Predicate Devices

K083124, K083242, K991583, K992869, K980148, K964869

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard intraoperative neurophysiological monitor that uses EMG activity and stimulation. There is no mention of AI or ML in the intended use, device description, or the sections specifically checked for AI/ML mentions.

Therapeutic

No.
The device is used for monitoring and identification of nerves during surgery, not for treating any condition or disease.

Diagnostic

Yes

The text states, "It can be used as an additional helping tool during surgical procedures for diagnostic issues. Its basic functions are similar to those of an EMG diagnostic device."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "multi-channel intraoperative neurophysiological monitor capable of connecting various styles of patient monitoring electrodes and supplying stimulus for evoked responses," indicating it includes hardware components beyond just software.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the living body (in vitro).
Device Function: The C2 NerveMonitor System is used for intra-operative monitoring and stimulation of nerves during surgery. It directly interacts with the patient's body to assess nerve function in real-time.
Intended Use: The intended use clearly states "intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery". This is a procedure performed on the patient, not on a specimen taken from the patient.
Device Description: The description mentions connecting to "patient monitoring electrodes" and supplying "stimulus for evoked responses," which are actions performed directly on the patient.

The device's function and intended use are consistent with a neurophysiological monitoring device used during surgery, not a device that analyzes biological samples in a lab setting.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The C2 NerveMonitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery, including spinal cord and spinal nerve roots. The C2 NerveMonitor device with the integrated user interface is only allowed for the surveillance, documentation and functional test of motor nerves. It can be used as an additional helping tool during surgical procedures for diagnostic issues. Its basic functions are similar to those of an EMG diagnostic device

Indications for C2 NerveMonitor System Monitoring Procedures include:

Intracranial, Extracranial, Intratemporal, Extratemporal, Neck Dissections, Thoracic Surgeries, and Upper and Lower Extremities.

Indications for C2 NerveMonitor System monitoring of Spinal procedures include:

Degenerative Treatments, Pedicle Screw Procedures, Fusion Cages, Rhizotomy, Orthopedic Surgery, Open and Percutaneous Lumbar and Cervical Surgical Procedures and Thoracic Surgical Procedures.

The system is not intended for monitoring life preserving functions.

The system may not be used for diagnosing brain death.

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

GWF, ETN

Device Description

The C2 NerveMonitor System is a multi-channel intraoperative neurophysiological monitor capable of connecting various styles of patient monitoring electrodes and supplying stimulus for evoked responses. The EMG activity monitoring console uses both video and audio output.

Responses monitored with the device may originate from operator applied stimulus or from direct or indirect mechanical stimulus occurring during the course of surgery.

The following probes and electrodes include a metal tip, an insulated elastic shaft and a profected electrical pin connector to attach them to the NerveMonitor:

Type	Description
522610	Microfork probe
522603	Bipolar concentric stimulation probe
522605	Bipolar BCS stimulation probe, bayonet
525603	Monopolar MS probe length 4.5cm angled
525608	Monopolar MS probe flexible
530626	2 SDN electrodes
530627	SDN electrode
530666	Electrode 15 mm bipolar

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

cranial and peripheral motor and mixed motor sensory nerves, spinal cord, spinal nerve roots.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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)

Preclinical testing verified the design of this device and that all specified requirements were fulfilled. The C2 NerveMonitor and all corresponding accessories are similar in their risks and benefits, as well as their manner of performance, to the predicate devices listed.

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.

K083124, K083242, K991583, K992869, K980148, K964869

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

§ 882.1870 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

0

Image /page/0/Picture/0 description: The image shows handwritten text. The text at the top reads "K111647". Below that, the text reads "P. 1 of 8". The text appears to be written in black ink on a white background.

OCT - 6 2011

510(k) Summary 807.92(c)

SPONSOR

807.92(a)(1)

Company Name:

inomed Medizintechnik GmbH

Company Address

Im Hausgruen 29 79312 Emmendingen, Germany

Telephone: Fax:

+49-7641-9414-0 +49-7641-9414-94

Contact Person: Telephone:

Saschka Busch +49-7641-9414-87

Summary Preparation Date: August 24, 2011

DEVICE NAME

Trade Name: Common/Usual Name: Classification Name: Regulation Number: Product Code: Device Class:

807.92(a)(2) C2 NerveMonitor System Nerve Stimulator/Monitor Evoked Response Electrical Stimulator 21 CFR 882.1870 GWF, ETN Class II

PREDICATE DEVICE

807.92(a)(3)

Company	Product	510(k) #
Medtronic Xomed	Nerve Integrity Monitor 3.0	K083124
Magstim	Nerve Avalanche Thyroid/EMG Motor
Nerve Monitor	K083242
Magstim	Neurosign 400 Motor Nerve Monitor	K991583
Medtronic Xomed	Xomed Ball-Tip Monopolar
Stimulation probe	K992869
Magstim	Neurosign 800. 8 Channel Motor
Nerve Monitor with accessories	K980148
Magstim	Neurosign 800 Motor Motor Nerve
Monitor with accessories	K964869

1

DEVICE DESCRIPTION

807.92(a)(4)

The C2 NerveMonitor System is a multi-channel intraoperative neurophysiological monitor capable of connecting various styles of patient monitoring electrodes and supplying stimulus for evoked responses. The EMG activity monitoring console uses both video and audio output.

Responses monitored with the device may originate from operator applied stimulus or from direct or indirect mechanical stimulus occurring during the course of surgery.

The following probes and electrodes include a metal tip, an insulated elastic shaft and a profected electrical pin connector to attach them to the NerveMonitor:

Type	Description
522610	Microfork probe
522603	Bipolar concentric stimulation probe
522605	Bipolar BCS stimulation probe, bayonet
525603	Monopolar MS probe length 4.5cm angled
525608	Monopolar MS probe flexible
530626	2 SDN electrodes
530627	SDN electrode
530666	Electrode 15 mm bipolar

DEVICE INTENDED USE

807.92(a)(5)

The C2 NerveMonitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery, including spinal cord and spinal nerve roots. The C2 NerveMonitor device with the integrated user interface is only allowed for the surveillance, documentation and functional test of motor nerves. It can be used as an additional helping tool during surgical procedures for diagnostic issues. Its basic functions are similar to those of an EMG diagnostic device

Indications for C2 NerveMonitor System Monitoring Procedures include:

Intracranial, Extracranial, Intratemporal, Extratemporal, Neck Dissections, Thoracic Surgeries, and Upper and Lower Extremities.

Indications for C2 NerveMonitor System monitoring of Spinal procedures include:

Degenerative Treatments, Pedicle Screw Procedures, Fusion Cages, Rhizotomy, Orthopedic Surgery, Open and Percutaneous Lumbar and Cervical Surgical Procedures and Thoracic Surgical Procedures.

The system is not intended for monitoring life preserving functions.

The system may not be used for diagnosing brain death.

Section / Page 5-3

K 111647

2

COMPARISON OF TECHNICAL CHARACTERISTICS

807.92(a)(6)

| Device | Predicate Device
Nerve Integrity
Monitor 3.0 | Predicate Device
Neurosign Avalanche
Thyroid/EMG Motor
Nerve Monitor | Predicate Device
Neurosign 400
Motor Nerve
Monitor | Subject Device
C2 NerveMonitor
System |
|---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Medtronic Xomed | Magstim | Magstim | inomed
Medizintechnik
GmbH |
| 510(k) Number | K083124 | K083242 | K991583 | N/A |
| Device Class | II | II | II | II |
| Product code | ETN, GWF | ETN | ETN | GWF, ETN |
| Description | NIM 3.0 is a multi-
channel
intraoperative
neurophysiological
monitor capable of
connecting various
styles of patient
monitoring
electrodes and
supplying electrical
stimulus for evoked
responses. | Motor Nerve Monitor,
based upon standard
computer
components, running
Windows XP
embedded operating
system; information is
provided to the
surgeon via a
waveform graph of
EMG activity, and
audio amplification of
this signal so that the
surgeon hears this as
he/she is operating | Motor Nerve
Monitor, based
upon proprietary
hardware and
software;
information is
provided to the
surgeon via a
waveform graph of
EMG activity, and
audio amplification
of this signal so
that the surgeon
hears this as
he/she is operating | C2 is a multi-
channel
intraoperative
neurophysiologic
al monitor
capable of
connecting
various styles of
patient
monitoring
electrodes and
supplying
electrical stimulus
for evoked
responses. |
| Intended Use | The NIM 3.0 is
intended for
locating and
identifying cranial
and peripheral
motor
and mixed motor-
sensory nerves
during surgery,
including spinal
cord and
spinalnerve roots.
The APS electrode
is an accessory
intended for
providing automatic
periodic stimulation
to nerves when
used with the
Medtronic Nerve
Monitoring
Systems. | Intra-operative
monitoring and
stimulation of cranial
and peripheral motor
nerves | Intra-operative
monitoring and
stimulation of
cranial and
peripheral motor
nerves | The C2 is
intended for intra-
operative
monitoring and
stimulation for
localization and
identification of
cranial and
peripheral motor
and mixed motor
sensory nerves
during surgery,
including spinal
cord and spinal
nerve roots. The
system can
provide an
automatic
periodic
stimulation of
nerves. |

3

| Device | Predicate Device
Nerve Integrity
Monitor 3.0 | Predicate Device
Neurosign
Avalanche
Thyroid/EMG
Motor Nerve
Monitor | Predicate Device
Neurosign 400
Motor Nerve
Monitor | Subject Device
C2 NerveMonitor
System with
accessories |
|-------------------------------------|---------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Hardware
(main unit) | unknown | Standard PC
components | Proprietary
microprocessor
design | Standard PC
components |
| Headbox
Bandwidth
Signal Gain | 4/8 Channel
15Hz - 1,85kHz ±
3db
unknown | 2/4 Channel
8Hz - 8kHz ± 3dB
500 | 4 Channel
10Hz - 5kHz ± 3dB
477 | 4/8 Channel
0.5Hz - 5kHz ± 3dB,
1-1000 |
| Software | unknown | Windows XP
Embedded | C++ proprietary
code | Windows XP
Embedded |
| Screen | Touch screen
256Hx256W | 15" colour touch
screen | 6"
electroluminescent
display | 8,4" LCD display |
| Method of
control | Touch Screen | Touch screen - all
controls via
software except
power ON/OFF | Controls via
dedicated buttons
or via software
using menus
selected using
front-panel buttons | Front-panel dedicated
soft keys, rotary knobs |
| Manner of
Stimulation | Electrical
stimulation via a
probe | Electrical
stimulation via a
probe | Electrical
stimulation via a
probe | Electrical stimulation
via a probe |
| Stimulation
Range | 0.01mA - 30mA | 0.05mA - 10mA | 0.05mA - 5mA | 0.01mA - 25mA |
| Stimulation
Type | Monophasic,
square pulse,
duration 50-250μs | Square wave,
negative edge,
200μs pulse width,
constant current | Square wave,
negative edge,
200μs pulse width,
selectable from 100
to 500μs, constant
current, constant
voltage | Monophasic, square
pulse, negative edge,
duration 200μs,
constant current |
| Stimulation
Frequency | 1Hz, 4Hz, 7Hz,
10Hz | 3 or 30Hz | 3 or 30Hz | 1 - 30Hz |
| Stimulation
Probes | Monopolar, bipolar | Monopolar, bipolar,
concentric | Monopolar, bipolar,
concentric | Monopolar, bipolar,
concentric |
| Electrodes | Cranial and
peripheral motor
and mixed-motor-
sensory monitoring | Laryngeal
electrode; needle
electrodes | Laryngeal
electrode; needle
electrodes | Cranial and peripheral
motor and mixed-
motor-sensory
monitoring |
| Training
Required for
Use | Yes; both for
surgeon and OR
staff | Yes; both for
surgeon and OR
staff | Yes; both for
surgeon and OR
staff | Yes; both for surgeon
and OR staff |
| Display and
Storage | Waveform Signals
displayed on
screen, Storage on
USB Storage
Device | Waveform signals
displayed on
screen; stimulated
responses may be
optionally
automatically | Waveform signals
displayed on
screen; individual
screens may be
stored in non-
volatile memory | Waveform signals
displayed on screen;
individual screens may
be stored in non-volatile
memory; Storage on
USB Storage Device |

Section / Page 5-5

风 111647

4

		recorded to disc
Print
Capacity	Waveform data can
be printed to a
external printer	Waveform data and
patient information
can be printed
using the internal
thermal printer or
via an external
Letter sized inkjet
printer for the
generation of
reports using
stored data and
annotated
comments	Waveform data can
be printed to a
proprietary external
thermal printer	Waveform data can be
printed on an external
printer
Power	100-240V 50/60Hz	110/230V 50/60Hz	110/230V 50/60Hz	100-240V 50/60Hz
Electrical
Safety	EN 60601-1, Type
BF, Class I	EN60601-1; Type
BF, Class I	EN60601-1; Type
BF, Class I	EN 60601-1; Type BF,
Class I
Compliance
Standards	CE-Mark	CE Mark; EN ISO
13485	CE Mark; BS EN
9001; EN ISO
13485	CE Mark,
EN ISO 13485

Accessories: Probes

…

| Device | Predicate Device
Nerve Integrity
Monitor 3.0 with
accessories | Predicate Device
Neurosign Avalanche
Thyroid/EMG Motor
Nerve Monitor with
accessories | Predicate Device
Neurosign 400/800
Motor Nerve
Monitor with
accessories | Subject Device
C2 NerveMonitor
System with
accessories |
|---------------------------------------|------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Manufacturer | Medtronic Xomed | Magstim | Magstim | inomed
Medizintechnik
GmbH |
| 510(k) Number | K083124, K992869 | K083242 | K991583,
K980148, K964869 | N/A |
| Device Class
Product code
Probe | II
ETN, GWF
82-25401, 82-
25100 | II
ETN
3600-00, 3602-00 | II
ETN
3600-00, 3602-00 | II
GWF, ETN
522610, 522603,
522605, 525603,
525608 |
| Manner of
Stimulation | Electrical stimulation
via a probe | Electrical stimulation via a
probe | Electrical stimulation
via a probe | Electrical stimulation |
| Stimulation
Range | 0.01mA - 30mA | 0.05mA - 10mA | 0.05mA - 5mA | 0.01mA - 25mA |
| Stimulation
Type | Monophasic, square
pulse, duration 50-
250μs | Square wave, negative
edge, 200μs pulse width,
constant current | Square wave,
negative edge, 200μs
pulse width,
selectable from 100 to
500μs, constant
current, constant
voltage | Monophasic,
square pulse,
negative edge,
duration 200μs,
constant current |
| Stimulation
Frequency | 1Hz, 4Hz, 7Hz, 10Hz | 3 or 30Hz | 3 or 30Hz | 1 - 30Hz |
| Stimulation
Probes | monopolar, bipolar | monopolar, bipolar,
concentric | monopolar, bipolar,
concentric | bipolar, concentric |
| Probe design | - tool holder

touch proof | -tool holder
-touch proof connectors | -tool holder
touch proof | - tool holder
touch proof |

Section / Page 5-6

亿川b47

)

5

| Device | Predicate Device
Nerve Integrity
Monitor 3.0 with
accessories | Predicate Device
Neurosign Avalanche
Thyroid/EMG Motor
Nerve Monitor with
accessories | Predicate Device
Neurosign 400/800
Motor Nerve
Monitor with
accessories | Subject Device
C2 NerveMonitor
System with
accessories |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| | connectors

cable assembly | - cable assembly | connectors
cable assembly | connectors
cable assembly |
| Probe
Dimensions | - cable assembly
types: 1 / 64 mm
electrode
length | - 100 mm electrode
length | - 100 mm electrode
length | - cable assembly
types:
1/45/85/130 mm
electrode
length |
| | - types: 0.6/1.1 mm
diameter | - types: 0.4/0.6 mm tip
diameter | - types: 0.4/0.6 mm
tip diameter | - types:
0.4/0.5/0.65/1.4
mm diameter
-angled |
| Tip Geometry | - fork electrode,
round tip, angled
bayonet type | - hemispherical tip,
bull's eye electrode,
straight, blunt tip | - hemispherical tip,
bull's eye electrode,
straight, blunt tip | - fork electrode,
hemispherical tip,
bull's eye
electrode, straight,
blunt tip round tip,
angled bayonet
type, straight, blunt
tip |
| Patient
contacting
material | - stainless steel | - stainless steel | - stainless steel | - stainless steel |
| Insulation
Material | Polypropylene | Polypropylene | Polypropylene | Polypropylene |
| Electrical
Insulation | Electrical insulation
on all surfaces not
intended to provide
electrical contact with
the patient | Electrical insulation on all
surfaces not intended to
provide electrical contact
with the patient | Electrical insulation
on all surfaces not
intended to provide
electrical contact with
the patient | Electrical
insulation on all
surfaces not
intended to provide
electrical contact
with the patient |
| Accessories: Electrodes | | | | |
| Device | Predicate Device
Nerve Integrity
Monitor 3.0 with
accessories | Predicate Device
Neurosign Avalanche
Thyroid/EMG Motor
Nerve Monitor with
accessories | Predicate Device
Neurosign 400/800
Motor Nerve
Monitor with
accessories | Subject Device
C2 NerveMonitor
System with
accessories |
| Manufacturer | Medtronic Xomed | Magstim | Magstim | inomed
Medizintechnik
GmbH |
| 510(k) Number | - | K083242 | K991583,
K980148, K964869 | N/A |
| Device Class | - | II | II | II |
| Product code
Electrodes | - | ETN
1699-00, 1705-00 | ETN
1699-00, 1705-00 | GWF, ETN
530626, 530627,
530666 |
| 510(k) Number | - | K083242 | K991583,
K980148, K964869 | To be defined |
| Electrode type | - | needle electrodes | needle electrodes | needle electrodes |
| Electrode
design | - | - tool holder
-touch proof connectors
cable assembly | - tool holder
-touch proof connectors
cable assembly | -PP tool holder
-touch proof connectors
cable assembly |
| Probe
Dimensions | - | - needle 20 mm
0.45 mm diameter | - needle 20 mm
0.45 mm diameter | - needle 15/20 mm
0.45/5 mm
diameter |
| Geometry | - | - straight, needle tip | - straight, needle tip | - handle 20 mm
straight,
45° angled
electrode, ground
electrode straight,
needle tip |
| Patient
contacting
material | - | - stainless steel | - stainless steel | - stainless steel |
| Insulation
Material | - | Polypropylene | Polypropylene | Polypropylene |
| Electrical
insulation | - | Electrical insulation on all
surfaces not intended to
provide electrical contact
with the patient | Electrical insulation
on all surfaces not
intended to provide
electrical contact
with the patient | Electrical insulation
on all surfaces not
intended to provide
electrical contact
with the patient |

. Section / Page 5-7

K111647

6

Accessories: Electrodes

Section / Page 5-8 从111647

7

NONCLINICAL AND CLINICAL TEST

807.92(b)

SAFETY and EFFECTIVENESS

Preclinical testing verified the design of this device and that all specified requirements were fulfilled. The C2 NerveMonitor and all corresponding accessories are similar in their risks and benefits, as well as their manner of performance, to the predicate devices listed.

CONCLUSION

807.92(b)(3)

The C2 NerveMonitor System with accessories are similar to the predicate devices in part or in whole in:

. intended use, .
materials and .
technological characteristics .

The C2 NerveMonitor System introduces no new questions concerning safety and efficacy.

Section / Page 5-9

8

Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved strokes.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Inomed Medizintechnik GMBH c/o Mr. Saschka Busch IM Hausgruen 29 Emmendingen Germany 79312

6 2311 ೧೮೯

Re: K111647

Trade/Device Name: C2 NerveMonitor System Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked Response Electrical Stimulator Regulatory Class: Class II Product Code: GWF, ETN Dated: August 30, 2011 Received: September 2, 2011

Dear Mr. Busch:

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

9

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set device-related adverse overlis) (21 CFR Part 820); and if applicable, the electronic forum in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you desire specific davide to: your von vernices/CDRH/CDRHOffices/usm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part nove the regardions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Tou may obtain other generers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Ru. Then. h

Malvina B. Eydelman, Ma Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

10

Indications for Use Statement

510(k) Number (if known): K | | | | 247

Device Name: C2 NerveMonitor System with accessories

Indications for Use:

The C2 NerveMonitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery, including spinal cord and spinal nerve roots. The C2 NerveMonitor device with the integrated user interface is only allowed for the surveillance, documentation and functional test of motor nerves. It can be used as an additional helping tool during surgical procedures for diagnostic issues. Its basic functions are similar to those of an EMG diagnostic device

Indications for C2 NerveMonitor System Monitoring Procedures include:

Intracranial, Extracranial, Intratemporal, Extratemporal, Neck Dissections, Thoracic Surgeries, and Upper and Lower Extremities.

Indications for C2 NerveMonitor System monitoring of Spinal procedures include:

Degenerative Treatments, Pedicle Screw Procedures, Fusion Cages, Rhizotomy, Orthopedic Surgery, Open and Percutaneous Lumbar and Cervical Procedures and Thoracic Surgical Procedures.

The system is not intended for monitoring life preserving functions.

The system may not be used for diagnosing brain death.

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation

Prescription Use
(Per 21 CFR 801.109)

(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K111647

Section / Page 4-2