dedicated outputs for intraoperative assessment." | Equal
Both devices are capable of delivering transcranial stimulation via dedicated outputs.
The ISIS Headbox is capable of recording MEP signals during transcranial electrical stimulation provided by the ISIS Neurostimulator. |
| | ISIS Neurostimulator 504180:
"It is suitable for continuous operation and can be used in the following fields: (...) direct cortical stimulation (DCS)." | "Cortical Stimulation: IOMAX delivers Low Current Stimulation (LCS) during surgical procedures to map various areas of the cortex." | Equal
Both devices are capable of delivering electrical current for direct cortical stimulation. |
| | ISIS Headbox 5042XX:
"The products support the clinical application of
(...) Electromyography (EMG)."
ISIS Neurostimulator 504180:
"It is suitable for continuous operation and can be used in the following fields: (...) direct nerve stimulation (DNS)." | "Triggered EMG (TEMG): IOMAX electrically stimulates the motor nerves, and displays, records, and stores the resulting compound muscle action potentials in the innervated muscle." | Equal
Both devices are capable of measuring triggered EMG signals.
The subject devices achieve this by combining the EMG measurement using the ISIS Headboxes and direct nerve stimulation (DNS) using the ISIS Neurostimulator. |
| ISIS Headbox 5042XX:
"The products are
intended for use in the
operating room to
measure and display the
electrical signals
generated by muscle,
peripheral nerves and
the central nervous
system."

ISIS Neurostimulator
504180:
"The ISIS
Neurostimulator is
intended for the
provision of
neurophysiological
stimulation (...) in the
following fields: (...)
Direct nerve stimulation
(DNS)." | "Nerve Conduction Study
(NCS): IOMAX measures,
displays, records, and stores
sensory and motor nerve
conduction time (latency) by
applying a stimulus to
peripheral nerves, the spinal
cord, and the central nervous
system." | Equivalent
Both devices can be
used to apply stimuli to
the peripheral nerves
and to the central
nervous system. The
subject device is
capable of measuring,
displaying and storing
electrical signals
generated by peripheral
nerves (for which the
nerve conduction
velocity is normally
measured). The subject
device can also
measure the latency
and latency differences
between evoked
potentials from different
sources. This difference
can be used to calculate
the nerve conduction
velocity. The calculated
result is, however, not
directly stored. This
difference does not
pose any questions in
terms of safety and
performance, because
the user can still perform
the nerve conduction
velocity measurement
and document the
results within the patient
report via manual
comment input. | |
| ISIS Headboxes
5042XX:
"The products support
the clinical application of
(...) Electromyography
(EMG)."

ISIS Neurostimulator
504180:
"The ISIS
Neurostimulator is
intended for the
provision of
neurophysiological
stimulation (...) in the
following fields: (...)
transcutaneous
electrical nerve
stimulation (TNS)." | "Train of Four (TOF) or Twitch
Test: IOMAX delivers a train of
four pulses and measures,
displays, records, and stores
the compound muscle action
potential amplitude fade for
analysis." | Equal
Both products can be
used for performing
twitch tests in order to
measure the level of
muscle relaxation due to
muscular blockers. This
measurement is
performed by employing
a simultaneous
transcutaneous
electrical nerve
stimulation and EMG
measurement. Although
the indications for use
statement of the subject
device does not
explicitly refer to the
TOF measurement, the
modality is available
within the device design
(software) and the
product labelling. This
difference in the
formulation of the
indications for use | |
| | | | |
| | | statement does not
pose any questions in
terms of safety and
performance. | |
| ISIS Headbox 5042XX:
"The products are not
intended for monitoring
life-sustaining
functions." | "SpO2: IOMAX measures and
displays oxygen saturation and
heart rate information. Remote
Reader: IOMAX provides
passive, real time remote
review of intraoperative
monitoring for a physician
outside of the operating room." | Not applicable
The subject device is
not intended for
measuring and
displaying oxygen
saturation and heart
rate. Vital parameter
measurement is out of
scope of the subject
device. SpO2 and heart
rate measurements are
one of several
physiological
parameters that are
normally tracked by
anesthesia and
available for IONM
personnel to consider
when interpreting
neurophysiologic
signals. The IONM
guidelines published up
to date do not specify
the SpO2 monitoring as
a required component of
neurophysiologic
monitoring systems
(MacDonald et al., 2013,
2019; Nuwer et al.,
2012; Sutter et al., 2007;
Tyner, FS., 1994). | |

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Technology The ISIS Headboxes and ISIS Neurostimulator including accessories Comparison: as part of ISIS IOM Systems (ISIS Xpert®Plus, ISIS Xpert®, ISIS Xpress) and the predicate device are equivalent in terms of the technological characteristics. Among others, the technological differences exist predominantly within the technology used for signal

recording and electrical stimulation.

The subject device can acquire physiological signals with a sampling rate and bandwidth lower than the predicate devices but using a higher number of recording channels. The differences in the recording technology do not raise questions in terms of performance because both the subject and predicate device employ oversampling and are capable of measuring signals within the clinically relevant bandwidth.

The stimulator of the subject device can deliver more energy than the predicate device, which results from the subject device being able to supply longer stimulation pulses or pulses at a higher frequency than the predicate. This is although the predicate can provide a higher current intensity in TcMEP mode than the subject device. This difference does not raise questions in terms of safety of the subject

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device because the resulting current densities for the cleared accessories are equivalent to those of the predicate device. Moreover, clinical performance is assured because the performance specifications of the predicate and subject devices fall within the wide range of stimulation parameters, pulse widths and intensities that are employed by well-established clinical methods to elicit physiological responses relevant for intraoperative neuromonitoring.

The technological differences do not raise questions in terms of safety and effectiveness of the device and are substantially equivalent for the use of the device for intraoperative neuromonitoring.

	Subject device	Predicate device
System	ISIS Headbox 5042XX and ISIS
Neurostimulator	Cascade IOMAX
Manufacturer	inomed Medizintechnik GmbH	Cadwell Industries, Inc.
	Technical aspects
Protection
against
electrical shock	Class I protection	Class I protection
Protection
against
electrical shock of
patient leads	Device type BF (Body Floating)	Device type BF (Body Floating)
System
configuration	Computer-based equipment with
dedicated hardware and software
components	Computer-based equipment with
dedicated hardware and software
components
	Signal recording
Measurement
principle	Amplifiers based on differential
(bipolar) and referential (unipolar)
type of recording	Amplifiers based on differential (bipolar)
and referential (unipolar) type of recording
Amplifier
components	Desired combination of ISIS
Headboxes with a total of 64
channels	One (1) Cortical Module
Up to four (4) Limb Modules

	Up to 64:	Up to 48:
	Module	Channels		Module	Channels
	ISIS Headbox
16 Ch. REF
(504261)	Unipolar: 16
Bipolar: 0		Cortical Module	Unipolar: 13
Bipolar: 3
Number of
amplifier
channels	ISIS Headbox
16 Ch. DIF
(504271)	Unipolar: 0
Bipolar: 16		Limb Module	Unipolar: 0
Bipolar: 8
	ISIS Headbox
16 Ch. REF –
AEP (504281)	Unipolar: 16
Bipolar: 0
	ISIS Headbox 8
Ch. DIF – 8 Ch.
REF – AEP
(504285)	Unipolar: 8
Bipolar: 8

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| A/D

resolution	16-bit	16-bit
Hardware
bandpass	Hardware high-pass filter:
0.5-120 Hz on all modules
Hardware low-pass filter:
2500, 5000 Hz on all modules	Hardware high-pass filter:
0.3-100 Hz on cortical module
0.5-100 Hz on limb module
Hardware low-pass filter:
30-5000 Hz on cortical module
30-10000 Hz on limb module
Sampling
frequency	20 kHz	25 kHz
Notch filter	50, 60 Hz	50, 60 Hz
Common-
mode
rejection ratio
(CMRR)	> 100 dB
Conformant with IEC 80601-2-
26:2019, clause 201.12.1.106
Common mode rejection.	> 115 dB
Conformant with IEC 60601-2-26:2012
clause 201.12.1.101.5 Common mode
rejection
Amplifier
noise	Conformant with IEC 80601-2-
26:2019, clause 201.12.1.104
Input noise	Conformant with IEC 60601-2-26:2012
clause 201.12.1.101.3 Input noise
Stimulation
TcMEP
stimulation	Realized by High Current
Stimulator (HC) in
transcranial stimulation
mode	Realized by Cortical Module in TcMEP
mode
Stimulator
type	Current controlled	Current controlled
and optional voltage controlled
No. of
outputs	12	9
Stimulation
intensity (I)
and pulse
width (PW)	Current controlled: up to 250 mA
(voltage limit of 410 V)
Voltage controlled: n/a	Image: Pulse width diagram
		Current controlled: up to 1500 mA (voltage
limit of 1000 V)
Voltage controlled: up to 1000 V
		0.05 - 0.5 ms
Intensity step	Constant current: 0.1 mA
Constant voltage: n/a	Constant current: 10 mA
Constant voltage: 5 V
No. of
stimulus
pulses	1-9	1-9
Stimulation
frequency (f)
range	Image: Stimulation frequency diagram
Limitation of
stimulation
frequency	1/10 pulse width to stimulation
period ratio	None
Limitation of
inter-stimulus
interval	Image: ISI	Image: Pulses
Absolute
minimum
inter-stimulus
interval	Limited to ½ pulse width to ISI	Minimum ISI: 0.1 ms
0.1 ms
Maximum
charge per
phase	189.66 μC	750 μC
Maximum
RMS
stimulation
intensity	30 mA RMS	7.1 mA RMS
Minimum
electrode size	0.39 cm²	Low EP: 0.04 cm²
TcMEP: 0.5 cm
Maximum
current
density	76.92 mA/cm²	Low EP: 90.8 mA/cm²
TCMEP: 14.1 mA/cm²
Maximum
charge
density	61.5 μC/cm²	Low EP: 275 μC/cm²
TCMEP: 100 μC/cm²
Maximum
power
density	160 W/cm²	Low EP: 10 W/cm²
TCMEP: 2,000 W/cm²
Power
limitation	≤50 mJ/pulse
Conformant to IEC 60601-2-
40:2016, clause 201.12.4.103.	≤50 mJ/pulse
IEC 60601-2-40:1998 (1st ed.), clause
201.12.4.103.
High-current
stimulator for
SEP and TOF	Realized by High Current
Stimulator (HC) in subcutaneous
stimulation (SEP, TOF) mode	Realized by Limb Module in High EP mode
Stimulator
type	Constant current	Constant current
No. of
outputs	12	5
Stimulation
intensity (I)	Image: Stimulation intensity	Image: Stimulation intensity
	Up to 75 mA	Up to 100 mA
Intensity step	0.1 mA	0.5 mA
Pulse width
(PW)	0.05 – 2 ms	0.05 – 1 ms
No. of
stimulus
pulses	1-9	1
Stimulation
frequency (f)
range	Image: Stimulation frequency diagram	Image: Stimulation frequency diagram
	SEP: Up to 500 Hz
TOF: 2 Hz (fixed)	Up to 50 Hz
Limitation of
stimulation
frequency	1/10 pulse width to stimulation
period ratio	None
Limitation of
inter-stimulus
interval	Image: Inter-stimulus interval diagram	Image: Inter-stimulus interval diagram
	Limited to ½ pulse width to ISI	n/a (only 1 pulse possible)
Absolute
minimum
inter-stimulus
interval	0.1 ms	n/a (only 1 pulse possible)
Maximum
charge per
phase	150 μC	100 μC
Maximum
RMS
stimulation
intensity	23.7 mA RMS	Low EP: 3.6 mA
High EP: 3.2 mA
Minimum
electrode size	0.272 cm²	Low EP: 0.04 cm²
High EP: 0.5 cm
Maximum
current
density	87.1 mA/cm²	Low EP: 90.8 mA/cm²
High EP: 6.4 mA/cm²
Maximum
charge
density	150.0 μC/cm²	Low EP: 275 μC/cm²
High EP: -
Maximum
power
density	20.7 W/cm²	Low EP: 10 W/cm²
High EP: -
Power
limitation	≤50 mJ/pulse
Conformant to IEC 60601-2-
40:2016, clause 201.12.4.103.	≤50 mJ/pulse
IEC 60601-2-40:1998 (1st ed.), clause
201.12.4.103.
Low-current
stimulator for
direct cortical
stimulation:	Realized by High Current
Stimulator (HC) in direct cortical
stimulation mode	Realized by Cortical Module in Low EP
mode

001_510(k) Summary.docx

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Image /page/15/Picture/0 description: The image shows the word "inomed" in black font, followed by a square containing a stylized "i" with curved arrows around it. The "i" in the square is white, while the square itself is black. The word "inomed" is in lowercase letters and appears to be a company logo or brand name.

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Stimulator type	Constant current	Constant current
Stimulation intensity (I)
	Up to 30 mA	Up to 20 mA
Intensity step	0.01 mA	0.01 mA
Pulse width (PW)	0.05 - 2 ms	0.05 - 1 ms
No. of stimulus pulses	1 – 9	1
Stimulation frequency (f) range
	Up to 500 Hz	Up to 50 Hz
Limitation of stimulation frequency	1/10 pulse width to stimulation period ratio	None
Limitation of inter-stimulus interval
	Limited to ½ pulse width to ISI	n/a (only 1 pulse possible)
Absolute minimum inter-stimulus interval	0.1 ms	n/a (only 1 pulse possible)
Maximum charge per pulse	60 μC	20 μC
Maximum RMS stimulation intensity	9.5 mA RMS	3.6 mA RMS
Minimum electrode size	0.126 cm²	Low EP: 0.04 cm²
Maximum current density	75.29 mA/cm²	Low EP: 90.8 mA/cm²
Maximum charge density	150.8 μC/cm²	Low EP: 275 μC/cm²
Maximum power density	7.1 W/cm²	Low EP: 10 W/cm²

Power
limitation	≤50 mJ/pulse
Conformant to IEC 60601-2-
40:2016, clause 201.12.4.103.	≤50 mJ/pulse
IEC 60601-2-40:1998 (1st ed.), clause
201.12.4.103.
Low-current
stimulator for
direct nerve
stimulation:	Realized by Direct Nerve
Stimulator (DNS) in direct nerve
stimulation mode	Realized by Cortical Module in Low EP
mode
Stimulator
type	Constant current	Constant current
No. of
outputs	1	1 + 1 (optional)
Stimulation
intensity (I)	Image: Stimulation intensity waveform	Image: Stimulation intensity waveform
	Up to 5 mA	Up to 20 mA
Intensity step	0.01 mA	0.01 mA
Pulse width
(PW)	0.05 – 2 ms	0.05 – 1 ms
No. of
stimulus
pulses	1 – 9	1
Stimulation
frequency (f)
range	Image: Stimulation frequency waveform	Image: Stimulation frequency waveform
	Up to 500 Hz	Up to 50 Hz
Limitation of
stimulation
frequency	1/10 pulse width to stimulation
period ratio	None
Limitation of
inter-stimulus
interval	Image: Inter-stimulus interval waveform	Image: Inter-stimulus interval waveform
	Limited to ½ pulse width to ISI	n/a (only 1 pulse possible)
Absolute
minimum
inter-stimulus
interval	0.1 ms	n/a (only 1 pulse possible)
Maximum
charge per
pulse	10 μC	20 μC
Maximum
RMS
stimulation
intensity	1.58 mA RMS	3.6 mA RMS

Minimum
electrode size	0.020 cm²	Low EP: 0.04 cm²
Maximum
current
density	79 mA/cm²	Low EP: 90.8 mA/cm²
Maximum
charge
density	158 µC/cm²	Low EP: 275 µC/cm²
Maximum
power
density	1.25 W/cm²	Low EP: 10 W/cm²
Power
limitation	≤50 mJ/pulse
Conformant to IEC 60601-2-
40:2016, clause 201.12.4.103.	≤50 mJ/pulse
IEC 60601-2-40:1998 (1st ed.), clause
201.12.4.103.

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Summary of Performance Testing:

Biocompatibility: The ISIS Headboxes and ISIS Neurostimulator including accessories as part of ISIS IOM Systems (ISIS Xpert®Plus, ISIS Xpert®, ISIS Xpress) have no patient contact materials, and therefore this section does not apply.

Software: The inomed NeuroExplorer Software is a MODERATE level of concern software. The software was designed and developed according to a rigorous development process, including software verification and validation. Software information is provided in accordance with internal requirements and the following guidance documents and standards:

FDA guidance: The content of premarket submissions for software contained in medical devices, May 11, 2005
FDA guidance: Off-the-shelf software use in medical devices, Sep 27, 2019
-FDA guidance: General principles of software validation: Final guidance for industry and FDA staff, Jan 02, 2002
-FDA guidance: Content of premarket submissions for management of cybersecurity in medical devices. Oct 02, 2014
-IEC 62304:2006, Medical device software - Software life cycle processes

Test results demonstrate that the inomed NeuroExplorer Software complies with its predetermined specifications, the applicable guidance documents, and standards.

Electrical Safety: The ISIS Headboxes and ISIS Neurostimulator including accessories as part of ISIS IOM Systems (ISIS Xpert®Plus, ISIS Xpert®, ISIS Xpress) were tested according to the following standards:

18

inomed fi www.inomed.com

510(k) Summary

ISIS Headboxes and ISIS Neurostimulator

| | IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR.
2:2007 + A1:2012 (or IEC 60601-1: 2012 reprint), Medical
electrical equipment – Part 1: General requirements for basic
safety and essential performance. |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | IEC 80601-2-26:2019, Medical electrical equipments – Part 2-
26: Particular requirements for the basic safety and essential
performance of electroencephalographs |
| | IEC 60601-2-40:2016, Medical electrical equipments – Part 2-
40: Particular requirements for the basic safety and essential
performance of electromyographs and evoked response
equipment |
| | Test results demonstrate that the products comply with the applicable
standards. |
| Electromagnetic
Compatibility: | The ISIS Headboxes and ISIS Neurostimulator including accessories
as part of ISIS IOM Systems (ISIS Xpert®Plus, ISIS Xpert®, ISIS
Xpress) were tested according to the following standards: |
| | - IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2:
General requirements for basic safety and essential
performance – Collateral standard: Electromagnetic
disturbances – Requirements and tests. |
| | Test results demonstrate that the products comply with the applicable
standards. |
| Performance
Testing - Bench | The essential performance and safety of the ISIS Headboxes and ISIS
Neurostimulator including accessories as part of ISIS IOM Systems
(ISIS Xpert®Plus, ISIS Xpert®, ISIS Xpress) were tested for
performance in accordance with internal requirements. The devices
including their accessories and corresponding intended combinations
with further products have been designed according to requirement
specifications formulated at the following levels: |
| | - Requirements for electrical medical systems

Requirements for the system carrier
Requirements for the amplifier (ISIS Headboxes) and stimulator
(ISIS Neurostimulator) modules
Requirements for the operating software (NeuroExplorer) incl.
ISIS Headbox and ISIS Neurostimulator firmware
ISIS Headbox and ISIS Neurostimulator accessories (adaptor
boxes) |
| | - Custom Microsoft® Windows 10 image
The products successfully underwent the bench testing to confirm the
fulfillment of the requirements at these levels as part of the verification
and validation process. |

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Image /page/19/Picture/0 description: The image shows the logo for Inomed. The logo consists of the word "inomed" in bold, black letters, with a stylized "i" in a black square to the right. Below the logo is the website address "www.inomed.com".

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Moreover, the testing of the influence of human factors on the devices demonstrates that the products are safe to use and that no further improvement of the user interface design relating to safety is necessary.

The non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device predicate.

Performance No additional clinical testing was performed for the ISIS Headboxes Testing and ISIS Neurostimulator including accessories as part of ISIS IOM Clinical Systems (ISIS Xpert®Plus, ISIS Xpert®, ISIS Xpress). Therefore, this section does not apply.
Conclusion In order to establish the performance and safety characteristics, the ISIS Headboxes and ISIS Neurostimulator including accessories as part of ISIS IOM Systems (ISIS Xpert®Plus, ISIS Xpert®, ISIS Xpress) underwent successful testing in terms of the device software, electrical safety, electromagnetic compatibility, bench testing, and human factors engineering. The results of these activities demonstrate that the devices are as safe, effective and perform as well as or better than the predicate device.

Therefore, the ISIS Headboxes and ISIS Neurostimulator including accessories as part of ISIS IOM Systems (ISIS Xpert®Plus, ISIS Xpert®, ISIS Xpress) are considered substantially equivalent to the predicate device.